A comparison between two paradigms of clinical reasoning within the osteopathic profession: an Evidence-Based Practice model vs a Complexity model Which paradigm is more suitable for the practice of traditional osteopathy? Kevin Fairfield

OCTOBER 2012 Thesis presented to an international jury

 

 

Thesis advisor

Eric Sanderson DOMP

 

Acknowledgements

I would like to thank all the contributors throughout this process:

• I dedicate this osteopathic journey to my hero, my father Ian Fairfield, who passed away in

the middle of the program. Your guidance and inspiration will never be forgotten.

• Many thanks to Mr. Eric Sanderson, my thesis advisor, for all of his precious time,

valuable input and thorough direction; your feedback is always greatly appreciated.

• Mr. Guy Voyer, the pedagogical director at the Académie Sutherland d’Ostéopathie du

Québec. He has been instrumental as a mentor in my professional life and his

paradigm of complex thinking has taught me a lifelong lesson in healing. I will always be

grateful for meeting you.

• Mr. John Winkels, editor of this memoir. John is a good friend who appreciates the

complexities of the English language.

• Mr. Sam Gibbs, for his guidance and for introducing me to Mr. Max Girardin, D.O., who

devotes his life to complexity thinking and living.

• Mr. John D’Aguanno and Mr. Craig Harness, for all those late night osteopathic

philosophy sessions and sharing of resource material.

• Last but not least, my beautiful wife Alexandra and my two wonderful children, Alexa and

Justin whom inspire me more each and every day. Words can neither adequately describe

my love for you nor express my gratitude for your constant patience in my journey with

life-long learning.

 

Table of Contents ABSTRACT (ENGLISH) RESEARCH QUESTION (ENGLISH) RÉSUMÉ (FRANCAIS) OBJET DE LA RECHERCHÉ (FRANCAIS)

i ii iii iv

Chapter 1: Introduction 1

1.1. The Foundation of critical thinking in physiotherapy……………………………… 1.2. Hypothetical case scenario in problem-based tutorials…………………………….. 1.3. The next chapter in critical thinking – The journey in osteopathy………………… 1.4. Definition in both paradigms……………………………………………………….

2 3 4 5

Chapter 2: Methodology 10

2.1. Foundation…………………………………………………………………………….. 2.2. Qualitative methods to answer the research question………………………………….

2.2.1 Grounded Theory……………………………………………………………. 2.2.2 Phenomenology……………………………………………………………… 2.2.3 Historical…………………………………………………………………….. 2.2.4 Appropriateness of study design…………………………………………….. 2.2.5 Document review……………………………………………………………. 2.2.6 Immersion & Crystallization…………………………………………………

2.3. Qualitative Methodological Terminology…………………………………………….. 2.3.1 Saturation and Data collection………………………………………………. 2.3.2 Sampling…………………………………………………………………….. 2.3.3 Transparency………………………………………………………………… 2.3.4 Bias………………………………………………………………………….. 2.3.5 Data coding / Analytical rigour……………………………………………… 2.3.6 Overall rigour………………………………………………………………..

11 12 12 12 13 14 14 15 15 16 16 17 17 18

Chapter 3: Evidence-Based Medicine Paradigm 19

3.1 Evidence-Based Practice (EBM) Paradigm………………………………………….. 3.1.1 The definition of Evidence-Based Medicine………………………………… 3.1.2 The history of Evidence-Based Medicine…………………………………… 3.1.3 Alternative definition of EBM………………………………………………

3.2 Quantitative and Qualitative research methods………………………………………. 3.2.1 Levels of evidence: The hierarchy of evidence………………………………

3.3 The introduction of EBM in the academic curriculum……………………………... 3.4 The strengths of EBM………………………………………………………………. 3.5 The weaknesses of EBM…………………………………………………………… 3.6 Challenging the powers that be……………………………………………………... 3.7 Conclusions regarding EBM and osteopathy………………………………………..

20 21 22 23 24 26 30 31 34 39 41

12

 

 

Chapter 4: Complexity and the Scientific Revolution. Where does osteopathy fit in? 47

Complexity and the Scientific Revolution………………………………………………….. 4.2 Introduction to the roots of the Complexity movement…………………………... 4.3 The Scientific Revolution – The shift in the scientific paradigm of reasoning……

4.3.1 The world according to Darwin…………………………………………. 4.4 Definition of modern science……………………………………………………... 4.5 Three eras of science in medicine………………………………………………… 4.6 Fundamental principles of osteopathy: Understanding its traditional beliefs……

4.6.1 The prominence of diagnosis in osteopathy…………………………….. 4.6.2 Osteopathy’s role in the future of the medical world…………………….

4.7 Order and disorder………………………………………………………………… 4.8 Edgar Morin – “The Godfather of Complexity”…………………………………..

4.8.1 “Blind Intelligence”……………………………………………………… 4.8.2 Complexity and self-organization……………………………………….. 4.8.3 The paradigmatic turning point………………………………………….. 4.8.4 Emergence and self-organization………………………………………... 4.8.5 Principle of Disjunction…………………………………………………..

4.9 Holism……………………………………………………………………………. 4.10 Fragmentability…………………………………………………………………... 4.11 Information-feedback system……………………………………………………. 4.12 Open systems versus closed systems…………………………………………….. 4.13 Resilience………………………………………………………………………… 4.14 Robustness………………………………………………………………………... 4.15 Hierarchical systems……………………………………………………………... 4.16 Entropy…………………………………………………………………………… 4.17 Ambiguity………………………………………………………………………... 4.18 Attractors…………………………………………………………………………. 4.19 Linear minds in a non-linear world………………………………………………. 4.20 Complexity and clinical knowledge……………………………………………… 4.21 Suggestions for Complexity research methods…………………………………... 4.22 Summary of Complexity systems………………………………………………... 4.23 The 10 Principles of Complexity and how they relate to the osteopathic

profession………………………………………………………………………… 4.24 Osteopathic research……………………………………………………………... 4.25 Study design……………………………………………………………………… 4.26 Osteopathic education…………………………………………………………….

48 49 50 54 55 56 58 58 59 60 61 63 65 65 68 69 69 70 70 70 70 71 71 71 72 72 73 73 74 77 77 79 80 83    

 

Chapter 5: Comparing EBM and Complexity models of low back pain 85

5.1 Appendix A – Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials 5.1.1 Critical appraisal checklist for systematic reviews………………………

5.2 Understanding osteopathic philosophy and reasoning and applying it in clinical practice…………………………………………………………………………...

5.3 Osteopathic reasoning using a Complexity paradigm of thinking for patients with low back pain………………………………………………………………………

5.3.1 Subjective assessment…………………………………………………… 5.3.2 Objective assessment…………………………………………………….. 5.3.3 Treatment of low back pain……………………………………………… 5.3.4 Conclusion………………………………………………………………..

86 88 89 89 90 90 91

Chapter 6: Conclusion 92

6.1 Conclusion…………………………………………………………………………. 6.2 What is the future of the Complexity movement?...................................................... 6.3 What is the future of osteopathy?.............................................................................. 6.4 Osteopathic instruction in schools…………………………………………………..

93 97 101 104

References 106

List of Tables, Figures & Appendices

1. Table 1A - Complication vs. Complexity terms…………………………………………. 2. Table 1B - Complication vs. Complexity definitions……………………………………. 3. Table 2 - Definitions of methodology terms used in Levels of Evidence Guidelines…… 4. Table 3 – Types of evidence……………………………………………………………... 5. Table 4 – Clinical Epidemiology Glossary………………………………………………. 6. Table 5 – Key features of a Complex System……………………………………………. 7. Figure 1 – Schematic review of polarization within the profession of osteopathy viewed

through the looking glass of the complex system theory………………………………… 8. Appendix A – Osteopathic manipulative treatment for low back pain: a systematic

review and meta-analysis of randomized controlled trials……………………………….

6 7 28 37 42 76 100 111

 i  

 

Abstract  

The supposition you are about to read compares two very distinct models of clinical and critical

reasoning as they apply to the profession and practice of osteopathy: an evidence-based practice

model and a complexity model. Both of these models, or paradigms, will be discussed in detail

throughout this document, including but not limited to their respective strengths and weaknesses,

as well any key terminology. The framework of this paper is presented as a traditional

qualitative thesis. The author feels that this style of monograph is best suited to outline this

scholarly topic. This paper holds true to the author’s journey within the medical field as a health

care professional. Having been exposed to both the evidence-based and complexity paradigms

within the disciplines of manual physiotherapy and osteopathy, the author strives to explore (or

examine) the possibility of co-existence between the two models. Is one approach more

applicable than the other to the practice of osteopathy and /or more relevant as they pertain to

improving overall patient health?

 ii  

Research question

A comparison between two paradigms of clinical reasoning within the osteopathic profession:

An Evidence-Based Practice model vs. a Complexity model.

Which paradigm is more suitable for the practice of traditional osteopathy?

 iii  

Résumé

L’hypothèse dont il sera question dans les présentes compare deux modèles très distincts de

raisonnement clinique et critique applicable à la profession et à la pratique ostéopathiques, soient

un modèle de pratique factuelle et un modèle de complexité. Les définitions de tous les

principaux termes ainsi que les avantages et désavantages de chacun des modèles, ou

paradigmes, seront exposés. Le présent document consiste en une thèse qualitative classique.

L’auteur estime que ce style de monographie est la meilleure méthodologie pour traiter de ce

sujet érudit. Le présent mémoire reflète étroitement le cheminement de l’auteur dans le domaine

médical, à titre de professionnel de la santé. Ayant observé les deux paradigmes, soit celui de

pratique factuelle et du modèle de complexité, dans la pratique de l’ostéopathie et de la

physiothérapie manuelle, l’auteur explore (ou examine) la possibilité de la coexistence de ces

deux modèles. Une de ces approches convient-elle davantage à la pratique de l’ostéopathie et/ou

est-elle plus appropriée pour améliorer la santé des patients dans l’ensemble?

 iv  

Objet de la recherché

Comparaison de deux paradigmes de raisonnement clinique au sein de la profession

ostéopathique :

modèle de pratique factuelle vs modèle de complexité.

Quel paradigme est le mieux adapté à la pratique de l’ostéopathie traditionnelle?

1  

 

Chapter 1: Introduction _____________________________________________________________________________

2  

 

1.1 The foundation of critical thinking in Physiotherapy

The author’s journey began 15 years ago upon acceptance into the Bachelor of Health Sciences

in Physiotherapy program at McMaster University (1997). McMaster is world-renowned for the

distinctive teaching and learning environments within its various medical disciplines, including

the field of physical medicine. The traditional pedagogical approach to learning offered at

McMaster was not a lecture format, but rather a tutorial- and problem-based learning forum

whereby individual students became independent learners of the science of medicine. This

revolutionary approach allowed for the emergence of discussion and thought provoking ideas to

be shared amongst fellow classmates and colleagues within small group settings. This model of

independent study highlighted the complexity of progressive thinking and challenged traditional

modes of how medicine is taught and carried forward through practice.

Throughout the author’s physiotherapy training at McMaster, he was introduced to the

philosophy of evidence-based practice/medicine (EBP / EBM) and its importance in cultivating

the decision-making process for practicing clinicians. With the information age rapidly emerging

in the late 90s, McMaster University was an academic front-runner that recognized the necessity

of equipping medical practitioners and teachers with both well-designed resources and the

conceptual tools necessary to harness them.1 An emerging biomedical informatics community at

McMaster spawned the field of clinical epidemiology, under the leadership of one David Sackett. 2 The adopted research-driven approach to thinking taught students not only how to critically

appraise one’s findings, but also how to integrate the research and have it shape one’s final

decisions for patient care. Ultimately, students were taught that this was the only way to think.

In a sense, one was indoctrinated to think that the EBM paradigm was superior to other methods

when making critical decisions in physical medicine. The author embraced this paradigm of

thought, learning extensively over a continuous 24-month program of academics and clinical

placements. However, throughout the author’s educational endeavours, he questioned the

process of evidence-based practice and its application towards individual patient-therapist

interaction. To clarify how evidence-based practice was used to definitively summarize

                                                                                                                         1  Covell, D.G. et al., as quoted in Wyer, P.C., & Silva, S.A. Where is the wisdom? I – A conceptual history of

evidence-based medicine. Journal of Evaluation in Clinical Practice, 15 (2009) 893. 2 Covell, D.G. et al., as quoted in Wyer & Silva, Where is the wisdom? 893.  

3  

 

intervention strategies, the author will give the reader a quick glimpse into a typical problem-

based tutorial session.

1.2 Hypothetical case scenario in problem-based tutorials

A hypothetical case scenario was provided to a group of six or seven students, depending on the

segmentalized unit of study of the body (i.e. in orthopaedics, a low back pain case study would

be provided including the typical mechanism of injury and the patient’s health history). The

students were expected to independently study the subject in terms of anatomy and physiology

and conduct the necessary research to determine what the evidence would conclude about the

treatment intervention for the patient. The learning process was enlightening and the author

flourished in this group dynamic. However, some of the conclusions extrapolated within this

study format, specific to how the systems of the body were covered, were problematic.

First and foremost, the concept of the body’s ‘wholeness’ – being more than the sum of its parts

– was not integrated within this model of physiotherapy. Orthopaedic problems were addressed

using only orthopaedic solutions (the only approach offered in classical allopathic medicine).

The interrelationships of the body’s systems, including their unique influence on each other,

were not even considered or discussed. For example, a comparison of the patients’ symptoms to

their overall mechanical and fluidic status was not even a concept given consideration. Linking

the muscular, vascular, fascial, skeletal and neurological components that could potentially

influence the outcome of the problem was not fully explored /examined. As for the evidence-

based research role in each scenario, the abundance of documentation was more than

satisfactory, however, the conclusions drawn by the research were neither categorical nor did

they provide direction for the clinical practitioner. More often than not, the research lacked

definitive solutions, typically concluding with the predictable “more research is necessary”.

Much of what is taught in both physiotherapy school and the manual therapy community is based

upon the evidence-based practice paradigm, in order to ultimately achieve acceptance in the eyes

of the medical system as a whole. Many facets of allopathic and alternative medicine streams

focus on proving their very existence in an attempt to validate their professional territory. It is

this powerful validation process that drives health care professionals to perform high-level

research and then communicate their findings to clinical practitioners, all in an attempt to

4  

 

improve clinical outcomes with patients. It is the author’s opinion that many who follow this

model wholeheartedly believe it is the only way to achieve the best success with clients. The

author himself was formerly one of these advocates, that is until he was introduced to the

traditional practice of osteopathic medicine and the teachings of Guy Voyer D.O.. Voyer

introduced the author to the complexity paradigm of thinking and its applications to the human

body and the world around us.

1.3 The next chapter in critical thinking – The journey in osteopathy

Over nine years ago, the author began a journey into the field of osteopathic medicine with the

Sutherland Academy of Osteopathy and the Académie Sutherland d’Ostéopathie du Québec,

with the intentions of building his clinical knowledge and level of expertise. That goal was

fulfilled and, to the author’s surprise, his entire approach to assessment, treatment and

knowledge of the complexities of the human body and spirit were enhanced dramatically. This

emergence of another level of comprehension is an extremely satisfying and humbling

experience.

It is this fundamental change in thinking, this shift in paradigm, that led the author to explore the

topic of his thesis and document the distinctive differences between the complexity and

evidence-based models and how they have helped shape the author’s professional and personal

life.

1.4 Definitions in both paradigms

The author would like to take this opportunity to provide some meaningful definitions of the

terminology that helped determine the framework of this paper.

Paradigm: A philosophical and theoretical framework of a scientific school or discipline within

which theories, laws and generalizations, and the experiments performed in support of them are

formulated; broadly: a philosophical or theoretical framework of any kind.3

                                                                                                                         3 Meriam-Webster On-Line Dictionary. An Encyclopaedia Britannica Co, 2012.

5  

 

Evidence-Based Medicine: The conscientious, explicit and judicious use of current best

evidence in making decisions about the care of individual patients.4

Complexity: Something complex; the quality or state of being complex.5

Complex: Consisting of interconnected or interwoven parts.6

Complexus: This original Latin word signifies entwined.7

Within the first few lectures on the history and tradition of osteopathy at the Sutherland

Academy, the author was introduced to the philosophical differences between allopathic medical

thinking and osteopathic reasoning. A 1-page hand-out distributed to the students would

eventually help to change the author’s clinical decision-making skills, in addition to the depth

and breadth of his respect for human existence. The following is a copy of the handout that was

distributed to the class, outlining several terms in a comparative format (Table 1A). Table

1Bfollows, providing definitions for the terms in Table 1A.

                                                                                                                         4 Sackett D. Evidence based medicine: what it is and what it isn’t. BMJ; 312 (Jan 1996): 312, 71-72.  5 Merriam-Webster On-Line Dictionary, 2012. 6 Merriam-Webster On-Line Dictionary, 2012.  7    Merriam-Webster On-Line Dictionary, 2012.

6  

 

Table 1A

Terms: Complication vs. Complexity

Complication vs. Complexity

Linear Interactive

Procedure Process

Dialectic Dialogue

Analytical Sense/Meaning

Definition How/Emergence

Repetition Synthesis

Prediction Turbulence

Program Objective/Goal

Control/Reference Relative/Reference

Integration Appropriation

Instruction Education

Absolute Possible

Probable Potential

Production Service

Repetition Rituals

Closed Open

Year 1 handout 1994 – Sutherland Academy of Osteopathy (Guy Voyer D.O.)

7  

 

Table 1B

Definitions: Complication vs. Complexity

COMPLICATION

Terms Definitions

Linear Involving a single dimension; of the first degree with respect to one or more variables.

Procedure A series of steps followed in a regular definitive order; traditional or established way of doing things.

Dialectic

Discussion and reasoning by dialogue as a method of intellectual investigation; the logic of fallacy; any systematic reasoning, exposition or argument that juxtaposes contradictory or opposed ideas and usually seeks to resolve their conflicts.

Analytical Separating something into component parts or constituent elements.

Definition

A statement expressing the essential nature of something; sharp demarcation of outlines or limits.

Repetition The act or an instance of repeating or being repeated.

Prediction The act of predicting: forecast.

Program An outline of the order to be followed; a sequence of coded instructions.

Control/ Reference To check, test or verify by evidence or experiments; to have power over: RULE. Consultation of sources of information.

Integration The operation of finding a function that has a known differential.

Instruction A direction calling for compliance; an outline or manual of technical procedure.

Absolute Being governed by or characteristic of a ruler or authority.

Probable Supported by evidence strong enough to establish presumption but not proof.

Production Something not specifically designed or customized and usually mass-produced.

Closed Not open; rigidly excluding outside influence.  

8  

 

COMPLEXITY

Terms Definitions

Interactive Mutually or reciprocally active; a two-way communication system.

Process A continuing natural or biological activity or function.

Dialogue An exchange between people.

Sense / Meaning

Conscious awareness or perception; specialized function or mechanism by which one receives and responds to external or internal stimuli. Something intended.

How / Emergence In what manner or way: to what degree or extent. To become manifest; to rise from; to come into being through evolution.

Synthesis The composition or combination of parts or elements so as to form a whole.

Turbulence Great commotion or agitation; causing disturbance.

Objective / Goal

Involving or deriving from sense perception or experience with actual objects, conditions or phenomenon. The end towards which effort is directed.

Relative / Reference A thing having a relation to or connection with or necessary dependence on another thing. Consultation of sources of information.

Appropriation The act of getting something for a specific use or purpose.

Education

The field of study that deals mainly with methods of teaching and learning in schools.

Possible Being within the limits of ability, capacity or realization.

Potential Existing in possibility; capable of development into actuality.

Service Contribution to the welfare of others; the work performed by one that serves: a helpful act.

Rituals An act or series of acts regularly repeated in a set precise manner.

Open Have no enclosing or confining barrier: accessible on all or nearly all sides.

8

                                                                                                                         8  Merriam-­‐Webster On-Line Dictionary, 2012.  

9  

 

Once the author internalized what was being said, even though it challenged his deeply

ingrained beliefs in the structured scientific thought process, he began to gradually change

his paradigm of thinking (both subjectively and objectively) when assessing patients. The

author started to observe and understand the human body in its wholeness, not the sum of its

parts. This statement sounds simple enough to integrate into clinical scenarios and many

health care professional would agree with the statement, however it allowed the author to

better appreciate the anatomical and physiological interrelationship of the eleven systems that

make up the human body (skeletal, muscular, fascial, cardiovascular, neurological,

respiratory, reproductive, hormonal, integumentary, immune and lymphatic systems). These

‘systems’ epitomize the complexity of the human body, its “container and contents” and the

means by which everything is enveloped in one functional system designed for dynamic

mobility, motility and stability. Together this mechanical and fluidic masterpiece is under

constant demands whereby adaptation and continual change are part of every moment and

experience. All of these systems of the body are working together in unison to maintain

optimal health and free oneself from disease. The human body has an amazing ability to heal

itself from the invasion of disease if given the chance; the right health care professional can

aid in the facilitation and governance of structure and function to compliment the body’s

natural ability.

10  

 

Chapter 2: Methodology

_____________________________________________________________________________

11  

 

2.1 Foundation

It was approximately two years ago when the author began thinking about the thesis process.

After much consideration, a research question was formulated: A comparison between two

paradigms of clinical reasoning within the osteopathic profession: An Evidence-Based Practice

model vs. A Complexity model. Which paradigm that is more suitable for the practice of

traditional osteopathy? The author wanted to capitalize on his experience learning these two

distinct concepts of thinking and to collectively compare and contrast them using a qualitative

format specific to the osteopathic field of study and clinical practice.

Two key methods typically predominate in the medical community with regards to research

driven protocols: the dominant positivism/quantitative movement and the interpretivism/

qualitative movement. For the purpose of this thesis, the interpretivism method was the obvious

choice to pursue because, for the traditional osteopathic practitioner, it offers a meaningful way

to gain insight by improving and redefining one’s comprehension of the body’s totality.

Qualitative research explores richness, depth and complexity of phenomenon. It is a method of

research that osteopaths can both understand and live by since its findings are not discovered by

means of statistical procedures and calculable measures.9 Qualitative research embraces the

belief that there is neither one truth, nor one consensus, that is necessarily achievable or an

essential goal. 10

Once the research question and general abstract was developed and approved, the author selected

Mr. Eric Sanderson, Osteopathic Manual Practitioner (DOMP) as a thesis advisor.

Collaboratively, the author and Mr. Sanderson began to quickly develop some of the core ideas

and concepts and potential research options. Once this initial step was complete, the next steps

were to determine the study design and to begin gathering data.

                                                                                                                         9  Strauss, A. & Corbin, J. Basics of qualitative research: General Theory procedures and techniques.

Newbury Park, CA: Sage Publication Inc. (1990), 17. 10  Johnson, R., & Waterfield, J. Making words count: the value of qualitative research. Physiotherapy

Research International, 9(3) 2004, 122.

 

12  

 

2.2 Qualitative methods to answer the research question

2.2.1 Grounded Theory

The Grounded Theory method of qualitative study design captures the essence of this paper. It is

an emergent design, dependent on continuous data analysis.11 The first full year of this thesis

endeavour involved the ongoing collection of research articles and books about EBM and

Complexity. It was a judicious process of gathering, scrutinizing and organizing information

specific to the primary research question of this thesis.

2.2.2 Phenomenology

Phenomenology answers the question “What is it like to have a certain experience?” It seeks to

understand the phenomenon of a lived experience.12 The educational experience is the very

reason why the author selected this path. The author has had the luxury of being exposed to two

very different and distinctive paradigms of thought. While the author embraced the EBM

approach early on in his health care career as a physiotherapist, more recently the author has

adopted the Complexity approach in his apprenticeship as an osteopath. The author feels that his

first-hand experience with these two phenomena has provided a solid foundation that enables

him to share meaningful knowledge and opinions, and determine a viable / successful path that

one can take within the science of osteopathy.

2.2.3 Historical

The Historical method is “a systematic collection and objective evaluation of data related to past

occurrences in order to test hypotheses concerning causes, effects, or trends of these events that

may help to explain present events and anticipate future events”.13 This quote defines the

evolution of both theories (EBM and Complexity) and their applicability to the science and art of

osteopathy. Some practitioners rely on the evidence-based research approach to navigate their

critical thinking skills, while others rely on the entrenched foundations of clinical intuition and

complexity thinking.                                                                                                                          11 Letts, L. et al. Guidelines for Critical Review Form: Qualitative Studies (Version 2.0) 2007, 3. 12 Letts, 2-3.  13  Gay, L.R. Analysis of Professional Literature Class 6 – Qualitative Research I. Education Research (5th Edition).

(New Jersey: Prentice Hall Inc, 1996), 2-3.  

13  

 

The author is of the opinion that this qualitative thesis offers a unique combination of the

Grounded theory, Phenomenology and Historical research design methods. Collectively, these

methods encapsulate deeply engrained beliefs and attitudes towards structured wisdom

concerning human nature, our existence and ultimately our survival within the universe.

2.2.4 Appropriateness of study design

This section questions the congruency of qualitative research based on an accepted definition of

‘appropriateness’, as identified by Letts et al.

1. The researcher expresses an interest in a point of view.14 For the purposes of this thesis,

this is the struggle between distinct methods of clinical reasoning in the osteopathic

profession: an EBM model of reasoning versus a Complexity Model of reasoning. Is one

method a superior, more relevant form of thinking for the traditional osteopath?

2. The researcher is seeking meaning and understanding via narrative form.15 This thesis

presents a detailed account of the history of both EBM and Complexity models and their

evolution in the decision-making realm of manual osteopathic medicine.

3. Seeks information from people who are experiencing or involved in the issue.16 The

author sought out the opinions of his physiotherapy colleagues (Mr. Alan Tram, MPT,

Mrs. Olga Boers, MPT) with regards to the most current EBM studies and trends. In

addition, the author gathered the opinions and received guidance from osteopathic

colleagues (Mr. Guy Voyer, D.O., Mr. Eric Sanderson, DOMP, Mr. Sam Gibbs, DOMP

and Mr. Max Girardin, D.O.) with regards to the Complexity material.

4. Qualitative research is oriented towards theory construction and the reasoning behind the

data analysis is inductive – the findings emerge from the data.17 The objective of this

thesis is to literally de-construct the most current and accepted research pertaining to both

paradigms of thought and to assess the relevance of each model to osteopathy in the 21st

century.

                                                                                                                         14 Letts, 4. 15 Letts, 4. 16 Letts, 4. 17 Letts, 4.  

14  

 

2.2.5 Document review

Document review is a flexible, open method by which the study and analysis of data (past and

present) help to provide the best way to answer the research question. It is a method that

requires the researcher to enter into an in-depth learning process to become a critical editor of all

necessary materials.18 This document review was accomplished through the rigorous application

of a variety of research strategies for the purpose of gathering a wide range of facts and figures

concerning EBM and Complexity. A literature review was performed using a variety of online

searches, while research pertaining to the topics of osteopathy, EBM and the complexity model

was gathered via a variety of university library resources. There was an abundance of published

material available on all of the topics listed above. The author attempted to focus his research

efforts, by utilizing some key search terms including, but not limited to:

• Evidence-Based Practice.

