A Comparison of the Effects of 2 Types of Massage and Usual Care on Chronic Low Back Pain

A Randomized Controlled Trial

AGUILAN, ALLANAGUILAR, JOY

ANGELES, ANNABADERA, RHEA

BAUTISTA, REYNALYN

DiscussionI. Introduction

II. Methodology

III.Results

IV. Conclusion

Introduction

Chronic Low Back Pain•Low back pain or lumbago is a common

disorder involving the muscles and bones of the back.

•Muscle,Nerve or Bone pain•Stress, Trauma or Injury•40% of people•Longer than 3 months

Massage• A mechanical stimulation of the tissues through

rhythmically applied pressure or stretching.•Swedish Massage warm up the muscle tissue,

releasing tension and gradually breaking up muscle "knots" or adhered tissues

•Neuromuscular therapy alternating levels of concentrated pressure (10-30 seconds) on the areas of muscle spasm

•Shiatsu acupressure with stretching, breathing and rotating

Objectives:•To compare the effectiveness of 2 types of

massage and usual care for chronic back pain.▫Relaxation Massage ▫Structural Massage

• Patients: 401 persons 20 to 65 years of age with nonspecific chronic low back pain.

• Limitation: Participants were not blinded to treatment.• Exclusion criteria

1) specific causes of back pain (for example, cancer, fractures,or spinal stenosis)2) complicated back problems (for example,sciatica, back surgery in the past 3 years, or medicolegal issues)3) conditions making treatment difficult(for example, paralysis or psychoses), 4) conditions that might confound treatment effects or interpretation of results(for example, severe fibromyalgia or rheumatoid arthritis),5) inability to speak English, 6) massage within the past year

Methodology

Methodology•Study Design•Randomization and Interventions•Study Treatments•Outcomes and Follow-up•Statistical Analysis•Role of the Funding Source

Study Design•aged 20 to 65 years•had outpatient visit diagnoses suggesting

nonspecificchronic low back pain •3 to 12 months after visits• low back pain lasting at least 3 months •at least 3 on a scale of 0 to 10

Randomization & Intervention•Randomization schedule was created by

a biostatistician and was blocked on massage therapist; allocation was centrally generated and concealed.

•Participants: randomly allocated in a 1:1:1 ratio to receive usual

care, relaxation massage, and structural massageknew whether they received massage but were

blinded to type; usual care recipients were aware that they had enrolled in a trial of massage.

•Therapist were not blinded to the type of massage that they provided.

•Study personnel assessing trial outcomes were blinded to study assignment.

Study Treatments

Therapists▫n=27▫with at least 5 years experience▫received protocol training▫treatment fidelity

Massage Techniques▫treatment at no cost

▫provided for 10 weekly treatments and follow-up visits after

▫“adherence” – completion of at least 8 follow-up visits

▫home exercises were recommended for participants in massage treatments

Structural massage

Relaxation massage

Structural Massage▫to identify and

alleviate musculoskeletal contributors to back pain

▫myofascial, neuromuscular, and other soft-tissue techniques

▫varied body areas▫for home exercise-

psoas stretch

Relaxation Massage▫to induce a sense of

relaxation▫effleurage,

petrissage, circular friction, vibration, rocking and jostling and holding

▫7-20 mins on back and buttocks

▫for home exercise- 2.5 minute relaxation exercise

Outcomes and Follow-up•Outcomes were measured at 10, 26 and

52 weeks by masked interviewers

•Primary Outcomes: 10 wks > Dysfunction was measured using the

modified RDQ >Symptoms were assessed by the

Symptom Bothersomeness

•Secondary outcomes: 26 and 52 wks > percentage of participants with

significant level of reduction in dysfunction based on RDQ and symptom bothersomeness scores.

> Short Form 12 Physical and Mental Health Survey.

> Effects on occupational activities

> Improvement in back – pain related dysfunction

>Satisfaction Rate(very satisfied- not very satisfied) :Using the Likert Scale

> Total Cost of back pain-related visits, imaging studies and medications during follow-up year .

Statistical Analysis• Sample size was calculated to ensure

adequate power at 10 weeks to detect a clinically meaningful 2-point mean difference between structural massage and usual care groups.

•Analysis were conducted using generalized estimating questions(12) w/ an independent working correlation structure

• Precision Variables > age, group, sex, baseline RDQ > symptom bothersomeness scores, SF-12 test,

education level, body mass index, type of work, original cause of backpain, more than 7 days of reduced back pain and mediation use in previous week.

• Least Significant differnce approach was used to control multiple comparisons.

