Best research that shows Iyengar Yoga improves severe back pain.

Annals of Internal Medicine

Yoga for Chronic Low Back Pain A Randomized Trial

Summary

12-week yoga program to adults with chronic or recurrent low back pain led to greater improvements in back function than usual care for up to 12 months. Yoga seems to be a safe and effective activity that clinicians could consider recommending for patients with a history of low back pain.

Annals of Internal Medicine Original Research © 2011 American College of Physicians Helen E. Tilbrook, BSc, MSc; n summary, we found that offering a Helen Cox, BSc, MSc; Catherine E. Hewitt, BSc, MSc, PhD; Arthur Ricky Kang’ombe, BSc, MSc; Ling-Hsiang Chuang, BSc, MSc, PhD; Shalmini Jayakody, BSc, MSc; John D. Aplin, MA, PhD; Anna Semlyen, BA, MSc; Alison Trewhela, DBL, CSL; Ian Watt, BSc (Med Sci), MB, ChB, MPH; and David J. Torgerson, MSc, PhD www.yogaforbacks.co.uk

Background: Previous studies indicate that yoga may be an effective treatment for chronic or recurrent low back pain.

Objective: To compare the effectiveness of yoga and usual care for chronic or recurrent low back pain.

Design: Parallel-group, randomized, controlled trial using computer generated randomization conducted from April 2007 to March 2010. Outcomes were assessed by postal questionnaire. (International Standard Randomised Controlled Trial Number Register: ISRCTN 81079604)

Setting: 13 non–National Health Service premises in theUK

Patients: 313 adults with chronic or recurrent low back pain.

Intervention: Yoga (n ! 156) or usual care (n ! 157). All participants received a back pain education booklet. The intervention group was offered a 12-class, gradually progressing yoga program delivered by 12 teachers over 3 months.

Measurements: Scores on the Roland–Morris Disability Questionnaire

(RMDQ) at 3 (primary outcome), 6, and 12 (secondary outcomes) months; pain, pain self-efficacy, and general health measures at 3, 6, and 12 months (secondary outcomes).

Results: 93 (60%) patients offered yoga attended at least 3 of the first 6 sessions and at least 3 other sessions. The yoga group had better back function at 3, 6, and 12 months than the usual care group. The adjusted mean RMDQ score was 2.17 points (95% CI, 1.03 to 3.31 points) lower in the yoga group at 3 months, 1.48 points (CI, 0.33 to 2.62 points) lower at 6 months, and 1.57 points (CI, 0.42 to 2.71 points) lower at 12 months. The yoga and usual care groups had similar back pain and general health scores at 3, 6, and 12 months, and the yoga group had higher pain self-efficacy scores at 3 and 6 months but not at 12 months. Two of the 157 usual care participants and 12 of the 156 yoga participants reported adverse events, mostly increased pain.

Limitation: There were missing data for the primary outcome (yoga group, n ! 21; usual care group, n ! 18) and differential missing data (more in the yoga group) for secondary outcomes.

Conclusion: Offering a 12-week yoga program to adults with

chronic or recurrent low back pain led to greater improvements in back function than did usual care.

Primary Funding Source: Arthritis Research UK.

Ann Intern Med. 2011;155:569-578. www.annals.org

For author affiliations, see end of text.

Back pain is a common and costly condition (1, 2).

Exercise treatment, although widely used and recommended, has only a small effect on back pain (3–5). Yoga may offer an alternative approach to the treatment of low back pain. The benefits of yoga may be greater than those of exercise alone because yoga offers a combination of physical exercise with mental focus, and patients are taught good posture, self-awareness, and self-care along with relaxation. We recently conducted a literature review and found evidence that yoga may be an effective treatment of chronic low back pain (6 –12). However, the previous studies had limitations, including small sample sizes, a single yoga teacher delivering the program, and short-term follow-up. We therefore conducted a trial to determine whether offering a 12-week yoga program to adults with chronic or recurrent low back pain led to greater improvements in back function than usual care (13)

METHODS

Design Overview

In this parallel-group, randomized, controlled trial, participants were allocated in an overall ratio of 1:1 to usual care or yoga. Participants were recruited between July 2007 and July 2008, with final follow-up in November 2009. The Leeds (East) Research Ethics Committee approved the study (reference 07/Q1206/35).