• Evidence-Based Medicine.

• Osteopathy and Evidence-Based Medicine.

• Complexity thinking.

• Osteopathy and Complexity.

• History of EBM.

• History of Complexity theory.

2.2.6 Immersion and Crystallization

The terms ‘immersion’ and ‘crystallization’ identify how one engages and applies oneself to the

research process: the collection, examination and interpretation of concrete material and data. In

the case of this thesis, it involves the scrupulous identification of common research patterns and

the amalgamation of all of the information pertaining to EBM and complexity. If one wants to

be true to their research question (in this case the two paradigms of critical reasoning), then all of

the gathered knowledge must be applicable, substantiated and reflect the way an osteopath thinks

and reasons about administering patient care. Upon collecting all of the relevant data, it became

clear that there is a strong movement within the osteopathic profession supporting the “validation

of therapy and treatment”. Osteopathy is following in the footsteps of many other healthcare                                                                                                                          18 Letts, 6.

15  

 

disciplines and the “supremacy of EBM” is one of the driving forces behind its conversion.

EBM is a paradigm designed to streamline “best practices” with reproducible results for the

masses. However, for the traditional osteopath, the application of both complexity theory and

reasoning in conjunction with EBM does appear to offer a complementary marriage, which can

help the profession flourish. An abundance of information is readily available, which explicitly

details the cohesiveness between complexity, osteopathy and patient-centered care. However,

one must answer the question “Is this competing paradigm socially acceptable in the 21st century,

an age of quantifiable medicine?”

2.3 Qualitative Methodological Terminology

2.3.1 Saturation and Data collection

When one is collecting data to satisfy a research question, saturation or duplication of material is

an important principle to consider to ensure that a thorough and exhaustive search has been

completed. For this thesis, a significant amount of data was collected. The utilization of

different methods for collecting similar data findings was accomplished via synthesized, filtered

and unfiltered sources. Examples of synthesized material sources included clinical practice

guidelines, and a variety of osteopathic publications and reference materials. Filtered sources

included systematic reviews, Meta-analysis, and a variety of critically-appraised articles. Lastly,

unfiltered sources used included the Google Scholar index and MEDLINE citations, abstracts,

journals and news sources. All efforts were made to ensure triangulation of data sampling and

information for maximum reassurance, validation and reliability (since no statistical analysis is

provided in this thesis regarding the author’s research strategies).

In addition to all of the published sources that were researched, compared and considered, peers

and professional colleagues were consulted for additional research ideas. Mr. Eric Sanderson

(thesis advisor), Mr. Guy Voyer (pedagogical director at the Académie Sutherland d’Ostéopathie

du Québec) Mr. Sam Gibbs (DOMP), Mr. Max Girardin (D.O.) and Mr. Craig Harness

(classmate) were the most influential participants throughout this process. The triangulation of

information stimulated interaction and dialogue that increased comprehension and overall

understanding regarding the research question.

16  

 

2.3.2 Sampling

In qualitative research, sample strategies do not seek to achieve statistical representativeness but

must be sufficient enough to generate depth of information. In order to achieve this, purposeful

sampling was done deliberately to select information-rich research that will give rise to data

relevant to the research aims.19 To accomplish this objective of purposeful sampling, most of the

EBM history and foundation material was extrapolated from physiotherapy and osteopathic

journals. As for the complexity content and research, the majority of the historical and current

perspectives came from sources that address the relevance of the complexity model as it pertains

to human subsistence and health. In addition, other journals were used, which challenged the

dominance of EBM philosophies.

2.3.3 Transparency

When gathering material for a thesis, one of the main objectives in a qualitative paper is to allow

readers the opportunity to follow the same guidelines and methodology, access the same

resources, and to see if they arrive at the same conclusions as the author. This is the format of

transparency, whereby all data is readily available and the steps for a given monograph are

outlined. The author of this thesis feels that he is in a unique position, having been exposed to

both paradigms/schools of thought (EBM and complexity). Therefore, the research can be used

as an “instrument” whereby one’s own experiences are a primary tool for data collection.

Documentation of the researcher’s credentials and previous experience (as outlined in the

introduction of this thesis) should lend substantiation to the conclusions drawn in the thesis and

increase the reader’s confidence in the process.20

Transparency can be a challenge even for the osteopathic practitioner who has diligently

followed a single path of reasoning throughout their academic and practical career; and in

today’s medical climate, the biomedical and epidemiological dominance has pushed for this

transparency in the form of EBM. However, an understanding of the depth and breadth of

complexity science and how it applies to the osteopathic method of promoting and augmenting

                                                                                                                         19 Johnson & Waterfield, 124. 20 Letts, 8.

17  

 

human healing, might be the only avenue that challenges the “power of validation” controlled by

the EBM approach.

2.3.4 Bias

It has been outlined throughout this paper that one of the strengths of a qualitative thesis is that it

allows for interpretation and creativity in its formulation and inferences. Yet another advantage

is the bias factor - the identification of assumptions and biases of the researcher. It is more

acceptable in a qualitative analysis than in a quantitative one. Given that the author has been

trained under the EBM model as a physiotherapist and the complexity model as an osteopathic

manual practitioner, certain biases are understood and accepted. This declaration is outlined in

this thesis and the researcher’s views about both phenomena are explicit.21

2.3.5 Data coding / Analytical rigour

Data Coding, also known as ‘analytical rigour’, is a method by which all the information

gathered is organized and logically synthesized into ideas and thoughts on paper. Categorization

is an important step of this method and fulfilled by creating multiple meaningful sections that

facilitate the understanding of the reader while forming the essential body of the thesis. In this

thesis, the segments were arranged as follows:

• Introduction to EBM and physiotherapy.

• Introduction to Complexity and osteopathy.

• History and evolution of EBM and reductionism.

• History and evolution of Complexity science.

• Clinical example of EBM – Meta-analysis of RCTs and critical appraisal.

• Clinical example of Complexity reasoning and osteopathy.

• Conclusion - what is the foreseeable future for osteopathy?

                                                                                                                         21 Letts, 8.

18  

 

2.3.6 Overall rigour

While quantitative research embraces concepts such as validity and reliability, qualitative

research covets a different form of terminology, namely the four components of trustworthiness

(which ensure the quality of the findings and increase the reader’s confidence in those

findings).22 The four components of trustworthiness are outlined here:

Credibility: Collecting data over a prolonged period of time. In this case, information was

gathered over a two year period (Jan 2010 to present). A variety of research methods were used

to ensure triangulation and reduce bias. Research for this thesis included: books, journals,

university databases, multiple online search engines, professional healthcare colleagues and

instructors.

Transferability: Can the findings from this paper be transferred to other situations? The EBM

and Complexity paradigms are major topics of discussion within all disciplines of health care,

not just osteopathy. For both paradigms, the ultimate goal is to have a tool that will assist in

clinical decision-making abilities as they pertain to patient health.

Dependability: Outlines the consistency between the information gathered and the conclusions

drawn. The author’s intention is to bring to light the debate between EBM and Complexity and

their defining roles within the field of osteopathy. While one is more entrenched in the tapestry

of medicine (EBM) the question still remains “Can both paradigms co-exist? And if so, at what

level?”

Confirmability: Involves maintaining a neutral and bias-free thesis presentation. The author of

this thesis has been exposed to both paradigms of thought and has attempted to challenge the

EBM proponents with a different viewpoint, one that compels us to contemplate the question

“Are we following the methodology best suited to enhance patient care and ultimately heal our

clients.”

                                                                                                                         22 Letts, 9.

19  

 

Chapter 3: Evidence-Based Medicine Paradigm

______________________________________________________________________________

20  

 

3.1 Evidence-Based Practice (EBM) Paradigm

For an osteopath to successfully conceptualize the systems approach to assessing, diagnosing and

treating the human body, mind and spirit, it is integral to understand that the “whole is greater

than the sum of its parts”. The ultimate goal for any osteopathic clinician is to have a

comprehensive, well-rounded knowledge base when it comes to anatomy, physiology, pathology

and other key tools to proficiently apply that knowledge to each and every individual patient

scenario within the clinical setting.

A topic of much heated debate within the osteopathic ‘community’ is whether professional

expertise alone is sufficient in order to continually achieve optimal success over one’s clinical

lifetime. Traditional osteopaths that view the body in terms of its complexity and emergence

will respond with a resounding “Yes!” However, there are many other health care professionals

practicing the art of osteopathy that would disagree and take a less conventional stance. They

would argue that clinical performance will inevitably decline throughout one’s career in manual

medicine, even with continual educational development. Furthermore, the non-traditionalist

osteopath would acknowledge that learning and development extend beyond clinical knowledge;

the integration of evidence-based medicine practices is a key component in the attainment of

continual success.

The objective for the evidence-based practice paradigm is to incorporate a few simple skills that

involve meticulous research, critical evaluation of that research and finally integration of the

validated findings into practice, for the purpose of enhanced patient care. Early adoption of this

rigorous, methodical approach to medicine is recommended in the academic curricula of many

osteopathic schools. As with other fields of medicine (including chiropractic, physiotherapy,

allopathic medicine and all of its disciplines and specialties), the reason for this assimilation

towards EBM is to gain acceptance and approval that can be validated across the masses.

Therefore, a linear process has been established utilizing clinical trial formations as a way to

obtain medical results that would be applicable to a target population of people with a certain

disease.23 Since it would be virtually implausible to perform a study on all individuals within a

                                                                                                                         23  Akobeng, A.K. Confidence Intervals and p-values in clinical decision making Acta Paediatrica, 97 (2008) 1004-1007.

21  

 

target population, a “sample” of the given population is commonly employed with the hope that

the overall results from that sample can be extrapolated to all individuals in that population. 24

3.1.1 The definition of Evidence-Based Medicine

Evidence-based medicine is the conscientious, explicit, and judicious use of current best

evidence, in making decisions about the care of individual patients. The practice of evidence-

based medicine involves the integration of individual clinical expertise with the best external

clinical evidence available from systematic research.25 This definition is the most accurate

description of what EBM should entail: relevant and current research accompanied by clinical

prowess. The question as to whether one’s research or clinical expertise should take precedence

is highly debated amongst osteopathic practitioners.

Clinical experience is acquired through the evolution of one’s efficient judgement decisions in a

clinical practice setting, over one’s career. The gradual development of this expertise is reflected

in many ways, especially through one’s ability to provide more effective and proficient diagnosis

and through the compassionate identification of individual patients’ predicaments, rights and

preferences when making clinical decisions about their care.26 As for understanding the research

aspect of this paradigm, one must consider the definition of relevant clinical research, as well as

how it is classified and valued. It has been stated that “new evidence from clinical research both

invalidates previously accepted diagnostic tests and treatments and replaces them with new ones

that are more powerful, more accurate, more efficacious and safer”.27 Jules Rothstein, a well-

known evidence-based research author, writes what he constitutes as evidence: “...evidence is not

faith or tradition. Evidence is viable findings from research, not theories underlying practice.

Evidence is data that shows whether treatments make a meaningful difference. Evidence is what

is published in credible and respected journals”.28

                                                                                                                         24 Akobeng, 1004. 25 Sackett, 71. 26 Sackett, 71. 27 Rich, N. Levels of Evidence. Journal of Women’s Health Physical Therapy, 29(2) 2005, 19. 28 Rich, 19.

22  

 

3.1.2 The history of Evidence-Based Medicine

The origins and practice of evidence-based medicine (EBM) date back to the 19th century, when

standardization for the teachings and practices within the spectrum of medicine were slowly

adopted by all types of health care professionals. However, this ideology has made a significant

surge within all medical fields, including osteopathy, since the early ‘90s. Since its inception,

we have witnessed unprecedented growth and popularity of EBM (across a variety of medical

disciplines), in shaping clinical decisions. The current trend is that through epidemiology, we

have come to realize that medicine is more than practicing a learned experience, and that it may

be a matter of reasoning, critical thinking, and virtues embraced by different forms of

epidemiology, biostatistics and clinical disciplines themselves.29 This rise in biomedical

informatics has been driven by the explosion of published information related to health care.30

The increased accessibility of information has (at least partially) spawned a new wave of

electronic resources, search filters for large databases, and entirely new databases (e.g. Cochrane

Collaboration). Consequently, clinical research has become more readily available to clinicians

and health policy makers in a conveniently synthesized, pre-digested and accessible form.31

With the advent of both the “clinical trial and clinical research” surrounding the mandate for

proof of efficacy via controlled trials—as a condition for approval in allopathic and

pharmacological fields of medical science 32—has this evolution sparked the same demand for

“evidence” in other health care fields, like osteopathy? Are the research designs devised for

investigating the efficacy of pharmaceutical therapy appropriate for validating therapies that

have human interaction at their core?33 The author explored his thesis topic in an attempt to

answer these questions, and with the hopes of providing some direction for the practicing

osteopathic clinician.

The EBM model was developed because of two related but distinct imperatives: “the need to

harness and codify the upsurge of clinically relevant published research, and the need to develop

rubrics for the evaluation of such research that would facilitate literacy and informed

                                                                                                                         29 Jenicek, M. The hard art of soft science: Evidence-Based Medicine, Reasoned Medicine or both? Journal

of Evaluation in Clinical Practice, 12 (2006), 411. 30 Wyer & Silva, 892. 31 Wyer & Silva, 892. 32 Wyer & Silva, 892. 33 Johnson & Waterfield, 122.

23  

 

consumption on the part of clinicians, and even the lay public”.34 The face of medicine,

including osteopathy, is changing. EBM has contributed to an evolution in critical thinking,

optimally facilitating improved patient management and care.

Socrates, one of the most celebrated philosophers and educators of all time, reminded us that

“the beginning of wisdom is the definition of terms”.35 Within the relatively short life of EBM,

there have already been a variety of definitions attempting to highlight the true meaning of this

paradigm to health care professionals.

3.1.3 Alternative definitions of EBM

According to Straus et al., “EMB is the entity which requires the integration of the best research

evidence with our clinical expertise and our patient’s unique values and circumstances”.36 This

hierarchy of evidence is supported by the advocates of EBM. It is the opinion of the author that

this is also an accepted methodology within many educational institutions and deemed to be

more important than clinical prowess alone.

Dr. Milos Jenicek, Professor, Department of Clinical Epidemiology & Biostatistics at McMaster

University, provides another definition of “evidence”: any data or information, whether solid or

weak, obtained through experience, observational research, or experimental work. This data or

information must be relevant and convincing to some degree either to the understanding of the

problem (case) or to the clinical decisions (diagnosis, therapeutic or care oriented) made about

the case. ‘Evidence’ is not automatically correct, complete, satisfactory and useful. It must first

be evaluated, graded and based on its own merit”. With Jenicek’s definition, the traditional

osteopath can feel comfort knowing that with their “global approach” to the body’s systems, and

their interrelationships, case by case studies and their individual successes should be the basis for

what should establish scientific merit.

‘Evidence’ is as old as medicine itself. Only the act of belief, and to some degree conviction,

faith, personal or others’ experience, or proclamation by authority, are being replaced by findings

from randomized double-blinded controlled trial(s) or systematic reviews. (definitions of these

                                                                                                                         34 Wyer & Silva, 893. 35 Jenicek, 411. 36 Jenicek, 411.

24  

 

are outlined in Table 2, p. 38). In this sense, medicine and all of its tributaries will always be

evidence-based but it will be judged on different scales of credibility. Evidence - especially

medical evidence - has numerous characteristics: it is provisional, defeasible, emergent,

incomplete constrained, collective and asymmetric.37 It is for these reasons that medicine is

often viewed as the “hard art of soft science”, while the field of osteopathy is viewed as more of

a true grassroots science and a comprehensive art form.

The EBM paradigm is an open-ended system. It is evolutionary rather than revolutionary. It is

an extension of fundamental, field and clinical epidemiology with rich contributions coming

from biostatistics and the factual knowledge and experience of their practitioner and others.

Without these grounds, even such fundamental notions as probabilities, chances, likelihood

ratios, disease risk and aetiology, or effectiveness of interventions, would be meaningless.38

3.2 Quantitative and Qualitative research methods

It is worthwhile to note the differences between the two types of research methods that embrace

EBM, those being quantitative and qualitative research respectively. The term “evidence” as

used in quantitative research, conjures up notions of information or “available facts” that have an

independent existence, thus enabling a particular argument or hypothesis to be proved or refuted,

or its validity to be established. By contrast, qualitative research seldom appeals to notions of

“evidence”, relying on the product of analysis from empirical data as “findings” and then

applying alternate or additional criteria. This is reflected in the use of different terminology to

discuss validity and rigour.39 The term “findings”, with its explicit recognition of agency on the

part of the researcher, acknowledges the importance of the context in which data is generated,

interpreted and presented.40

Qualitative research generally aims to answer research questions which are rather different from

those addressed by quantitative research.41 “Qualitative research is essentially exploratory,

setting out to describe, understand and explain a particular phenomenon. It may address                                                                                                                          37 Miles, A. et al. New perspectives in the evidence-based healthcare debate. Journal of Evaluation in Clinical

Practice, 6 (2000), 78. 38 Jenicek, 412. 39 Lincoln & Guba, as quoted in Barbour, R.S. The role of qualitative research in broadening the “evidence base” for

clinical practice. Journal of Evaluation in Clinical Practice, 6 (2000), 155. 40 Barbour, 155. 41 Barbour, 156.

25  

 

“‘what?’, ‘why?’ and ‘how?’ but not ‘how many?’ or ‘how frequent?’ ”42 The qualitative

research method is considered “open-ended” in that it allows the researcher to concentrate on

issues which have salience for those being studied and thus allow different perspectives to be

explored.43 Qualitative samples tend to be much smaller, as this method attempts to reflect and

mirror the diversity within a given population or group; the approach does not attempt to get at

the “truth”, but rather it seeks to acknowledge the existence and study the interplay of “multiple”

views and voices.44 Within the scope of qualitative research, the objective is to study the

decision-making processes of clinicians and patients; to illuminate the multiplicity of meanings

attached to a particular set of circumstances by different individuals. However, critics of this

research method will point to the limitations of qualitative findings including its apparent

inability to provide evidence on prevalence, prediction, cause and effect, or outcomes and its

failure to statistically generalize findings.45 The author is of the opinion that these criticisms and

apparent limitations are not limitations at all, but rather advantages that support the osteopathic

views on complexity and medicine. Despite these questionable pitfalls, one of the major

strengths of this type of research method and the reason it correlates well with the osteopathic

philosophy of practice, is that it furnishes explanations that may be theoretically generalizable

and transferable.46 The impact of qualitative findings may be persuasive, although not amenable

to measurement, and its research has considerable potential to influence practice. In the

osteopathic community, this is of vital importance because it helps to ensure the adage that “the

whole is greater than the sum of its parts”.47

Understanding the differences between the two approaches to research outlined above,

quantitative on the one hand, being measurable and proven, and qualitative on the other hand,

being exploratory and open-ended, establishes a clearer path for which the discipline of

osteopathy should follow in its attempt for validation. The osteopathic profession needs to align

itself with these new and innovative qualitative research styles in order to fully integrate the

nuances and complexity of its approach and method of delivering health care to patients. The                                                                                                                          42 Gantley et al., as quoted in Barbour, “The role of qualitative research in broadening the “evidence base” for

clinical practice, 156. 43 Barbour, 156. 44 Barbour, 156. 45 Barbour, 157. 46 Lincoln & Guba as quoted in Barbour, “The role of qualitative research in broadening the “evidence base” for

clinical practice, 158. 47 Barbour, 162.

26  

 

very nature of how osteopaths interpret and manipulate the human body, its structure, its

mechanics, and its fluidics, makes for a challenging protocol regardless of its design.

3.2.1 Levels of Evidence: The hierarchy of evidence

Collectively, the levels of clinical evidence outlined below enable decision-making to be

optimized based on categories of research strength (from the strongest, most reliable, least biased

and trustworthy to the weakest, least reliable, most biased and untrustworthy). EBM pioneer Dr.

David Sackett outlines these levels of evidence as follows:

1A = Systematic Review of Randomized Controlled Trials (RCTs)

1B = RCTs with Narrow Confidence Interval

1C = All or None Case Series

2A = Systematic Review Cohort Studies

2B = Cohort Study/Low Quality RCT

2C = Outcomes Research

3A = Systematic Review of Case-Controlled Studies

3B = Case-Controlled Study

4 = Case Series, Poor Cohort, Case-Controlled

5 = Expert Opinion 48

Other authors, such as Hadorn and Rich have created even further confusion by identifying

oversimplified, graded levels of evidence that offer only three categories:

Level A = Well-conducted RCT with 100 patients or more (including multi-centre and meta-

analyses), well-conducted RCT with fewer than 100 patients (one institution and meta-analysis;

well-conducted study).

                                                                                                                         48 Rich, 19.

27  

 

Level B = Well-conducted case-control study, poorly controlled or uncontrolled (including RCT

with one or more major or three or more minor methodological flaws), observation studies with

high potential for bias (case series with comparison to historical controls), case series or case

reports, conflicting evidence with more support.

Level C = Expert opinion. 49

Table 2 provides the reader with additional details regarding the categories and definitions of

each methodological guideline for evidence.

The two most common classifications upon which clinical decision-making is based are Levels

A and B. Of these classifications of evidence, Level C (Expert opinion) commonly receives

criticism as the weakest link, the most biased, the least reliable and the least trustworthy way of

conducting oneself as a health care professional. The traditional osteopathic clinician would

challenge the hierarchy described above (Levels A, B and C) on the grounds of what constitutes

“expert opinion”. Does expert opinion include those practitioners who have dedicated their lives

to lifelong manual therapy training? Does it include those who have dedicated themselves to a

lifetime of experience in anatomy, physiology, biomechanics or other related disciplines, similar

to a journeyman apprenticeship? Does expert opinion simply mean years of experience? Or is it

a combination of duration and practical experience? All of these questions need to be discussed

in order to properly define what characterizes “expertise”.

                                                                                                                         49 Rich, 19-20.

28  

 

Table 2: Terminology and definitions used in Levels of Evidence Guidelines

Term Definition

Systematic review A systematic review is typically restricted to RCTs. Initially, a group

of reviewers will search the available literature via bibliographic

databases. The reviewers search for common terminology, navigate

the search results and retrieve copies of all articles specific to the

search criterion. Once the applicable articles are in-hand, they

proceed to critically evaluate the methodologies and content. The

final product is a synthesis of the research into a format that is

informative and relevant to practicing medical practitioners/clinicians.

The Cochrane Database of Systematic Reviews provides some

excellent examples of this methodology.

(http://www.cochrane.org/cochrane/revabstr/mainindex.htm)

Meta-analysis This method is a subset of systematic reviews, which uses statistical

methods to combine and analyze multiple investigations.

Randomized

controlled trials

When a study involves a randomized controlled procedure, subjects in

the study are indiscriminately allocated to each group included in the

study. Each subject has an equal chance of being assigned into an

intervention group, a control group, a placebo group or a sham

treatment group. This eliminates the over-representation of any one

characteristic in one group. If the randomization is correctly

performed, each group should be similar with respect to baseline

characteristics. Furthermore, this process eliminates any bias in the

assignments of individuals to groups. Without this method, it is

possible for a research study to assign the less-involved patients to the

intervention group and the more-involved patients to the control

group. Randomized controlled trials are known to be the ‘Gold

Standard’ for establishing the effects of a treatment.

29  

 

Term Definition

Cohort studies The cohort study is also commonly referred to as a prospective study,

or a longitudinal study. This study design involves the selection of a

large population of people who have the same condition and/or

receive the same intervention, are followed over time and are

compared to a group not affected by the condition. This study

employs observation as the research method. The interventions are

not manipulated in cohort studies.

Matched case-

controlled study

This design involves the selection of two patients, or two groups of

patients, who have been exposed to two different interventions. The

investigator performs a retrospective analysis to determine which

patient or group of patients achieved a better outcome.

Outcome research For this design, a large group of individuals who receive the same

intervention are evaluated retrospectively for their outcomes.

Case-series These are reports on a series of patients with a pre-identified problem.

Case report This involves a report on the intervention and outcome for a single

patient or client.

50

For the traditional osteopathic clinician, the case report seems to be the model best-suited to

accurately represent the patient-therapist interaction and relationship. Despite being a

methodology at the lowest tier of the hierarchy for evidence-based guidelines, it is the opinion of

the author that, in practice, the case report method actually offers significant upside for both the

patient and clinician. The case report method has the potential to highlight each and every

encounter that the therapist has with their patient and the results can be tailored to that one

                                                                                                                         50 Rich, 20.

30  

 

individual. In practice, an osteopath treats one patient at a time and should customize the

treatment based on the unique needs of the individual.

In consideration of the various levels of evidence offered, one may be inclined to ask whether or

not there is a universally accepted definition of “best evidence”. Best evidence comes from

research that includes the randomized assignment of subjects or participants. Double-blinded

design, where the actual treatment group is neither disclosed to the investigators nor the patients,

and the use of both a control and a placebo group are also necessary. This type of systematic

research significantly increases the confidence with which a medical practitioner can believe in

the effectiveness of a treatment. In addition, by virtue of the rigorous design of the study,

readers are more inclined to trust the research and believe wholeheartedly that it was the

treatment itself that caused the outcome and not some ancillary factor.51

3.3 The introduction of EBM in the academic curriculum

The body of mainstream health evidence is located in the “confined domain”, with the testing of

linear interventions on discrete individual parts with randomized controlled trials, which typifies

the evidence-based medicine tradition of clinical practice.52 Under this simple system, cause and

effect can be separated and by understanding their relationship, one can control outcomes, and

predict and prescribe behaviours in the form of guidelines, protocols and best practices.53

Currently, most medical schools (including osteopathic schools) are introducing the philosophies

of EBM and teaching new health care providers the various methods of harnessing these critical

thinking skills (Note: the preceding statement applies only to American medical schools where a

degree in osteopathy requires additional education following the completion of traditional

medical training. This is not the case in osteopathic programs here in Canada, where regulation,

governance and education have no formal medical affiliation; this process is not discussed in

detail as part of this thesis). The role of argument-based or reasoned medicine is often

highlighted as an important adjunct to EBM within osteopathic schools. Identified here are two

of the more traditional definitions of argument-based medicine, which emphasize its foundations:

                                                                                                                         51 Rich, 20. 52 Martin, C.M., & Felix-Bortolotti, M. W(h)ither complexity? The emperor’s new toolkit? Or elucidating the

evolution of health systems knowledge? Journal of Evaluation in Clinical Practice, 16 (2010) 416. 53 Martin, 416.

31  

 

“... the intellectually disciplined process of actively and skillfully conceptualizing, applying, synthesizing, and or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication as a guide to belief or action.” 54

“... a higher order thinking skill which mainly consists of evaluating arguments. It is a purposeful, self-regulating judgement which results in interpretation, analysis, evaluation and inference, as well as explanations of the evidential, conceptual, methodological, or contextual considerations upon which the judgement is based.” 55

These definitions highlight the co-existence between EBM and the critical thinking skills that are

now key foundations within several university and college curriculums for medical programs and

other health related fields, such as osteopathy.