• Adjusted mixed-effects model to asses effects

• Intraclass correlation coefficient was calculated to quantify the degree of variability

Role of the Funding Source•The research is funded by the National

Center for Complementary and Alternative Medicine

Results

Results• Study Recruitment and Follow-up• Baseline Characteristics• Study Treatments• Primary Outcomes• Secondary Outcomes• Practitioner Effects• Co-interventions and Subsequent Use of Massage• Cost of Back Pain-Related Health Care After

Randomization• Adverse Effects

STUDY RECRUITMENT AND FOLLOW UP

•Of 9127 invitations and 1161 responses•402(35% ) were eligible and allocated•Others (Not Randonmly Assigned): 1.) Ineligible: 662 2.) Unable to Contact : 8 3.) Recruitment ended before eligibility

was determined : 26 4.) Declined : 63

• STRUCTURAL MASSAGE (n=132) > Massage Therapists (Group A): 27 > Participants treated by therapist: median (5) min : 1 max : 13

• RELAXATION MASSAGE (n=136) > Massage Therapists (Group B) : 27 > Participants treated by therapist : median (5) min : 0 max : 13

• USUAL CARE ( n=133)

BASELINE CHARACTERISTICS• Middle-aged• Female• White • RDQ: 10.8• Symptom Bothersomeness: 5.7

STUDY TREATMENTSTRUCTURAL MASSAGE RELAXATION MASSAGE• 88% adhered to treatment

(8-10 visits)• 12% did not complete

treatment (0-7 visits)

• PT’s recommended 7 home exercises▫ Psoas stretch

• 93% adhered to treatment(8-10 visits)

• 7% did not complete treatment

(0-7 visits)

• PT’s recommended 7 home exercises▫ Conscious relaxation

PRIMARY OUTCOMESat 10 wks:

▫Improvement was evident in both types of massage▫RDQ scores are lower for the massages than for

usual careat 26 wks:

▫Continuous improvement for all treatments, but better improvement evident in massage

▫Massage groups RDQ increasesat 52 wks:

▫Relaxation massage was shown to be slightly more effective than structural massage (lower RDQ by 1.2 pts)

SECONDARY OUTCOMESat 10 wks

▫both physical and mental health scores were better for the two types of massage than it was for usual care

at 52 wks:▫for mental health – SF-12 scores decreased for both

massages types and increased for usual care▫for physical health – SF-12 scores increased for both

massage types and decreased for usual care▫concluding overall that massage is better than usual

care based on secondary outcomes

PRACTITIONER EFFECTS•Therapists’ treatment skills were effective

CO-INTERVENTIONS AND SUBSEQUENT USE OF MASSAGEat 10 wks:

▫more participants from the usual care group visited a provider for back pain than the massage groups

▫usual care participants sought out for massage treatment

between 10 – 26 wks:▫lesser participants from the usual care group reported

to have visited a provider for back pain than the massage groups

at 52 wks:▫it was observed from the patients that massage,

particularly relaxation massage, was effective▫two participants from the usual care group and one

from the structural underwent back surgery

COST OF BACK PAIN-RELATED HEALTH CARE AFTER RANDOMIZATION•Average cost: $540

Average cost per treatment session•Usual care cost: $25 •Relaxation massage cost: $78 •Structural massage cost: $38

ADVERSE EFFECTS•4% of relaxation massage recipients and

7% of structural massage recipients reported adverse effects, mostly increased pain

•Some experienced nausea, SOB and chest pain from the structural group but those were classified to be unrelated to treatment

CONCLUSION

• Massage therapy improved function and decreased pain more than usual care in pts with uncomplicated chronic low back pain after 10 weeks.

• Relaxation massage has the same effect to those of structural massage.

• No evidence of differential effectiveness among the massage therapists, and both relaxation and structural massage had very low rates of adverse effects.

• The study has limitations.

•In summary, results suggest that both relaxation massage and structural massage are reasonable treatment options for persons with chronic low back pain.

A Comparison of the Effects of 2 Types of Massage and Usual Care on Chronic Low Back Pain

A Randomized Controlled Trial

Daniel C. Cherkin, PhD | Karen J. Sherman, PhD, MPH | Janet Kahn, PhD

Robert Wellman, MS | Andrea J. Cook, PhD | Eric Johnson, MSJanet Erro, RN, MN | Kristin Delaney, MPH | Richard A. Deyo, MD,

MPH

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Retrieved on 15 June 2015 from http://annals.org/article.aspx?&year=2011&volume=155&page=1

PEDRO SCALE1.) Eligible Criteria

2.)Subject Randomized

3.)Allocation of Data Concealed

4.)Allocation Concealed in Figure 1 5.) Blinding of all subjects

6.)Blinding of all therapists

7.) Blinding of all assessors

8.) At least 85% complete

9.) Intention to Treat

10.) Comparison w/ othe r groups TOTAL: 8/10