Setting and Participants

Thirty-nine general practices were recruited to the study. Participating general medical practices searched patient databases and mailed out an invitation packet to all individuals aged 18 to 65 years who had a visit for low back pain in the past 18 months; database searches were undertaken in 2 waves. In addition, during the second wave of recruitment, advertisements were also placed in local media. Individuals who were interested in participating were asked to return a consent form and an eligibility Annals of Internal Medicine Original Research © 2011 American College of Physicians 569 questionnaire containing the Roland–Morris Disability

Questionnaire (RMDQ) (14)—a 24-item questionnaire with scores ranging from 0 (best) to 24 (worst)—to the York Trials Unit. Trial coordinators determined eligibility; criteria were as follows: a score of 4 or more on the RMDQ, musculoskeletal pain bounded by the lowest ribs and gluteal folds, and ability to attend 1 of the yoga venues. Patients were excluded if they 1) did not return a baseline questionnaire (second recruitment wave only), 2) had performed yoga in the previous 6 months, 3) could not get off the floor unaided, 4) could not use stairs, 5) were pregnant, 6) had life-threatening comorbid conditions, 7) had previously undergone spinal surgery, 8) had severe documented psychiatric problems or alcohol dependency, and 9) had indications of serious spinal neurologic abnormality (1 or more of the following: difficulty passing urine; numbness around their back passage, genitals, or inner thighs; numbness, pins and needles, or weakness in both legs; or unsteadiness on feet). Eligibility was confirmed through the participant’s general practitioner.

Randomization and Interventions

The randomization sequence was computer generated by an independent data manager and was stratified by participants’ prespecified availability to attend yoga classes from a list of classes available, with 1 block per class. Eligible participants’ details were entered into a randomization database by the trial coordinators and secretary, who were blinded to the allocation sequence. A variable allocation ratio was used for each class to ensure that no more than 15 participants were allocated to any 1 class. Classes for which fewer than 15 participants expressed availability had an allocation ratio favoring the intervention group to ensure that there were equal numbers of participants in each group. Seven participants were added later and were randomly assigned individually in a 1:1 ratio.  All participants received a back pain education booklet (The Back Book [15]) and usual care. The intervention group was also offered a yoga program. The usual care group was offered a 1-time session of yoga after final follow-up.

Yoga for Healthy Lower Backs

Twenty experienced yoga teachers from 2 yoga associations—the British Wheel of Yoga and Iyengar Yoga (10 from each)—were recruited for the study. Teachers attended program training sessions over 2 weekends. All

teachers taught the same form of yoga according to the teachers’ manual class plans and the pose descriptions and sequences contained in the students’ manual. For each course, 2 teachers were selected: 1 to teach and 1 to serve as back-up. Treatment fidelity was assessed on 2 separate occasions by the back-up yoga teachers. At each assessment, a report was completed and sent to the trial coordinators for review. The fidelity of content was verified by this process, and no changes resulted from the monitoring sessions. Yoga was delivered in nonmedical centers in England (Cornwall, North and West London, Manchester, and York) and was delivered in twelve 75-minute classes (1 class per week). The classes ran from November 2007 to February 2008 and from September 2008 to December 2008. At the first class, participants were given the student manual, a mat, and a relaxation compact disc (which featured 4 narrated guided relaxations focusing on body parts, color meditation, breath awareness, and mental positivity). Home practice sheets were distributed in the class at 4 intervals over the 12 weeks.

The yoga program introduced participants to the foundational elements of yoga adapted appropriately for low back pain, including asana, pranayama, relaxation techniques, mental focus, and philosophy. Classes consistedof an introduction to the weekly theme; pain relieving or settling-in relaxing poses; a program of seated, standing, prone, and supine poses; educative postural advice and 5 to 15 minutes of relaxation. Poses targeted stiff, weak, and uneducated areas of the whole body, with the intention of improving mobility, strength, and posture and reducing pain. Later classes featured postures that built on previous weeks, with the aim of increasing confidence in performing more daily activities. Classes sought to train participants in using yoga in everyday life and at home.