3.4 The strengths of Evidence-Based Medicine

There is a commonly held belief that amongst a significant number of health care providers there

is a “progressive decline in their knowledge of appropriate clinical practice and they often fail to

address (their) daily needs for clinically important knowledge (which) may lead to a progressive

decline in (their) clinical competency” 56 For years, the term “evidence” represented

extrapolations of pathophysiological principles and logic rather than established facts based on

data derived from comprehensive research protocols involving the treatment of patients. In

response to this evolution in EBM, clinicians have been advised that integrating research into

clinical decision-making is the only manner by which to halt this progressive deterioration in

clinical performance. Medical educators are increasingly recognizing the power of probabilistic

reasoning, which has shifted us from an older anecdotal standard to a newer epidemiological one

so that authoritarian medicine may be gradually yielding ground to authoritative medicine.57

The following five-step process can be applied in a clinical practice setting, in order to facilitate

one’s understanding of the EBM paradigm of thinking:

1. Form an answerable question. Identify need(s) for evidence (problem formulation).

                                                                                                                         54 Jenicek, 413.  55 Jenicek, 413. 56 Sackett, D., & Rosenberg, W. On the need for evidence-based medicine. Journal of Public Health Medicine 17(3)

(1995) 331. 57 Miles, A. et al. Evidence-based healthcare, clinical knowledge and the rise of personalised medicine. Journal of

Evaluation in Clinical Practice, 14 (2008) 640.

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2. Seek out the best evidence to answer your question. This involves evidence production,

evidence finding and research synthesis.

3. Critically evaluate the literature used in your research.

4. Integrate the best evidence with your clinical expertise and the patient’s unique

circumstances.

5. Critique your performance. 58

This five-step task cycle has become the instructional model for EBM that has been universally

accepted and can be simplified as: “Ask, acquire, appraise and apply.” 59 Whenever there is

doubt within a clinical intervention involving a patient, the osteopath should perform diligent

research using accessible resources (i.e.: online search engines), identify which studies (or

literature, etc.) are current and meaningful, organize the relevant materials, exploit them through

meticulous critical appraisal skills, and retain the information for future reference.

The following are some of the most commonly shared expert opinions regarding the advantages

of adopting the EMB paradigm of reasoning:

• The information literacy model known as EBM emphasizes the need to critically review

and evaluate the quality of information obtained by performing electronic searches.

EBM has provided us with a complete package that combines clinically framed concepts

of critical appraisal together with streamlined electronic resources and databases required

for judicious access to new research information as it emerges.60

• The EBM model equates evidence with scientific evidence and supports clinical expertise

as an important factor when transitioning from research navigation into therapist–patient

interaction.61

• Utilizing the EBM paradigm to guide the decision-making process within the clinical

setting gives the practitioner an objective and observational reality – a “truth” to the

interventions being carried out.62

                                                                                                                         58 McMaster University Handout, 1997. 59 Wyer & Silva, 893. 60 Wyer & Silva, 896. 61 Miles, 78. 62 Miles, 78.  

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• The truth is out there, waiting to be revealed. The RCT has been developed as the key

weapon for medicine to produce objective, value-free knowledge. Mathematical models

of statistical and clinical significance weigh the importance of the evidence in these trials.

This ensures that the underlying findings of the trial(s) are reproducible.63

• Traditional research evaluation criteria were designed for quantitative inquiry.

Qualitative data are descriptive and unique to a particular context and therefore cannot be

reproduced time and again to demonstrate “reliability”. Instead of trying to control

extraneous variables, qualitative research takes the view that reality is socially

constructed by each individual and should be interpreted rather than measured; that

understanding cannot be separated from context.64

When one investigates the emergence of EBM and its increased acceptance into the global

medical community, it becomes apparent that there are a number of key events and people that

helped to bring this paradigm to the forefront of medical decision-making. The Cochrane

Collaboration, founded in 1993 in response to the call of Dr. Archie Cochrane—a pioneer in the

use of RCTs—was a key development for clinical disciplines such as osteopathy.65 This

organization compiles systemic research summarizing the highest level of evidence concerning

clinical practice. In addition, the impact of Alvan Feinstein, renowned clinician, researcher and

epidemiologist, in defining the principles of quantitative clinical reasoning, brought significant

awareness to the topic to clinical research. Dr. Feinstein’s writings are some of the most

commonly studied books in clinical epidemiology.66 Last but not least, a pioneer of the EBM

paradigm, David Sackett’s innovative teachings in the area of clinical appraisal have helped to

streamline the way health care professionals, including osteopaths, reason about patient care.67

All three of these people and the events surrounding their unique contributions, have helped

EBM rise to the forefront of medical and osteopathic decision-making, while reducing the

emphasis on unsystematic clinical experience and pathophysiological rationale.68

                                                                                                                         63 Sweeney, K., & Kernick, D. Clinical Evaluation: constructing a new model for post-normal medicine. Journal of

Evaluation in Clinical Practice, 8(2) (2002) 133. 64 Johnson & Waterfield, 123. 65 Wikipedia, 2012. 66 Wikipedia, 2012. 67 Guyatt, G, et al. Evidence based medicine has come a long way. BMJ (2004) 990-1. 68 Guyatt, 900-1.  

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From a purely epidemiological perspective, it seems clear that the “evidence” for an EBM

approach is strong; it appears to be a logical path to follow for the osteopathic practitioner who

wants to ensure that treatment interventions are producing the desired therapeutic effect.

3.5 The weaknesses of Evidence-Based Medicine

On the other side of this debate are the commonly held criticisms of the EBM approach. While

there are many who support the EBM paradigm, there are also many who criticize this linear

method of analysis. Included here are some of the most commonly shared opinions regarding the

disadvantages of the EMB paradigm:

• One of the most common arguments against EBM is that it is a linear and overly

simplistic method of breaking down the “whole into its fragmented parts.” This approach

suppresses an osteopath’s way of thinking as well as their freedom within the clinical

setting. Without clinical expertise, daily clinical practice would become tyrannised by

evidence, for even high quality research may be inapplicable to or inappropriate for an

individual patient.69

• Science and clinical practice move in different directions. Science moves from

individual observations to theories and laws that can be generalized. It is clinical practice

that brings this generalized body of knowledge to the benefit of the individual patient, all

within the context of the relationship that is established between the osteopath and the

patient in the initial assessment and subsequent treatment sessions. Clinical practice is

therefore not a science but rather a human endeavour which utilizes science and good

science is necessary, but in and of itself, not the sole determinant factor of good clinical

practice.70

• “The hierarchy of evidence” has done nothing more than glorify the results of imperfect

experimental designs on unrepresentative populations in controlled research

environments, above all other sources of evidence which may be equally valid or far

more applicable in given clinical circumstances.71

                                                                                                                         69 Sackett, 72. 70 Miles, 78. 71 Miles, 79.  

35  

 

• “At each level of complexity entirely new properties appear; and research on the whole cannot be extrapolated from research on its constituent parts.” 72

• The continual trend of science is to isolate objects, one from another, and isolate them

from their environment. The principle of scientific experimentation allows taking a

physical body in nature, isolating it in an artificial, controlled laboratory environment,

and then studying this object’s behaviours and variations. This makes it possible to know

only a limited number of qualities and properties at best.73

• Many critics reject that EBM encompasses both scientific evidence and clinical evidence;

the definition of EBM should include the multiple dimensions of evidence, including

scientific evidence, theoretic evidence, practical evidence, expert evidence, judicial

evidence and ethics-based evidence. All of these facets of evidence would strengthen the

overall spectrum of EBM.74 (Note: Definitions of these forms of evidence can be found

in Table 3 on pages 48-9).

• “The experimental testing of a scientific theory is not a mechanical, automatic process. There is no prescribed set of procedures we can go through, at the end of which we give the theory some stamp of approval that says it has passed its test. The process of testing a theory, like the process of making one up in the first place, is a never-ending process, and a creative, imaginative one. We have to exercise some subjective judgment about what kind of experimental evidence will make a real difference one way or another in our degree of belief.” 75

• The construction of scientific theories requires that mathematics be employed as the

language of science and not merely as a tool of analysis.76 The failure to appreciate the

fundamental epistemological and logical differences between these two roles underlies

the deep flaws in EBM; and at the heart of this debate is the highly-touted RCT that uses

mathematics (probability and statistics) solely as a tool of analysis rather than as the

language of science, and this affects the validity of causal claims. 77 Many areas of

medical research and knowledge involve models in which mathematics is used as the

                                                                                                                         72 Doll, W.E., & Trueit, D. Complexity and the health care professions. Journal of Evaluation in Clinical Practice,

16 (2006) 846. 73 Morin, E. Restricted Complexity, General Complexity. 21(37) (2008) 14. 74 Miles, 78. 75 Goldstein M, & Goldstein, I. (1984). The experience of science an interdisciplinary approach. (Plenum: New

York, 1984), 305. 76 Thompson, P.R. Causality, mathematical models and statistical association: dismantling evidence-based medicine.

Journal of Evaluation in Clinical Practice, 16 (2010) 267. 77 Thompson, 267.  

36  

 

language in which to describe dynamical systems. These include physiology,

immunology, medical genetics, neurosciences and other similar fields. Epidemiology

and biostatistics are fields where RCTs are prominent and models of dynamic systems are

rare. Modern physics, astronomy, chemistry and biology make little use of RCTs. RCTs

fail to give answers to crucially important questions and EBM’s almost total reliance on

RCTs suggests that it is never in a position to provide answers.78

• Werner Heisenberg’s Uncertainty Principle (quantum theory) defines the limitations of a

science’s ability to measure systems and predict events. The act of observation

determines the observability of a system. The very act of measurement itself can never

be objective and observations merely reflect the mechanisms of the observing instrument,

rather than the nature of the system observed.79

                                                                                                                         78 Thompson, 273. 79 Sweeney & Kernick, 132.  

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Table 3: Types of Evidence

Type of Evidence Description

Theoretical Evidence According to Albert Einstein, theories are “free creations of the

human mind”. They can apply to empirical or non-empirical

phenomenon. Theories are like a “road map” linking the ideology

to what is experienced and or observed. It defines the “facts” as

reasonable and credible. It “plants the seed” for idea generation and

speculation, where answers are not cut and dry, black or white.

Practical Evidence Evidence based on an individual’s interpretations of an experience.

This form of evidence cannot be reduced to the objectivity of

observable science or EBM. Instead, they transform beyond the

biomedical model and seek to navigate the complexity of the human

experience and human consciousness. These insights go beyond

what can easily be explained. Practical evidence offers situational

empathy to the patient as a whole, including how they live in their

particular environment and cope with their unique anxieties in life.

Practical evidence “gives context and perspective to the patients

predicament”. However, this approach is not without its limitations

including lack of transparency, personal bias, and lack of

accountability and reliability.

Expert Evidence Evidence based on the statements or actions of individuals or groups

whose authority as “experts” is vested in public recognition of their

knowledge, experience and reputation. Expert evidence and the

“trust me, I am the professional” approach can have the associated

risks of weak substance and misguidance, however, expert evidence

can also provide the building blocks to the answers that science

cannot always explain.

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Type of Evidence Description

Judicial Evidence Defines what is admissible or believable in the eyes of our judicial

system or in a court of law. This type of evidence is commonly

regarded as truthful and reliable. Judicial evidence can write the

standards of EBM, set boundaries for medical decision-making and

define the boundaries of the scope of practice for a particular

profession.

Ethics-Based Evidence Ethics-based evidence uses “moral knowledge” to answer questions

of what “ought” to be permissible or done. This moral foundation

has a history in society that is based on the beliefs and values of

what is good and right. The focus of morality is a social contract by

which individuals live their lives. 80

Consider the question, “Can linear thinking, mathematical calculations and man-made

experimental designs really extrapolate meaningful interpretations of human experiences in the

natural world?”

A strong argument can be made by the traditional osteopath that the patient-therapist encounter

during the initial assessment and follow up treatment interventions should not be based only

upon literature searches, probabilistic reasoning and standardized algorithms (which collectively

are referred to as “practice guidelines”).81

EBM has been referenced as a “recipe” or “cookbook” approach to the practice of osteopathic

manual medicine. Its rigid and structured parameters, involving adequate sample sizes, inclusion

and exclusion criteria and linear statistical analysis, does not represent the average clientele one

sees on a daily basis with multiple co morbidities and numerous system dysfunctions, both

mechanical and fluidic in nature.

                                                                                                                         80  Buetow, S., & Kenealy, T. Evidence-Based Medicine: the need for a new definition. Journal of Evaluation in

Clinical Practice, 6(2) (2000): 87-90. 81  Shahar, E. Evidence-based medicine: a new paradigm or the Emperor’s new clothes? Journal of Evaluation in

Clinical Practice, 4(4) (1998): 277.

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External clinical evidence, while informative, can never replace individual clinical expertise. It is

this expertise that determines whether the research in question applies to the individual patient at

all, and if it does apply, how it should be integrated into a clinical decision.82 The conclusions of

this type of research often leave the reader puzzled because they are unconvincing in their

findings, suggesting that “more research is needed” to make a reasonable and informed decision.

In addition, there is an inherent problem with the application of the results generated from these

studies in a clinical setting. This lack of implementation in a clinical setting has many reasons

including: a lack of self-directed learning with critical appraisal of research studies, poor results

from study methods, or a provider’s interests in other clinical specialties (i.e. manual therapy);

all of these reasons detract health care providers from staying up-to-date with research and EBM.

Given these and other obstacles, is the future of this type of modern science achievable and

realistic? The author is of the opinion that for the osteopathic profession, the answer is “No”.

Giving greater priority to research studies and the levels of evidence as opposed to experience or

expertise fails to acknowledge the multiple systems and variables that are encountered when

assessing and treating an individual patient. The experience and interaction between the patient

and the osteopath, from one treatment session to another, is ever-changing and in essence defines

medical intervention as an art rather than a quantifiable science.

Due to the inherent complexity and interrelationships of the eleven systems of the human body

(integumentary, skeletal, muscular, fascial, neurological, cardiovascular, pulmonary, digestive,

reproductive, endocrine and immune) both the osteopath’s input through manual therapy and the

output reaction from the patient’s body are often uncertain, and yet patterns emerge that cannot

be predicted on the basis of analysing the underlying parts.

3.6 Challenging the powers that be

It appears that EBM, by its very design, is telling the medical community to trust neither clinical

expertise, nor historical experience, nor “pathophysiologic rationale”. EBM proposes that

scientific evidence in medicine comes only from clinical research and the only type of clinical

                                                                                                                         82 Sackett, 72.  

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research that provides truly reliable evidence for the effectiveness of proposed therapies is the

RCT.83

One must ask the question: “Is the evidence applicable to individual patients?” Specifically, one

should consider whether or not one’s patient is similar to those who responded well to treatment

in randomized, multiple blinded controlled clinical trials.84 The application of evidence to an

individual patient relies on the compatibility of the patient’s demographic and clinical

characteristics and on his or her clinical setting within the studies providing the evidence of

interest.

It is difficult for the medical practitioner to evaluate EBM as the leading paradigm for clinical

decision-making because many of the outcomes are hard to quantify. In the realm of osteopathic

medicine, the quantification of results is a difficult task since patient case loads are filled with

multiple problems that have gone unsolved by conventional therapies and allopathic

interventions. The “evidence” for these scenarios is either lacking or non-existent and often it is

the complexity approach used by the osteopath that helps to direct treatment down the right path

to recovery.

There are several important variables existing within a clinical environment, which cannot

simply be put under the epidemiological microscope or be measured by biostatistical analysis.

Dr. Milos Jenicek quotes Dr. David Isaacs (clinical professor) and Dr. Dominic Fitzgerald

(physician), who both make the case that there are several types of medicine, which EBM can

never entirely replace:

• Claim-based medicine: Blind, or as a justified conclusion of a logical argument.

• Faith-based medicine: Belief and trust in something.

• Experience-based medicine: As given by the active involvement of a recorded or

unrecorded individual in an activity or exposure to events or people over a period of time

that leads to an increase in knowledge and skills.

                                                                                                                         83 Worrall, J. Evidence: philosophy of science meets medicine. Journal of Evaluation in Clinical Practice, 16

(2010): 356. 84 Jenicek, 415.  

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• Conviction-based medicine: Based on firmly held opinions and beliefs with or without

grounds.

• “Big-heart”-based medicine: As dictated by the health care professional’s compassion,

empathy and will to help and the affection for the human suffering.

• Reference (spoken and written word) -based medicine: As conveyed to listeners and

readers.

• Gut-feeling-based medicine: As instinctive and intuition-driven understanding into

decision-making.

• Authority-based medicine: Has the right or power, justified or not, to enforce rules or

give orders that are administrative or competency-based.85

All in all, these types of medicine (whether they yield satisfactory evidence or not) offer

important tangible and intangible considerations to the osteopathic practitioner to help the patient

in the healing process.

3.7 Conclusions regarding EBM and osteopathy

Where do osteopaths go from here? Like many other health care professions, mainstream

osteopathy is leaning towards the merits of the EBM paradigm. However, many traditional

osteopaths oppose this direction for the profession. The challenge is to determine whether the

EBM approach produces better results and benefits for patients than the alternative methods

being practiced today. Does this debate require a double-blinded randomized control trial

comparing the two paradigms? For the osteopath, does ‘best evidence’ imply the existence of

individual testimonials proclaiming their successes in healing? Or does it mean the “best

evidence” is in the form of documented clinical trials with smaller sample sizes, covering

multiple variances in patient characteristics (i.e. case studies only)? These are some of the

important questions that need to be discussed amongst the osteopathic profession in order to

ensure optimal success and health for our patient populations.

                                                                                                                         85  David Isaacs, Dominic Fitzgerald, as quoted in Jenicek, “The hard art of soft science,” 412.  

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Table 4

Clinical Epidemiology Glossary

Term Definition ANOVA (Analysis of Variance)

A method of statistical analysis broadly applicable to a number of research designs, used to determine differences among the means of two or more groups on a variable. The independent variables are usually nominal, and the dependent variables are usually an interval.

Blind Assessment The evaluation of an outcome made without the evaluator knowing which results are from the test group and which are from the control or “gold standard”.

Blind(ed) Study A study in which observer(s) and /or subjects are kept ignorant of the group to which the subjects are assigned, as in an experimental study, or of the population from which the subjects come, as in a non-experimental or observational study. Where both observer and subjects are kept ignorant, the study is termed a double-blind study. The purpose of “blinding” is to eliminate sources of bias.

Co-interventions Interventions other than the treatment under study that may have been applied differently to the study and control groups. Co-intervention is a serious problem when double-blinding is absent or when the use of very effective non-study treatments is permitted.

Confidence interval (CI)

The CI gives a measure of the precision (or uncertainty) of study results for making inferences about the population of all such patients. The 95% CI is the range of values within which we can be 95% sure that the true value applies for the whole population of patients from whom the study patients were selected. Wide confidence intervals indicate less precise estimates of effects. CI is affected by sample size and by variability among subjects. The larger the trial’s sample size is, the larger the number of outcome events and the greater the confidence that the true relative risk reduction is close to the value stated: the confidence intervals narrow and precision is increased.

Confounding variables

A characteristic that may be distributed differently between the study and control groups and that can affect the outcome being assessed. Confounding may be due to chance or bias.

Content Analysis Is a form of analysis that counts and reports the frequency of concepts/words/behaviours held within the data. The researcher develops brief descriptions of the themes and meanings, called codes. Similar codes may be grouped together to form categories.

Efficacy A measure of the benefit resulting from an intervention for a given health problem administered to patients under ideal conditions (i.e. perfect compliance).

Empathic Neutrality A quality of qualitative researchers who strive to be non-judgemental when compiling findings.

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Term Definition Empirical Research “...the process of developing systematized knowledge gained from

observations that are formulated to support insights and generalizations about the phenomenon under study”.86

Exclusion criteria Stated conditions, which preclude entrance of candidates into an investigation even if they meet the inclusion criteria.

Follow-up Observation over a period of time of an individual, group, or initially defined population whose relevant characteristics have been assessed in order to observe changes in health status or health-related variables.

Generalizability The extent to which research findings and conclusions from a study conducted on a sample population can be applied to the population at large.

Gold standard Ideally, the criterion used to unequivocally define the presence of a condition; or practically, the method, procedure or measurement that is widely accepted as being the best available to detect the presence of a condition.

Grounded Theory Aims to generate a theory that is ‘grounded in’ or formed from the data and is based on inductive reasoning. This contrasts with other approaches that stop at the point of describing the participants’ experiences. In terms of data analysis, grounded theory refers to coding incidents from the data and identifying analytical categories as they emerge from the data, rather than defining them at the beginning.

Holistic perspective Taking almost every action or communication of the whole phenomenon of a certain community or culture into account in one’s research.

Likelihood ratio The likelihood ratio for a test result compares the likelihood of a given result in patients with disease to the likelihood of the same result in patients without disease.

Negative predictive value

The proportion of people who receive a negative test result who are truly free of the target disorder.

Outcome Measures Outcome measures must be able to discriminate among patients or health states at a designated point in time and be adept at assessing change over time. These measures provide information about a patient’s current state and whether a change has occurred since the previous assessment. Standardized measures have explicit instructions for administration and calculation.

Odds ratio The odds of the experimental group showing either positive or negative effects of an intervention or exposure, in comparison to the control group.

 

                                                                                                                         86 Lauer & Asher, as quoted in (http://writing.colostate.edu/guides/research/glossary/) (1988), 7.  

44  

 

Term Definition P- value The possibility that any particular outcome would have occurred by

chance. Statistical significance is usually p < 0.05. Considered to be inferior to confidence intervals in determining significance of studies.

Power The ability of a study to demonstrate an association or causal relationship between two variables, given that an association exists. For example, 80% power in a clinical trial means that the study has an 80% chance of showing a statistically significant treatment effect if there really was an important difference between outcomes. If the statistical power of a study is low, the study results will be questionable (the study might have been too small to detect any difference). By convention, 80% is an acceptable level of power.

Predictive value (positive and negative)

In screening and diagnostic tests, this refers to the probability that a person with a positive test is a true positive (i.e. does have the target disease), or that a person with a negative test truly does not have the disease. The predictive value of a screening test is determined by the sensitivity and specificity of the test, and the prevalence of the condition for which the test is used.

Pre-test probability Probability of disease before a test is performed. Post-test probability Probability of disease after a test is performed. Reflexivity The open acknowledgement by the researcher of the central role the

researcher plays in the research process. A reflexive approach considers and makes explicit the effect that the researcher may have had on the research findings.

Relative risk The ratio of the probability of developing, in a specified period of time, an outcome among those receiving the treatment of interest or exposed to a risk factor, compared with the probability of developing the outcome if the risk factor or intervention is not present.

Reliability (Dependability and Auditability in qualitative studies)

The consistency of measurement. It is also concerned with error in measurement. If the extent to which measurement error is slight, then a measure is said to be reliable.

• Absolute reliability: quantifies measurement error. • Intra-rater reliability: the same rater performs all the

measurements. • Interrater reliability: two or more raters assess all patients. • Relative reliability: measures the ability to differentiate among

the objects of measurement (e.g. ICC – intraclass correlation coefficient from 0-1, the higher the score the more reliable).

• Test-retest reliability: patients provide responses on two or more occasions.

• Internal consistency: this type of reliability examines the extent to which responses to items are consistent.

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Term Definition Reproducibility The results of a test or measure are identical or closely similar each

time it is conducted. Rhetorical Inquiry “entails...1) identifying a motivational concern, 2) posing questions, 3)

engaging in a heuristic search, 4) creating a new theory or hypotheses, and 5) justifying the theory”.87

Rigor Degree to which research methods are scrupulously and meticulously carried out in order to recognize important influences occurring in an experiment.

Sample size Is the size of the population under study. Larger samples usually mean more precise results. Sample size usually depends on the purpose of the study, the population size from which the sample will be pulled, the level of precision, the level of confidence or risk that is acceptable, and the degree of variability in the attributes being measured.

Selection bias A bias in assignment or a confounding variable that arises from study design rather than by chance. This can occur when the study and control groups are chosen so that they differ from each other by one or more factors that may affect the outcome of the study.

Sensitivity Percentage of patients with a disease who have a positive test for the disease in question.

Specificity Percentage of patients without a disease who have a negative test for the disease in question.

Statistical significance

How likely the result of a study is due to chance. The probability that an event or difference occurred by chance alone.

T-Test A statistical test. A T-test is used to determine if the scores of two groups differ on a single variable.

Transferability The ability to apply the results of research in one context to another similar context. Also, the extent to which a study invites readers to make connections between elements of the study and their own experiences.

Triangulation The use of a combination of research methods in a study (i.e. surveys, interviews, observations etc.). It is a process by which the area under investigation is looked at from different perspectives. Used to ensure that the understanding of an area is as complete as possible or to confirm interpretation through comparison of different data sources.

 

   

                                                                                                                         87  Lauer & Asher, as quoted in (http://writing.colostate.edu/guides/research/glossary/) (1988), 5.  

46  

 

Term Definition Validity The degree to which the results of a study are likely to be true,

believable and free of bias. This is entirely independent of the precision of the results and does not predict the results of one’s patients.

• Face validity: a test that appears to be measuring what it is intended to measure.

• Content validity: a test that comprehensively samples from the domain of interest.

• Construct validity: a test that provides results consistent with theories concerning the attribute of interest.

• Criterion validity: a test that provides results consistent with a gold standard for the attribute of interest.

Internal validity (Credibility and Truth Value in qualitative studies)

Refers to the integrity of the experimental design.

External validity (Transferability, Applicability and Fittingness in qualitative studies)

Refers to the appropriateness by which a study’s results can be applied to non-study patients or populations.

88

                                                                                                                         88 American Academy of Family Physican (2012). Retrieved from

http://www.aafp.org/online/en/home/publications/journals/afp/afpebmglossary. Buckingham, J., Fisher, B., & Saunders, D. (2008) Evidence based medicine toolkit. EBM Toolkit. University of Alberta. Retrieved from http://www.ebm.med.ualberta.ca/Glossary.html. Qualitative research terms (n.d.). United Lincolnshire Hospitals. Retrieved from http://www.hello.nhs.uk/documents/Qualitative_Critical_Appraisal_Glossary.pdf Colorado State University (n.d.) Glossary of key terms. Colorado State University. Retrieved from http://writing.colostate.edu/guides/research/glossary/. Johnson & Waterfield, 123. Stratford P, 2009, McMaster University Reliability and Validity Design Module.

 

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Chapter 4: Complexity and the Scientific Revolution

Where does osteopathy fit in?

