By Medolutions, LLC

THE MOST COMFORTABLE NAME IN BACK PAIN RELIEF Dear Doctor: Thank you for your consideration of the Bio-Back lumbar Orthosis in your treatment of low back conditions. An advancement of an age old technology, the Bio-Back is not a variation of every other brace design that's been around for 50 years, big, bulky, and restrictive. Patients love the Bio-Back and they actually wear it! Bio-Back is:

• A safe, drug-free alternative for treating LBP. • A functional brace that helps your patients regain mobility and strength while reducing pain

to promote an active lifestyle. • Comfortable and easy to use, which results in better patient compliance for improved clinical

outcomes. The Bio-Back combines innovative and patented design features with an incredibly small, low profile, size to immediately provide support and improve posture. Bio-Back’s unique counter-force pressure changes muscle tone and reduces the stress on pain sensitive structures (muscles, discs, joints, and nerves) in the lower back to help relieve pain and restore function for acute, sub-acute and chronic low back pain sufferers. The Bio-Back may be appropriate in treating the following conditions:

Strain/sprains of the lower back Ruptured, Herniated, Bulging, Prolapsed disc conditions Unstable joint mechanical conditions in the lower back Weak or deconditioned lower back spinal muscles Inflammatory arthritic conditions of the spine Degenerative disc and joint disease Spondylolisthesis and Spondylolsis Osteoporosis conditions of the spine Mechanical low back pain

Bio-Back uses easily adjustable straps to allow one size to fit most patients • Standard Size fits 22” and 50” waists • A second larger size is available for patients with 51” to 78” waists • Smaller front panels can be provided, upon request, for your very petite patients. • Once familiar with fitting, the Bio-Back can be adjusted for a patient within minutes The Bio-Back should be worn comfortably tight to encourage a neutral spine posture and to attain the best results. The Bio-Back may be worn while sitting, standing, sleeping, driving or performing other daily activities. Please review the fitting instructions DVD provided with the Bio-Back or available on our website at www.medolutions.com.

Bio-Back encourages activity to help the patient return to a more active, healthier lifestyle, making Bio-Back an effective complement to your treatment of low back conditions for improved functional outcomes.

By Medolutions, LLC

Bio-Back Patient Benefits Decreases Lower Back Pain Decreases Inflammatory Reaction Decreases Intervertebral and Joint Pressure

in the Lower Back Region Promotes Core Stability and Neutral Spine

Posture-providing for improved body mechanics

Helps Improve Functional Outcomes Increases Lower Back Range of Motion Stabilizes Lower Back Enables Lower Back Pain Suffers to Pursue

the Activities of Daily Living with Less Back Pain

Enclosed please find information regarding the Bio-Back along with other studies regarding the use of bracing, to include: • Explanation of the Bio-Back’s Efficacy, • Bio-Back Needle EMG Study (Abstract), • Bio-Back Patient Evaluation Survey Results (Pain Management Patient Survey) • Bio-Back Awarded National Organizations Seal of Approval (Press Release) • Copy of Official Disability Guidelines regarding lumbar supports, • Excerpt of Study information (Evidence Based Prevention and Rehabilitation, Stuart Mcgill) • Study: Effectiveness of a lumbar belt in subacute low back pain (Calmels, 2009), • Study: The Influence of Prophylactic Orthoses on Abdominal Strength and Low Back Injury

in the Work Place (Walsh 1990), • Study: Lumbar Supports and Education for the Prevention of Low Back Pain in Industry

(Van Poppel & Colleagues 1998), • Study: Lumbar Supports to Prevent Recurrent Low Back Pain among Home Care Workers

(Roelofs & Colleagues 1997)

By Medolutions, LLC

Explanation of Bio-Back’s Efficacy

Bio-Back’s design features relieve pain, promote a neutral spine posture and restore function. The Bio-Back’s design features include:

• Bi-Lateral Opposing Forces combined with a Lumbar Dome that fits into the small of the back • A pair of straps that connect two panels (front and back) that tighten the brace against the

patient’s abdomen and lower back • Compact design that allows near total range of movement to promote patient compliance and

comfort

Clinical Effect Explanation / Benefit

Improves Posture

The Bio-Back’s Bi-Lateral Opposing Forces and Lumbar Dome promote a neutral spine posture for improved body mechanics during lifting, bending and other ADL’s.

Reduces Strain on and Changes Tone of Low Back Musculature

Bio-Back actively engages the abdominal muscles to balance the strain across the core, thereby reducing the stress placed upon the low back musculature.

Needle EMG demonstrated that use of the Bio-Back orthosis, tensioned to 16 pounds on patients standing in a neutral spine position, reduced low back muscle activity by an average of 46% overall. The two muscle groups tested were the Longissimus and the Multifidus with the following specific reductions in muscle activity:

• The Longissimus at L4 by an average of 51% • The Multifidus at L4 by an average of 38%

Reduces the Load on Intervertebral Discs and Facet Capsular Joints

By changing the tone or reducing the activity of low back musculature and promoting neutral spine posture the Bio-Back reduces the load placed on the intervertebral discs and facet capsular joints.

Helps Stabilize the Lower Back while in an Injured State

The Bio-Back’s counter force pressure enhances joint stability in the lumbar spine for improved functional training.

Relieves Pain

The effects of changing the muscle tone and reducing the load on the intervertebral discs and facet joints is to reduce the inflammatory reaction, resulting in back pain relief.

A Pain Management Clinic conducted a subjective study of twenty-nine (29) low back pain sufferers, who wore the Bio-Back for varying lengths of time (one month to one year), reported the following results:

• 78% reported pain relief • 73% reported pain prevention • 7% reported a decrease in consumption of opioids • 84% would recommend the Bio-Back

Helps Restore Function

The Bio-Back with its unique counter force design helps restore the lumbar spine’s ability to function in a normal or near normal manner by relieving pain and improving posture to encourage more ergonomically correct motions. Thus, Bio-Back can be utilized effectively in a rehabilitative fashion for numerous lower back conditions.

Patient evaluations have demonstrated improvements in range of motion to the point of increased pain of between 10% and 30% in acute and sub-acute low back pain sufferers.

The effect of a novel lumbar orthosis on paraspinal muscle activity: a pilot study Charles W. Lindquist Jr. D.C. DACNB Correspondence:

Frederick M. Graff, D.C. DABCO, Medical Director Medolutions, LLC Telephone: (614) 543.1743, ext 102 Email: fgraff@medolutions.com ABSTRACT Modifying the activity and improving the endurance of lumbar musculature during dynamic and static activities is a key component of treatment for low back pain. This paper presents a pilot study assessing the effect of a novel lumbar orthosis on lumbar muscle activity. Nine asymptomatic volunteers (7 males and 2 females) ranging in age from 22 to 55 years were recruited and six subjects were included in the final analysis. The electromyographic (EMG) signals of the paraspinal muscles at the L4 vertebral level were assessed while participants stood in a neutral position with or without the orthosis. When wearing the orthosis, the electrical muscle activity was reduced by 51.3% (p=.03) and 38.8% (p=.09) for longissimus and multifidus muscles, respectively. Collectively, use of the orthosis reduced the activity of the paraspinal musculature by 46.2% (p<.05). This pilot study suggests that this novel orthosis may provide external stability to the spine and relieve muscle strain by reducing the recruitment of the paraspinal muscles. Further well-controlled outcomes studies are needed to validate the effectiveness of this orthosis in a large symptomatic patient population.

Study Design: Used electromyographic (EMG) signals to measure paraspinal muscle activity at the L4 vertebral level, pre and post utilization of a novel lumbar orthosis.

Objective: The orthosis evaluated utilizes a unique and patented design and has been subjectively demonstrated to help relieve pain. Electromyography was utilized to determine the effect of this orthosis on paraspinal musculature.

Summary of Background Data: There is limited evidence of efficiency of lumbar supports for treatment of low back pain.

Results: When wearing the lumbar orthosis, the mean electrical muscle activity was reduced for the paraspinal muscles by an average of 46.2% (95% CI -5.6, 45.2).

Conclusion: This pilot study provides initial data on the effectiveness of a novel lumbar orthosis at reducing paraspinal muscle activity. The decreased EMG activity may provide temporary symptomatic relief to patients suffering from low back pain.

Key words: lumbar, orthosis, back pain, muscle endurance, electromyographic signal.

EMG muscle activity for longissimus and multifidus with and without an orthosis. Error bars represent one standard deviation.