Participants were encouraged to undertake yoga for 30 minutes daily or to practice at least 2 times per week, and to use the compact disc. See the Video Supplement (available at www.annals.org) for further information.

Context:

Is yoga an effective therapy for low back pain?

Contribution

In this trial, adults with chronic or recurrent low back pain were randomly assigned to a 12-session, 3-month yoga program (n ! 156) or usual care (n ! 157). The yoga group had better back function but similar back pain and general health scores at 3, 6, and 12 months compared with the usual care group. Eight participants reported adverse events, such as increased pain, that were perhaps related to yoga.

Caution:

Compliance with yoga was incomplete, and some outcome data were missing.

Implication

Yoga can improve some outcomes in adults with chronic low back pain.

—The Editors

Original Research Yoga for Chronic Low Back Pain

570 1 November 2011 Annals of Internal Medicine Volume 155 • Number 9 www.annals.org

Figure 1. Study flow diagram.

Included in analysis at 6 mo (n = 137)

Not assessed at 6 mo (n = 19)

Lost to follow-up at 6 mo: 6

Withdrew: 8 (did not want to continue: 4; GP

deemed ineligible after randomization: 3; unable to attend classes: 1)

Questionnaires not returned‡: 4

Change from baseline score could not be calculated: 1

Included in analysis at 6 mo (n = 135)

Not assessed at 6 mo (n = 22)

Lost to follow-up at 6 mo: 9

Withdrew: 4 (did not want to continue: 1; GP deemed ineligible after randomization: 3)

Questionnaires not returned‡: 7

Change from baseline could not be calculated: 2

Included in analysis at 3 mo (n = 135)

Not assessed at 3 mo (n = 21)

Lost to follow-up at 3 mo: 5

Withdrew: 7 (did not want to continue: 3; GP

deemed ineligible after randomization: 3; unable to attend classes: 1)

Questionnaires not returned‡: 8

Change from baseline score could not be calculated: 1

Excluded (n = 779)

Roland–Morris Disability Questionnaire Score <4: 19

!1 "red flags"*: 435

Attended yoga in past 6 mo: 46

Involved in back pain trial in past 6 mo: 42

Unable to get off the floor unaided and/or unable to walk up and down stairs: 156

Had spinal surgery: 84

Pregnant: 3

Outside of age range: 4

Could not attend any of the classes on offer: 86

Not seen GP in past 18 mo and/or withdrawn before randomization by GP: 5

Did not return baseline questionnaire: 20

Withdrew before randomization: 3

Had upper back pain not low back pain: 1

Included in analysis at 3 mo (n = 139)

Not assessed at 3 mo (n = 18)

Lost to follow-up at 3 mo: 6

Withdrew: 4 (did not want to continue: 1; GP deemed ineligible after randomization: 3)

Questionnaires not returned‡: 6

Change from baseline scores could not becalculated: 2

Included in analysis at baseline (n = 152)

Not assessed at baseline (n = 4)

Lost to follow-up at baseline†: 1

Withdrew (did not want to continue): 2

Questionnaire not returned†: 1

Included in analysis at baseline (n = 147)

Not assessed at baseline (n = 10)

Lost to follow-up at baseline†: 4

Withdrew: 2 (did not want to continue: 1; GP

deemed ineligible after randomization: 1)

Questionnaires not returned‡: 4

Assigned to yoga (n = 156)

Did not attend any sessions: 23

Randomly assigned (n = 313)

From GP recruitment: 279

From media recruitment: 34

Screening forms returned (n = 1093)

From GP recruitment: 995

From media recruitment: 98

Assigned to usual care (n = 157)

Included in analysis at 12 mo (n = 135)

Not assessed at 12 mo (n = 21)

Lost to follow-up at 12 mo: 13

Withdrew: 8 (did not want to continue: 4; GP deemed ineligible after randomization: 3 unable to attend classes: 1)

Included in analysis at 12 mo (n = 137)

Not assessed at 12 mo (n = 20) Lost to follow-up at 12 mo: 12 Withdrew: 5 (did not want to continue: 1; GP deemed ineligible after randomization: 3;

death: 1)

Change from baseline could not be calculated: 3

GP ! general practitioner. * An indicator of a more serious medical condition. † Baseline questionnaires were sent out after randomization to the first-wave participants (n ! 165) and before randomization to the second-wave participants (n ! 148). Participants who did not return a baseline questionnaire in the second wave were not randomly assigned.