______________________________________________________________________________

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4.1 Complexity and the Scientific Revolution

When one attaches the adjective “complex” to a subject, it is reasonable to assume that the

subject is complicated, elaborate, intricate or sophisticated – anything but simple. Complexity,

in essence, does not suggest a definitive explanation, but rather it makes reference to the

difficulty of providing one. The “aura of complexity” defines a form of thinking, whereby all

doors will not and cannot be open in search for an answer - the right answer. Therefore, it

should come as no surprise that within the complexity paradigm of thinking, difficulty and

uncertainty will forever be present. It is for this reason that paradigms centred on simplistic

reasoning prevail in our society, centres of learning and in many schools of thought. Our

consistent quest for finality and all-encompassing solutions, coupled with our consistent

exposure to simple paradigms, leads us down a narrow path in search of simple answers to

simple problems, simple formulas for simple laws.89

In terms of its application to the osteopathic practitioner and in relation to the human body,

“complexity thinking” requires that one fully comprehends all of the associations between the

parts and the whole. The complexity practitioner recognizes that knowledge of the all the parts

is not complete and by the same token knowledge of the whole “as a whole” is not sufficient.

The successful osteopathic provider understands that there must be a mutual implication of the

whole-part relationship.

At the turn of the century, world-renowned theoretical physicist Stephen Hawking made a

profound statement that propelled complexity forms of thinking to the forefront of science: “I

think the next century will be the century of complexity”. Hawking was making reference to the

emergent and transdisciplinary domain of complexity wisdom.90 This “new science” involving

complexity reasoning is anything but “new” to disciplines like physics, chemistry and

osteopathy. The great thing about this methodology is that there is no “gold standard”, no hard

and fast rules that encompass all there is to know about complexity. The complexity paradigm

aims to embrace, blend and elaborate upon the insights of any and all relevant domains of human

                                                                                                                         89  Morin, E. On Complexity. (Cresskill, NJ: Hampton Press Inc., 2008), 84.  90  Davis, B., & Sumara, D. Complexity and Education; Inquires into Learning, Teaching and Research. (New York:

Routledge., 2006), 3.

 

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thought. Complexity thinking does not rise above, but rather rises among other discourses,

incorporating multiple schools of thought.91

Under the umbrella of complexity theory, change is everywhere, and stability and certainty about

most things in life are rare. Complexity is all about adaptation, evolution and constant

development for survival. It challenges the domains and foundations of reductionist models and

linear predictability, embracing the holistic, the organic and the interconnectedness of the

relationships around us.92 For the healthcare professional that studies and practices the art of

traditional osteopathy, these characteristics exemplify the grassroots ideology of complexity

theory.

4.2 Introduction to the roots of the Complexity movement

If one traces the origins and meanings of the term complexity, one will discover numerous

descriptions of a similar nature: encompassing, encircling, embracing, comprising, plaited

together, interwoven. The term “complexity” is commonly used as the opposite of the term

“simplicity”. Its meaning pertains to the holistic, global or non-linear form of intellect necessary

to comprehend a phenomenon.93

“All things, even the most separated from one another, are imperceptibly linked one to the other, all things assist and are assisted, cause and are caused.” 94

Quotes such as the one above and certain key concepts of the complexity model have emerged

throughout history over the last 2000 plus years (between 300 BC to the present) where several

thinkers and events planted the seeds of complexity. These groundbreaking philosophies

contributed to the early development and eventual metamorphosis of the complexity paradigm,

as we know it today.

Let’s start at the beginning with one of the foremost influential philosophers of our time

(especially in the western world), Aristotle (384-322 BC), who gave us great insight into

medicine, metaphysics, mathematics and biology. Some of Aristotle’s primary contributions to

science involved the formulation of “logic” and the introduction of concepts such as the “Laws

                                                                                                                         91 Davis & Sumara, 8. 92 Mason, M. Complexity Theory and the Philosophy of Education. (UK: Wiley-Blackwell, 2008), 16. 93 Mason, 63. 94 Blaise Pascal, as quoted in Edgar Morin, Realism and Utopia. Diogenes, 209, (2006), 140.  

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of Identity”. He coined some of the most famous phrases, many still applicable today, such as

“the whole is more than the sum of its parts”, and “movement is life”. It was this type of logic

and reasoning that were important factors in the formulation of his original four natural elements

(earth, water, air and fire) and the holistic thinking of his time. These beliefs ring true to the

essence of osteopathic medicine and the complexity movement pertaining to human existence

and the world we live in.

For many centuries, this “natural philosophy” described the study of the physical universe and

was the focal point for science and educators such as Aristotle. Like most concepts pertaining to

the study of life and universal existence, there was an evolution of thought – a gradual

ideological shift – that took hold during the 16th and 17th centuries. This shift in thinking

represented a movement from the descriptive-metaphysical Aristotelian concept of the universe

to a mathematical-positivistic Galilean concept of the world.95

4.3 The Scientific Revolution – The shift in the scientific paradigm of reasoning

If we fast-forward through the shift in scientific and intellectual thought during the 15th, 16th and

17th centuries, we have the birth of “The Scientific Revolution”. There are many contributors to

the development of modern science and the eventual paradigm and ideological shift that became

more reductionist, fixed, stable and universal.

Leonardo Da Vinci (1452-1519), the Italian scientist, anatomist and artist was a major

contributor to scientific inquiry by reinforcing a rational and systematic approach to

experimentation with repeated observations to ensure reliability and accuracy. His

methodological approach to science was a huge step from the Dark Ages into the modern era of

medical thinking.96

William Gilbert (1540-1603) and Francis Bacon (1561-1626) are two English scientists whose

work solidified the methodology behind the scientific revolution by dispelling superstition and

religious fervour and reinforcing rational scientific inquiry and inductive reasoning based on

repeated testing and proof. Both challenged the Aristotelian view of the world and the

                                                                                                                         95 Von Bertalanffy, L. The History and Status of General Systems Theory. The Academy of Management Journal,

15(4), (1972), 408. 96 Jon Balchin, Quantum Leaps: One Hundred Scientists Who Changed the World, (London, Arcturus Publishing

Limited, 2010), 37.  

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metaphysical baggage that came with it in order to transition with the evolving reductionist

movement.97

The contributions of Galileo Galilei (1564-1642), the Italian mathematician, helped to forge the

modern scientific approach to experimentation with mathematical analysis. Galileo would

breakdown the whole into its essential parts, do research trials and analyse the results with

mathematical expressions.98

René Descartes (1596-1650), described by many as the first truly “modern” mathematician and

philosopher, was responsible for the scientific movement away from uncertainty to one of

certainty. Descartes was more concerned with mind / body dualism and exploring the laws of

thinking and inquiry; he believed that there should be rules for the direction of the mind, to orient

people towards a particular way of thinking; disjointing the thinking subject and the thing being

thought of; a focus on simple, reductionist thought processes.99 He adopted more of a

mechanistic interpretation of the natural world and the human body – with the mind and body

being isolated from one another, as distinct entities.100

Sir Isaac Newton (1642-1727), the English mathematician and physicist, was yet another key

figure. Newton’s discoveries regarding the laws of nature, attraction and motion have left what

some would argue to be the most significant legacy of all time. He utilized his mathematical

expertise to formulate scientific principles and standards for modern physics. The tools and

principles proposed by Newton shed new light on man’s ability to observe and measure natural

phenomena. Newtonian mechanics explore the development of the laws of nature and focus on

prediction, order and determinism. This helped shape the age of experimentation within the

scientific methodology, where systems were compartmentalized into their simplest forms.

Newton explained that the world is composed of essential building blocks called atoms, that

these atoms exist independent from their environment and the study of their behaviour could help

predict the future of the system as a whole.101

                                                                                                                         97 Balchin, 43-4. 98 Balchin, 46. 99 Morin, Xxvi & 3. 100 Balchin, 54-5. 101Morin, xxx.  

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Within Newton’s world, matter (atoms) and energy were the rulers of absolute space and time.

By understanding the location, mass and speed of matter within the universe, the prophecy of the

future was inevitable and absolute. Every event in life and all living things that thrive within the

universe could be predicted and mapped out. Through the application of Newton’s science, a

complex set of events could be understood only when broken down into their elementary

interactions.102 This deterministic view of the world according to Newton was coined “the

triumph of necessity”. Simple rules and precise laws were fundamental to this paradigm of

thought regarding our universe; anything outside this order was considered disorder, and its

complexity was a mere flaw in our knowledge base.103 With Newtonian mechanics, there existed

a clockwork phenomenon of order, causality and stability in the world with measurable cause

and effect relationships.

Newton’s ideas regarding our existence within the universe were unmatched in the scientific

community, helping to define a “new scientific method” of experimentation. The ultimate goal

within the sciences became the search for irrefutable results that involved calculations and

measurements, backed by research methods that were sound, quantifiable, objective and

reproducible. Fast-forward to the 21st century and it becomes clear that the legacy of Newtonian

mechanics helped to shape the very climate for the emergence of EBM and helped to define our

expectations of the osteopathic profession as it strives to establish credibility within the eyes of

the medical community.

In the infancy of the Scientific Revolution, Galileo, Descartes and Newton all made early

contributions to the concept of “simple systems”, through their studies and analysis of the

interaction between small numbers of variables. The purpose of such studies was to reduce

mechanical phenomenon to basic laws and elementary particles. These studies triggered the

beginning of the reductionist movement towards human existence within the universe. The

contributions of these key leaders in the scientific community acted as a springboard for the

“analytic methodology”, whereby all phenomena within the universe are fragmented into their

most elementary parts, in order to definitively calculate life and the events that shape it.104

                                                                                                                         102 Laszlo, E. The Systems View of the World: A Holistic Vision for Our Time. (Cresskill, NJ: Hampton Press Inc.,

(1996), 7. 103 Morin, xxxi. 104 Davis & Sumara, 9-10.  

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However, all of the scientists outlined above acknowledged a limitation central to this

methodology: At any given time, there are multiple variables that can either positively or

negatively influence life, and the rudimentary calculations of simple systems cannot begin to

explain more complex phenomena. As a result, a more elaborate system of thought was

required: the “complicated system of analysis”. Together all of these ideas helped to shape the

very foundations of critical thinking and specialization within organized institutions (such as

universities and other centres for higher learning). It is these very same establishments that

(today) help to establish the dogma of higher learning.

In opposition to Descartes and many who held steadfastly to the beliefs of traditional philosophy,

German philosopher Immanuel Kant (1724-1804) believed that dogmatic rationalism was too

constraining to describe the human predicament.105 Kant presented the scientific community

with an understanding of organic form and of the patterns produced by the interaction of

components; the self-organizing interaction of the parts of the organism.

“In machines, parts exist for each other, whereas in organisms they also exist by means of each other in the sense of producing one another. We must think of each part as an organ that produces the other parts, so that each reciprocally produces the other...because of this the organism will be both an organized and self-organizing being.” 106

During the scientific revolution, there were several competing ideologies surfacing and a second

wave to the science evolution emerged with the laws of thermodynamics (4 laws in all, but with

special emphasis on the second law). This 2nd law, coined the “principle of irreversibility”,

challenged the beliefs of the reversible world that Newton described. Irreversibility meant that

every event that happens in life has a temporal relationship and cannot be “undone” or

“changed.” 107 In the mid-19th century, Rudolf Clausius (1822-1888) added a familiar concept,

termed ‘entropy’, to this law of thermodynamics to describe the disorder and randomness of a

system.108 Only in an open system is entropy fully realized, where time, the external

environment and all of the intrinsic variables that make up an organism co-exist and constantly

adapt to optimize existence.

                                                                                                                         105 Sweeney & Griffiths, 24. 106 Sweeney & Griffiths, 25. 107 Morin, xxxii. 108 Morin, xxxii.  

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For the osteopathic practitioner, the order–disorder paradox is constantly being evaluated and

balanced to assist in the body’s ability to heal itself. This principle of entropy should be

embraced in order to help explain how manual input (whether mechanical or fluidic) re-

organizes the human systems’ function and vitality.

4.3.1 The world according to Darwin

Charles Darwin’s (1809-1882) world was one of evolution and progression, unlike Newton’s,

which was static, and Clausius’, which was decaying. Darwin outlined that human life started

out as simple micro-organisms (which we now know is anything but simple) and eventually

evolved into a system of complex entities. It was his principle of natural selection that

highlighted “interaction” between time and life. The presence of order-disorder and organization

all have a complex relationship with interaction;109 and it is this interplay that allows an open

system, like human life to adapt to change, nurture, survive and thrive in a world of complexity

and uncertainty. The common theme in his infamous body of works concerns an organism’s

ability to survive in its environment; and it is this interaction that allows for the emergence of

new behaviour and new forms of organisms.110

In the 19th century, newer, more complicated methods of analysis were being developed using

statistical methods and probability, yet the fundamental concept that everything in life is fixed

and can be reduced to the sum of its parts, still permeated the consciousness of the scientific

community. This prediction-oriented endeavour of modern science was driven to measure and

calculate that which, in essence, is not calculable.

French Mathematician Henri Poincaré (1854-1912) stated:

“Even if it were the case that natural laws no longer held any secret for us, we could still only know the initial situation approximately. If that enables us to predict the succeeding situation with the same approximation, that is all we require, and we should say the phenomenon had been predicted, that is governed by laws. But it is not always so; it may happen that small differences in the initial conditions produce great ones in the final phenomenon. A small error in the

                                                                                                                         109 Morin, xxxiii. 110 Sweeney, K., & Griffiths, F. Complexity and Healthcare: An Introduction. (Abingdon, UK: Radcliffe Medical

Press Ltd., 2002), 26

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former will produce an enormous error in the latter. Prediction becomes impossible.” 111

Poincaré was driving at the idea that the systems of the universe that encompass life are

dynamic, adaptive and self-organizing. As these concepts evolved over time, the final system

(defined by American scientist and mathematician Warren Weaver) emerged into the limelight of

scientific inquiry: “the complex system”. Weaver developed a classification system for simple,

complicated and complex systems.112

4.4 Definition of modern science

As identified earlier in this thesis, the definition of “science” has undergone significant change

over many centuries, gradually shifting from a narrow focus to include a broader spectrum of

meanings today. The volatility of the definition lies in the fact that it is not clear where one

draws the line between science and pseudo-science? Today’s “science”, or rather the modern

definition of the term, is in accordance to Thagard’s demarcation criteria (named after Canadian

philosopher of science, Paul Thagard from the University of Waterloo):

• Uses correlation thinking (e.g. A regularly follows B in controlled experiments).

• Seeks empirical confirmations and disconfirmations.

• Practitioners care about evaluating theories in relation to alternative theories.

• Uses highly consilient (i.e. explains many facts) and simple theories.

• Progresses over time: develops new theories that explain new facts.113

In consideration of the above definition of science, it is a commonly held belief, rightly

or wrongly, that science is the “supreme arbiter of truth, objectivity and rationality”.

Therefore any knowledge within this field is held in higher regard than other types of

knowledge and it is this privileged position of science that can sometimes lead to fraudulent

use of the term “science”.114

                                                                                                                         111 Davis & Sumara, 9.  112 Davis & Sumara, 9. 113 Richardson, K., & Cilliers, P. What is Complexity Science? A View from Different Directions. Emergence,

3(1), (2001), 9. 114 Richardson & Cilliers, 19.  

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4.5 Three eras of science in medicine

• Normal science – based on logical positivism; there is a single universal condition

that can be understood and validated; the paradigm of certainty.

• Post-Modern science – the process of knowing becomes important; truth is socially

constructed, contingent, provisional, influenced by power and social context.

• Post-normal science – distinguishes complicated systems from complex adaptive

systems. Reductionism no longer is a valuable tool for understanding the latter. The

interaction of the parts of a system becomes crucial. Some systems are better

understood by standing back and observing patterns of behaviour.115

The question this author would like to pose is whether “science” is the only objective

paradigm of the world we live in? Is the objectivity of science merely a myth? Within the

scope of the scientific community, many people work within a rather rigid set of rules,

unable to explore these important questions. This has resulted in an upsurge of innovation on

the technological side of scientific inquiry and a withering away of any appreciation for the

value of exploring the philosophical side, to keep it in harmony with the technology.116 The

scientific model, specifically the EBM model, is almost universally accepted without much

debate, while the complexity paradigm is all about stepping outside the boundaries set by the

classical scientific community; it’s about incorporating different frameworks that retain the

knowledge of science and its belief structure but involves the encoding, decoding and

mapping of the environment around us.117

According to the French philosopher, Edgar Morin, Classical Science rejects the Complexity

Paradigm based on three key principles:

1. The principle of universal determinism – knowing all past events and predicting all

future events.

2. The principle of reduction – knowing any composite from only the knowledge of its

basic constituting elements.

                                                                                                                         115 Sweeney & Kernick, 135. 116 Mikulecky, D. C. The Circle That Never Ends: Can Complexity Be Made Simple? Complexity in Chemistry,

Biology, and Ecology. Springer, (NY, NY, 2003), 100. 117 Mikulecky, 101.  

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3. The principle of disjunction – isolating and separating cognitive difficulties from one

another, leading to the separation between disciplines, which have become secluded from

each other.118

Throughout its evolution, classical science has become so entrenched in the principles of

rejection described above, that its philosophy is viewed as superior, and any other paradigm,

such as “complexity”, has taken on an air of ambiguity and mystification.

In today’s science-based research, complexity (or systems theory) is gradually being renamed

“complexity science” to fit in or assimilate with research-based ideologies, however the

traditional definition of science remains the same: A collection of established principles on the

nature of the universe and the particular methods of investigation and verification by which those

principles are established. These methods are organized around the standard of proof through

replication: Hypotheses become facts and theories become truths, as researchers are able to

demonstrate that predictable and repeatable results can be obtained. 119 This is where the

traditionalist of osteopathy would disagree, in an attempt to reinforce the holistic reasoning of

life and their surrounding environment. Unfortunately, science has been true to its roots in

“separating one thing from another”, by “splitting, rending, cleaving and dividing” the known

entities that exist in the universe.120

When one begins to scrutinize the all-encompassing definition of “science”, it becomes clear

that, in actuality, the definition is lacking. Gaps exist, which can be filled by the complexity

paradigm; specifically, the standards of replication. For many years, disciplines such as biology,

geology and astronomy have identified that the universe is neither fixed nor finished, but rather it

seems to be evolving, and not in a predictable manner or fashion. Science made a shift from an

emphasis on dichotomization to one of bifurcation. The difference between the two is as

follows: To dichotomize is to generate two independent and unambiguously defined pieces;

bifurcation on the other hand is “two-pronged” or “forked” allowing for growth into two

branches, as opposed to fragmentation into two pieces.121

                                                                                                                         118 Morin, 1. 119 Davis & Sumara, 17. 120 Davis & Sumara, 31. 121 Davis & Sumara, 31-2.  

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4.6 Fundamental principles of osteopathy: Understanding its traditional beliefs

According to Andrew Taylor Still, the founder of osteopathy, the practice of osteopathy is based

on a few key ideas. The first of these philosophies is the natural self-sufficiency of the human

body; the second is that normal structure and normal function go hand in hand.122 Still’s ideas

were not entirely new, in fact throughout history many of the scientific community’s greatest

physicians held many of these same virtues. For example, Hippocrates claimed that the whole

aim of the science of medicine must be to study natural processes and facilitate them “so that the

sick man may conquer the disease with the help of the physician.”123 By understanding the

complexity of the human body and all of the systems that support its existence and health, the

osteopathic practitioner is a unique professional in the field of health care. The role of the

traditional osteopath is not so much to combat the various disease states that afflict the human

body, as it is to promote health and assist the body’s innate ability to defy or overcome

disease.124

“Osteopathy is based on the perfection of Nature’s work. When all parts of the body are in line, we have health. The work of the osteopath is to adjust the body from the abnormal to the normal, then the abnormal condition gives place to the normal, and health is the result of the normal condition.” 125

Osteopathy is the most comprehensive evaluation and treatment discipline in the manual therapy

world; it can make this bold claim because osteopaths are “generalists of the body”. A well-

trained and educated osteopath understands the entire human body (inside and out) through the

application of palpation skills (i.e. 10-finger osteopathy) and intimate intention, induction,

replication and duplication of anatomy, physiology and pathology.

4.6.1 The prominence of diagnosis in osteopathy

Osteopathy aims to develop a new science of diagnosis, in addition to the traditional methods of

diagnosis by palpation, auscultation and percussion. This new diagnosis necessitates a refined

and sensitive tactician. A complete understanding of the human anatomy includes knowledge of

                                                                                                                         122 Proby, J.C. Essay On Osteopathy: Its Principles, Application and Scope.

Osteopathic Institute of Applied Technique (1955), 7. 123 Proby, 7. 124 Proby, 9. 125 Littlejohn, J.M. Osteopathy... Explained. Boston Institute of Osteopathy, (1900), 5.

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the system from the standpoint of “educated touch “, so that proper discrimination may be made

between the normal and the abnormal. The osteopath is trained to excel in the art of touch, to the

extent that one can gain significant insight through delicate manipulation of the human body.

The basis of this highly refined tactile education is found in the physiological structure and

specialized activity of the minute nerve fibers and neuro-muscular organs in the fingers. At the

basis of all the senses lies the essential principle of sensibility, so that in the education of the

senses, this sensibility may be acutely specialized.126

4.6.2 Osteopathy’s role in the future of the medical world

Science is in a constant state of flux, making significant strides with unprecedented regularity,

reaching new heights and making groundbreaking discoveries at an accelerated pace. However,

many of these rapid changes and new discoveries have also been accompanied by much scrutiny;

no science or art more so than that of medicine. The process of rapid change has demanded that

the scientific community address and answer some very important questions. Should osteopathy

become merely a specialty? Should it remain a separate entity developing parallel to general

medicine? Or will its contribution to the facts of disease and therapy eventually be of the

greatest service if osteopathy becomes incorporated into the system of scientific medicine.127

How does osteopathy coalesce with the emergence of EBM?

As a discipline that embraces the complexity model of analyzing the human body and its disease

processes, osteopathy should challenge (but not reject) the logic behind experimental medicine

where research protocols are the norm in defining the legitimacy of therapeutic interventions.

Osteopaths value the fundamental idea that the whole is more than the sum of its parts and are

determined to champion this holistic philosophy. Osteopathy should stand its ground, based on

its beliefs that a thorough understanding and expertise in anatomy, physiology and similar

disciplines are crucial to the successes witnessed in the clinical setting, where, by comparison,

EBM fails to produce similar results in the same environment.

In the realm of health care, one must clearly identify the criteria of scientific merit. To provide a

comprehensive account of the objectives of science, one must accept certain general standards of

                                                                                                                         126 Littlejohn, 29. 127 Tucker, E., & Wilson, P. (1936). The Theory of Osteopathy. (Kirksville, Mo: The Journal Printing Co., 1936), 8.

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judgement. Good science fulfills these purposes; bad science does not.128 There is no universal

recipe for success for all science and all scientists, any more than there is for all cakes and all

cooks. There is much in science, which cannot be created according to set rules and methods at

all. Even the general nature of science itself suggests a constant state of development. Our

standards of judgment are liable to amendment, and vary from one field of study to another; and,

in some cases, it actually happens that a strong point in one theory turns out – in a different

context – to be a weak point in another.129

Science has numerous aims and endeavours, and its progression has emerged through many

difficult stages. It is therefore futile to look for a single, all purpose “scientific method”; the

growth and evolution of scientific thought depends not on a single philosophy or method, but

rather a broad range of distinctive inquiries. Science as a whole – the activity, its aims, its

methods and ideas – evolves by variation and selection.130

The main focus of science is the search for knowledge and the desire to make the course of

nature not only predictable but also intelligible. This has ultimately given rise to the journey for

making rational observations based on patterns and connections. We are confronted by some

difficult questions, namely “what patterns of thought and reasoning establish scientific

understanding?” and “what factors determine which theories or explanations yield greater

understanding?”131

4.7 Order and disorder

“For many centuries, science has been dominated by the Newtonian and thermodynamic paradigms, which present the universe as either a sterile machine, or in a state of degeneration and decay. Now there is the paradigm of the creative universe, which recognizes the progressive, innovative character of physical processes. The new paradigm emphasizes the collective, cooperative, and organizational aspects of nature; its perspective is synthetic and holistic rather than analytic and reductionistic.” 132

                                                                                                                         128 Toulmin, S. (1961). Foresight and Understanding: An Enquiry into the Aims of

Science. (New York: Harper & Row Publishers, 1961), 15. 129 Toulmin, 15. 130 Toulmin, 17. 131 Toulmin, 99.  132 Paul Davies as quoted in Morin, E. On Complexity. (Cresskill, NJ: Hampton Press Inc., 2008), xxix.

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The above quote from theoretical physicist Paul Davies highlights a philosophical shift, a

different way of thinking about not only the universe we live in but also with regards to the

entirety of human existence and its emergence within this universe; it is a paradigm shift towards

a more complex perspective, one consistent with the philosophy and teachings of Edgar Morin.

4.8 Edgar Morin – “The Godfather of Complexity”

Edgar Morin (1921) is a French philosopher and sociologist whose work spans many disciplines

(ecology, education, systems theory, media studies, etc.) but it is his transdisciplinary ideologies,

in making the connection between the soft and hard sciences with complexity concepts, that have

influenced readers around the globe. A summary of the Morin’s transdisciplinary concepts are

outlined below:

1. Inquiry-driven: developing knowledge that (a.) relies heavily on investigation and (b.)

has an outcome that will be more active and creative in the world.

2. Construction of knowledge: the underlying assumptions that form the paradigm through

which disciplines and perspectives construct knowledge.

3. Organization of knowledge: to understand the simple thought process derived from

reductionist and disjunctive paradigms; and the gradual shift to a complex thought process

derived from the interconnectiveness of the systems of the world.

4. Integration of the knower in the process of inquiry: to thoroughly understand and

comprehend an individual’s assumptions and thought process and how they evolve and

emerge through the different constructs of knowledge.133

In the world of osteopathic medicine, this transdisciplinary approach makes perfect sense in that

it allows for inquiry and investigation, something performed everyday within the clinical setting

when attempting to solve a patient’s problems and assist the natural healing process of the body.

The osteopath is constantly probing for information by asking questions, and thinking outside the

box within the complex realm of possibility in an effort to provide a differential diagnosis. The

osteopath’s foundation of knowledge and distinct perspective of the patient as “a whole being” is

unique to the health care field, and all-inclusive in its vision and outlook.

                                                                                                                         133 Morin, xxvi.  

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Reductive and/or analytical approaches to health care issues can neither account for, nor provide

sufficient comprehension of, complex and interrelated phenomena. Instead of accepting a

particular finding as “unknown” or considering the possibility of limitations within one’s thought

process, the reductionist will separate or isolate phenomenon from their intrinsic environment

and use the logic of “either/or.” 134

In comparison to many other health care professionals, osteopaths are unique in their approach

and analysis of human health and disease. The philosophy of traditional osteopathy embraces

the realization that with order comes disorder, with equilibrium comes disequilibrium; there is

constant interaction between the two for life to exist and function. Osteopaths practice and

provide care in an integrated manner, one that recognizes the principle of continuity and

contiguity within the human body. The osteopath acknowledges that there is a constant

interaction between two or more opposing variables, enabling life to exist and function. The

human body and spirit have a remarkable ability to organize and reorganize, to heal itself and be

free from disease; osteopathic intervention, combined with patient awareness and participation,

can not only facilitate the healing process but also expedite recovery and enhance patient health.