0

10

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70

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Patient Evaluation of the

Bio-Back Lumbar Orthosis

for low back pain relief and pain prevention

April 2008

Patient Evaluation of the Bio-Back Lumbar Orthosis for low back pain relief and pain prevention

Purpose

This study was performed by the medical staff at Pain Control Consultants, Inc; a pain management practice located in Columbus Ohio, during April 2008. The study was performed to obtain patient feedback regarding their use of and experience with the Bio-Back lumbar orthosis.

Method and Subjects

Twenty-nine symptomatic patients suffering from chronic back pain were asked to respond to a series of questions regarding their utilization of the Bio-Back lumbar orthosis. These patients had used the Bio-Back for varying lengths of time, but for not less than thirty days.

Results

Summary of patient responses:

o Seventy-eight (78%) percent reported pain relief,

o Seventy-three (73%) percent reported pain prevention,

o Seven (7%) percent reported a decrease in consumption of opioids, and

o Eighty-four (84%) percent would recommend the Bio-Back.

Conclusions

While subjective, this study demonstrates that for most patients, use of the Bio-Back orthosis will provide pain relief for low back pain and will also help prevent low back pain from occurring. It was very interesting to note that seven percent of the patients indicated a decrease in the consumption of opioids indicating that for low back pain patients, the Bio-Back may provide a useful tool in reducing narcotic utilization.

Reported Pain Relief

Reported Pain Prevention

Reported Decreased Opiod Usage

Will Recommend the Bio-Back

0%

10%

20%

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70%

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90%

Subjective Study of Chronic Back Pain Sufferers

Congress of Chiropractic State Associations (COCSA) Grants Bio-Back Lumbar Orthosis Their Seal of Approval

| 29 Apr 2010 | 01:40 PM ET

DUBLIN, Ohio, April 29, 2010 /PRNewswire via COMTEX/ -- COCSA and Medolutions, LLC are pleased to announce that the Bio-Back Lumbar Orthosis has been awarded the COCSA Seal of Approval. The patented Bio-Back is a licensed product of Medolutions, LLC and is clinically proven to help relieve back pain and restore function. The Bio-Back's small, light-weight design makes it an effective tool in the treatment of low back pain.

About COCSA The Congress of Chiropractic State Associations was founded in 1969 with the mission of providing an open nonpartisan forum for the advancement of the chiropractic profession through service to its member state associations. The COCSA Seal of Approval is granted to products or services deemed to have exceptional value to our state association members or the chiropractic profession. In speaking of the Bio-Back, First Vice President Dr. Kate Rufolo said, "On behalf of the Board, let me say that the Bio-Back represents the best of what is out there to improve the profession and to benefit our patients. We look forward to working with Medolutions." Additional information about COCSA is available at http://www.cocsa.org.

About Medolutions (Photo: http://www.newscom.com/cgi-bin/prnh/20100429/CL95771 ) Medolutions was founded in 2007 to develop a line of pain relief products based on unique and patented design architecture. The Company's initial product is the Bio-Back, with patented features that include "Bilateral Opposing Forces" and a "Lumbar Dome". Together these features help relieve back pain and restore range of movement to improve functional outcomes. The Bio-Back is clinically proven, healthcare reimbursed and provides an effective, drug free and complementary device for the treatment of a wide variety of low back conditions. Medolutions President and CEO, Richard J. Gerace said, "We are very pleased to be associated with COCSA whose mission is vital to the chiropractic profession. Their Board is represented by dedicated professionals who strive for the advancement of the profession, their membership and the patients served. Additional information about Medolutions and the Bio-Back may be found at www.medolutions.com.

For additional information regarding this press release, please submit inquires to COCSA at amy4hardin@yahoo.com or submit inquires to Medolutions at pr@medolutions.com.

SOURCE Medolutions www.prnewswire.com Copyright (C) 2010 PR Newswire. All rights reserved -0- KEYWORD: Ohio INDUSTRY KEYWORD: HEA

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SPINE Volume 34, Number 3, pp 215–220©2009, Lippincott Williams & Wilkins

Effectiveness of a Lumbar Belt in Subacute LowBack PainAn Open, Multicentric, and Randomized Clinical Study

Paul Calmels, PhD, MD,* Patrice Queneau, MD,† Claude Hamonet, PhD, MD,‡Claude Le Pen, PhD,§ Frederique Maurel,§ Claire Lerouvreur,§and Philippe Thoumie, MD, PhD¶

Study Design. Multicentric, randomized, and con-trolled study of clinical evaluation of medical device insubacute low back pain.

Objective. To evaluate the effects of an elastic lumbarbelt on functional capacity, pain intensity in low back paintreatment, and the benefice on medical cost.

Summary of Background Data. There is limited evi-dence of efficiency of lumbar supports for treatment oflow back pain. There is also a lack of the methodology inthe studies reported on the efficiency of this device.

Methods. This study is randomized, multicentric, andcontrolled with 2 groups: a patient group treated with alumbar belt (BWG) and a control group (CG). The maincriteria of clinical evaluation were the physical restorationassessed with the EIFEL scale, the pain assessed by avisual analogic scale, the main economical criteria wasthe overall cost of associated medical treatments.

Results. One hundred ninety-seven patients have par-ticipated. The results show a higher decrease in EIFELscore in BWG than CG between days 0 and 90 (7.6 � 4.4vs. de 6.1 � 4.7; P � 0.023). Respectively significant re-duction in visual analogic scale was also noticed (41.5 �21.4 vs. 32.0 � 20; P � 0.002). Pharmacologic consump-tion decreased at D90 (the proportion of patients who didnot take any medication in BWG is 60.8% vs. 40% in CG;P � 0.029).

Conclusion. Lumbar belt wearing is consequent insubacute low back pain to improve significantly the func-tional status, the pain level, and the pharmacologic con-sumption. This study may be useful to underline the in-terest of lumbar support as a complementary andnonpharmacologic treatment beside the classic medica-tion use in low back pain treatment.

Key words: low back pain, lumbar belt, pain, func-tional assessment, economical assessment. Spine 2009;

34:215–220

Low back pain is a very frequent symptom in industrial-ized countries. Sixty percent to 90% of adults suffer orhave suffered from low back pain during their life inindustrialized countries,1–3 and the prevalence increaseconstantly in these countries. Back complaints accountedfor 6.9%1 of consultations with physicians in cities.

Although nonspecific low back pain accounts for avery large majority of low back pain, a distinction ismade between acute (less than 4 weeks progression),subacute (between 4 weeks and 3 months), and chroniclow back pain (more than 3 months).2 Low back painevolution is frequently quickly favorable in few days,with or without treatment, with a frequent risk of recur-rence.4 Indeed, for Coste et al,5 50% of episode last lessthan 1 week and 90% less than 2 weeks, but for vonKorff,6 “the course of back pain is highly variable, oc-curring in transient, recurrent, and chronic phases.” Theevolution must be evaluated at long-term follow-up. Forvon Korff and Saunders,7 after 1 year or more of an acuteepisode, “33% report intermittent or persistent pain ofat least moderate intensity, 1 in 7 continue to report backpain of severe intensity, and 1 in 5 report substantialactivity limitations.” More recently Enthoven et al8 re-ported after a 5-year follow-up that 52% of subjectshave always pain and functional limitations. In theseconditions, low back pain has a considerable impact interms of medical costs (consultations, medical pre-scriptions, . . .) and repercussion on occupationalactivity.1,7–9

Many propositions of treatment, sometimes withcombination, are reported. In acute or subacute lowback pain, treatment tries to reduce or control the painintensity to enable fast resumption of occupational andpersonal activities.