‡ Participants who did not return a questionnaire at that time point but completed questionnaires at subsequent follow-ups. Therefore, the numbers given for “questionnaire not returned” are not cumulative. Number included in analysis refers to numbers included in the main mean Roland–Morris

Disability Questionnaire analyses.

Yoga for Chronic Low Back Pain Original Research

www.annals.org 1 November 2011 Annals of Internal Medicine Volume 155 • Number 9 571

Outcomes and Follow-up

Questionnaires were posted with a prepaid envelope.

Non-responders were initially followed up with postal reminders and then with a telephone call by the trial coordinators or secretary to collect the primary outcome measure. A subset of participants was randomly assigned to receive an electronic reminder on the day

Table 1. Baseline Characteristics of Participants With Low Back Pain Allocated to Yoga or Usual Care*

Characteristic Usual Care Group Yoga Group

Participants,

n

Data Participants,

n

Data

Age 157 156

Mean (SD) 46.3 (11.5) y 46.4 (11.3) y

Median (interquartile range) 46.4 (38.5–55.5) y 47.2 (37.6–56.0) y

Male participants 157 43 (27) 156 50 (32)

Age when participant left full-time education 146 152

!16 y 50 (34) 51 (34)

17–19 y 34 (23) 42 (28)

"20 y 59 (40) 55 (36)

Still in full-time education 3 (2) 4 (3)

Completed further education since leaving school, college, or university 140 79 (56) 141 85 (60)

Employment status 142 143

Employed part-time 33 (23) 30 (21)

Employed full-time 61 (43) 63 (44)

Unemployed 9 (6) 7 (5)

Unable to work because of poor health 10 (7) 9 (6)

At home, not looking for paid employment 11 (8) 18 (13)

Self-employed 18 (13) 16 (11)

Type of employment 140 135

Foreman/supervisor 3 (2) 14 (10)

Manager 27 (19) 27 (20)

Self-employed with employees 6 (4) 6 (4)

Self-employed without employees 18 (13) 14 (10)

Other employee 85 (61) 74 (55)

Never been in paid employment 1 (1) 0 (0)

Current back pain 143 110 (77) 152 118 (78)

Medication use 147 81 (55) 152 87 (57)

Disability

Median time that the participant has been unable to undertake usual activities (range)

144 0 (0–28) d 150 0 (0–28) d

Median time that back pain kept the participant in bed (range) 145 0 (0–7) d 151 0 (0–14) d

Duration of back pain problems 155 153

Median (range) 72 (3–480) mo 96 (3–540) mo

Mean (SD) 113.5 (115.3) mo 130.28 (117.0) mo

Intervention preference 156 155

Yoga 95 (61) 112 (72)

Usual care 7 (4) 4 (3)

Indifferent 54 (35) 39 (25)

Belief that yoga works 157 156

Yes 81 (52) 93 (60)

No 0 (0) 1 (1)

Don’t know 76 (48) 62 (40)

Expectation that yoga works 157 156

Yes 87 (55) 89 (57)

No 0 (0) 2 (1)

Don’t know 70 (45) 65 (42)

* Unless otherwise noted, values are the numbers (percentages) of participants.

Original Research Yoga for Chronic Low Back Pain

572 1 November 2011 Annals of Internal Medicine Volume 155 • Number 9 www.annals.org

they were due to receive the 6-month questionnaire

(16). First-wave participants received £5 with the 12- month questionnaire, and second-wave participants received £5 with the 3-, 6-, and 12-month questionnaires.