By leveraging the body’s inherent ability to heal, and in recognition of the body’s constant state

of flux, the osteopath can resolve much of the ambiguity and multiplicity unique to the disorders

experienced by patients and create order so that healthy structure can govern healthy function.

According to Morin:

“We need a kind of thinking that reconnects that which is disjointed and compartmentalized, that respects diversity as it recognizes unity, and that tries to discern interdependencies. We need a radical thinking (which gets to the root of problems), a multidimensional thinking, and an organizational or systemic thinking”.135

The above quote by Edgar Morin epitomizes what traditional osteopathy stands for. At the heart

of osteopathy is the concept of thinking outside the box, in an effort to understand the

complexity behind the interrelationships of the multiple systems of the human body, and

ultimately, to promote optimal health. Morin asks the osteopath to challenge the deeply

ingrained educational beliefs of the traditional medical model.

                                                                                                                         134 Morin, xxiii. 135 Morin, vii.

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Within this section of the paper, the author will explore the multifaceted paradigm of complexity

thinking and reasoning, examining how this model aligns itself to the critical thinking approach

taken by the traditional osteopath when assessing and treating patients. The complexity model is

often viewed as a “paradigm of simplicity” because it takes a transdisciplinary approach to the

organization of knowledge rather than the traditional reductive and disjunctive approach

common to many health care disciplines. The complexity paradigm challenges many of the

commonly held opinions and beliefs faced by osteopathy and other health care professions with

regards to EBM.

“For the systems theorist, human beings are part of a homogeneous, stable, theoretically knowable, and therefore, predictable system. Knowledge is the means of controlling the system. Even if perfect knowledge does not yet exist, the equation: the greater the knowledge the greater the power over the system is, for the systems theorist, irrefutable.136

The traditional osteopath would concur with Morin’s statement, in its application to the

grassroots foundation with what the profession originally stands for, which emphasizes the

crucial need to learn and develop expertise in all aspects of health and all of the manual therapy

skills that accompany it. The goal of the osteopath here is to internalize the relationships

between the systems of the body, which collectively construct “the whole”: one mind, one body

and one spirit. In today’s osteopathic environment (especially in the United States) this ideology

is commonly considered secondary to the need to justify patient outcomes with a research-based

methodology.

4.8.1   “Blind  Intelligence”    

Edgar Morin describes blind intelligence as the phenomenon whereby science destroys unities

and totalities. It involves the isolation of all objects from their surrounding environment in an

attempt to better predict, evaluate and quantify human existence. Blind intelligence is the term

coined to describe linearizing complexity to forms of simplicity.137 It is this very concept of

simplification that impacts the medical community through the segmentalization and formation

of hyper-specializations for all of its disciplines. This fragmentation process however does not

apply to the traditional osteopathic philosophy of education and clinical practice (which is the

                                                                                                                         136 Morin, 248. 137 Morin, 4.  

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holistic and comprehensive approach to the human body and its disease processes). The approach

of the practicing osteopath is unique in comparison to other medical disciplines; the osteopath

believes that complexity embraces not only all that is certain, but also all that is uncertain with

life, health and disease. For the osteopath, complexity enables one to view the fabric and

structure of the human body and all of its constituent parts as inseparable and interconnected,

creating “the whole” as an entity that thrives in an ever-changing environment.

Osteopaths view living beings not only as complex systems, but also as open systems. Every

part of the human body, every molecule and every cell undergoes a process of constant change

and renewal even though our physical structure and foundation appear to be the same. Our

interaction with the external environment is intimate and therefore impossible to predict and

calculate under normal circumstances. Methodologically, trying to study open systems is a very

difficult task to conceptualize because there are too many variables to measure in a self-eco-

organizing system like the human body and the world we live in.

There is an interesting paradox that exists between the self-organizing living system and the

simply organized artificial machine. It is the artificial machine where we see reliable elements,

however as a whole, much less reliable than its isolated parts. In fact if you have a mechanical

dysfunction affecting the parts, the whole breaks down. This is not the same reality for the self-

organizing living system, whereby the parts are not as reliable as the whole.138

...“We see that in an organism, the molecules, as well as the cells, die and are renewed, to the point that the organism remains identical to itself even though all of its constituent parts have been renewed. There is, then, as opposed to the artificial machine, great reliability of the whole and weak reliability of the parts”.139

                                                                                                                         138 Morin, 17. 139 Morin, 17.  

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4.8.2 Complexity and self-organization

For centuries, the culture of western science and medicine has been to simplify our complex

world into rudimentary units, with the goal of trying to quantify our health using statistical

calculations. We seek concrete answers to the many questions that we have regarding the

diseases we endure. Complexity science is searching for these very same answers, however it

looks beyond the quantitative methodology and investigates a qualitative point of view, whereby

random phenomenon, chance and uncertainty are embraced and the limits of our ability to make

bold predictions are recognized. The complexity paradigm of thinking is one that embraces

creativity and the self-eco-organized being, whereas classical science rejects the accidental, the

unexplainable, the individual.140 In today’s health care environment, medical practitioners

commonly separate the subject from the object in order to enhance the impartiality of the

information under study.

“The object is knowable, determinable, isolatable, and by consequence, manipulable. It holds objective truth and, because of this, is all for science; the subject, however is the unknown because it is indeterminate, because it is a mirror, because it is foreign, because it is a totality”.141

4.8.3 The paradigmatic turning point

The EBM paradigm that dominates our critical thinking in medicine is both reductionist and

quantitative. EBM is reductionist in the sense that its foundations of reasoning are clear, distinct

and segmentalized. Ultimately, EBM and reductionist science have a “divide and conquer”

mentality that is deemed acceptable in critical thinking forums. EBM is quantifiable because its

method of reasoning and conclusions are reproducible and calculable. This quantitative rationale

and reasoning is designed to maintain equilibrium while limiting contradiction or deviation.

Reductionist thinking wants us to “keep it simple”, to take a complex idea and break it down into

layman’s terms and follow a straightforward path of reasoning. Multiple problems in a system

were and are tackled piecemeal.142 To this day in the medical community, including the

                                                                                                                         140 Morin, 33. 141 Morin, 25. 142 Ahn, A.C., et al. The Limits of Reductionism in Medicine: Could Systems

Biology Offer an Alternative? PLos Med, 3(6), e208.doi/10.1371/journal.pmed.0030208 (May 23, 2006).

 

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osteopathic profession, the EBM paradigm maintains a stronghold on the decision-making taught

at institutions of higher learning and practiced in a clinical setting.

In contrast to EBM, the complexity paradigm of thinking, accepts order and disorder, harmony

and disharmony, and the co-existence of the subject and the object. Osteopathic practitioners

who follow the complexity paradigm embrace the uncertainty of life and the challenges that it

brings. It is the commitment to lifelong learning through education and clinical apprenticeship in

manual therapy that allows the well-informed osteopath to interpret a patient’s layers of

dysfunction, and help facilitate their road to recovery and optimal vitality.

Historically, when one is faced with contradiction in one’s reasoning, it signifies error and

minimizes the strength of conviction; however, under a complexity perspective, this same

contradiction opens up the doors for a deeper understanding of our reality that sometimes is

beyond human comprehension.143 The totality of knowledge, the completion of our

understanding, is not plausible, but rather it is ravelled in layers, in depths that cannot be

measured and statistically analyzed. So in essence, complexity theorists don’t want to abandon

the foundations of science and EBM, but rather they want to challenge the unjustified faith

everyone has in the analytical methods.144

Traditional osteopathic thinking shares the viewpoints inherent in the complexity paradigm in a

way that leaves them vulnerable to criticism from the rest of the medical community. The strong

push for quantitative data and the search for answers based on measuring a few interacting

variables within the universe we live in are commonplace in mainstream health care. Yet, while

isolation of the subject from the object and its environment is the foundation for following EBM,

this approach is viewed as unacceptable in the eyes of the well-informed osteopath. Osteopaths

recognize there is almost no predictive value to the complex phenomena of everyday life.

Osteopathy seeks to comprehend the relationships between the many systems of the body and the

intrinsic and extrinsic experiences confronted by patients. It is with this understanding that the

osteopath can provide effective intervention and measure his or her success.

                                                                                                                         143 Morin, 45. 144 Davis & Sumara, 25.  

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New ideas in the field of science, new theories and new discoveries, happen each and every day.

Consider the comparison of an individual grain falling into a pile, where the grain is an idea, and

the pile is the collective knowledge of the scientific community. New scientific ideas are

constantly falling into the “pile” of knowledge. A new idea may stick, and add to the growing

structure, or it may place a portion of the knowledge under such stress that the idea (and other

ideas) will topple. The toppling effect may stop quickly or may run for a long while — the

avalanche has no inherent or expected size. The smallest of scientific revolutions are happening

every day, and may involve only a few key ideas. In fact, much like the single grain, they may

be virtually invisible, just like the tiny earthquakes going on all the time beneath our feet. By

contrast, the largest revolutions may wipe away much of science as we know it, and are liable to

happen at any moment.145

Traditional osteopathy, much like the metaphor of the grain and the pile, recognizes the potential

for rapid and radical change within the scientific community. There is a potential revolution in

our midst as the medical community shifts towards research, technology and testing as the

driving force behind both education and clinical practice.

There are some key principles that govern the osteopath’s approach to the practice of manual

medicine:

• “Comprehensive Generalists”: Osteopaths approach patient care as “comprehensive

generalists”, leveraging a thorough understanding of anatomy, physiology and

pathophysiology, acknowledging all of the interrelated systems of the human body and

the effects that the external world has upon them.

• 10-finger osteopathy: The application of “educated touch” through 10-finger osteopathy

helps the practitioner to assess and treat patients utilizing their palpatory skills. In a

sense, this approach harkens back to the traditional, pre-technological treatment methods

used more than 100 years ago.

• System-based Exercise: The osteopath prescribes system-based exercises as a method of

treatment. For example: ELDOA (Etirements Longitudinaux avec Decoaptation Osteo-

Articulaire) or LOADS (Longitudinal Osteo Articular Decopatation Stretches).

                                                                                                                         145 Davis & Sumara, 48-9.

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These invaluable skill sets remain extremely relevant and effective to this day. The fact that

osteopaths continues to rely on these methods to improve patient health, sets them apart from

much of the medical community. A quote from the famous American naturalist, conservationist

and author John Muir, serves as a good summary of the osteopathic understanding of treatment:

“when we try to pick out anything by itself, we find it hitched to everything else in the

universe”.146

The following principles fall under the umbrella of the complexity paradigm and help it take

shape as a future model of critical reasoning for the osteopathic profession.

4.8.4 Emergence and self-organization

Edgar Morin defined emergence as “qualities and properties that appear once the organization of

a living system is constituted, qualities that evidently do not exist when they are presented in

isolation”.147 Systems like the human body possess the property of self-organization – the ability

to structure themselves, to create new structure, to learn, diversify, and complexify.148

To the osteopathic practitioner, the principles of emergence and self-organization are

synonymous. When one has taken the time to assess the mechanical and fluidic systems of the

body, has identified the many lesions (primary, secondary, tertiary, etc.) and begins treatment,

one really doesn’t know how the human body is going to respond to the change of input one is

creating. Each patient is unique (and somewhat unpredictable) given that the osteopath may

generate different reactions and/or responses when delivering the same treatment method to

multiple individuals. An individual patient’s “sensitivity” may be unknown for the first few

visits. One cannot predict the number of treatments it may take to resolve any one issue since

each patient is complex and unique, with distinct problems and aliments in terms of acuteness or

chronicity. Emergence and self-organization are remarkable processes that represent a real

opportunity for the osteopath, who can tap into and facilitate the body’s inherent, organic ability

to heal.

                                                                                                                         146 Davis & Sumara, 57.  147 Morin, 5. 148 Meadows, D. H. Thinking in Systems. (White River Junction, Vermont: Chelsea Green Publishing, 2008), 81.

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The notion of emergence implies that within a complex system of events (and an ever- changing

environment) a critical point will be reached, known as a “critical mass”, signifying that a

transitional phase is reached and a sustainable autocatalytic state occurs.149 What this means to

the osteopathic clinician is that as one assists the body in the healing process, there is a point in

the treatment when the auto-normalization of the body takes over and makes the necessary

corrections and adaptations to maintain the new and improved state of healthy being. There is a

“changing of the guard” if you will, with the mapping or patterning that takes place in the

physical and the neurological systems of the body. Utilizing manual therapy skills and exercise

prescription, the osteopath establishes a mutual interaction and exchange of information with

their patients in an attempt to mould and enhance the plasticity of their body’s self-organization.

4.8.5 Principle of Disjunction

In explaining the Principle of Disjunction, Edgar Morin identifies that separation (between

objects, disciplines and notions, between subject and object of knowledge), should be substituted

by a principle that maintains the distinction, but that tries to establish the relation.150 For the

osteopath, there is a need to accept both the order and disorder that surround us and acknowledge

their interconnectedness. Secondly, one must recognize that if the order and disorder are

internalized, they will inevitably alter the way one views the world in which we live.

4.9 Holism

The term “holistic” was first coined by the founder of the League of Nations, one Jan Smuts, in

the mid-1920s as a means of describing everything pertaining to human behaviour. Smuts’

definition was profoundly and fundamentally different from the prevailing views of the

reductionist perspective. In a sense, Smuts’ “holism” was an antidote to the reductionist

epistemology, which underlies modern scientific thought.151 However under the complexity

paradigm (and for the traditional osteopath), holism represents an ideology that is built into the

very fabric of existence, as a thinking process and a medical discipline.

                                                                                                                         149 Mason, 33.  150 Morin, 7. 151 Carlson, R.J. Holism and Reductionism as Perspectives in Medicine and Patient

Care. The Western Journal of Medicine, 131 (1979): 467.

 

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4.10 Fragmentability

The term “fragmentability” pertains to the reduction of systems to their material parts, leaving

recognizable material entities as the end results. A system is not considered to be fragmentable

if something essential about the system is destroyed when it is reduced to its separate parts. The

human body is a classical example of a complex system that has interdependent functional

components, so therefore, by definition, it is not fragmentable.152

4.11 Information-feedback system

Systems of information-feedback control are fundamental to all life and human endeavours.153

Throughout the patient-osteopath interaction process, there is a constant flow of information-

feedback (positive and negative) as various states of disease, re-patterning and re-programming

of the patient’s body transforms their health status.

4.12 Open systems versus closed systems

All living systems of the world, especially the human species, are essentially classified as open

systems whereby there is an intrinsic relationship between the body and the external

environment. These types of dynamic systems require input and output for feedback. Open

systems create an equation of equilibrium and a constant interaction with their surroundings;

inputs and outputs are equal. In contrast, closed systems do not have an interchange with the

environment, but rather they are isolated from the outside world, entirely cut off from external

factors; there is no interaction.

4.13 Resilience

Resilience is the ability to spring back into shape or to return to an original position after being

stretched or pressed. This is also known as elasticity. Resilience is a measure of a system’s

ability to survive and persist within a variable environment.154 Resilience arises from a rich

structure of many feedback loops that can work in different ways to restore a system, even after a

large perturbation.155 The human body is an astonishing example of a resilient system. It can

                                                                                                                         152 Mikulecky, 108. 153 Meadows, 25. 154 Meadows, 76. 155 Meadows, 76.  

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fend off thousands of different kinds of invaders, it can tolerate wide ranges of temperature and

variations in food supply, it can reallocate blood supply, repair sprains and strains, and gear up or

slow down metabolism. Resilient systems are neither static nor constant over time, but rather

they are dynamic.156 During treatment, the osteopath is affecting all of the different systems of

the body, increasing the resilience of the human body, improving its ability to fight disease, and

enabling the patient’s health to flourish.

4.14 Robustness

Robustness is defined by the ability to maintain stable functioning despite various perturbations.

Natural systems such as the human body demonstrate an uncanny ability for robustness, which is

necessary for survival and evolution. Robustness is attained by the mechanisms of feedback

control, structural stability, redundancy, modularity and adaption.157

4.15 Hierarchical systems

All living organisms are arranged in hierarchies. Hierarchies evolve from the bottom up (cell,

organ, organism and so forth). The purpose of the upper layers of the hierarchy is to serve the

functions of the lower layers.158 Osteopaths influence all levels of the human systems’ hierarchy

through local and global intervention, and through mechanical and fluidic treatment. One of the

more common beliefs of the osteopathic profession highlights this hierarchical system; “micro-

movements produce macro-function”.

4.16 Entropy

The term entropy comes from the Greek word “entropia” meaning “a turning toward” and was

coined by Clausius to describe the Second Law of Thermodynamics (discussed previously in this

thesis, under the section on Order and Disorder). Entropy describes the tendency of a closed

system, at equilibrium, to move from a state of higher available energy and asymmetric order

(low entropy) to a state of lower available energy and symmetric disorder (high entropy); most

living organisms generally begin at a state of low entropy and grow in the opposite direction

                                                                                                                         156 Meadows, 77. 157 Ahn, 7. 158 Meadows, 84-5.

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towards greater order and complexity.159 In other words, entropy is a measure of uncertainty

and/or complexity within a living system. A high value of entropy means that a large amount of

information is needed to describe an outcome for which there is a great deal of uncertainty, and

therefore complexity is high.160

4.17 Ambiguity

One of the most challenging aspects of being an osteopath, and for that matter any health care

professional, is the ambiguous nature of one’s daily work. Providers need to understand that

there are different ways to approach the same problem, that there is no right answer to a

situation, no magic formula for best practice, no assurance that any particular act or practice will

yield the results that we desire.161 Like a detective, the osteopath should approach this ambiguity

as a “missing clue” and enthusiastically pursue the “culprit”, the inherent cause of the patients

aliment; in a sense hypothesizing, speculating as to the underlying reasons for disease processes.

Osteopaths confront circumstances of uncertainty head on and adapt with their unique clinical

knowledge and complex ways of thinking about the body and disease. The osteopath realizes

that when dealing with patients in a time-oriented interaction, new levels of thought emerge and

new insights are created; these insights loop back on themselves and raise consciousness to a

new height.162

4.18 Attractors

Comprehensive predictability is lacking within complex systems. However, patterns of

behaviour do exist, which provide clues about the system. These patterns are referred to as

“attractors” - they have a unique characteristic of reproducibility known as “patterns of points”.

In the clinical setting, osteopathic practitioners recognize attractors and patterns of mechanical

and visceral restrictions that afflict the body and its surrounding tissues, using precision

palpation skills. These attractors go undetected when using conventional diagnostic testing

instruments.                                                                                                                          159 Topolski, S. Understanding health from a complex systems perspective. Journal of Evaluation in Clinical

Practice, 15 (2009): 750. 160 Costa-Santos, C., et al. Complexity and categorical analysis may improve the interpretation of agreement studies using continuous variables. Journal of

Evaluation in Clinical Practice, 17 (2011): 512. 161 Doll & Truiet, 846. 162 Doll & Truiet, 846.  

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4.19 Linear minds in a non-linear world

Linear relationships are understandable; linear equations, solvable. Linear systems have an

important modular virtue: they can be taken apart and then put back together. The pieces of the

system add up. Non-linear systems on the other hand (generally) can neither be solved nor put

back together. Nonlinearity means that the very act of playing the game has a way of changing

the rules. This factor of odd changeability makes nonlinearity difficult to calculate, but it also

creates rich and abundant qualities of behaviour that never occur in linear systems.163 This

dynamic changeability, with infinite possibilities and opportunities, encapsulates the essence of

how the traditional osteopath views medicinal therapy and treatment. It is with an appreciation

for changeability and an unyielding commitment to challenge mainstream thought, that the

osteopath aims to promote well being amongst their patient population.

4.20 Complexity and clinical knowledge

Osteopathic practitioners view their interactions with the human body as a complex process and

challenge the perception of what constitutes scientific knowledge, research and the application of

the “scientific method”. The results that one interprets from appraising current research need to

bring to light the methods used rather than treating the individual patient with a generalized

approach. The effects of population-based studies and their interventions cannot be considered

as predictable outcomes for individuals. The osteopathic practitioner therefore needs to come up

with new ways that embrace the intimate relationships between individuals, such as the

qualitative methodological approaches, and specifically case study analysis.164

Nicolis and Roughgarden suggest that “Practicing medicine required interpretive skills –

recognising the patterns of symptoms and signs that are the essence of an expert clinical method.

These methods of knowing have more in common with the social sciences, economics and law

than the physical sciences. They believe that we should acknowledge the richness and

complexity of the social interaction that sits at the heart of the therapist-patient relationship and

move away from measurement and reductionist methods”.165

                                                                                                                         163 Meadows, 91. 164 Sweeney & Griffiths, 69. 165 Sweeney & Griffiths, 70.  

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4.21 Suggestions for Complexity research methods

Under a complexity paradigm of thought, osteopathy should adopt a research methodology that

includes: case studies that are qualitative, participatory, multi-perspective and collaborative (self-

organized) and partnership-based forms of research, premised on interactionist, qualitative and

interpretative accounts.166 This framework highlights the “new science of qualities” alongside the

current trend of quantities and is therefore relevant to the osteopath. The reason for having a

distinctive set of research criteria (different from the protocols currently being used) is that under a

complex system, too many variables co-exist and cannot be sufficiently or accurately portrayed under

the current modelling system of research.

When conducting research about osteopathic manual therapy, its interventions and treatment results,

one has to understand the broad scope of its intentions. Osteopaths view the human body, mind and

spirit as an open system, one that provides feedback, is adaptable, capable of self-organization, and

emerges towards a state of optimal health. Osteopaths know that when one treats a patient’s disease

states under a complexity system, the inevitable occurrences of change, unpredictability and

disequilibrium should be embraced in order to optimize survival. In addition, clinical osteopathic

practitioners who apply “complex adaptive systems” to treat patients understand the need to balance

the intrinsic systems of the body while accounting for any adjustments by the extrinsic environment

that influence the body. Traditional osteopaths who view the human body as a collection of interrelated

systems, which are evolving, dynamic, mechanical and fluidic, understand that under an EBM

paradigm, the manipulation of variables in a controlled environment does not provide an accurate

depiction of clinical results and can consequently be very misleading.

Therefore, as a measure to improve the research methodology behind studying human endeavours, the

author has outlined a few suggestions that might be more appropriate in capturing the essence of the

osteopathic-patient encounter.

Qualitative study design: Complexity research methodology focuses on small groups of individuals,

attempting to capture the richness of individual experiences.167 Supporters of quantitative studies

criticize the qualitative study design for not being generalizable across large population domains.

                                                                                                                         166 Mason, 3. 167 Mason, 153.  

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However, since the traditional osteopathic practitioner assesses and treats each patient as a unique case,

the “bottom up” results of qualitative studies (as opposed to “top down” results) are the preferred

method of reasoning. The individual human being is thought of as a dynamic system, where genetic,

environmental, biological, sensory, emotional and conscious processes all continually work together to

keep the person healthy.168

Cross-sectional and comparative analysis: These forms of analysis are used to identify important

types of patterns and linkages and outline the flexibility of the variables and measurements being

studied.169

The application of complexity research and forms of thinking (and deduction outright) challenges the

“gold standard of research methodology” with randomized controlled trials. Classical experimental

methods, abiding by the need for replicability and predictability, may not be entirely accurate and

advantageous since, in a complex world with complex phenomenon, results are never clearly replicable

or predictable.170 To atomize phenomenon into measurable variables without embracing multiple

interacting elements, is to miss synergies and the significance of the whole.171

Complexity offers principles; it does not substitute for thoughtfulness. Complexity presents additional

or alternate ways of thinking about the organization of the world, while simultaneously pointing to the

impossibility of accuracy in knowledge and prediction. The author believes this is one of its greatest

advantages. By engaging the paradigm with an open mind, complexity can foster reflection and

thoughtfulness, to the benefit of both the patient and osteopath. By accepting complexity as conceptual

and theoretical, one can engage in an imaginative, creative process that enables the osteopath to convert

complex ideas into particularities. Complexity does not offer tried and true research “recipes”, but

rather a framework to consider alternatives and ask meaningful questions. Through a researcher’s

engagement with complexity, in combination with a detailed osteopathic intervention and researching

preferences, one can evolve appropriate complexity-informed research approaches and strategies.172

                                                                                                                         168 Mason, 160. 169 Mason, 154. 170 Mason, 25. 171 Mason, 25.  172 Mason, 177.

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Table 5

Key features of a Complex system

COMPLEX SYSTEMS - KEY FEATURES

1. Consist of multiple components. These systems are only understood by observing the rich interaction of these components, and not merely understanding the system’s structure.

2. The interaction between components can produce unpredictable behaviours.

3. Have a life history and are sensitive to initial conditions or patterning.

4. Interact with and are influenced by their environment.

5. The interactions between elements of a complex system are non-linear. Small inputs may have large effects, and vice versa. It is this nonlinear interconnectivity that places fundamental limitations on one’s ability to validate the models of complex systems.

6. Interactions between elements of the system generate new properties, called “emergent behaviours” of the system, which cannot be explained by studying the elements of the system.

7. Emergent behaviour cannot be predicted.

8. Are open systems: when observed, the observer becomes part of the system.

9. The elements of complex systems interact dynamically by exchanging energy or information.

10. Operate at conditions far from equilibrium.

11. Have memory or history that is captured at both microscopic and macroscopic levels.

12. Have no boundaries. Boundaries are inferred only as a way to allow one to begin to make sense of one’s surroundings.

13. Are incompressible, that is, it is impossible to have an account of a complex system that is less complex than the system itself without losing some of its aspects.

173 174 175

                                                                                                                         173 Sweeney & Griffiths, 2. 174 Cilliers, P. What Can We Learn From a Theory of Complexity? Emergence 2(1) (2000): 24. 175 Richardson, K., et al. Complexity Science: A “Gray” Science for the “Stuff in

Between”. Emergence, 3(2) (2001): 7-8.

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4.22 Summary of Complex systems

The patterns of complex systems represent dynamic components and resultant interactions that

are unpredictable. The whole is irreducible and the cause and effect cannot be separated because

they are intimately intertwined and highly contextualized. Unlike “best practice” models,

complex systems acknowledge multiple layers of dynamic knowledge. Such knowledge cannot

validly and reliably be organized into simple or complicated “evidence-based guidelines”.176

The practice and philosophy of traditional osteopathy embraces this dynamic approach known as

complexity. Osteopathy internalizes the belief that our existence and our environment are ever-

changing and active, never static. Too many of life’s tangible and intangible variables (work,

stress, finances, etc.) impact our physical, psychological and spiritual well-being to be accurately

represented and quantitatively predicted by population-focused research criteria.

“There are no easy answers or simple solutions, because complexity science, by design, does not pretend to offer them. Instead, it offers diverse avenues for discovering what may end up being a multiplicity of answers that are differentially sensitive to and grounded in specific circumstances, conditions, people, times and places. Therein lies the real promise of the complexity science tapestry”.177

4.23 The 10 principles of Complexity and how they relate to the osteopathic profession

1. Self-Organization: The tendency to spontaneously create order. It cannot be

predetermined in any quantifiable way, or even planned, but it has a definitive impact on

the healing process of the body.