Lumbar orthosis (corsets or belts) are proposed as apart of the wide range of therapeutic10–12 and preven-tion13–15 options in practice. The antalgic effect is ex-pected because of the control of lumbar mobility, therelative immobilization of the lumbar spine, and somesubjective effects (heat, massage, continuous stimula-tion).12,16 These effects are still the subject of debate.Recent literature17,18 about the efficacy of lumbar beltsin low back pain reported that their use as a mean ofpreventing low back pain is not proved and currentknowledge does not allow a judgment of their interestin the treatment of low back pain. For van Tulder et al,there is some scientific information, which emphasizes

From *Service de Médecine Physique et Réadaptation, Université JeanMonnet, Hôpital Bellevue, Saint Etienne, France; †Centre Hospitalierde Saint Etienne, Saint-Etienne, France; ‡Service de Médecine Physiqueet Réadaptation, Hôtel-Dieu, Paris, France; §Aramis Consultants,Neuilly sur Seine, France; and ¶Service de Rééducation Neuro-Orthopédique Hôpital Rothschild APHP, Paris, France.Acknowledgment date: January 4, 2008. First revision date: July 13,2008. Second revision date: August 27, 2008. Acceptance date: August27, 2008.The manuscript submitted does not contain information about medicaldevice(s)/drug(s).No funds were received in support of this work. No benefits in anyform have been or will be received from a commercial party relateddirectly or indirectly to the subject of this manuscript.Address correspondence and reprint requests to Paul Calmels, PhD,MD, Service de Médecine Physique et Réadaptation, CHU Saint-Etienne, Hôpital Bellevue, 42055 Saint Etienne Cedex 2, France.E-mail: paul.calmels@chu-st-etienne.fr

215

the therapeutic potential of lumbar belts for low backpain.18 Nevertheless, few studies have been carried outon the therapeutic efficacy of lumbar belts and, those thathave been carried out are now outdated, contain contra-dictory results and/or are often not comparable. Further-more, the methodologic weakness of most of these stud-ies reported in the Cochrane review18 (low number ofsubjects included, cointervention not documented . . .)does not allow robust interpretation of their results.More recently, in a review, van Tulder et al19 concludethat there is limited evidence of efficiency of lumbar sup-ports in comparison with no treatment and that they aremore effective than other interventions for treatment oflow back pain. Therefore, a controlled study is neces-sary, with randomization of the patients, exclusion ofacute low back pain, and use of valid, reliable, and sen-sitive instruments for measuring efficacy.

Objective

The objective of the study was to assess the effectivenessof the lumbar belt in the treatment of patients sufferingfrom subacute low back pain. Efficacy criteria—2 clinicaleffectiveness criteria and 1 economical criterion were de-fined and evaluated over the whole follow-up period:

The functional recovery measured over 3 months us-ing EIFEL scale (French version of the Roland-Morrisscale).

The change in pain intensity measured with a visualanalogical scale (VAS) of 100 mm assessed.

The medical consumption assessed by number of dayswith analgesic, anti-inflammatory, and/or myorelax-ant agents.

Materials and Methods

The trial was a multicentric, open, prospective, and random-ized clinical study of a lumbar belt and “control group” (CG) inthe treatment of subacute low back pain with follow-up mon-itoring lasting 3 months. This study was approved by EthicCommittee (CCPPRB Rhone Alpes–Loire N° 2004-13) andhad received Centre National Informatique et Liberte authori-zation for data collection.

PopulationThe studied population was made up of patients suffering fromsubacute low back pain treated by a family practitioner. Inclu-sion and exclusion criteria are presented in Table 1.

The sample size had an estimated total of 210 patients. Twogroups are randomized (the “wearing belt group” (WBG) andthe CG with 105 patients in each group. The number of neces-sary subjects was estimated to highlight a significant differencein the level of score on the EIFEL scale between the 2 groupsanalyzed. A difference of 2 points on the EIFEL scale of amaximum score of 24 is considered to be clinically significant.Under these hypotheses, with an alpha risk of 0.05 and a betarisk of 0.1 (statistical power of 90%) the number of patientsrequired is 84 per group, or 168 patients in total. To take intoaccount patient compliance issues regarding wearing of thelumbar belt, a 25% increase in the number of persons involvedwas allowed.

Recruitment of the patients was proposed by the practitio-ners to all subjects consulting for subacute low back pain andhad to stop after all the 210 patients had been recruited. For theWBG the practitioners gave the belt (which was provided anddelivered to the practitioners) to the eligible randomized pa-tients. The instructions were to wear it during the whole dayand over the whole duration of the trial and to explain how toadjust it. A call center was set up to answer all the questionsasked by the patients regarding the belt. For the CG the patientsdid not receive the belt. The practitioners asked them not topurchase the belt or to wear a lumbar belt for the whole dura-tion of the study. At the end of the 3 months of the study, if thepractitioner considered it to be necessary, prescription of abelt could be suggested to the patient. For each group theother treatments were left to the discretion of the investigat-ing practitioner.

Randomized assignment was carried out initially with ablock of 6 patients for each practitioner. During the study, tocompensate for the insufficient number of patients recruited bycertain practitioners, the block was increased from 6 to 8, justfor them who had already included 6 patients and able to in-clude 2 more. After the inclusion of each patient (satisfying theeligibility criteria and consent form), the practitioner connectedwith a vocal server (AREMIS Consultants) to find out whichgroup the patients were included.

Recruitment of the investigating practitioners was carriedout randomly from a database of practitioners developed byCEGEDIM Company (Boulogne-Billancourt, France). On a listof 757 practitioners solicited, 61 had accepted to participle and44 were active for patient’s recruitment. Participation of theinvestigating practitioners required that they accept the proto-col, agree the remuneration, the quality control process, becapable of fulfilling the recruitment.

Table 1. Inclusion and Exclusion Criteria

Inclusion criteriaMen or women between 20 and 60 yr of ageTreatment for an initial episode or recurring nonspecific low back painEpisode lasting 1 to 3-moNo contraindications to step I or step II analgesics, NSAID,

benzodiazepines and thiocolchicosideSigning the consent form, which was explained to them firstExclusion criteriaPatients who have used a lumbar belt during the last 6 moPatients who have low back pain irradiating beyond the knee and/or

accompanied by neurological signs, including sciatica,Patients who have suffered from a low back pain episode during the 6

mo preceding inclusionPatients who had had a spinal operation during the 5 yr preceding

inclusionPatients who have secondary low back pain due to an accident at

workPatients who have a history of spinal arthrodesisPatients who have an unstabilized or symptomatic, chronic cardiac or

respiratory complaintPatients who suffer from low back pain with an inflammatory, tumoural,

or infectious causePatients with a contraindication to step I or step II analgesics, NSAID,

benzodiazepines, and thiocolchicosidePatients who are pregnantPatients whose higher functions do not enable them to properly

comprehend the protocol or to reliably record the dataExclusion of patients with a chronic cardiac or respiratory complaint

was justified by the theoretical warning of the potential effect ofwearing a lumbar belt on the increase in cardio-respiratory load

216 Spine • Volume 34 • Number 3 • 2009

Medical Device ExperimentedIt was an elastic textile lumbar belt Combitex with crossedbands and posterior metallic reinforcement (Lomba-Cross Ac-tivity, Thuasne, France). It is a class 1 medical device “CEmarked” in conformity with n° 93/42/CEE directive.

Outline of the StudyThe total duration of the study was 24 months (09/2004-09/2006), with an inclusion phase of 12 months. The patients wereexamined 3 times, on D0 inclusion, on D30 � 3 days, onD90 � 3 days, and an intermediate contact was realized atD60 � 3 days (D60) by a phone survey. The collected infor-mations during the follow-up were:

At inclusion (D0), questionnaire with: complete sociode-mography data of the patient (age, sex, height, weight); generalclinical state and clinical conditions of the low back pain, his-tory, and previous treatments; measurement of the EIFEL scaleand pain VAS; and current treatment and prescribed treatment.

At the visits (D30, D90) and phone survey (D60), question-naire with: assessment of wearing the belt since the last visit(patient compliance for WBG); measurement of the EIFELscale and pain VAS; and use of medical treatments since the lastvisit (pharmaceutical intake) and just for the visits, treatmentsprescribed. The data were collected at D0, D30, D60, and D90,and the analysis was carried out in an anonymous way byARAMIS Consultants.

InstrumentThe EIFEL scale is a valid and reliable self-questionnaire forassessing functional capacity in low back pain.20,21 It consistsof 24 questions. The patient must answer each question infunction of the difficulty applicable on the day the question-naire is completed. Each question equals 1 point and the totalEIFEL score corresponds to the sum. Thus, a score of 24 cor-responds to the most unfavorable situation (total functionalincapacity associated with their low back pain). The pain VASwas measured with a horizontal scale from 0 (no pain) to 100(maximal pain).

Statistical AnalysisThe statistical analyses had been carried out on: the intention totreat population (ITTP) corresponds to all randomized patientsfulfilling the inclusion and noninclusion criteria without regardthey complied with the lumbar belt wearing recommendationsor not; the per protocol population (PPP) corresponds all thepatients in the ITT whose efficacy criteria (EIFEL and VAS)were measured at D0 and D90 and who wore a lumbar belt atleast once a week during the whole duration of the follow-upfor the WBG and those who never wore a belt for CG.

A descriptive analysis of the population was carried out onthe 2 groups at D0 to compare them. The efficacy analyses werecarried out on the various treatment groups by means of avariance analysis with recurring measurements for comparingthe main and secondary efficacy criteria (variations in theEIFEL and VAS scores, days of analgesic intake). In addition, acomparison was carried out on the rate of patients responding(i.e., showing an improvement in EIFEL score of at least 2points from 24).