Outcomes were measured before randomization; at baseline; and at 3, 6, and 12 months. The prespecified primary outcome was back function at 3 months, immediately after the yoga intervention. Back function was measured by using the RMDQ (14). Secondary outcomes were 1) 6- and 12-month measures of the primary outcome; 2) physical and mental

health Short Form-12 (SF-12) Health Survey component summary scores (17, 18); 3) back pain scores on the Aberdeen Back Pain Scale (ABPS) (19); 4) self-efficacy scores on the Pain Self-Efficacy Questionnaire (PSEQ) (20); 5)

EuroQol-5D health index (21) (results reported separately); 6) number of days spent in bed and number of days with restricted activity (follow-up data reported separately); 7) economic data, including medication use over the previous 4 weeks and other health care use (reported separately);

8) beliefs, expectations, and preferences for treatment at baseline (22, 23); 9) class attendance (self-reported And class registers); and 10) use of yoga at home. We did not collect data on participants’ use of nonsteroidal antiinflammatory drugs or other physical activities. Finally, participants were asked to call if they experienced an adverse event or became pregnant. All events werereported in accordance with National Research Ethics guidelines. Adverse events were assigned potential causality by 1 author (a practicing general practitioner and professor of primary and community care) within the time frame stated in the guidelines. There was no predefined list of possible adverse events. An independent steering committee reviewed all adverse events.

Statistical Analysis

The United Kingdom BEAM (Back Pain Exercise and Manipulation) trial (3) found that a change in the RMDQ score of 1.57 points was a cost-effective difference. Assuming an SD of 4 points (as in the United Kingdom BEAM sample size), this results in an effect size of 0.39. To detect this effect size, assuming 80% power and 20% attrition, we required a total of 262 participants (131 per group).

The analysis plan was agreed on in advance by an independent trial steering committee. Analyses were conducted according to the original randomized treatment assignment regardless of adherence to protocol. Analyses were performed by using SAS software, version 9.2 (SAS Institute, Cary, North Carolina). The statistician was blinded to randomized group. Analyses were conducted by using a linear mixed model (proc mixed in SAS) to compare changes from baseline in RMDQ scores between the groups over time. The linear mixed model assumed that data were missing at random. Time was treated as a categorical variable and was included as a fixed effect in addition to group, age, sex, eligibility RMDQ score, class preference (stratification factor), group and time interaction, and duration of back pain. The likelihood ratio test was used to select the best covariance pattern.

Figure 2. Mean RMDQ scores over time, by randomly assigned group.

Mean Change From Baseline RMDQ Score

Time of Follow-up

Usual care

Yoga

Baseline Month 3 Month 6 Month 12

–3

–4

–2

–1

0

1

Mean changes from baseline are all predicted means and 95% CIs, estimated from the mixed-effects models, and were adjusted by month, age, sex,

eligibility score, class availability, and duration of back pain as fixed effects and random intercepts as random effects. RMDQ ! Roland–Morris Disability

Questionnaire.

Yoga for Chronic Low Back Pain Original Research

www.annals.org 1 November 2011 Annals of Internal Medicine Volume 155 • Number 9 573 also were normally distributed with constant variance, and random intercept effects did not depart significantly from the normal distribution (24, 25). Difference in scores between the groups at 3 (primary outcome) months and at 6 and 12 months (secondary outcomes), and 95% CIs were estimated from the model. To explore the effect of participant intervention preference, the above model was extended to include intervention preference and an interaction term between intervention preference and group. The Fisher exact test was also used to explore the association between adherence and intervention preference. To assess departures from the missing-at-random assumption in the primary outcome model, a best-case and worst-case sensitivity analysis was undertaken. Under the best-case analysis, all yoga participants with missing data were assigned the lowest RMDQ score from yoga participants with observed data, and all usual care participants with missing data were assigned the highest RMDQ score from usual care participants with observed data. Under the worst-case analysis, all yoga participants with missing data were assigned the highest RMDQ score from yoga participants with observed data, and all usual care participants with missing data were assigned the lowest RMDQ score from usual care participants with observed data. The ABPS, SF-12 mental and physical component scores, and PSEQ were analyzed by using the same analysis method as used for the primary outcome. The number of adverse events by participant and the total number of events by group were summarized. Role of the Funding SourceThis trial was funded by Arthritis Research UK and sponsored by the University of York. The funding source had no role in designing the study; collecting, analyzing, and interpreting the data; writing the report; or deciding to

submit the manuscript for publication.