2. Emergence: Is the property of complex systems through which self-organization takes

place.

3. Connectivity: There are varying degrees of connectivity. Not all connections are

equally strong. Yet all of the systems of the body (barring certain disease states) are in

continuity and contiguity with each other. One of the objectives of the osteopathic

practitioner is to facilitate this interconnectedness.

                                                                                                                         176 Martin et al, 416. 177 Richardson & Cilliers, 17.  

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4. Interdependence: The connectedness of the body causes the systems to be

interdependent on each other. This influence is both internal (within the body) and

external (caused by the environment).

5. Feedback: In complex systems, small perturbations can amplify to cause a huge impact.

Alternatively, relatively large perturbations may have minimal impact. This reciprocal

feedback system underscores a famous osteopathic saying “micro-movements produce

macro-function”.

6. Far from Equilibrium: The world around us is constantly changing or at least requires

significant effort to be kept the same. This effort does not refer to maintenance, but

rather the effort required to manage or avoid change.

7. Space of Possibilities: Complexity suggests that to thrive (not just survive), an entity

needs to explore its options and generate variety. Complexity theory also proposes that

the search for a single “optimum” strategy may neither be possible nor desirable. In a

complex system like the human body, it is not possible to explore all possibilities that are

available. Quite simply, there are always more possibilities than what we have time to

explore.

8. Co-evolution: A process whereby every entity constantly undergoes an evolution to a

new order, irreversibly changing. To initiate change, something as complex as the human

body does not require intervention. It is constantly evolving to new order through co-

evolution.

9. Historicity & Time: The body has a memory, a history of its experiences. These

memories, both positive and negative, are deep-seated and evolve over one’s existence.

Some of these experiences are easy to adjust and influence, while others are more

difficult to change.

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10. Path dependence: Over time, the decisions people make can have an impact that will

determine whether certain courses of action are possible. Past choices define future possibilities

and options. There is however a degree of unpredictability along this path.178

4.24 Osteopathic research

For the osteopath working in the community alongside other manual therapists and medical

practitioners, the EBM paradigm appears to be streamlining decision-making and patient care.

All of these disciplines are moving towards standardization of care models and research

protocols that try to validate the efficacy of their treatment interventions. Although this initiative

seems straightforward and just, the conclusions that are drawn from these population-based

studies are very often inconclusive.

Traditional osteopaths understand the limitations of the EBM methodology and would rather are

inclined to adopt a more holistic approach to understanding disease, human strife and struggles;

in essence accepting that diversity of expression is what complexity embraces and what

reductionism ignores. Reductionism dismisses the circular interplay between the material body

and the impalpable mind, spirit, feeling, and belief.179 Throughout this paper, there has been a

recurrent theme outlining the dominance of objective, quantifiable and reproducible

methodologies that have taken precedence in osteopathy and the rest of the medical disciplines

around the world. The subjective experiences, the immense and unique constellation of factors

in and around the patient, are often seen as too “soft” for the scientific community; yet rather

favour linear causality – one way cause-effect relationships.180 It is this segmentalized

framework within the reductionist paradigm that fails to meet the requirements of osteopathic

research. The totality of the human systems, their interactions, their interconnectedness

(physical, chemical, mental, emotional, social and environmental) is what research studies

should embrace if they are to stay true to the roots of the founding fathers of osteopathy. What is

more, when the human body is restored to its context, new light is cast on each part: properties,

                                                                                                                         178 Van Thinking 10-day Online Course on Complexity Thinking. 179 Korr, I. M. Osteopathic research: The needed paradigm shift. JAOA, 91(2) (1991): 162. 180 Korr, 162.  

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functions and interactions emerge that are not evident in isolation but only realized as a whole

unit.181

One of the major creeds of the osteopathic profession is “the body’s powerful ability to heal

itself”. A body comprises all of the homeostatic, defensive, and healing functions, the capacity

for self-repair and regeneration.182 It is the role and responsibility of the osteopathic healer to

support these natural functions of the body so that the patient can heal naturally, from the inside

out. It is these intrinsic mechanisms present within the human body that allow for the recovery

from disease, a process that osteopaths attempt to complement. This key understanding of the

body’s wholeness, and its natural abilities to recover, is at the core the very definition of

osteopathy, especially in comparison to other health care providers. It would seem logical then,

that our research design methods should embrace these very ideas.

4.25 Study design

A study design is needed that can accurately assess the effect of treatment, the impact that

treatment has on the total person and make possible comparisons with other systems of care.183

Most clinical trials are designed to assess the effects of therapy on a given clinical problem. The

therapy however, is often so uniform and standardized that its effect is hardly, if at all,

influenced by the person who prescribes or administers it. It matters a great deal, however, who

administers the osteopathic intervention, when one considers the experience, training, treatment

techniques, choice of diagnostic reasoning, etc.184 This variability is further compounded by

variation in response, not only between individual patients but also between visits, and even from

moment to moment as the osteopath treats and assesses tissues, considers a patient’s responses

with to each technique, and then selects and applies succeeding manoeuvres accordingly; there is

a feedback system between patient and therapist at all times, a “silent dialogue” in which each

responds to the other’s changing input.185

In traditional clinical trials, the methodology behind randomization of patients is that they are

representative of the existing population. Subjects are then divided into experimental and control                                                                                                                          181 Korr, 162. 182 Korr, 162. 183 Korr, 167. 184 Korr, 167. 185 Korr, 167.  

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groups; this is the foundation of how the study is designed and compartmentalized. This format

attempts to compensate statistically for unavoidable sources of ambiguity, such as the variability

scenarios in the underlying effects of therapy intervention described above. Ironically, it is these

unpredictable variations in the patients’ responses (or lack of responses), from one treatment

session to another, which osteopathy endorses as changes that must be embraced in the ongoing

search for a more representative research style.

Another inaccuracy that should be highlighted from the osteopathic perspective is the arbitrary

and spontaneous improvements and recovery that sometimes occurs in patients, in the absence of

treatment.186 To compensate for such occurrences, a placebo or sham treatment is administered

to the members of the control group, who are matched as closely as possible (by age, sex, clinical

status, etc.) to the experimental group, who are in fact receiving the real treatment intervention.

Both groups of patients and their evaluating research staff are “blinded” from the group

allocation process and the treatment application (i.e. who is getting what?).187 In any case such

as this, the “placebo therapy” appears to be virtually identical to the real therapy and a

favourable response by the placebo group to the placebo therapy is deemed the “placebo effect”.

This has to be taken into statistical consideration in the assessment of efficacy of the treatment

being tested.188

To the traditional osteopathic practitioner, the response to the placebo effect” (or any noted

improvements by patients to the sham intervention) is still an active response of the patient’s

intrinsic healing mechanism and is a very complex and interesting phenomenon that is difficult

to explain and rationalize. These positive effects can be justified by the numerous intangibles

that occur within human species including their dynamic emotional and spiritual beliefs. For

example, confidence in the treatment protocol, optimistic attitudes and belief structure, positive

outlook, faith and hope are all factors that cannot be discounted within the complex realm of

healing. The osteopath must acknowledge and embrace the possibility that each individual

patient is capable of such “natural” potential. Osteopaths want to encourage these and other very

real emotional experiences and not suppress them simply due to their ambiguousness. A manual,

hands-on relationship with the patient throughout the treatment process is of optimal importance

                                                                                                                         186 Korr, 167. 187 Korr, 167. 188 Korr, 167.  

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to the osteopath. The palpation and intimate physical and social contact, the direct

communication (both verbal and non-verbal), the confidence factor elicited by both parties, in

particular by the experienced practitioner, are all of vital importance and yet, they are changeable

and unpredictable from one treatment session to another. Therefore, that which is regarded as a

nuisance and source of error from one perspective is viewed as an essential source of clinical

results from the osteopathic perspective.189

How can one objectively measure all of these intangibles that are of extreme relevance within a

research study? Is it possible? It is here that there exists a very real dilemma for osteopaths who

are pressured to “show efficacy” to the rest of the medical community, so that it can be analyzed

and likely scrutinized.

It is widely believed that to properly measure osteopathic treatment interventions, there should

be changes to study design, which can be tailored to what is actually occurring in the clinical

setting. The design has to somehow incorporate the patient-therapist interaction and ongoing

relationship since this is integral to the underlying success of the treatment. This cannot be

separated, blinded, and/or mathematically calculated because too many uncontrolled variables

exist within a one-to-one interaction, let alone multiple patient interactions. This is the reality of

the clinical environment in which the osteopath operates. Therefore, in order to have an

experimental study design that reflects the true treatment environment of the practicing

osteopath, some realistic suggestions have to be presented for discussion:

1. Use of case-by-case studies that focus on the individual patient-therapist interaction and

results.

2. Osteopathic techniques and manual hands-on interventions cannot be standardized and

uniform; their “dosages” cannot be confined.

3. The “placebo response” is an important factor, an inseparable aspect of the patient’s

changing profile towards the osteopathic care they are receiving.190

In consideration of the obvious constraints that exist with designing research in line with the

reality of osteopathic practice, there are a few models that may be better aligned with this

                                                                                                                         189 Korr, 168. 190 Korr, 168.  

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particular medical discipline. The first is the Medical Outcome Study (MOS). In the MOS, there

are six categories of criteria for clinical outcomes, each of which includes a number of

quantitatively assessable items that are collectively amendable to a high degree of reliability for

statistical analysis:

• Physical functioning (ability to perform a variety of physical activities).

• Role (ability to carry out daily activities such as housework, vocational work).

• Socialization (ability to conduct social and group activities, visiting with friends).

• Mental health (general mood or affect, sense of well-being).

• Health perception (self-rating of current health in general).

• Bodily pain.191

Other research protocols and designs that are worth investigating and encapsulate the complexity

behind osteopathic reasoning are intra-subject (so called “N of 1”) and inter-subject designs

involving smaller sample sizes of individual patients or emphasis on a clinical trial involving a

single case study.192 Lastly, if a comparison study wants to be conducted involving traditional

osteopathy and allopathic medical care then longitudinal studies on comparative outcomes, such

as incidence of minor illnesses and disabilities and of various diseases, degrees of recovery, etc.

would be of great interest and value.193

4.26 Osteopathic education

Academic institutions offering courses in osteopathy typically follow one of two paths: They

either adopt an EBM philosophy and this paradigm is deeply integrated into the practices and

teachings (i.e. those offered at many universities and private colleges) or they implement the

complexity paradigm as the preferred approach to osteopathy (i.e. such as that offered through

the Académie Sutherland d’Ostéopathie du Québec). Complexity science offers an antidote to

the fragmentation of professional health education; it provides a different way of understanding

the medical practice, and the education process that is essentially preparation for that practice.194

                                                                                                                         191 Korr, 169. 192 Korr, 169. 193 Korr, 169. 194 Mennin, S. Complexity and health professions education. Journal of Evaluation

in Clinical Practice, 16 (2010): 835.

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“Educators in all fields need to rethink not only the model used for instruction but also the “very concept of model”. Some prefer the dynamic, ambiguous interplay of complex events that draw more on metaphor than on model. Where models provide a single representation, metaphors provides alternative ways of understanding that hinge upon the unique conditions of each situation and the participants and objects involved. Ambiguity is necessarily embraced as a fundamental aspect of complex systems, of the messiness of “lived” experience, rather than as something to be eliminated or controlled”.195

Each practitioner has their own unique style of grasping concepts, retaining and duplicating

medical information and applying the information in a clinical practice setting. However, the

context and the actual learning process in osteopathy have to be dynamic, collaborative and

productive. The problem-based tutorials commonly taught in many academic institutions today

are a prime example of this dynamic approach to learning. That being said, the author is of the

opinion that more emphasis should be given to the craft, art and science of osteopathy, more

approaches provided that encourage students to think differently, to think “outside the box”; the

ability to integrate (in a meaningful way) all of the information pertaining to the systems of the

body and their unique interrelationships, is a key component of an osteopath’s success when

solving the many problems that can afflict human life.

Osteopaths are health care professionals who think differently, do things differently and bring

different approaches when looking at the injuries of the body. Traditional osteopaths are trained

to process information and examine for causation and not to focus solely on patient

symptomology. These differences are integrated as an emergent property in reasoning and

understanding of self-organization (in terms of a patient’s health and as a healing practitioner).

The author has experienced first-hand the positive influence of both problem-based and group

tutorial sessions as effective means of learning the medical concepts pertaining to disease and

dysfunction. However, in some cases, there was a strong EBM component to this learning

process, which unfortunately proved to be very ineffective in streamlining favourable evidence

towards therapeutic interventions. It is time to take this group learning format and integrate a

new conceptual shift by allowing complexity science and paradigms of thinking to gain

pedagogical traction and have a positive influence on schools of osteopathy.

                                                                                                                         195 Mennin, 835.

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Chapter 5: Comparing EBM and Complexity models of low back pain

______________________________________________________________________________

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5.1 Appendix A - Osteopathic manipulative treatment for low back pain: a

systematic review and meta-analysis of randomized controlled trials.

It is the intention of the author to clarify the differences in logic and reasoning between the

osteopath following the EBM philosophy versus the one following that of complexity thinking.

In this chapter, the author will review one of the most common clinical conditions encountered

by osteopaths, low back pain. The author will compare and contrast the EBM and Complexity

approaches, their unique interpretations of the condition, and ultimately the inconsistencies of

their findings. See Appendix A or visit http://www.biomedcentral.com/1471-2474/6/43 to

read the article.

5.1.1   Critical appraisal checklist for systematic reviews

This critical appraisal checklist for systematic reviews is used as a guideline for the health care

professional to evaluate the validity and reliability of the research articles; ultimately, to make

the determination as to whether the collaborative results of the studies support a clinical

intervention that can be effectively utilized for patient care.

Are the results valid?

QUESTION YES CAN’T TELL NO Did the review explicitly address a sensible clinical question?

Yes – to assess the efficacy of OMT (osteopathic manipulative technique) as a complementary treatment for low back pain.

Was the search for relevant studies detailed and exhaustive?

Yes – search strategies (timetables, databases and search terms) were clear and outlined in an on-line appendix.

Were the primary studies of high methodological quality?

Yes – six randomized controlled trials (RCT’s) of OMT were included.

Were assessments of studies reproducible?

Yes.

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What are the results?

QUESTION YES CAN’T TELL NO Were the results similar from study to study?

Yes – OMT significantly reduced low back pain.

What are the overall results of the review?

OMT is an effective tool for the treatment of low back pain.

How precise were the results?

Confidence interval of 95% for short-term, intermediate-term and long-term follow up. Both best-case and worst-case scenarios demonstrated a greater reduction in pain with OMT. The meta-analysis results are quite robust as indicated by the comprehensive sensitivity analyses.

How can one apply the results to patient care?

QUESTION YES CAN’T TELL NO How can I best interpret the results to apply them to the care of patients in my practice?

Taking manual therapy courses in osteopathic spinal manipulation is an effective tool to have in treating low back pain.

Were all clinically important outcomes considered?

Yes.

Are the benefits worth the costs and potential risks?

The benefits of OMT were outlined for low back pain.

Potential risks were not outlined.

196 197 198

                                                                                                                         196 Critical Appraisal Skills Programme (CASP), Public Health Resource Unit, Institute of Health Science, Oxford. 197 Oxman AD, Cook DJ, Guyatt GH. Users’guides to the medical literature. VI. How to use an overview. JAMA 272 (1994): 1367-1371. 198 Oxman AD, Cook DJ, Guyatt GH. Users’ guides to the medical literature.1E. Summarizing the Evidence. AMA (2002): 155-173.  

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Additional critical appraisal information not outlined in the critical appraisal checklist:

Advantages

• Exclusion criteria / eligibility criteria was provided.

• Each eligibility trial was independently reviewed by two of the researchers in order to extract data on methodological characteristics. Conflicting data were resolved by consensus.

• Potential study limitations were outlined and accounted for.

• Study was not funded by party of interest.

Disadvantages

• No clear definition/description of what Osteopathic Manipulative Treatment (OMT) entails.

• Confusion as to the type of spinal manipulation used (distraction, translation, extension, flexion techniques).

• Confusion as to what defines low back pain (lumbar spine, sacroiliac, pelvic, sciatica, hormonal).

• Inter-rater reliability issues with regards to treatment intervention (different osteopathic practitioners, from experienced clinicians to students).

• The study didn’t discuss the risks and or benefits of OMT.

5.2 Understanding osteopathic philosophy and reasoning and applying it in clinical

practice

To grasp the true essence of the osteopathic profession, it is important for one to embrace the

teachings of Andrew Taylor Still, the founder of osteopathic medicine. Still believed in the

philosophy of a solid foundation in anatomy and physiology as the basis for sound medical

practice. He emphasized the importance of the intense study of the “human machine”.199

Practicing osteopaths generally agree that there are a handful of crucial beliefs that distinguish

them from other health care professionals:                                                                                                                          199 Northup, G.W. A compilation of the thoughts of George W. Northup, DO, on the philosophy of osteopathic

medicine. JAOA, 98(1) (1998): 53.

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• The body is a unit; the person is a unit of body, mind and spirit.

• The body is capable of self-regulation, self-healing and self-maintenance.

• Structure and function are interrelated and interdependent.

• Rational therapy is based on an understanding of the body unity, self-regulatory

mechanisms, and the interrelationship of structure and function.

• Motion is the chief means for maintaining physiological harmonies. The motion and

activity of every cell and every organ in the body have rhythmical movements.200 201

5.3 Osteopathic reasoning using a Complexity paradigm of thinking for patients with

low back pain

Traditional osteopathic clinicians who practice under the umbrella of the complexity paradigm

have a very methodical examination process when assessing and treating patients, possibly one

that is more thorough than health care providers in many other disciplines. First and foremost,

osteopaths have a temporal relationship that is critical to their success, in that they allocate a

significant amount of time to the patient-therapist encounter. Depending on the dysfunction or

disease state that the patient is experiencing, the osteopathic practitioner will typically allocate

between 45 minutes and 1 hour of assessment and/or treatment to facilitate in the healing

process. In addition, the scope of the relationship is holistic and comprehensive. Consider the

following example of a typical osteopathic examination (using the complexity paradigm) of low

back pain and the rationale applied to treat the patient:

5.3.1 Subjective assessment

It is common for health care professionals who practice manual medicine to ask their patients

detailed questions, as a means to investigate potential sources of a disease or dysfunction (i.e.

location of pain, current and past pain patterns, mechanism of injury, VAS – visual analog scale

for measuring pain intensity and irritability, aggravating and easing factors, etc.). However, the

osteopath will go beyond peripheral investigative techniques, performing a more elaborate

assessment, one that includes an evaluation of the 11 systems of the body. Following the                                                                                                                          200 Northup & Peterson, 53. 201 Lyne, S.T. Osteopathic Philosophy of the Cause of Disease. JAOA, 100(3) (2000): 181-2.

 

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rigorous methodology of the complexity paradigm, the osteopath is often able to discover the

root cause of various disorders not typically considered by many other medical disciplines or

found using diagnostic technologies. For example, surgical interventions such as hysterectomies,

C-sections, appendix and gallbladder scars may be linked to visceral restrictions that cause many

of the hidden pelvic and spinal disorders. Osteopaths are always digging beyond the surface for

information from the patient’s past, even as far back as their birth, to determine if any of their

“life experiences” can shed light on the holding patterns that contribute to their dysfunction. In a

sense, the osteopath views the patient much like one would view an iceberg, where only a small

amount is visible on the surface, but a huge percentage of the whole remains out of sight.

5.3.2 Objective assessment

When it comes to the objective assessment and the physical palpatory exam (some refer to this as

the beginning of the 10-finger osteopathy experience), the osteopath will often evaluate the entire

body, from head to toe. Osteopaths are less concerned with the symptomology of the patient and

more focused on causation, the culprit(s) behind the symptoms, and not the effect itself. During

a thorough low back examination, the osteopath will perform an in-depth assessment of the

descending and ascending forces that act upon and influence the body’s centre of gravity. One

will perform weight-bearing and non weight-bearing assessments of the pelvic axes (22 in all)

for quality of sacroiliac, pelvic mobility and alignment. This manual therapy approach is a true

osteopathic expression of complexity thinking based upon a theoretical and biomechanical

model. All of the biomechanical links above and below the pelvis are assessed using active and

passive movement techniques to rule-in and rule-out articular asymmetries. All fascial and

connective tissue chains are evaluated for length, tension, suppleness and pliability (i.e. 9 chains

in the lower appendages and 9 in the upper appendages, all converging with each other and

connected to the framework of the body trunk proper). In addition, the osteopath will perform an

evaluation of the four diaphragms of the body, (pelvic, thoracic, cervico-thoracic and cranial)

and their connections with the viscera of the abdomen and thorax.

5.3.3 Treatment of low back pain

Depending on what is discovered during the objective assessment, the osteopath will determine

the optimum course of treatment. Cases of low back pain are commonly caused by a pelvic

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dysfunction or sacroiliac mechanical restriction with accompanied visceral and fascial

immobility. In such cases, the osteopath can provide various manual therapy techniques such as

osteo-articular pumping and mechanical and fluidic visceral normalization to restore the normal

physiology, alignment and mobility of the pelvis and the body in general. After each treatment

session, reinforcement exercises (i.e. ELDOAs, MFS) are given to the patient to facilitate the

auto-normalization process of healing.

5.3.4 Conclusion

Each patient that seeks treatment from a traditional osteopath will typically receive some

variation of this detailed assessment in order to comprehensively evaluate the patient’s “being”

(i.e. how they are living in their body). Information pertaining to all aspects of “the container

and its contents” is then interpreted to determine what follow-up treatment intervention strategies

will be performed. This process (or one similar) is completed for each treatment session in order

to evaluate the progression of the patient with each organic intervention. This detailed

preliminary analysis, which is part of the initial assessment, integrates the complexity process of

thinking in a manner that is specific to the osteopathic clinician and the unique systematic

methodology they are trained to perform. The complex osteopathic methodology, including the

deduction of how a physical body, comprising many different yet interrelated systems, can be

examined using palpation skills and an exhaustive expertise in anatomy, physiology and

pathology, is very unique to the health care profession. In the opinion of the author, the

complexity paradigm deployed by the osteopathic practitioner is one of the most thorough

approaches to manual therapy analysis that exists today in the world of medicine.

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Chapter 6: Conclusion

______________________________________________________________________________

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6.1 Conclusion

There has been no substantiated article (published or otherwise) showing the superiority of the

EBM approach or paradigm of thinking for the field of osteopathic medicine. In order to qualify

as a “paradigm”, EBM would need to develop a theoretical structure with explanatory power and

extensive empirical corroboration, which it has not done.202 Osteopathy, with its unique

understanding of all the interrelated systems of the body, is a profession that also recognizes the

importance of the various intangibles that are so vital to successful medical treatment (i.e.

listening, compassion, reassurance and empathy for patients’ hopes, fears and anxieties).

Unfortunately, many of these key factors are neglected by EBM in a clinical practice setting. In

today`s current paradigm of EBM reasoning, scientific judgement and experimentation are the

main objectives. The dominance of this method has led to a “devaluing of the personal” and the

desire to develop formal mechanisms for making all serious decisions.203 This is not only

depersonalizing the provider-patient relationship, but also abandoning a valuable part of the

treatment equation. This is a common sentiment amongst those traditional osteopathic

practitioners who look beyond the studies and trials that try to generalize outcomes for individual

treatments and interventions. The osteopathic community is fully aware of the gap that currently

exists between the recommendations of EBM and what actually occurs on a daily basis in a

clinical practice. Osteopaths use a case-by-case reasoning process, exploring the nuances of the

patient, rather than a generalized global perspective, which often has no relevance to individual

circumstances. The following comparison of the practicing clinician and the practicing

statistician clarifies the polarity of the two methods:

“The mind of the doctor quoted and the mind of the statistician quoted – the first is concerned to make a decision in the interest of the individual patient, whereas the second appears preoccupied with the concept of ‘patient groups’. The first is worried about the fallibility of scientific knowledge and possible heterogeneity by personal identity, whereas the second denies any heterogeneity until ‘proven’ otherwise... the doctor is not sure about his treatment decision for a single

                                                                                                                         202 Miles et al, 622. 203 Miles et al, 625.

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patient and the statistician has no doubt about how all patients should be treated”.204

It is the opinion of the author that one of the key problems that still exist today is the reluctance

of EBM to alter the “hierarchy of evidence” criteria, keeping the “gold standard” of RCTs as the

primary protocol to follow while other methods, such as expert opinion are at the bottom of the

list. What seems like “best practice” for a statistician or epidemiologist does not have the same

“criterion of validity” for the traditional osteopathic clinician; to the former, medicine is a

deterministic science that strives to be “black and white”, while for the latter, medicine is a

science and an art form that celebrates the many unpredictable and emerging shades of grey.

It would be constructive for health care professionals to look at science as the currency of their

discourse, sometimes the strongest weapon in their armoury, and at other times a wolf in the

sheep’s clothing of evidence-based medicine.205 Much of what we have learned about the human

body, its processes, diseases, treatments and interventions, is based upon a reductionist

philosophy dating back to the 16th and 17th century. Interestingly, complexity thinking,

considered by many traditionalists to be a “new” paradigm, has been around for far longer than

most of the medical community can appreciate (100 plus years); it has done so outside the

spotlight of mainstream medicine. Still, there is a common misconception that complexity is a

philosophical problem and not a scientific one. In a bizarre way, this is both true and false.

Complexity reasoning has a philosophical background, often enveloped in chaos and difficult to

comprehend and express and yet under scientific inquiry, firmly embraced in the annals of

medical ideology (studying the intricacies of the body is an extremely complex endeavour). The

intelligence of the complexity paradigm is apparent in its ability to explore the field of

possibilities, without restricting it by what is formally probable.206 Complexity invites us to

reform, even revolutionize our way of thinking and question our thought process, especially in

the field of manual medicine.

Throughout this paper, the author has identified that reductionism and linearity have served the

scientific community well. The application of complexity paradigms of thinking is not an

argument against EBM. It is possible to embrace the world of research and apply it to the

                                                                                                                         204 Miles et al, 629.  205 Sweeney & Griffiths, xi. 206 Morin, 25.  

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complex world we live in. Utilizing the best available evidence to support an intervention

largely based on clinical expertise is wise, however in a clinical setting, the results of EBM apply

only to a small percentage of the osteopath’s patients.207 Within the many disciplines of health

care, providers all remain disciples of Descartes and Newton (at least to some extent), relying on

the linear notion of causality and separating the mind from the body.208 Despite our criticism of

the EBM paradigm of thinking within the field of medicine, especially osteopathy, there is no

doubt as to their influential role in the medical advances spanning many centuries.