The qualitative variables were presented with the personsinvolved and frequency of representation for each modality.The quantitative variables were presented with their average,standard deviation, median, and extreme values. All the de-scriptive analyses were carried out according to the randomiza-tion group (WBG and CG) and for the whole population. Foreach variable, a comparison test was carried out between the 2groups studied, and was presented in the table of results: t testfor the quantitative variables; �2 for the qualitative variables.The missing data (no answer) for the main clinical criteria(EIFEL score and VAS score) was taken into account by apply-ing the imputation method to the average data. For an individ-ual, the missing data of a variable were replaced with the aver-age of the calculated values based on the individuals in the samesubpopulation.

Analysis of the variance of the repeated data enables theexisting correlation between different measurements (overtime) for the same individual to be taken into account.ANOVA, with repeated data were carried out using the

Figure 1. Population and number of persons in each group for each of the visits (D0, D30, and D90) or telephone contact (D60).

217Lumbar Belt in Subacute Low Back Pain • Calmels et al

MIXED procedure of SAS, with retention of the repeatedoption for the individuals. The statistical analyses were car-ried out using the SAS software V8.02 in the Windows en-vironment.

Results

PopulationTwo hundred seven patients were randomized (106WBG and 101 CG)(Fig. 1). After checking and validatingthe data, 197 patients correspond to the ITTP, 102WBG, and 95 CG (6 patients did not observe the inclu-sion criteria and for 4 patients we never received theinclusion questionnaires, 2 in WBG and 2 CG). The PPPcontained 171 persons (90 WBG and 81 CG) (Fig. 1).The characteristics of ITTP were a ratio of 54.8% men,an age average of 43 � 10.7 years, weight of 73 � 15.4kg, and height of 170 � 8.7 cm. The PPP characteristicswere comparable.

There were no significant differences between the 2groups regarding their socio-demographic characteris-

tics, way of life, physical activities and occupation,health status at the beginning of the study, medical his-tory on the spine, previous medical treatment for lowback pain, and characteristics of this low back pain epi-sode (duration, responsible factors, . . .). There was alsono significant difference regarding the efficacy criteria atthe beginning of the study: EIFEL score: 10.3 � 4.3 WBGand 10.1 � 4.3 CG; VAS score: 60.9 � 17.7 WBG, and59.7 � 18.1 CG; drugs consummation: 66% of patientsdon’t use medication at the inclusion, with 64.7% WBGand 67.4% CG.

In WBG, the patients wore the belt, on average andper week, 5 days at D30, 4 days at D60, and 3 days atD90. In addition, the number of daily hours on which thebelt was worn was 8 hours at D30, 6 hours at D60, andfinally 5 hours at D90.

Change in EIFEL ScoreThere was a significant difference of change of EIFELscore between WBC and CG: from D0 to D30, respec-

Figure 2. Change in EIFEL scorebetween D0 and D90.

Figure 3. Change in VAS scorebetween D0 and D90.

218 Spine • Volume 34 • Number 3 • 2009

tively, reduction in the average EIFEL score by 5.4 � 4.1and 4.0 � 4.3 for CG (P � 0.022); from D0 to D90reduction by 7.6 � 4.4 and 6.1 � 4.73 (P � 0.023) (Fig. 2).

Change in Pain IntensityThere was a significant difference of change of VAS painintensity between WBG and CG: from D0 to D30, re-spectively, reduction in the average VAS score by 26.8 �18.2 and 21.3 � 18.7 (P � 0.038); from D0 to D90reduction in the average VAS score by 41.5 � 21.49 and32.0 � 20.0 (P � 0.002) (Fig.3).

Medication ConsumptionThere was a significant difference of the medication con-sumption between WBG and CG: at D90, the proportionof patients who did not take any medication in WBG is60.8% versus 40% in CG (P � 0.029).

The proportion of patients who took at least 1 medi-cation at the time of inclusion was identical for bothgroups (33% WBG and 32.6% CG), increased duringthe first month of follow-up (D30: 66.7% WBG and78.9% CG; P � 0.039), and fall after (D90: 34.3% WBGand 56.8% CG; P � 0.002), so that WBG consumed farfewer medication treatments than CG.

Discussion

The results of this study show that wearing a lumbar beltin the subacute low back pain is benefic for functionalrecovery, pain intensity control, and medication con-sumption.

At our knowledge there is no comparable study in lowback pain with a so large population, a CG, and a ran-domization, with a multicentric participation, and tak-ing into account antalgic, functional, and medicationconsumption benefices during a so long-phase of treat-ment. Some methodologic characteristics of this studyare in agreement with the recommendations of the just 3studies can be considered for the effects reported on painintensity.

Penrose et al22 reported the results of wearing a pneu-matic belt during 6 weeks in low back pain. This was arandomized study with a CG but without any precisionabout the low back pain history, the duration of theepisode, and the complementary treatment. The evalua-tion was made on pain, muscle strength, and mobility ofthe back. Each subject has been evaluated after 1 hour, 3,and 6 weeks of wearing the belt. The results show asignificant decrease of pain intensity for BWG respec-tively with 18%, 46%, and 73% at 1 hour, 3, and 6weeks. The results were significantly less for the CG. Itwas the same for muscle strength and mobility. The com-pliance to the wearing of the belt was not evaluated.

Valle-Jones et al11 have analyzed the benefices ofwearing a back support in the treatment of acute nonspecific low back pain, at 10 to 12 days. This random-ized, controlled, parallel-group clinical trial was carriedout in general practice. Two hundred sixteen patientshave been included (111 wearing corset and 105 con-trols). All the patients had also paracetamol from 1 to 4 g

a day if necessary to control pain. A self evaluation wasmade daily during 3 weeks, with pain intensity level (atrest, at night, and during activity), limitation activitylevel, antalgic consumption, and ability to work. A clin-ical examination of back mobility was realized at thebeginning and end of the period. After 21 days, all thepatients were ameliorated for pain intensity, limitationactivity level, but this amelioration was significantgreater for wearing group than CG. A significantlyhigher proportion of patients in the wearing group couldwork normally respectively 85% vs. 67% (P � 0.02) andfor the wearing group the analgesic consumption wassignificantly lower (P � 0.0001). Clinical assessmentscores were significantly superior in the wearing group(P � 0.002).

Calmels et al23 have conducted a randomized andmulticentric study with a CG on the effects of the wear-ing of a tissue belt during 3 weeks after acute low backpain. The results showed, after 8 days, a significant de-crease of pain intensity evaluated by VAS for wearingbelt group (P � 0.029) and of the mobility (outdistancehand-ground) (P � 0.05); after 21 days a significant in-crease of functional capacities (0.028 � P � 0.032) andmedical consumption (P � 0.028). For this study as thisof Valle-Jones et al, the limitations are a too small pop-ulation and a too short period of assessment.

First, our study reports a clinical efficiency of lumbarbelt wearing for the subacute low back pain as a comple-mentary treatment to medication. The use of belts, cor-sets, or orthoses is frequently reported as an alternativetherapeutic associated in low back pain but withoutstrong evidence. The benefice can be explained by somemechanical effects in regard with all the components oflow back pain: limitation of the back mobility,24,25 andmore specifically the limitation of the flexion in subjectsdaily activities, which is reported as an important factorof disc constraint26,27 and back pain intensity28; increaseof intra-abdominal pressure,26,29 which is an other fac-tor to decrease disc pressure,26 limit disc compression,and disc pain; postural control with an educative effectby belt to maintain spine in a relative extension as pro-posed to prevent back problems30; spine stability andadaptation of muscle activity.29,31–33 In the case of belt,the limitation of the mobility and pressure are less thanfor rigid orthoses but the effect on postural control canexplain the clinical benefice reported by recent studies onthe benefices of belt wearing.34–37

The second important aspect and never analyzed inthis clinical situation is the global benefice on medicalconsumption. This constitute an important argument,because of the economic impact and the potentially de-crease of iatrogenic effects of some antalgic or anti-inflammatory drugs used to treat low back pain. If thisresult is interesting, it must be discussed. There is a moreimportant and significant decrease of medication use forWBG than CG at the end of the study, but in each groupit is also reported an increase in the first month; this wasdue that, at inclusion, the practitioners can prescribe

219Lumbar Belt in Subacute Low Back Pain • Calmels et al

medication with belt to reduce pain intensity for thispatients who consulted for the first time for this backpain episode. It is also reported no difference between thenumber of medication use at the beginning and at the endof the study for WBG; this must be considered in thisstudy as “wearing belt” decreases medication consump-tion comparatively with “no wearing,” but does not sup-presses all medications; wearing belt is a complementaryand not the primary treatment of back pain. In regardswith different treatments proposed for low back pain, itis also interesting to underline that lumbar belt wearingdoes not induce secondary or iatrogenic effects and thatthere is no contraindication, which can induce some pref-erences to a belt wearing than more aggressive therapy.