Continuation of Tillbrook et al study

RESULTS

A total of 1093 individuals with low back pain were

screened, and 313 (28.7%) were randomly assigned from 5

centers: 156 to yoga and 157 to usual care (Figure 1).

Participants were mostly middle-aged employed women

(Table 1); the average duration of back pain was 10 years

(SD, 9.7), and 77% had current back pain. At baseline,

207 (67%) participants expressed a preference for yoga, 11

(4%) preferred usual care, and 93 (30%) had no preference.

Two participants did not express a preference.

Study Treatments

There were 16 yoga courses, and the average number

of participants allocated to each was 9.75 (SD, 3.68; median,

10 [range, 3 to 15]). The range in mean change from

baseline RMDQ scores at 3 months by class was "6.5 to

0. Ninety-three (60%) participants attended at least 3 of

the first 6 classes and at least any other 3 classes (adhered);

of the remaining participants, 40 (26%) attended at least 1

class but did not meet the above criteria (mean attendance,

3.1; median attendance, 3.0 [range, 1 to 8]) and 23 (15%)

did not attend any classes. Of participants who adhered,

Table 2. Results of the Linear Mixed Model for the RMDQ Outcome Measure: Main Analysis and Sensitivity Analysis

Variable Mean  Baseline RMDQ  Score (SD)

Mean Change in RMDQ Score From Baseline (95% CI)*

Month 3 P Value Month 6 P Value Month 12 P Value

Main analysis

Yoga group 7.84 (3.96) "2.14 ("3.00 to "1.29) "2.42 ("3.27 to "1.57) "2.04 ("2.90 to "1.19)

Usual care group 7.75 (4.72) 0.03 ("0.89 to 0.94) "0.94 ("1.86 to "0.02) "0.48 ("1.39 to 0.43)

Between-group difference in means

"2.17 ("3.31 to "1.03) #0.001 "1.48 ("2.62 to "0.33) 0.011 "1.57 ("2.71 to "0.42) 0.007




Article Published Online by Medical News Today • MNT

Comment sent to Medical News Today by Evlaleah

B.K.S. Iyengar, now 93, named 1 of a '100 most influential people of the 20th C., hero/icon class, resurrected ancient therapeutic methods and developed/dispensed prescriptions for chronic ailments over now 7 decades.  In my 20s as a dancer, I got hurt, bent my spine/ruptured lumbar discs and was bedridden and unable to walk.  Before fusion/surgery I was told I'd have permanent pain/ limp and would never dance or do yoga again and may become paralyzed.  I called my teacher and told him what happened.  I left the hospital, went to India, Iyengar  fixed my back against worst odds, then had me bring what he taught me: 'Yoga for Backcare' to the US.  For over four decades, I've done only what he recommended and helped many.


In their 1st session people always say, I feel so much better when nothing else helped me, why has no one shown me this before!"  The UK study does not clarify the teachers were certified to do the work.  No teacher knows the medical yoga without upper rung certification and training which avoids hurting students and method.  It is not postural correction, but precise improvement (root scar tissue, deformation and disordering etc.) associated with individual need. Teachers claiming they teach Iyengar yoga without a license are not trained/cert.  Thank you for allowing my comment: evlaleah.com   

Link to 9 Studies / Yoga Research/Iyengar Yoga Therapy



Chronic Back Pain Sufferers Benefit From Yoga

Yoga can provide more effective treatment for chronic lower back pain than more conventional methods according to the UK's largest ever study into the benefits of yoga.


The study, led by the University of York and funded by Arthritis Research UK, found that people offered a specially-designed 12-week yoga program experienced greater improvements in back function and more confidence in performing everyday tasks than those offered conventional forms of GP care.