There is an urgent need in the medical field to address the health status of the individual person

as a “whole” being. Health, sickness and suffering are all part of the essence of the human

being; osteopathic clinicians who have been trained to treat and take care of the whole person

know that we embrace all of the dimensions of the human person: physical, psychological,

spiritual and social.209 It is the responsibility of the osteopathic profession to re-introduce within

medicine the person-centred, holistic model of care that was ingrained within the traditions of the

field before the advent of biomedical reductionism in medical theory and practice and its over-

reliance on science in the overhaul of patient care.210

In today’s day and age, there is a prevailing obsession with statistics and numbers, placing

greater value on what can be measured and “proved” than on what cannot be quantified.

Quantity has taken precedence over quality.211 There is something in the human mind that is

attracted to straight lines, not curves, to whole numbers, not fractions, to uniformity, not

diversity, and to certainties, not mysteries.212 The manual practice of traditional osteopathy

encourages curves and fractions, avoids making assumptions and discourages cutting corners

when it comes to patient management and facilitating the healing process.

“What we need is not better research data but better philosophy... we need to rediscover or remember what we know about the healing craft that is not tied to a specific context”.213

                                                                                                                         207 Sweeney & Griffiths, 71. 208 Sweeney & Griffiths, xxi. 209 Miles, A. Towards a Medicine of the Whole Person – knowledge, practice and

holism in the care of the sick. Journal of Evaluation in Clinical Practice, 15 (2009): 888. 210 Miles, 888. 211 Meadows, 175-6. 212 Meadows, 181. 213 Sweeney & Griffiths, 164.  

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Osteopaths need to remember their roots and re-evaluate what skills contribute to their unique

ability to heal. Under the large and diverse umbrella of medicine, there are numerous disciplines

of healing but all providers share a common goal: to promote optimal health and freedom from

disease. The question the author proposes is this: “What ‘medicine’ exactly is being alluded to

in the term “evidence-based medicine?” It appears that all facets of clinical medicine, including

osteopathy, are under the microscope of EBM, specifically those practitioners who are involved

in therapeutic interventions. However, there are several other areas of medicine that are exempt

from this EBM validation arena such as biology, chemistry, genetics and several other

disciplines. Should osteopathy be added to this list of exceptions to the rule of EBM?

The more one investigates, the more one is left with many questions pertaining to EBM. Is

“evidence-based medicine” merely convenient vernacular, a catchphrase for the medical field?

Is evidence-based medicine truly a definitive shift from one paradigm to another? And if so,

does such a shift represent a progression, a regression or a conversion? According to 20th century

philosopher and scientist Thomas Kuhn, a paradigm shift in science is infrequent. Kuhn states

that:

“One accepts a new scientific paradigm because one believes that adopting it will better solve the unsolved scientific problems of the present, not because one knows that the new paradigm is any better than the old paradigm”.214

Given this evidence-based climate of what defines medicine, including osteopathy and many

other health care professions in the twenty-first century, there seems to be an illusion of certainty

that rides on the coat tails of this paradigm of thinking. Certainty is seen as the “Holy Grail” of

science, providing comfort and surety, despite the fact that science itself is based on doubt, and

that good medical practitioners always leave a door open for an alternative explanation to their

findings. The “million dollar question” in this heated debate is whether or not modern medicine,

with all of its accolades and extraordinary discoveries, is truly more effective than traditional

medicine.215

                                                                                                                         214 Shahar, E. Evidence-based medicine: a new paradigm or the Emperor’s new

clothes? Journal of Evaluation in Clinical Practice, 4(4) (1998): 279. 215 Sturmberg, J.P. The illusion of certainty – a deluded perception? Journal of

Evaluation in Clinical Practice, 17 (2011): 507.

 

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Within the various disciplines of the scientific community, there are a wide range of treatment

methods. This diversity of methods should continue to exist outside of any hierarchical ranking

or status. The scientific community benefits from both mathematical equations and narrative

descriptions. Perhaps one is more appropriate than the other under certain circumstances, but

one should not be seen as more “scientific” than the other. As long as science is focused on

finding answers, gathering new information, and increasing knowledge, humanity will need both

words and symbols, both simulations and descriptions. It means that a well-constructed

philosophical argument can further our scientific understanding in a similar way to that of a

beautiful equation.216

In the 21st century, the osteopathic profession needs to educate the scientific community with its

own unique approach to solving the problems of disease. This objective of integrating the

philosophy of complex thinking into mainstream science is an uphill battle, especially when

attempting to shift an entire movement that is already positioned at the opposite end of the

philosophical spectrum. Osteopaths embrace the potential uncertainty that is part of any

interactions with patients and their dysfunctions; they understand that when working within a

complexity framework, the guidelines are not black and white and the education of patients and

their families on simplified cause and effect models can be problematic. Within health care,

there is inevitably a certain degree of uncertainty, misdiagnosis and error in clinical judgment. It

is the responsibility of the osteopath to clearly communicate with patients and to provide

solutions that meet their unique health care needs. The osteopath sees the world as dynamic, in a

process of constant change, with the whole system in a continual state of flux, with probability

replacing certainty and interpretation replacing prediction.217

6.2 What is the future of the Complexity movement?

There clearly appears to be a division between the traditional osteopathic way of thinking and the

mainstream reductionist perspective, with regards to the optimal delivery of health care. The

main objective of the powerful EBM movement is to promote a paradigm of validation that seeks

“the ultimate truth” using algorithms and statistical calculations, while dismissing scientific

curiosity and/or any form of uncertainty. Proponents of EBM believe that knowledge that can be

                                                                                                                         216 Richardson & Cilliers, 12. 217 Doll & Trueit, 846.  

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established and measured is the only compelling knowledge and the only knowledge worth

promoting. Complexity theorists on the other hand would argue that the rigid approach of EBM

is in contradiction to the true spirit of scientific discovery, and that health problems are not

solved based on the mathematical results of studies, but rather through human interaction and

patient-specific care. While science has made enormous strides in understanding the universe,

the next great uncharted frontier is the phenomenon of complexity science.

Throughout the processes of data collection, collaboration and idea generation for this thesis, the

author came across two excellent examples of the complexity movement that are directly

applicable to the osteopathic reasoning process. The first of these examples is an EVOST study

(EVOST is an acronym for Evolutionary Osteopathy) and the second is the Santa Fe Institute.

EVOST, or “Evolutionary Osteopathy”, refers to evolutionary medicine in the field of

osteopathy. This philosophical approach focuses on knowledge, consciousness and questioning.

The EVOST study is not concerned with knowledge in the sense of simply acquiring

information, but rather knowledge in the sense of “knowing”, a conviction in understanding how

the human body functions and adapts to life’s encounters.218 This form of medicine stems from

the Darwinian “theory of micro-evolution and (his) natural selection principles”, which have

various practical medical applications; for instance Gastro-enteric medicine, internal medicine,

psychology and osteopathy. The affiliates at EVOST have elaborated upon the 4 major

osteopathic ideologies (described on page 89-90 of this thesis from a complexity perspective.

The following is a summary of EVOST’s modified, complexity-specific ideologies:

1. Human organisms are complex adaptive systems that self-organized and evolved in

“Form”, with consciousness, mind and spirit as emergent behaviour, as an indivisible

whole.

2. Complex adaptive systems like human organisms demonstrate health maintenance and

resilience by means of self-regulation, self-repair mechanisms and replication;

individually and as a species.

                                                                                                                         218 Girardin, M., & Hoppner, J.P. (2012). Retrieved from http://evost.org/.

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3. Self organization, micro- and macro-evolution composes interrelated structure and

function as “Form”, while natural selection favours the best adapted “Form” to the

environmental conditions.

4. Rational treatment is based upon an understanding of the complex adaptive systems and

the basic principles on which they behave, being: “Form” unity, “Form” resilience (self-

maintenance and replication) and “Form” adaptation to the environmental conditions.219

See Figure 1 - Complex adaptive systems matrix.

                                                                                                                           219 Girardin, M & Deslee, E. & Cortoos, J.M. (2008). De-Still-ed Osteopathy: Methodological Essay on Osteopathic

Thought and Terminology. EVOST (2008): 23.  

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Figure 1

Schematic review of polarization within the profession of osteopathy

Viewed through the looking glass of the Complex Systems Theory

The “traditional vitalist” approach uses an obsolete terminology.

Complexity is seen as a whole.

Loses sight of the validation by a lack of scientific approach to the details

(local agent relation).

The “scientific reductionist” approach, valid and quantifiable.

Complexity and emergence are left aside because they are ungraspable and unquantifiable.

Loss of the holistic view tends to reject philosophy and resulting concept.

The red oval (in the figure above) represents the Gordian knot, or the battle front on which the two factions confront.220

                                                                                                                         220 Girardin et al, 24.

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The Santa Fe Institute is a private, non-profit transdisciplinary research community where

researchers have organized and defined the science of complex adaptive systems (CAS). Its goal

is to expand the boundaries of scientific understanding, to discover, comprehend and

communicate the common fundamental principles of CAS that underlie the most profound

challenges facing the global scientific community today . The institute is of the opinion that

time-honoured methodologies and perspectives have stifled innovative thinking and have led to

overall stagnation under a reductionist regime. The founders of the Santa Fe Institute recognized

that no scientific platform existed from which questions could be presented about emergent,

adaptive and co-evolving behaviours. The Institute feels that complexity science is widely

accepted as a worthy scientific endeavour.221

The Institute’s philosophy of complex systems and its research efforts seem to be very congruent

with the practices of traditional osteopathy. It would be an appropriate marriage (the merging of

osteopathy and the Institute’s approaches) of hybrid intellect incorporating complexity research

and case-controlled studies regarding osteopathic treatment and intervention; this blended

philosophy could provide a new direction of problem-driven science.

The Santa Fe Institute is a complexity research and education centre representing leading

scientists from various disciplines: sponsored research, publications, working paper

Fellowships, community and education outreach programs and various professional development

courses.

6.3 What is the future of osteopathy?

How will science, EBM and complexity thinking evolve in the future? There is plenty of room

in the scientific and osteopathic communities for clinicians to provide “speculative imagination,

scrupulous honesty, mathematical command, logical perspicuity as well as experimental

inventiveness and ingenuity”.222 All of these are relevant within the overall framework of

osteopathy, medicine and science.

                                                                                                                         221 Santa Fe Institute. (2012). Mission and vision. Santa Fe Institute. Retrieved from

http://santafe.edu/about/mission-and-vision/ 222 Toulmin, 115.  

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The question asked in this paper is “Which paradigm of thinking (EBM or complexity) is best

suited for the osteopathic profession?” Here we have two rival ideologies which possess some

similar characteristics but also some very fundamental differences. There is certainly a place for

biomedical and mathematical statistics in various fields of medicine; osteopathy is not one of

those fields. Osteopathy is about expanding the viewpoints of the medical community and

allowing for conceptual innovations in the treatment of patients. It should come as no surprise

then that osteopathy dismisses the rigid structure of research protocols that cannot answer the

difficult questions that continue to emerge within the human body. Mathematical forecasting

and prediction fail to encompass the multiple variables (intrinsic and extrinsic) affecting the

systems of the human body, whereas osteopathy and complexity thinking leverage a non-

exclusive methodology, and at least make a conscientious effort to accurately account for all

changes and variables. Current scientific methodology prefers a quantitative approach because

its results can be calculated into an authoritative result. Its main objective is to arrive at non-

decomposable elementary units that can be grasped clearly and distinctly, on their own. The

logic of the West is a homeostatic logic, destined to maintain the equilibrium of the discourse by

banning contradiction or deviation; it controls and guides all developments of thinking.223 A

fundamental shift towards a complexity paradigm of thinking, would encourage greater

acceptance of imagination and creativity amongst health care practitioners, enable the

osteopathic profession (at a grassroots level) to challenge the edifice of EBM and promote an

environment of individualized, dynamic and patient-focussed care. Osteopathic practitioners

recognize that despite science and philosophy being separate entities, they are inevitably linked

in a way that is not commonly being instructed in today’s healthcare environment. Too much

specialization, fragmentation and compartmentalization exists, thereby overlooking the need to

focus attention on the individual patient as a whole person.

Having been trained as a physiotherapist at McMaster University (one of the world’s foremost

authorities in EBM and problem-based learning), the author has had the privilege of learning the

ins and outs of EBM and applying this theory in a private practice setting, and in patient

treatments and interventions. It was not until the author was introduced to the profession of

osteopathy and the complexity paradigm of thinking that he began to question some of the deep-

                                                                                                                         223 Morin, 34.

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rooted educational beliefs that stem from reductionist foundations. Health care providers have

learned well how to separate the many different parts of the body from the whole and in doing

so, further disconnect “the subject from the object, and the object from the environment”. This

has lead to an evolution of specialization in medicine that inevitably isolates one’s way of

thinking about and communicating with the individual, the patient, and the client. However, the

traditionally trained osteopath understands the flaws in the way the medical system has trained

them and therefore offers a unique insight into the “wholeness” of the systems that make up

human beings and the disease states that impact us.

“The science of autonomy is founded on the new vision of the physical universe. This universe is no longer subject solely to deterministic order, but obeys the rules of the game of order/disorder/organization. For the last hundred years, in all sectors, physics recognizes chance and works with chance. Henceforth we see the universe in terms of probability and improbability, and we have discovered that it is in the zones of improbability that innovations, the pilot-fish of becoming, can arise. In fact, therefore, our physical, biological, and anthropo-social universe, the universe of our existence and understanding, is a mix/combination of order (laws, regularities, constants structures, probabilities) and disorder (chance, agitations, random meetings, collisions, dispersions). This apparent incoherent universe is nevertheless the only one where we can conceive of becoming and innovation. We cannot see how change and the new could arise in a totally deterministic universe; we cannot see organization in a totally random universe”.224

After considerable exposure to both paradigms of thinking and the frequent application of both

paradigms in clinical patient care settings as a health care provider (both a physiotherapist and an

osteopath), the complexity concept of assessing, treating and making clinical decisions ranks far

superior in patient outcome management. Osteopaths understand the logic / reasoning behind

looking at humans as self-organizing beings.

“On our planet, we are essentially living beings – are systems that are not only closed (protecting their integrity and their identity) but also open to their environment, from which they derive matter, energy, information, and organization. Self-organizing beings, therefore, are self-eco-organizing beings, which leads to this fundamental complex idea: all autonomy constitutes itself in and through ecological dependence. As far as we are concerned, our ecological independence is not only natural but social and cultural as well”.225

                                                                                                                         224 Morin, 112. 225 Morin, 113.  

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In his quote above, Edgar Morin brings to light the advantage that osteopaths possess through

their methodology, in comparison to other health care professions: everything that makes up the

human body and its systems are interrelated, and nothing is ever truly isolated in the universe. It

is therefore of the greatest importance to have optimal knowledge of the parts that make up the

whole and knowledge of the whole that is comprised of many parts. It is the responsibility of

osteopaths to study and become experts in the anatomy, physiology, and pathophysiology of all

the systems of the body and to become masters of the manual therapy skills that accompany

them.

6.4 Osteopathic instruction in schools

It is the humble opinion of the author that our educational system has been structured around a

linear analytical approach to learning and that it is this ideology that is embraced by EBM.

Students and osteopathic clinicians alike need to be encouraged that learning is a lifelong

process, and that the appreciation of intuition and the promotion of creative thinking are what

make osteopaths distinctive in their global approach to (and perspective of) the human body and

its health and disease processes. Learning is a complex activity and has to be instructed as such.

A famous quote of Chinese philosopher Zhuanghi, dating back to the 3rd and 4th centuries, says:

“A good butcher changes his knife once a year, because he slices flesh. A mediocre butcher changes his knife once a month, because he hacks at bone. Close observation of a skilled artisan at work, such as a master butcher, reveals an internal coherence to the execution of the skill. It is economical, fluid, elegant and – paradoxically restrained. The knife’s edge seems to “fall” into the meat. The best artisans are at one with their tools and the objects of their work – they do not force. Indeed, there is a sense of minimal interference from the hands, a kind of “lifting off, where the tool does the work. Paradoxically, while “grip” may seem key to control tools, it is “release” that distinguishes the expert from the novice. The novice’s grip is taut and fearful, where the master butcher shows “ease and relaxation” in the heat of work. It is to this level of expertise that every novice aspires, in any trade of profession”.226

Students of osteopathy, as well as current practitioners, should strive to achieve the level of

expertise noted in Zhuanghi’s quote. Osteopathic practitioners should continually look to refine

their skills, and wholeheartedly internalize complexity as the philosophy of their professional

                                                                                                                         226 Bleakley, A. Blunting Occam’s razor: aligning medical education with studies of complexity. Journal of

Evaluation in Clinical Practice, 16 (2010): 849.

 

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career. Osteopaths should embrace the clinical intuition they possess as long as its foundation is

based upon sound, concrete medical knowledge. It is the unwavering dedication to education in

one’s discipline that is the constant reminder that we are all apprentices; journeymen on a

mission of lifelong learning, striving to perfect our craft and, in time, become masters.

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Appendix A:

Osteopathic manipulative treatment for low back pain: a systematic

review and meta-analysis of randomized controlled trials

______________________________________________________________________________

BioMed Central

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BMC Musculoskeletal Disorders

Open AccessResearch articleOsteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trialsJohn C Licciardone*1, Angela K Brimhall2 and Linda N King3

Address: 1Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth, TX 76107, USA, 2Department of Family Medicine, University of North Texas Health Science Center, Fort Worth, TX 76107, USA and 3Gibson D. Lewis Health Science Library, University of North Texas Health Science Center, Fort Worth, TX 76107, USA

Email: John C Licciardone* - jlicciar@hsc.unt.edu; Angela K Brimhall - abrimhal@hsc.unt.edu; Linda N King - lking@hsc.unt.edu

* Corresponding author

AbstractBackground: Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used byosteopathic physicians to complement their conventional treatment of musculoskeletal disorders.Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressedOMT and generally have focused on spinal manipulation as an alternative to conventional treatment. Thepurpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain.

Methods: Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and theCochrane Central Register of Controlled Trials were supplemented with additional database and manualsearches of the literature.

Six trials, involving eight OMT vs control treatment comparisons, were included because they wererandomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatorysettings. Data on trial methodology, OMT and control treatments, and low back pain outcomes wereabstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overallmeta-analysis, stratified meta-analyses were performed according to control treatment, country where thetrial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overalland stratified meta-analyses.

Results: Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 – -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vsactive treatment or placebo control and OMT vs no treatment control. There were significant painreductions with OMT regardless of whether trials were performed in the United Kingdom or the UnitedStates. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up.

Conclusion: OMT significantly reduces low back pain. The level of pain reduction is greater thanexpected from placebo effects alone and persists for at least three months. Additional research iswarranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are longlasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.

Published: 04 August 2005

BMC Musculoskeletal Disorders 2005, 6:43 doi:10.1186/1471-2474-6-43

Received: 08 November 2004Accepted: 04 August 2005

This article is available from: http://www.biomedcentral.com/1471-2474/6/43

© 2005 Licciardone et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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BackgroundHistorically, low back pain has been the most commonreason for visits to osteopathic physicians [1]. More recentdata from the Osteopathic Survey of Health Care in Amer-ica has confirmed that a majority of patients visiting oste-opathic physicians continue to seek treatment formusculoskeletal conditions [2,3]. A distinctive element oflow back care provided by osteopathic physicians is oste-opathic manipulative treatment (OMT). A comprehensiveevaluation of spinal manipulation for low back painundertaken by the Agency for Health Care Policy andResearch in the United States concluded that spinalmanipulation can be helpful for patients with acute lowback problems without radiculopathy when used withinthe first month of symptoms [4]. Nevertheless, becausemost studies of spinal manipulation involve chiropracticor physical therapy [5], it is unclear if such studies ade-quately reflect the efficacy of OMT for low back pain.

Although the professional associations that representosteopaths, chiropractors, and physiotherapists in theUnited Kingdom developed a spinal manipulation pack-age consisting of three common manual elements for usein the UK Back pain Exercise and Manipulation (UKBEAM) trial [6], there are no between-profession compar-isons of clinical outcomes [7,8]. It is well known thatOMT comprises a diversity of techniques [9] that are notadequately represented by the UK BEAM trial package.Professional differences in spinal manipulation are morepronounced in research studies, where chiropractors havefocused almost exclusively on high-velocity-low-ampli-tude techniques [10]. For example, a major trial of chiro-practic manipulation as adjunctive treatment forchildhood asthma used a high-velocity-low-amplitudethrust as the active treatment [11]. The simulated treat-ment provided in the sham manipulation arm of this chi-ropractic trial, which ostensibly was thought to have notherapeutic effect, had a marked similarity to OMT[10,12]. Further, because differences in professional back-ground and training lend themselves to diverse manipula-tion approaches, clinicians have been warned aboutgeneralizing the findings of systematic reviews to practice[13].

In addition to professional differences in the manual tech-niques themselves, osteopathic physicians in the UnitedStates, unlike allopathic physicians, chiropractors, orphysical therapists, can treat low back pain simultane-ously using both conventional primary care approachesand complementary spinal manipulation. This representsa unique philosophical approach in the treatment of lowback pain. Consequently, there is a need for empiricaldata that specifically address the efficacy of OMT for suchconditions as low back pain [14]. The present study wasundertaken to address this need by conducting a system-

atic review of the literature on OMT and performing ameta-analysis of all randomized controlled trials for lowback pain performed in ambulatory settings.

MethodsSearchA search of the English language literature was performedthrough August 2003 to identify reports of randomizedcontrolled trials of OMT. We searched MEDLINE, OLDM-EDLINE, EMBASE, MANTIS, OSTMED, Alt Health Watch,SciSearch, ClinicalTrials.gov, CRISP, and the CochraneCentral Register of Controlled Trials. A detailed descrip-tion of the search strategy is provided in the Appendix [seeAdditional file 1]. Additionally, reports were sought fromrelevant reviews or meta-analyses of spinal manipulation[9,15-32] and manual searches of reference citations inthe reviewed literature sources.

SelectionThe search bibliographies and relevant reports werereviewed by the authors to identify randomized control-led trials involving OMT in human subjects. To assess theefficacy of OMT in primary care, eligibility was limited torandomized controlled trials of OMT performed by osteo-paths, osteopathic physicians, or osteopathic trainees thatincluded blinded assessment of low back pain in ambula-tory settings. Trials that involved manipulation underanesthesia, industrial settings, or hospitalized patientswere not included. Because there is potential confusionregarding the type of manipulation performed in some tri-als [33], the reported methods in each trial were carefullyreviewed to assess eligibility for the meta-analysis. Over-all, seven studies known or purported to involve OMT forlow back pain were reviewed and excluded for not meet-ing all eligibility criteria [34-40]. A subsequent source [41]indicated that an osteopathic manipulation techniquewas used in the Irvine study [42]. Although several of thesix included OMT trials were identified in multiple bibli-ographic databases, five [42-46] were indexed inMEDLINE. The Cleary [47] trial was identified exclusivelythrough the Cochrane Central Register of ControlledTrials.

Data extractionEach eligible trial was independently reviewed by two ofus to abstract data on methodological characteristics,OMT and control treatments, and low back pain out-comes. Conflicting data were resolved by consensus.

Trial characteristicsAs shown in Table 1, the six OMT trials were conductedbetween 1973 and 2001 in the United Kingdom or theUnited States [42-47]. Two of the six trials each includedtwo control treatments [43,46], thus providing eight OMTvs control treatment comparisons. The trials generally

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Table 1: Summary of trials.

Hoehler 1981 [42] Gibson 1985 [43] Cleary 1994 [47]

Years conducted 1973–1979 ... 1991–1992Country United States United Kingdom United KingdomSetting University clinic Hospital outpatient clinic Ambulatory clinicNo. of subjects randomized 95 109 30*Comparison OMT vs soft tissue massage and sham

manipulationOMT vs short-wave diathermyOMT vs detuned short-wave diathermy

OMT vs sham manipulation

Subjectcharacteristics

Age, yMean ± SD OMT, 30.1 ± 8.4

Controls, 32.1 ± 9.8OMT, 34 ± 14Short-wave diarthermy controls, 35 ± 16Detuned short-wave diathermy controls, 40 ± 16

Overall age range, 50–60

Sex% male OMT, 59

Controls, 59OMT, 49Detuned short-wave diathermy controls, 68Short-wave diarthermy controls, 53

OMT, 0Controls, 0

Type of low back pain Referred patients with acute or chronic low back pain

Referred patients with low back pain of greater than 2 months' and less than 12 months' duration

Recruited subjects with chronic low back pain in conjunction with menopausal symptoms

OMT protocolTechnique High-velocity, low-amplitude thrust

onlyVariety of techniques Low-force techniques

No. of treatmentsMean ± SD OMT, 4.8 ± 2.7

Controls, 3.9 ± 2.54, per protocol 10, per protocol

Outcomes assessment Blinded Blinded Assessment independent of treatment, blinding not specified

No. of pain contrasts 3 6 (3 for each of the two OMT vs control treatment comparisons)

1

Type of pain outcome Dichotomous pain outcomes Dichotomous pain outcomes Dichotomous pain outcomeTiming of pain contrasts

Short-term First treatment and mean, 20–30 days following randomization

2 and 4 weeks ...

Intermediate-term Mean, 41–51 days following randomization

... ...

Long-term ... 12 weeks 15 weeksAndersson 1999 [44] Burton 2000 [45] Licciardone 2003 [46]

Years conducted 1992–1994 ... 2000–2001Country United States United Kingdom United StatesSetting Health maintenance organization Hospital orthopedic department University clinicNo. of subjects randomized 178 40 91Comparison Usual care and OMT vs usual care

onlyOMT vs chemonucleolysis Usual care and OMT vs usual care and

sham manipulationUsual care and OMT vs usual care only

Subject characteristicsAge, y

Mean ± SD OMT, 28.5 ± 10.6Controls, 37.0 ± 11.0

Overall, 41.9 ± 10.6 Usual care and OMT, 49 ± 12Usual care and sham manipulation controls, 52 ± 12Usual care only controls, 49 ± 12

Sex% male OMT, 41

Controls, 44Overall, 48 Usual care and OMT, 31

Usual care and sham manipulation controls, 43Usual care only controls, 35

Type of low back pain Patients with low back pain of 3 or more weeks' and less than 6 months' duration

Recruited patients with low back pain and sciatica; mean duration, 30 and 32 weeks in OMT and chemonucleolysis groups, respectively

Recruited subjects with low back pain of at least 3 months' duration

OMT protocol

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were comparable in their methodology, with the possibleexception of the Cleary [47] trial. Twenty contrasts werereported in the six trials (a contrast refers to a within-trialcomparison between OMT and a control treatment withrespect to a low back pain outcome at a given point intime). Following randomization, nine contrasts were

reported within one month (short-term outcomes),another seven contrasts were reported within threemonths (intermediate-term outcomes), and the remain-ing four contrasts were reported within 12 months (long-term outcomes).