In conclusion, this study reports significant results of theclinical and functional benefices to wearing a tissue belt as acomplementary treatment of subacute low back pain, witha significant decrease of medication consumption.

Key Points

● It is a multicentric, randomized, and controlledstudy of clinical evaluation of a lumbar belt in sub-acute low back pain.● The clinical criteria were the physical restorationassessed with the EIFEL scale, the pain assessed bya VAS, the economical criteria was the overall costof associated medical treatments.● One hundred ninety-seven patients have partici-pated. The results show a higher decrease in EIFELscore, VAS score, and pharmacologic consumptionin wearing belt group than CG.

References

1. Vallat JP. Epidemiologie des lombalgies. Rev Rhum (Ed Fr) 1998;65:172S–174S.

2. Frymoyer JW. Back pain and sciatatica. N Engl J Med 1998;318:291–300.3. Abenhaim L, Rossignol M, Vallat JP, et al. The role of activity in the thera-

peutic management of back pain. Report of the International Paris TaskForce on back pain. Spine 2000;25:1S–33S.

4. Andersson GBJ. The epidemiology of spinal disorders. In: JW Fryomer, ed.The Adult Spine: Principles and Practice. 2nd ed. Philadelphia, PA: Lippin-cott-Raven; 1997;93–141.

5. Coste J, Delecoueuillerie G, Cohen de Lara A, et al. Clinical course andprognostic factors in acute low back pain: an inception cohort study inprimary care practice. BMJ 1994;308:577–80.

6. von Korff M. Studying the natural history of back pain. Spine 1994;19:2041S–6S.

7. von Korff M, Saunders K. The course of back pain in primary care. Spine1996;21:2833–7.

8. Enthoven P, Skargren E, Oberg B. Clinical course in patients seeking primarycare for back or neck pain: a prospective 5-year follow-up of outcome andhealth care consumption with subgroup analysis. Spine 2004;29:2458–65.

9. Fryomer JW, Cats-Baril WL. An overview of the incidences and costs of lowback pain. Orthop Clin North Am 1991;22:263–71.

10. Calmels P, Fayolle-Minon I. An update on orthotic devices for the lumbarspine based on a review of the literature. Rev Rhum (Eng Edit) 1996;63:285–91.

11. Valle-Jones JC, Walsh H, O’Hara J, et al. Controlled trial of a back supportin patients with non-specific low back pain. Curr Mel Res Opin 1992;12:604–613.

12. Koes BW, van Den Hoogen HMM. Efficacy of bed rest and orthoses on lowback pain. A review of randomized clinical trials. Eur J Phys Med Rehabil1994;4:86–93.

13. Barron A, Feuerstein M. Industrial back belts and low back pain: mecha-nisms and outcomes. J Occup Rehabil 1994;4:125–39.

14. Minor SD. Use of back belts in occupational settings. Phys Ther 1996;76:403–8.

15. Dillingham TR. Lumbar supports for prevention of low back pain in theworkplace. JAMA 1998;279:1826–8.

16. van Poppel MN, de Looze MP, Koes BW, et al. Mechanisms of action oflumbar supports: a systematic review. Spine 2000;25:2103–13.

17. Jellema P, van Tulder MW, van Poppel MN, et al. Lumbar supports forprevention and treatment of low back pain: a systematic review within theframework of the Cochrane Back Review Group. Spine 2001;26:377–86.

18. van Tulder MW, Jellema P, van Poppel MN, et al. Lumbar supports forprevention and treatment of low-back pain (Cochrane Review). The Co-chrane Library. Chichester, UK: John Wiley & Sons; 2004.

19. van Tulder MW, Jellema P, van Poppel MN, et al. Lumbar supports forprevention and treatment of low-back pain. Cochrane Database Syst Rev2007:CD001823.

20. Roland M, Morris R. A study of the natural history of back pain. Part I:development of a reliable and sensitive measure of disability in low backpain. Spine 1983;8:141–4.

21. Coste J, Le Parc JM, Berge R, et al. Validation francaise d’une echelled’incapacite fonctionnelle pour l’evaluation des lombalgies EIFEL. RevRhum (Ed Fr) 1993;60:335–41.

22. Penrose KW, Chook K, Stump JL. Acute and chronic effects of pneumaticlumbar support on muscular strength, flexibility and functional impairmentindex. Sports Training Med Rehabil 1991;2:121–9.

23. Calmels P, Galtier B, Carzon JG, et al. Etude de l’effet antalgique et fonc-tionnel du port d’une ceinture lombaire souple dans la lombalgie aigue. AnnReadapt Med Phys 1999;42:333–40.

24. Axelsson P, Johnsson R, Stromqvist B. Effects of lumbar orthosis on inter-vertebral mobility. A roentgen stereophotogrammetric analysis. Spine 1992;17:678–81.

25. Giorcelli RJ, Hughes RE, Wassell JT, et al. The effect of wearing a back belton spine kinematics during asymmetric lifting of large and small boxes. Spine2001;26:1794–8.

26. Nachemson A, Schultz A, Andersson G. Mechanical effectiveness studies oflumbar spine orthoses. Scand J Rehabil Med 1983;9:139–49.

27. Adams MA, May S, Freeman BJ, et al. Effects of backward bending onlumbar intervertebral discs. Relevance to physical therapy treatments for lowback pain. Spine 2000;25:431–7.

28. Donelson R, Grant W, Kamps C, et al. Pain response to sagittal end-rangespinal motion. A prospective, randomized, multicentered trial. Spine 1991;16:S206–212.

29. McGill SM, Norman RW, Sharratt MT. The effect of an abdominal belt ontrunk muscle activity and intra-abdominal pressure during squat lifts. Ergo-nomics 1990;33:147–60.

30. Larsen K, Weidick F, Leboeuf-Yde C. Can passive prone extensions of theback prevent back problems? A randomized, controlled intervention trial of314 military conscripts. Spine 2002;27:2747–52.

31. Reyna JR Jr, Leggett SH, Kenney K, et al. The effect of lumbar belts onisolated lumbar muscle. Strength and dynamic capacity. Spine 1995;20:68 –73.

32. Thoumie P, Drape JL, Aymard C, et al. Effects of a lumbar support on spineposture and motion assessed by electrogoniometer and continuous record-ing. Clin Biomech 1998;13:18–26.

33. Cholewicki J, Juluru K, Radebold A, et al. Lumbar spine stability can beaugmented with an abdominal belt and/or increased intra-abdominal pres-sure. Eur Spine J 1999;8:388–95.

34. Dalichau S, Scheele K. Effects of elastic lumbar belts on the effect of a muscletraining program for patients with chronic back pain. Z Orthop Ihre Gren-zgeb 2000;138:8–16.

35. Pfeifer K, Vogt L, Klingler J, et al. Sensomotor function while wearing lum-bar support ortheses. Z Orthop Ihre Grenzgeb 2001;139:12–8.

36. Cholewicki J, Shah KR, McGill KC. The effects of a 3-weeks use of lumbo-sacral orthoses on proprioception in the lumbar spine. J Orthop Sports PhysTher 2006;36:225–31.

37. Oleske DM, Lavender SA, Andersson GB, et al. Are back supports pluseducation more effective than education alone in promoting recovery fromlow back pain? Results from a randomized clinical trial. Spine 2007;32:2050–7.

220 Spine • Volume 34 • Number 3 • 2009

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Original Contribution | June 10, 1998

Mireille N. M. van Poppel, MSc; Bart W. Koes, PhD; Trudy van der Ploeg, MD; Tjabe Smid, PhD; Lex M. Bouter, PhD

ABSTRACTContext.— Low back pain is a frequent and costly health problem. Prevention of low back pain is important both for the individual patient and from an economic perspective.

Objective.— To assess the efficacy of lumbar supports and education in the prevention of low back pain in industry.

Design.— A randomized controlled trial with a factorial design.

Setting.— The cargo department of an airline company in the Netherlands.

Participants.— A total of 312 workers were randomized, of whom 282 were available for the 6-month follow-up.

Interventions.— Subjects were randomly assigned to 4 groups: (1) education (lifting instructions) and lumbar support, (2) education, (3) lumbar support, and (4) nointervention. Education consisted of 3 group sessions on lifting techniques with a total duration of 5 hours. Lumbar supports were recommended to be used during workinghours for 6 months.

Main Outcome Measures.— Low back pain incidence and sick leave because of back pain during the 6-month intervention period.