The research focused on back function - people's ability to undertake activities without being limited by back pain, which was measured using the Roland Morris Disability Questionnaire. Although improvements in back function were more pronounced at three months, researchers found there was still an improvement in people's ability to perform tasks such as walking more quickly, getting dressed without help or standing up for longer periods of time even nine months after the classes had finished.


The trial involved two groups of people who were both receiving GP care for chronic or recurrent back pain. A 156-strong group were offered group yoga classes specially designed to improve back function, while a second control group of 157 people were offered GP care alone.


The findings of the study, which was carried out by researchers from the Department of Health Sciences at the University of York and the Hull York Medical School, are published in the Annals of Internal Medicine this week.


Lower back pain is a common episodic condition, with 80 per cent of the UK population suffering from it at some point in their lives. It is estimated that around 4.9 million working days a year are lost due to back pain. However, few effective, evidence-based treatments exist.


The yoga program, which involved 20 experienced yoga teachers, was designed and delivered by Truro-based Alison Trewhela, an Iyengar Yoga teacher and Senior Practitioner in Yoga on the British Register of Complementary Practitioners, in collaboration with York-based yoga teacher Anna Semlyen, a Back Care Advisor to the British Wheel of Yoga.


The classes were designed for complete beginners, with yoga teachers given extra training in back care. Participants were recruited from 39 general practices in seven Primary Care Trust areas, with classes held in non-NHS premises in Cornwall, North London, West London, Manchester and York.


Chief Investigator Professor David Torgerson, Director of York Trials Unit, in the University's Department of Health Sciences, said: "Back pain is an extremely common and costly condition. Exercise treatment, although widely used and recommended, has only a small effect on back pain. We therefore set out to investigate an alternative approach using a specially-developed weekly yoga program for back pain sufferers to see if this allowed them to manage their back pain more successfully.


"While previous studies have focused on the short-term benefits of yoga, we also wanted to see the long-term effects and measured improvements three, six and 12 months after entry into the study. Our results showed that yoga can provide both short and long-term benefits to those suffering from chronic or recurrent back pain, without any serious side-effects."


Medical Director of Arthritis Research UK Professor Alan Silman said: "We're delighted that our trial has shown that yoga provides such positive benefits for people with chronic low back pain. This extremely common condition cannot be managed with painkillers alone and there is an urgent need to have non-drug therapies that sufferers can utilize in their own home. This trial is part of our larger commitment to seek self-help solutions to this common musculoskeletal problem. There are compelling explanations why yoga may be helpful and this trial lends powerful support to the wider use of this approach."


Trial participants completed a questionnaire at three, six and 12 months from the start of the program. On average, members of the yoga group were able to undertake 30 per cent more activities compared with those in the usual care group after three months, a statistically significant difference between the two groups which has been recognized as clinically important.


The trial showed that there was more reduction in pain in the yoga group than the usual care group, but of marginal statistical significance.


Researchers also compared the results from the yoga program with those for high-quality randomized trials for exercise and manipulation, the Alexander technique and cognitive-behavioral treatment. The results suggested that the 12-week yoga group program may improve back function more than exercise and manipulation, cognitive-behaviour treatment and six sessions of 1-to-1 Alexander technique, but not as much as 24 sessions of 1-to-1 Alexander technique.


Trial participant Sue Faulkner, 68, retired from her job as an administrator four years ago with the intention of spending her time gardening. However, within six months of retiring her back was so bad she found that walking any distance was painful and she needed to stop regularly to rest. Gardening was out of the question.


Sue from Bishopthorpe in York said: "I felt a definite benefit after the program as it made me more flexible and we were taught positions to relieve certain types of back pain. I've continued going to yoga classes and still do the positions I was taught during the 12-week program. Walking around is no longer a problem and I can do my gardening now so long as I pace myself. I've even taken on an allotment with my daughter and son-in-law and no longer take pain killers."


Those attending the specially-designed yoga program, which involved step-by-step gentle classes, were encouraged to become self-sufficient in the long-term. Classes were supported with four home practice sheets, a manual, and a four-track audio CD teaching how to relax physically and mentally.