Technique Variety of techniques, individualized to patient

Variety of techniques, individualized to patient

Variety of techniques, individualized to subject

No. of treatmentsMean ± SD 8, per protocol Mean for OMT, 11; range 6–18 7, per protocol

Outcomes assessment Blinded Blinded BlindedNo. of pain contrasts 1 3 6 (3 for each of the two OMT vs

control treatment comparisons)Type of pain outcome Pain scale Pain scales Pain scalesTiming of pain contrasts

Short-term ... 2 weeks 1 monthIntermediate-term 12 weeks 6 weeks 3 monthsLong-term ... 12 months 6 months

OMT denotes osteopathic manipulative treatment.*A total of 30 subjects with menopausal symptoms were randomized; however, only 12 subjects had low back pain.

Table 2: Summary of analyses.*

Meta-Analyses Sensitivity Analyses

Overall Median Contrasts Best-case and worst-case scenarios4 possible combinations of contrasts including one control treatment per trialCleary [47] trial excludedAll 20 contrasts

Stratified Median ContrastsA. Control Treatment

1. Active treatment or placebo control Best-case and worst-case scenarios2 possible combinations of contrasts including one control treatment per trialCleary [47] trial excludedAll 16 contrasts

2. No treatmentB. Country Where Trial was Performed

3. United Kingdom Best-case and worst-case scenarios2 possible combinations of contrasts including one control treatment per trialCleary [47] trial excludedAll 10 contrasts

4. United States Best-case and worst-case scenarios2 possible combinations of contrasts including one control treatment per trialAll 10 contrasts

C. Duration of Follow-Up5. Short-term Best-case and worst-case scenarios

All 9 contrasts6. Intermediate-term 4 possible combinations of contrasts including one control treatment per trial7. Long-term 2 possible combinations of contrasts including one control treatment per trial

Cleary [47] trial excluded

*There were insufficient contrasts to perform sensitivity analyses for the no treatment stratified analysis. For the short-term stratified analysis, the median contrast was defined to be that corresponding to the eighth combination when effect sizes for the 16 possible contrast combinations were rank ordered from least to greatest. For the intermediate-and long-term stratified analyses, the median contrasts defaulted to the all-contrasts analyses because there were no repeated measures within these time intervals in any trial. All possible contrast combinations were included in the sensitivity analyses for intermediate-and long-term follow-up because of the limited numbers of combinations for these analyses.

Table 1: Summary of trials. (Continued)

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The methodological quality of four of the OMT trials [42-45] was independently confirmed in a recent systematicreview that included a best evidence synthesis incorporat-ing eight explicit quality criteria, including similarity ofbaseline characteristics of subjects or reporting of adjustedoutcomes; concealment of treatment allocation; blindingof subjects; blinding of providers or other control forattention bias; blinded or unbiased outcomes assessment;subject dropouts reported and accounted for in the analy-sis; missing data reported and accounted for in the analy-sis; and intention-to-treat analysis or absence ofdifferential co-interventions between groups in studieswith full compliance [13]. The Cleary [47] trial was noteligible for this review because it did not include a suffi-ciently large number of subjects. Although the Licciardone[46] trial was not eligible for the review because it waspublished after the closing date of December 2002, it hasbeen characterized as an innovative and important trialwith many rigorous design features [48], and morerecently has been identified as an evidence-based supple-ment relative to the previous review from the CochraneLibrary [49].

Quantitative data synthesisWe used the effect size, computed as Cohen's d statistic, toreport all trial results [50]. A negative effect size repre-sented a greater decrease in pain among OMT subjects rel-ative to control treatment subjects. Dichotomous painmeasures were transformed to effect sizes by first comput-ing the relevant P-value and then determining the effectsize and 95% confidence interval (CI) that would obtainunder the assumption of a two-tailed t-test for measuringthe standardized mean difference between OMT and con-trol treatments in the relevant number of subjects [50].The meta-analysis results were weighted by the inversevariance for each OMT vs control treatment comparison.The Q statistic was used to test the homogeneity of trialsincluded in each analysis [51].

The overall meta-analysis included the eight OMT vs con-trol treatment comparisons. Four of the six trials, involv-ing six of the eight OMT vs control treatmentcomparisons, each reported three contrasts [42,43,45,46](Table 1). The median contrast, as identified by the inter-mediate effect size among the three reported pain out-comes for a given OMT vs control treatment comparison,was used to represent the pain outcome for each of thesesix comparisons. These median contrasts were thencombined with the lone contrasts reported in each of thetwo remaining OMT vs control treatment comparisons[44,47]. Based on the similarity among trials (Table 1), afixed-effects model initially was used to perform meta-analysis and the results were then compared with those ofa random-effects model.

Flowchart of trialsFigure 1Flowchart of trials.

Potentially relevant

reports identified during

original searches (n=389)

Excluded reports (n=268)

· Not related to osteopathic

manipulative treatment

· Duplicate reports

· False drops

Screened reports based

on available title, subject,

heading, or abstract (n=121)

Excluded reports (n=75)

· Not related to osteopathic

manipulative treatment

· Did not meet randomized

controlled trial criteria

Retrieved reports for

detailed evaluation (n=46)

Excluded reports (n=29)

· Not related to osteopathic

manipulative treatment

· Did not meet meta-analysis

inclusion criteria

Evaluated reports for low

back pain outcomes (n=17)

Excluded reports (n=11)

· Antibody response to

hepatitis B vaccine

· Bronchial asthma

· Bronchiolitis

· Fibromyalgia

· Menstrual cramps

· Muscle contraction headaches

· Shoulder pain

· Otitis media

· Pancreatitis

· Pneumonia

· Post-operative atelectasis

Included randomized controlled

trials (n=6): 8 osteopathic

manipulative treatment vs

control treatment comparisons

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A series of sensitivity analyses were then performed. First,to address the possibility of bias by using the median con-trasts method, analyses were repeated using the best-caseand worst-case scenarios for the six relevant OMT vs con-trol treatment comparisons [42,43,45,46]. Second, toaddress the possibility of bias by including comparisonsinvolving the same OMT group vs two different controltreatment groups in two trials [43,46], analyses wererepeated using only one OMT vs control treatment com-parison for each of these trials. Each of the four possiblecombinations of contrasts was analyzed. Third, the analy-sis was repeated after excluding the Cleary [47] trial.Finally, an analysis was performed using all 20 low backpain contrasts. Similar analyses were performed after strat-ifying trials according to control treatment, country wherethe trial was performed, and duration of follow-up.

As summarized in Table 2, there were 43 analyses per-formed, including the overall meta-analysis, seven strati-fied meta-analyses, and 35 sensitivity analyses. Meta-analysis was performed only when there were at leastthree contrasts available for data synthesis. Database man-agement and analyses were performed using the Compre-hensive Meta-Analysis software package (Version 1.0.23,Biostat, Inc, Englewood, NJ 07631, USA).

ResultsOverall analysesThe search for reports is summarized in Figure 1. A totalof 525 subjects with low back pain were randomized inthe eligible trials. The overall results are presented in Fig-

ure 2. There was a highly significant reduction in painassociated with OMT (effect size, -0.30; 95% CI, -0.47 – -0.13; P = .001). The Q statistic was non-significant, thussupporting the assumption of homogeneity among trials.The primary sensitivity analyses are presented in Table 3.Using a random-effects model, the results were virtuallyidentical to those observed with a fixed-effects model.There were 729 (36 × 12) possible combinations of con-trasts for analysis based on three contrasts for each of sixOMT vs control treatment comparisons [42,43,45,46] andone contrast for each of the two remaining OMT vs con-trol treatment comparisons [44,47]. The efficacy of OMTfor low back pain was supported in both the best-case(effect size, -0.37; 95% CI, -0.55 – -0.20; P < .001) andworst-case (effect size, -0.18; 95% CI, -0.35 – 0.00; P =.046) scenarios. Similarly, when each trial was limited toone OMT vs control treatment comparison, OMT wasfound to be efficacious in each of the four analyses. OMTalso demonstrated significantly greater low back painreduction than control treatment in analyses with theCleary [47] trial excluded and with all 20 contrastsincluded.

Stratified analysesThe results of stratified meta-analyses are presented inTable 4. There was a significant reduction in low back painassociated with OMT in trials vs active treatment or pla-cebo control (effect size, -0.26; 95% CI, -0.48 – -0.05; P =.02), independent of fixed-effects or random-effectsmodel specification. There were 243 (35 × 11) possiblecontrast combinations based on three contrasts for each

Effect size for low back painFigure 2Effect size for low back pain. CI denotes confidence interval; OMT, osteopathic manipulative treatment. Overall effect size, -0.30; 95% CI, -0.47 – -0.13; P = .001.

Control No. of subjects

Source, year treatment

Hoehler 1981 [42] Active and placebo 56 39 17

Gibson 1985 [43] Active treatment 38 27 12

Gibson 1985 [43] Placebo control 39 33 14

Cleary 1994 [47] Placebo control 8 4 2

Andersson 1999 [44] No treatment 83 72 29

Burton 2000 [45] Active treatment 20 20 8

Licciardone 2003 [46] Placebo control 32 19 9

Licciardone 2003 [46] No treatment 42 17 9

Overall 318 231 100

Effect size (95% CI)WeightControlOMT

-2.00 -1.00 0.00 1.00 2.00

Favors OMT Favors Control

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of five OMT vs control treatment comparisons[42,43,45,46] and one contrast for another remainingOMT vs control treatment comparison [47]. Both the best-case and worst-case scenarios demonstrated a greaterreduction in pain with OMT than active treatment or pla-cebo control, although the worst-case results did notachieve statistical significance. OMT was found to signifi-cantly reduce pain in the remaining analyses that limitedOMT vs active treatment or placebo control comparisonsto one per trial, excluded the Cleary [47] trial, andincluded all 16 contrasts. The OMT vs no treatment con-trol comparisons were observed in trials in which all sub-jects received usual low back care in addition to theirallocated treatment (ie, OMT and usual care vs only usualcare) [44,47]. For these trials, the all-contrasts model (ie,the only model with sufficient contrasts for data synthe-sis) demonstrated a highly significant reduction in painwith OMT.

Trials in both the United Kingdom (effect size, -0.29; 95%CI, -0.58 – 0.00; P = .050) and the United States (effectsize, -0.31; 95% CI, -0.52 – -0.10; P = .004) demonstratedsignificant reductions in low back pain associated withOMT. In the sensitivity analyses, effect sizes were generallyof comparable magnitude in both countries, althoughresults in American trials consistently achieved statisticalsignificance as a consequence of the larger sample sizes inthese trials (Table 4).

There were significant reductions in low back pain associ-ated with OMT during the short-term (effect size, -0.28;95% CI, -0.51 – -0.06; P = .01), intermediate-term (effectsize, -0.33; 95% CI, -0.51 – -0.15; P < .001), and long-term(effect size, -0.40; 95% CI, -0.74 – -0.05; P = .03) follow-

up periods. Sensitivity analyses for temporal outcomesdemonstrated that intermediate-term results consistentlyachieved statistical significance, generally because of thegreater number of subjects in these analyses (Table 4). Theresults of the meta-analyses and sensitivity analyses arefurther summarized in Figure 3.

DiscussionEfficacy of osteopathic manipulative treatmentThe overall results clearly demonstrate a statistically sig-nificant reduction in low back pain with OMT (Figure 2).Further, the meta-analysis results are quite robust as indi-cated by the comprehensive sensitivity analyses (Figure3). Stratified meta-analyses to control for moderator vari-ables demonstrated that OMT significantly reduced lowback pain vs active treatment or placebo control and vs notreatment control. If it is assumed, as shown in a review[52], that the effect size is -0.27 for placebo control vs notreatment in trials involving continuous measures forpain, then the results of our study are highly congruent(ie, effect size for OMT vs no treatment [-0.53] = effect sizefor OMT vs active treatment or placebo control [-0.26] +effect size for placebo control vs no treatment [-0.27]).

It has been suggested that the therapeutic benefits of spi-nal manipulation are largely due to placebo effects [53]. Apreponderance of results from our sensitivity analysessupports the efficacy of OMT vs active treatment or pla-cebo control and therefore indicates that low back painreduction with OMT is attributable to the manipulationtechniques, not merely placebo effects. Also, as indicatedabove, OMT vs no treatment control demonstrated painreductions twice as great as previously observed in clinicaltrials of placebo vs no treatment control [52]. Thus, OMT

Table 3: Overall results.

No. of Subjects

Model No. ofContrasts

OMT Control EffectSize

95% CI P

Median contrastsFixed-effects model* 8 318 231 -0.30 -0.47 – -0.13 .001Random-effects model 8 318 231 -0.31 -0.49 – -0.13 .001

Best-case scenario 8 293 220 -0.37 -0.55 – -0.20 <.001Worst-case scenario 8 298 221 -0.18 -0.35 – 0.00 .046Median contrasts, one OMT vs control treatment comparison per trial

Gibson [43] active treatment control and Licciardone [46] placebo control 6 237 181 -0.30 -0.49 – -0.10 .003Gibson [43] active treatment control and Licciardone [46] no treatment control

6 247 179 -0.39 -0.59 – -0.20 <.001

Gibson [43] placebo control and Licciardone [46] placebo control 6 238 187 -0.26 -0.45 – -0.06 .01Gibson [43] placebo control and Licciardone [46] no treatment control 6 248 185 -0.35 -0.54 – -0.15 <.001

Median contrasts, Cleary [47] trial excluded 7 310 227 -0.29 -0.47 – -0.12 .001All contrasts 20 727 520 -0.29 -0.40 – -0.17 <.001

CI denotes confidence interval; OMT, osteopathic manipulative treatment.*Test for homogeneity, P = .37.

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Table 4: Stratified results.

No. of Subjects

Model No. ofContrasts

OMT Control EffectSize

95% CI P

OMT vs. Active Treatment or Placebo Control

Median contrastsFixed-effects model* 6 193 142 -0.26 -0.48 – -0.05 .02Random-effects model 6 193 142 -0.26 -0.48 – -0.05 .02

Best-case scenario 6 174 132 -0.34 -0.57 – -0.11 .004Worst-case scenario 6 183 134 -0.07 -0.29 – 0.16 .54Median contrasts, one OMT vs control treatment comparison per trial

Gibson [43] active treatment 5 154 109 -0.33 -0.58 – -0.08 .01Gibson [43] placebo control 5 155 115 -0.26 -0.51 – -0.02 .03

Median contrasts, Cleary [47] trial excluded 5 185 138 -0.24 -0.47 – -0.02 .03All contrasts 16 534 400 -0.21 -0.34 – -0.08 .002

OMT vs. No Treatment Control

All contrasts 4 193 120 -0.53 -0.76 – -0.30 <.001Trials Performed in the United Kingdom

Median contrastsFixed-effects model* 4 105 84 -0.29 -0.58 – 0.00 .050Random-effects model 4 105 84 -0.30 -0.63 – 0.02 .06

Best-case scenario 4 105 88 -0.36 -0.64 – -0.07 .01Worst-case scenario 4 100 83 -0.11 -0.40 – 0.19 .48Median contrasts, one OMT vs control treatment comparison per trial

Gibson [43] active treatment 3 66 51 -0.46 -0.83 – -0.09 .02Gibson [43] placebo control 3 67 57 -0.30 -0.66 – 0.05 .10

Median contrasts, Cleary [47] trial excluded 3 97 80 -0.26 -0.56 – 0.04 .09All contrasts 10 294 247 -0.23 -0.40 – -0.06 .01

Trials Performed in the United States

Median contrastsFixed-effects model* 4 213 147 -0.31 -0.52 – -0.10 .004Random-effects model 4 213 147 -0.32 -0.57 – -0.06 .01

Best-case scenario 4 188 132 -0.38 -0.61 – -0.16 .001Worst-case scenario 4 198 138 -0.22 -0.44 – 0.00 .050Median contrasts, one OMT vs control treatment comparison per trial

Licciardone [46] placebo control 3 171 130 -0.24 -0.47 – -0.01 .04Licciardone [46] no treatment control 3 181 128 -0.36 -0.59 – -0.14 .002

All contrasts 10 433 273 -0.33 -0.48 – -0.18 <.001Short-Term Follow-Up

Median contrastsFixed-effects model* 5 181 130 -0.28 -0.51 – -0.06 .01Random-effects model 5 181 130 -0.31 -0.61 – -0.01 .046

Best-case scenario 5 196 142 -0.41 -0.62 – -0.19 <.001Worst-case scenario 5 181 136 -0.10 -0.32 – 0.12 .38All contrasts 9 357 258 -0.23 -0.39 – -0.07 .01

Intermediate-Term Follow-Up

Median (all) contrastsFixed-effects model* 7 283 209 -0.33 -0.51 – -0.15 <.001Random-effects model 7 283 209 -0.36 -0.63 – -0.10 .01

Median contrasts, one OMT vs control treatment comparison per trialGibson [43] active treatment and Licciardone [46] placebo control 5 209 161 -0.31 -0.52 – -0.10 .004Gibson [43] active treatment and Licciardone [46] no treatment control 5 209 158 -0.45 -0.65 – -0.24 <.001Gibson [43] placebo control and Licciardone [46] placebo control 5 209 166 -0.25 -0.46 – -0.05 .02Gibson [43] placebo control and Licciardone [46] no treatment control 5 209 163 -0.39 -0.59 – -0.18 <.001

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may eliminate or reduce the need for drugs that can haveserious adverse effects [44].

Because osteopathic physicians provide OMT to comple-ment conventional treatment for low back pain, they tendto avoid substantial additional costs that would otherwisebe incurred by referring patients to chiropractors or otherpractitioners [54]. With respect to back pain, osteopathicphysicians make fewer referrals to other physicians andadmit a lower percentage of patients to hospitals thanallopathic physicians [1], while also treating back painepisodes with substantially fewer visits than chiropractors[55]. Although osteopathic family physicians are lesslikely to order radiographs or prescribe nonsteroidal anti-inflammatory drugs, aspirin, muscle relaxants, sedatives,and narcotic analgesics for low back pain than their allo-pathic counterparts, osteopathic physicians have a sub-stantially higher proportion of patients returning forfollow-up back care than allopathic physicians [56]. In theUnited Kingdom, where general practitioners may referpatients with spinal pain to osteopaths for manipulation,it has been shown that OMT improved physical and psy-chological outcomes at little extra cost [57].

In our study, the effect sizes for OMT in the United King-dom, where osteopaths are not licensed physicians, weregenerally comparable to those in the United States, whereOMT is provided by licensed physicians. This consistencysuggests that the results truly reflect the effects of OMTitself, and not other elements of low back care. It is notsurprising that osteopaths in the United Kingdomachieved pain reduction with OMT similar to that of theirphysician counterparts in the United States. The trainingof osteopaths in the United Kingdom is highly focused onOMT, whereas osteopathic physicians undertake amedical curriculum that necessarily relegates OMT to oneof many therapeutic approaches, albeit a fundamentalone for osteopathic practitioners. Regardless of the career

training path of the provider, it appears that OMTachieves clinically important reductions in low back pain.

Potential limitationsThere are several potential limitations of this study thatshould be addressed. First, as with any meta-analysis, theindividual trials varied somewhat with respect to method-ology, including trial setting, subject characteristics, OMTand control treatment interventions, and pain measures(Table 1). Such heterogeneity has been commonlyobserved in previous meta-analyses of spinal manipula-tion, including a recent meta-analysis performed in col-laboration with the Cochrane Back Review Group [31].The latter study addressed potential heterogeneity by pre-senting stratified results according to chronicity of lowback pain, type of control group, and duration of follow-up. This approach is analogous to the methods used inour study. Further, it should be noted that the assumptionof homogeneity among trials was not rejected statisticallyin any of our eight overall or stratified median contrastsmeta-analyses.

Second, because five trials each included repeated painmeasures and two trials each included two control treat-ments, there was no unique set of independent outcomesfor meta-analysis. Such interdependencies were noted tobe a problem in an early meta-analysis of spinal manipu-lation [15]. We used the median contrasts method toaddress this problem because the median outcome repre-sents an observed outcome that is easy to compute and isless vulnerable to extreme observations than other meas-ures of central tendency. Further, sensitivity analysis wasused to assess the range of possible combinations of out-comes. Thus, for the overall meta-analysis, there were 729potential contrast combinations. Of these, both the best-case and worst-case scenarios demonstrated statisticallysignificant results favoring OMT, thereby providing une-quivocal evidence for the efficacy of OMT. Robust find-

Long-Term Follow-Up

Median (all) contrastsFixed-effects model* 4 87 53 -0.40 -0.74 – -0.05 .03Random-effects model 4 87 53 -0.41 -0.82 – -0.01 .046

Median contrasts, one OMT vs control treatment comparison per trialLicciardone [46] placebo control 3 55 38 -0.23 -0.65 – 0.19 .28Licciardone [46] no treatment control 3 55 34 -0.64 -1.08 – -0.20 .01

Median contrasts, Cleary [47] trial excluded 3 79 49 -0.36 -0.72 – 0.01 .054

CI denotes confidence interval; OMT, osteopathic manipulative treatment.*Tests of homogeneity, P = .45 and P = .06 for active treatment or placebo control, and no treatment control groups, respectively; P = .32 and P = .26 for trials in the United Kingdom and the United States, respectively; and P = .14, P = .06, and P = .28 for short-term, intermediate-term, and long-term follow-up, respectively.

Table 4: Stratified results. (Continued)

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ings were also observed for trials performed in the UnitedStates and for intermediate-term outcomes.

Third, because there were a relatively small number of eli-gible trials, there were not sufficient contrasts for certainanalyses and some results were imprecise. The latter phe-nomenon likely obviated the statistical significance ofsome results. Nevertheless, it is important to note that thedirection of results favored OMT in each of the 43 meta-analyses and sensitivity analyses presented herein (Figure3).

Fourth, there exists the possibility that the results ofunpublished trials of OMT for low back pain may havealtered significantly the conclusions of this study. Toaddress this issue, we performed file drawer analysis bycomputing the fail-safe N [58]. This represents thenumber of unpublished trials of OMT for low back painthat would have met our inclusion criteria, and that alsowould have demonstrated an effect size averaging ≥ -0.10,which is assumed to reflect clinically insignificant levels ofpain reduction. A total of 16 unpublished trials (assumingone control group per trial) with, in the aggregate, clini-

cally insignificant pain reduction outcomes would havebeen needed to obviate the significance of our results.Only recently has government funding for research in thearea of complementary and alternative medicine becomemore widely available, in response to the public's interestin such treatments. Historically, it is highly unlikely that16 trials of OMT for low back pain would have been spon-sored, conducted, and subsequently not published.

Finally, this study focused only on the efficacy of OMTwith respect to pain outcomes. Generic health status,back-specific function, work disability, and back-specificpatient satisfaction are other recommended outcomedomains [59] that were not assessed because the includedOMT trials did not consistently report these data.

ConclusionThe present study indicates that OMT is a distinctivemodality that significantly reduces low back pain. Thelevel of pain reduction is greater than expected from pla-cebo effects alone and persists for at least three months.Additional research is warranted to elucidate mechanisti-cally how OMT exerts its effects, to determine if OMT ben-

Summary of meta-analysis resultsFigure 3Summary of meta-analysis results. A denotes all-contrasts model; B, best-case scenario model; C, Cleary [47] trial excluded model; M, median contrasts model; NT, no treatment control; OMT, osteopathic manipulative treatment; W, worst-case sce-nario model. 1, 2, 3, and 4 indicate alternative models restricted to one OMT vs control treatment comparison per trial. A dia-mond indicates the inclusion of the relevant contrast or observation of the stated result. Sensitivity analyses are shaded in gray. Results are presented for each of the 43 analyses, including the overall meta-analysis, seven stratified meta-analyses, and 35 sensitivity analyses.

NT

Comparison Duration of

Source, year treatment follow-up M B W 1 2 3 4 C A M B W 1 2 C A M M B W 1 2 C A M B W 1 2 A M B W A M 1 2 3 4 M 1 2 C

Hoehler 1981[42] Active and placebo Immediate � � � � � � � � � � � � � � � � � �

Hoehler 1981 [42] Active and placebo 20-30 Days � � � � � � � � �

Hoehler 1981 [42] Active and placebo 41-51 Days � � � � � � � � � � �

Gibson 1985 [43] Active treatment 2 Weeks � � � � � � � �

Gibson 1985 [43] Active treatment 4 Weeks � � � � � � � � �

Gibson 1985 [43] Active treatment 12 Weeks � � � � � � � � � � � � � � � �

Gibson 1985 [43] Placebo control 2 Weeks � � � � � � � �

Gibson 1985 [43] Placebo control 4 Weeks � � � � � � � � � � � � � � � �

Gibson 1985 [43] Placebo control 12 Weeks � � � � � � � � �

Cleary 1994 [47] Placebo control 15 Weeks � � � � � � � � � � � � � � � � � � � � � � �

Andersson 1999 [44] No treatment 12 Weeks � � � � � � � � � � � � � � � � � � � � �

Burton 2000 [45] Placebo control 2 Weeks � � � � � � � � � � � � � � � � � � � � �

Burton 2000 [45] Placebo control 6 Weeks � � � � � � � � � � �

Burton 2000 [45] Placebo control 12 Months � � � � � � � � � �

Licciardone 2003 [46] Placebo control 1 Month � � � � � � � �

Licciardone 2003 [46] Placebo control 3 Months � � � � � � � � �

Licciardone 2003 [46] Placebo control 6 Months � � � � � � � � � � � � � � � �

Licciardone 2003 [46] No treatment 1 Month � � � � � � � � � � � �

Licciardone 2003 [46] No treatment 3 Months � � � � � � � �

Licciardone 2003 [46] No treatment 6 Months � � � � � � � �

Number of contrasts in analysis 8 8 8 6 6 6 6 7 20 6 6 6 5 5 5 16 4 4 4 4 3 3 3 10 4 4 4 3 3 10 5 5 5 9 7 5 5 5 5 4 3 3 3

Direction of effect favors OMT � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �

Statistically significant effect � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �

Reversal of significance with random-effects model � � �

Test of homogeneity is statistically significant � � �

Overall analysis

Active/placebo ShortUnited Kingdom United States Long

Stratified analyses

Control treatment Country where trial was performed Duration of follow-up

Intermediate

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efits are long lasting, and to assess the cost-effectiveness ofOMT as a complementary treatment for low back pain.

Competing interestsThe author(s) declare that they have no competinginterests.

Authors' contributionsJCL, AKB, and LNK conceived and designed the study.LNK performed the literature searches. JCL and AKBextracted the data. JCL performed the statistical analyses.JCL, AKB, and LNK interpreted the data and drafted themanuscript. JCL will act as guarantor for the paper. Theguarantor accepts full responsibility for the conduct of thestudy, had access to the data, and controlled the decisionto publish. All authors approved the final manuscript.

Additional material

AcknowledgementsThis research was supported in part by a grant (No. D56HP00170) from the Health Resources and Services Administration, United States Depart-ment of Health and Human Services. The funding organization had no role in the design, conduct, and reporting of this study.

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Additional File 1this file provides the timetable, databases, and search terms used to iden-tify relevant studies for the meta-analysis.Click here for file[http://www.biomedcentral.com/content/supplementary/1471-2474-6-43-S1.doc]

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