Results.— Compliance with wearing the lumbar support at least half the time was 43%. In the 282 subjects for whom data were available, no statistically significant differencesin back pain incidence (48 [36%] of 134 with lumbar support vs 51 [34%] of 148 without, P=.81) or in sick leave because of low back pain (mean, 0.4 days per month withlumbar support vs 0.4 days without, P=.52) were found among the intervention groups. In a subgroup of subjects with low back pain at baseline, lumbar supports reduced thenumber of days with low back pain per month (median, 1.2 vs 6.5 days per month; P=.03).

Conclusions.— Overall, lumbar supports or education did not lead to a reduction in low back pain incidence or sick leave. The results of the subgroup analysis need to beconfirmed by future research. Based on our results, the use of education or lumbar supports cannot be recommended in the prevention of low back pain in industry.

LOW BACK PAIN occurs frequently and is one of the most costly health problems affecting industry and society. Lifetime prevalences of 60% to 90% have been reported1 andthe total (direct and indirect) costs for back pain were estimated to be $27.9 billion in 1990 in the United States.2 Therefore, it is not surprising that many measures are availablethat claim to reduce low back pain and its recurrence. Aside from ergonomic adjustments in the workplace, the most commonly used preventive strategies in industry are fitnessexercises, education on back mechanics and lifting techniques, and lumbar supports.3 Although these measures are widely used, their efficacy is still uncertain.

In particular, the efficacy of lumbar supports is under debate. To date, at least 3 randomized trials are available that evaluate the effect of lumbar supports on the prevention ofback pain in industry. In 2 of these, no effect of lumbar supports was reported.4- 5 The third study found a small reduction in the number of days lost from work in a groupreceiving both a lumbar support and education compared with a control group.6 In addition, 2 nonrandomized controlled trials reported a positive effect of lumbar supports inthe reduction of back pain incidence.7- 8 Review articles concluded there is insufficient evidence for or against the effectiveness of lumbar supports in the prevention of lowback pain and that further research is needed.3,9- 11 The same conclusion was reached in a report of the US National Institute for Occupational Safety and Health (NIOSH) and,consequently, the use of lumbar supports among uninjured workers was not recommended by NIOSH.12

We conducted a randomized controlled trial to determine the effectiveness of lumbar supports and education in the prevention of back pain in industry conducted in theNetherlands.

METHODSA factorial randomized design was used: group 1 received both a lumbar support and education in the form of lifting instructions, group 2 received only education, group 3received only a lumbar support, and group 4 received no intervention (control group). In a factorial design, in addition to assessing the effect of interventions by comparing themwith a control group, the combination of 2 interventions is compared with each intervention alone and with a control group, thus allowing investigation of the interactionbetween the 2 interventions.

Workers were recruited from the cargo department of a major Dutch airline at Schiphol Airport. All workers whose jobs included manual material handling were invited toparticipate. Typical tasks of these workers included the loading and unloading of cargo pallets and containers and the sorting and transportation of cargo, both manually and witha forklift truck. Workers who had a permanent partial work disability were excluded from the study. The study was approved by the Medical Ethical Committee of the VrijeUniversiteit, Amsterdam, the Netherlands. Workers received personal information about the procedures of the trial and enrolled after giving consent. The duration of theintervention period was 6 months.

The Work S'port back support (The Saunders Group Inc, Chaska, Minn) was chosen over 2 other lumbar supports in a pilot study. In the pilot study the comfort of the differentsupports was tested in a group of 20 workers who were not included in the randomized trial. The lumbar support used in the study has adjustable elastic side pulls with Velcrofasteners and flexible stays, and is kept in place with an anchor belt. The lumbar support has no shoulder straps and is available in 4 sizes. The workers were given written andverbal instructions on the use of the lumbar support and were instructed to wear the lumbar support at all times during work hours and to tighten the side pulls for strongersupport when performing strenuous tasks.

Education was given in the form of lifting instructions. The lifting instructions were given by 2 experienced paramedical therapists. Instructions were designed to make workersaware of their movements and postures during work. Lifting instructions were given in 3 sessions for groups of 10 to 15 workers; the first session of 2 hours took place at thestart of the intervention period, and the other 2 sessions of 1.5 hours each were given at 6 weeks and at 12 weeks. In the first session, information was given about the anatomyof the spine and back muscles and about lifting techniques. Lifting techniques were practiced in simple situations. In the second session, the instructions on lifting techniqueswere repeated, and relaxation exercises for neck, shoulder, and back muscles were explained and practiced. In the third session, which took place at the workplace when workerswere actually loading and unloading cargo, individual advice was given on working methods.

The work at the cargo department was organized in work modules (n=6), with each work module consisting of 6 work groups containing 6 to 20 workers each. Workers in allwork modules performed manual lifting tasks and used a forklift truck. The work modules differed slightly in the proportion of time spent using a forklift truck and performinglifting tasks. A total of 380 workers in 36 work groups were eligible for the study. We assumed that compliance would be higher if all workers in a group, rather than a subset of

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the group, were asked to wear a lumbar support. Furthermore, it was practical to use the existing work-group organization for the education sessions. Therefore, the 36 workgroups, not individual subjects, were randomized over the 4 treatment groups. Because of the slight variation in tasks among some work modules, randomization was stratifiedfor work modules.13 For each work module, a separate randomization list was prepared. Random permuted blocks of 4 were used within each stratum. The blocks were assignedto the strata using a random numbers table.

Randomization was performed by an investigator who was blinded with respect to the characteristics of the work modules and the workers within the work groups. Assignmentto the intervention groups took place after completion of the baseline measurements.

At baseline subjects completed a questionnaire on demographic data, history of back pain, work perception,14 and health status.15- 16 During the intervention period, subjectsreceived a monthly questionnaire on the occurrence of low back pain and sick leave. Subjects were asked if they had experienced low back pain in the past month and, if theyanswered positively, how many days they experienced low back pain. They were also asked if they had lost time from work in the past month (and the number of days lost) andif they had lost time from work because of back pain (and the number of days lost). All subjects worked full time. The same questionnaire on back pain and sick leave wascompleted at 9 months and 12 months after randomization.

At baseline and at 6 months, the end of the intervention period, trunk-muscle strength was measured to assess whether wearing a lumbar support affected trunk muscle strength.Subjects with current or past back pain who felt they might injure or reinjure their backs by performing the tests were excluded from the trunk-muscle tests. The endurancestrength of the abdominal muscles was determined with subjects lying supine with knees at 90° and feet flat on the floor or table without support.17 Subjects were asked to curlup with hands straight toward knees and fingertips of both hands reaching midpatella. This posture was held for a maximum of 240 seconds. If the posture was lost, the test wasstopped and the number of seconds was noted. The dynamic strength of the abdominal muscles was measured with subjects lying supine with knees at 90° and feet flat on thefloor without support.18 Subjects were asked to perform 3 series of 5 sit-ups with increasing difficulty. The number of sit-ups performed by each subject was noted. Endurancestrength of the back muscles was determined with subjects prone on the examination table with buttocks and legs fixed and trunk unsupported.19 Subjects were asked to holdtheir upper body and head horizontal for a maximum of 240 seconds. If the posture was lost and could not be corrected, or if a subject showed signs of exhaustion, pain, orcramping, the test was stopped and the number of seconds was noted.

Compliance with wearing the lumbar support was measured every month. In the monthly questionnaire subjects were asked if they had worn the lumbar support in the previousmonth. Subjects were considered compliant if they reported wearing the lumbar support in more than half of the questionnaires.

Based on the difference in days lost from work and corresponding variance reported by Walsh and Schwartz,6 it was estimated that with a significance level of .05 and a powerof 80%, a difference of 0.9 lost work day per 6 months could be detected with 50 subjects per intervention group. Our goal was to include 75 subjects per intervention group inorder to prevent inadequate power because of low compliance or withdrawals.

Differences in outcomes at the 6-month follow-up were analyzed for the 4 intervention groups. Differences between groups were tested for statistical significance by using χ2

tests for categorical data (ie, experience of back pain and sick leave) and Student t tests for continuous data (ie, age, scores on trunk muscle tests). Nonparametric testing (theMann-Whitney U test or the Kruskal-Wallis test, corrected for ties) was used for data on the number of days with back pain or sick leave, since the distribution of these data isskewed. Differences were considered statistically significant at the .05 level. For categorical data, differences between groups and 95% confidence intervals (CIs) werecalculated.20

Possible effect modification in the group with both lumbar support and education was studied in an analysis in which the 2 groups with a single intervention were combined andcompared with the group that received both interventions. The control group was removed from this analysis. If effect modification were present, the groups would differsignificantly. If no effect modification were present in the group with the combination of lumbar support and lifting instructions, groups would be combined as follows toincrease the number of subjects in the compared groups. The 2 groups with lumbar supports would be compared with the 2 groups without lumbar supports, and a similarcomparison would be made for education.

For the effect of lumbar supports, 2 types of analyses were performed: an analysis of the intervention group in which all subjects for whom data were available were included,regardless of compliance with wearing the lumbar support; and 2 subgroup analyses assessing only subjects who were compliant with lumbar support use and whether subjectshad a history of low back pain at baseline.

RESULTSOf 380 eligible workers, 20 (5%) refused to participate and 312 (82%) completed the baseline measurements (Figure 1). Because of holidays and a large workload, workers werenot always available for the study. Consequently, baseline measurements were missing for 48 workers. During the intervention period of 6 months, 30 workers (10%) withdrewfrom the study. Twenty-one workers (7%) withdrew because they lost interest in the study after the baseline measurement (mostly because workers did not think that the studywas useful to them). Nine workers (3%) transferred to another workplace or left the company. Another 14 workers (4%) transferred to other workplaces in the second 6 monthsof the follow-up period. Only 1 of the 23 workers who transferred to another workplace left the cargo department because of low back pain. The distribution of the withdrawalsamong the intervention groups is shown in Figure 1. A description of the study population is given in Table 1. There were no substantial differences among the 4 interventiongroups regarding the most important prognostic factors, such as age, history of back pain, and past sick leave because of back pain. Work modules were evenly distributedamong the intervention groups; for all modules, about half of the workers were given education and half received a lumbar support.

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At baseline, 243 subjects were asked about their expectations of preventive measures. Of these, 146 (60%) expected that lumbar supports could be helpful in the reduction oflow back pain in the workplace, and 170 (69%) felt lifting instructions could be useful. The attendance rate for the first educational session was 80%, and all workers attended atleast 2 of the 3 sessions. Subjects were asked each month if, in their own opinion, they lifted according to the techniques taught in the educational sessions. Of 142 subjects, 16(11%) answered that they always lifted as taught, 104 (73%) answered that they lifted as taught some of the time, and 15 (11%) answered that they never lifted as taught.Compliance with wearing the lumbar support was low; only 58 (43%) of the 134 subjects in the lumbar support groups reported wearing the support in more than half of thequestionnaires. In random checks by the principal investigator at the workplace, compliance was approximately the same as the subjects reported (40%-50%). When subjectswere asked how satisfied they were with the lumbar support, 39 (49%) of 79 subjects reported the support restricted their freedom of movement, 39 (48%) of 81 reported theycould not sit comfortably with the support, and 36 (45%) of 80 thought the support was too warm. On the other hand, 49 (62%) of 79 thought the support provided support forthe back and 37 (46%) of 80 reported the support was easy to use.

No data were available for 30 subjects (Figure 1, subjects withdrawn during intervention). Of the remaining 282 subjects, 99 (35%) experienced an episode of low back painduring the intervention period and 29 (10%) reported having taken sick leave because of low back pain (Table 2). No statistically significant differences were found among the 4intervention groups. No effect modification could be detected when comparing the group with lumbar support and education with the other 2 intervention groups combined.Therefore, the groups receiving lumbar supports were combined, as were those receiving education. Table 2 shows the main outcomes for the groups. No statistically significantdifferences were present. Low back pain incidence was about 35% in all groups, and subjects reporting sick leave due to low back pain varied from 8% to 13%.

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A subgroup analysis was conducted in which subjects who wore the lumbar support were compared with subjects in the groups without lumbar support. No significantdifferences were observed (Table 3).

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Table 4 shows the results of the analysis of subgroups based on the history of back pain. In the subgroup of subjects who had never had low back pain (n=130), a higher numberof days of sick leave because of low back pain was observed in the group with lumbar support (P=.05), although the median number of days of sick leave per month was 0 daysin both groups. In the subgroup of subjects with low back pain at baseline (n=42), a reduction in the number of days with low back pain per month was found in the group withlumbar support compared with the group without lumbar support (median of 1.2 days per month vs 6.5 days per month; P=.03). No significant differences were found betweengroups with and without education in the subgroup analysis (data not shown).

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To detect possible adverse effects of lumbar supports, we measured trunk-muscle strength before and after the intervention period. Furthermore, after the intervention period,subjects were followed up for an additional 6 months to evaluate the occurrence of low back pain after subjects discontinued wearing the lumbar supports. In the groupcompliant with lumbar support use during the intervention period, 25% of the subjects reported low back pain during the 6 months following completion of the intervention vs20% in the group without lumbar support (risk difference=5%; 95% CI, −13% to 23%; P=.6). Compliant subjects had a mean of 1.8 days of back pain vs 1.1 days in the groupthat did not receive the lumbar support (median of 0 days in both groups; P=.5 by Mann-Whitney U test corrected for ties). Results of the trunk-muscle strength tests are shownin Table 5. Thirty-eight subjects felt they would injure or reinjure themselves by performing the trunk-muscle tests and were excluded from the tests (10 in the combinationgroup, 5 in the education only group, 12 in the lumbar support only group, and 11 in the control group). Most subjects scored lower in the posttest, but the difference betweencompliant subjects and subjects without lumbar support was not significant.

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COMMENTNo effect of education alone in the prevention of low back pain could be demonstrated in this study. This result confirms previous controlled trials,4,6,21- 24 all of which foundno effect of providing lifting instructions or instructions on body mechanics. The only controlled study that reported a positive effect of education was a study in a population ofbus drivers who received no lifting instructions but received a back school program consisting of information on back care, physical fitness, nutrition, relaxation, and copingwith stress.25

Lumbar supports were not effective in the prevention of low back pain and sick leave in this study. Two other randomized studies have reported the same findings.4- 5 Somenonrandomized studies reported positive findings,7- 8,13 but these studies are more susceptible to various forms of bias. A recently published study by Kraus et al26 that included36000 subjects reported a reduction in acute low back injury rate. However, because of the nonrandomized, noncontrolled design of the trial, the findings may be explained byconfounding factors, such as changes in exposure or workers' compensation laws.

In our study, the combination of lumbar support and education also was not effective. Two other studies that combined these interventions showed conflicting results. Walsh andSchwartz6 reported a reduction in the number of days with sick leave, while Reddell et al4 found no effect. The cause of the contradictory results is unknown, but factors such aswork characteristics, differences in lumbar support (the study by Walsh and Schwartz6 used a rigid plastic support), and compliance rates could be important.

The study by Reddell et al4 had a compliance rate nearly identical to our study (42% and 43%, respectively). The only other study reporting compliance rate is the study byAnderson et al,7 in which the compliance was 80% according to the supervisors at the workplace. Although our analysis of only subjects who were compliant failed to show apositive effect of lumbar supports, it is possible that because of self-selection of compliant subjects, an effect of lumbar supports may have been missed. However, in theNetherlands an employer would be unlikely to require use of lumbar supports or impose sanctions in the case of noncompliance. Therefore, the results presented here representwhat can be expected if an employer provides but does not require lumbar supports for manual material–handling workers.

Subgroup analysis is difficult because it is potentially misleading, even if the analysis is prospectively planned.27- 28 Yusuf et al27 state that they "regard observed qualitativeinteractions (treatment is beneficial in one subgroup and harmful in another) with considerable skepticism, for they are often shown to be spurious when the same comparison ismade in similar trials." Yusef et al27 recommend that results from subgroup analyses should not be accepted until they are confirmed by the results of other studies.

The present study demonstrates a qualitative interaction. On one hand, the use of a lumbar support seemed to increase sick leave due to low back pain in subjects who had neverhad low back pain before the start of the intervention (n=130). On the other hand, in a small group of subjects who had low back pain at the start of the intervention (n=42), theuse of lumbar supports reduced the number of days per month with low back pain.

Among workers without a history of low back pain, the differences between groups were small (0.6 vs 0.2 mean days per month of sick leave) and perhaps not clinicallyrelevant, and because we did not correct for multiple comparisons, differences may be due to chance. Therefore, we draw no conclusions from this analysis but believe studiesshould investigate the effect of lumbar supports for this subgroup in more detail.

Walsh and Schwartz6 reported a larger effect of the combination of lumbar supports and education in a subgroup of workers who had low back pain in the 6 months prior to thestudy, while we found no effects in a group of subjects who had low back pain in the year prior to the study (n=69).

A review on the effectiveness of orthoses in the treatment of back pain concluded that the therapeutic effect of lumbar supports for subjects with back pain has not yet beendemonstrated, although some promising findings were reported in the literature.29 This is consistent with our finding of a positive effect of lumbar supports in the subgroup of

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workers with low back pain at baseline. Nevertheless, future randomized trials on the effects of lumbar supports for patients with low back pain are needed to determine theirtherapeutic value, if any.

No effects of lumbar supports on trunk-muscle strength were observed. Other studies also reported no adverse effects of lumbar supports on abdominal and back-musclestrength.6,30 These results indicate the use of lumbar supports will not cause atrophy of trunk muscles.

Reddell et al4 reported an increase in incidence of sick leave because of back injury in groups of workers who stopped wearing a lumbar support during the intervention period.We could not reproduce these findings, as no increase in the incidence of back pain was found after compliant workers discontinued wearing lumbar supports.

The major limitation of this study is the lack of blinding; neither the subjects nor the therapists who conducted the educational sessions were blinded for the intervention. Thedirection and magnitude of the potential bias is not clear. It could lead to a larger estimate of the effect of the intervention,31 or perhaps to a smaller estimate, depending on theexpectations of subjects and investigators. However, at baseline most workers believed both interventions would be beneficial, so any potential bias from expectations would bein the positive direction.

The subjects in our study all had very similar work tasks of loading and unloading cargo, including heavy-lifting tasks. Extrapolation of the results is most relevant for situationsin which workers perform similar lifting tasks.

Based on the results of our study, we do not recommend education (in the form as investigated in our study) or the use of lumbar supports in the prevention of low back pain.The therapeutic effectiveness of lumbar supports for workers with low back pain in industry needs further investigation.

REFERENCES

1 Andersson GBJ. The epidemiology of spinal disorders. In: Frymoyer JW, ed. The Adult Spine: Principles and Practice. New York, NY: Raven Press;1991:107-146.

2 Frymoyer JW, Cats-Baril WL. An overview of the incidences and costs for low back pain. Orthop Clin North Am.1991;22:263-271.

3 Lahad A, Malter AD, Berg AO, Deyo RA. The effectiveness of four interventions for the prevention of low back pain. JAMA.1994;272:1286-1291.

4 Reddell CR, Congleton JJ, Huchingson RD, Montgomery JF. An evaluation of a weightlifting belt and back injury prevention training class for airlinebaggage handlers. Appl Ergonomics.1992;23:319-329.

5 Alexander A, Woolley SM, Bisesi M, Schaub E. The effectiveness of back belts on occupational back injuries and worker perception. ProfessionalSafety.1995;40:22-26.

6 Walsh NE, Schwartz RK. The influence of prophylactic orthoses on abdominal strength and low back injury in the workplace. Am J Phys MedRehabil.1990;69:245-250.

7 Anderson CK, Morris TL, Vechio DC. The Effectiveness of Using a Lumbar Support Belt. Dallas, Tex: Advanced Ergonomics Inc; 1993.

8 Thompson L, Pati AB, Davidson H, Hirsh D. Attitudes and back belts in the workplace. Work.1994;4:22-27.

9 Barron BA, Feuerstein M. Industrial back belts and low back pain: mechanisms and outcomes. J Occup Rehabil.1994;4:125-139.

10 Genaidy AM, Simmons RJ, Christensen DM. Can back supports relieve the load on the lumbar spine for employees engaged in industrialoperations? Ergonomics.1995;38:996-1010.

11 van Poppel MNM, Koes BW, Smid T, Bouter LM. A systematic review of controlled clinical trials on the prevention of back pain in industry. OccupEnviron Med.1997;54:841-847.

12 National Institute for Occupational Safety and Health Back Belt Working Group. Workplace Use of Back Belts: Review and Recommendations. Washington, DC: US Dept of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention; 1994. DHHS (NIOSH)publication 94-122.

13 Pocock SJ. Clinical Trials: A Practical Approach. New York, NY: John Wiley & Sons Inc; 1983:83-87.

14 Dijkstra A, van der Grinten MP, Schlatmann MJT, de Winter CR. Funktioneren in de Arbeidssituatie: Uitgangspunten, Ontwerp en Handleiding VoorOnderzoek Onder Werknemers Naar Gezondheid, Werk en Werkomstandigheden. Leiden, the Netherlands: NIPG-TNO; 1981.

15 Larson CO, Hays RD, Nelson EC. Do the pictures influence scores on the Dartmouth COOP Charts? Qual Life Res.1992;1:247-249.

16 Scholten JHG, van Weel C. Functional Status Assessment in Family Practice: The Dartmouth COOP Functional Health Assessment Charts/WONCA. Lelystad, the Netherlands: Meditekst; 1992.

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17 Hyytiäinen K, Salminen JJ, Suvitie T, Wickström G, Pentti J. Reproducibility of nine tests to measure spinal mobility and trunk muscle strength. ScandJ Rehabil Med.1991;23:3-10.

18 Oja P, Tuxworth B. Eurofit for Adults: Assessment of Health-Related Fitness. Tampere, Finland: Council of Europe; 1995.

19 Biering-Sørensen F. Physical measurements as risk indicators for low-back trouble over a one-year period. Spine.1984;9:106-119.

20 Altman DG. Practical Statistics for Medical Research. London, England: Chapman & Hall; 1991.

21 Donchin M, Woolf O, Kaplan L, Floman Y. Secondary prevention of low-back pain: a clinical trial. Spine.1990;15:1317-1320.

22 Daltroy LH, Iversen MD, Larson MG. et al. Teaching and social support: effects on knowledge, attitudes, and behaviours to prevent low back injuriesin industry. Health Educ Q.1993;20:43-62.

23 Daltroy LH, Iversen MD, Larson MG. et al. A controlled trial of an educational program to prevent low back injuries. N Engl J Med.1997;337:322-328.

24 Feldstein A, Valanis B, Vollmer W, Stevens N, Overton C. The back injury prevention project pilot study: assessing the effectiveness of Back Attack, aninjury prevention program among nurses, aides, and orderlies. J Occup Med.1993;35:114-120.

25 Versloot JM, Rozeman A, van Son AM, van Akkerveeken PF. The cost-effectiveness of a back school program in industry: a longitudinal controlled fieldstudy. Spine.1992;17:22-27.

26 Kraus JF, Brown KA, McArthur DL. et al. Reduction of acute low back injuries by use of back supports. Int J Occup Environ Health.1996;2:264-273.

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Summaries for Patients

Back Supports to Prevent Back Pain in Home Care Workers with Previous Low Back PainSummaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.

Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians.

What is the problem and what is known about it so far?

Low back pain is a common problem that causes pain and inability to participate in usual activities. It is a common reason for people to be absent from work, especially among workers whose jobs involve physical labor. Treatment for low back pain aims to decrease pain and help patients resume their normal activities through exercise therapy, patient education, and pain-relieving drugs.

Patients also sometimes use “back belts” or “back supports” (lumbar supports) to prevent or treat back pain. These supports come in a variety of styles, but all involve a wide belt worn around the back and abdomen to support the muscles of the lower back. People whose work involves physical labor or lifting often use back supports. Unfortunately, good information about the benefit of back supports is scarce. The available studies suggest that back supports do not prevent a first episode of back pain, but they may help to prevent repeated episodes among workers with previous back pain.

Why did the researchers do this particular study?

To see whether adding back supports to a course on healthy work habits would help to decrease the number of low back pain episodes and days absent from work among home care workers who had previous low back pain.

Who was studied?

360 home care workers in the Netherlands who reported a history of low back pain. The workers' jobs involved housekeeping or help with personal care in people's homes.

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How was the study done?

All of the workers participated in a short course on healthy work habits that included information on strategies to prevent back injury, such as good ways to lift heavy things. The researchers then assigned half of the patients to select and receive 1 of 4 types of back support. The workers who got back supports were advised to wear them on days when they had or thought they might get low back pain.

What did the researchers find?

Over 12 months, the workers with the back supports reported an average of 53 fewer days with low back pain than those reported by the other workers. However, days missed from work because of sickness were similar in both groups of workers.

What were the limitations of the study?

The researchers did not have good information on whether back pain was the reason for the sick days.

What are the implications of the study?

Adding back supports to a short course on healthy work habits may reduce low back pain days, but not the total number of sick days, among workers.

Article and Author Information

The summary below is from the full report titled “Lumbar Supports to Prevent Recurrent Low Back Pain among Home Care Workers. A Randomized Trial.” It is in the 20 November 2007 issue of Annals of Internal Medicine (volume 147, pages 685-692). The authors are P.D.D.M. Roelofs, S.M.A. Bierma-Zeinstra, M.N.M. van Poppel, P. Jellema, S.P. Willemsen, M.W. van Tulder, W. van Mechelen, and B.W. Koes.

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