Iyengar Yoga teacher Alison Trewhela said: "The yoga program offers poses for pain-relief and mental calming; mobilizing, stretching, strengthening and relaxation; improving awareness of posture; education about how a healthy back functions; and positive mental focus. Yoga aims to treat the whole person - not just the physical.


"As most back pain conditions recur, these lifelong self-management skills are likely to be useful as a preventative measure. As a result of smaller previous trials, one million Americans currently practice yoga as a recommended treatment for low back pain."


Participants in the yoga program were surveyed nine months after classes had finished and more than half of those who responded we

re still regularly practicing yoga, mostly at home, twice a week.

Sensitivity analysis

Best-case analysis†

Yoga group "2.90 ("3.89 to "1.91) "3.10 ("4.09 to "2.11) "2.85 ("3.84 to "1.86)

Usual care group 0.52 ("0.55 to 1.58) "0.10 ("1.16 to 0.97) "0.08 ("1.15 to 0.98)

Between-group difference in means

"3.42 ("4.75 to "2.08) #0.001 "3.01 ("4.34 to "1.67) #0.001 "2.77 ("4.11 to "1.43) #0.001

Worst-case analysis‡

Yoga group "0.29 ("1.30 to 0.72) "0.78 ("1.79 to 0.23) "0.10 ("1.11 to 0.91)

Usual care group "0.18 ("1.26 to 0.91) "1.41 ("2.49 to "0.33) "0.93 ("2.01 to 0.15)

Between-group difference in means

"0.11 ("1.47 to 1.24) 0.87 0.63 ("0.73 to 1.98) 0.36 0.83 ("0.53 to 2.19) 0.23

RMDQ ! Roland–Morris Disability Questionnaire.

* Mean changes from baseline and between-group differences (yoga minus usual care) are predicted means and 95% CIs, estimated from the mixed-effects models and adjusted by month, age, sex, eligibility score, class preference, and duration of back pain as fixed effects and random intercepts as random effects in all models. A lower score indicates better health.

† All yoga participants with missing data were assigned the lowest RMDQ score from yoga participants with observed data, and all usual care participants with missing data were assigned the highest RMDQ score from usual care participants with observed data.

‡ All yoga participants with missing data were assigned the highest RMDQ score from yoga participants with observed data, and all usual care participants with missing data were assigned the lowest RMDQ score from usual care participants with observed data.

Original Research Yoga for Chronic Low Back Pain

574 1 November 2011 Annals of Internal Medicine Volume 155 • Number 9 www.annals.org 72% (n ! 66) expressed a preference for yoga at baseline,1% (n ! 1) preferred usual care, and 27% (n ! 25) had

no preference; 1 person did not express a preference. Of participants who did not adhere, 73% (n ! 46) expressed a preference for yoga, 5% (n ! 3) preferred usual care, and 22% (n ! 14) had no preference. There was no association between treatment preference at baseline and adherence

(P ! 0.39, Fisher exact test).


RMDQ Scores

The yoga group had better back function at 3 (primary outcome), 6, and 12 (secondary outcomes) months than the usual care group (Figure 2 and Table 2). The adjusted mean RMDQ score was 2.17 points (95% CI, 1.03 to 3.31 points) lower in the yoga group at 3 months, 1.48 points (CI, 0.33 to 2.62 points) lower at 6 months, and 1.57 points (CI, 0.42 to 2.71 points) lower at 12 months. There was no overall association between RMDQ score and class preference (P ! 0.119), and the effect of treatment did not vary by baseline intervention preference (P for interaction ! 0.39) or whether the participant had current back pain at baseline (P for interaction ! 0.27).


Sensitivity Analyses

Under the best-case analysis, participants in the yoga group continued to have better back function at 3, 6, and 12 months than participants in the usual care group, with larger treatment effect estimates (Table 2). Conversely, under the worst-case analysis, there was no evidence of a difference in back function between the yoga and usual care groups.


Secondary Outcome Measures

The yoga and usual care groups had similar back pain and general health scores at 3, 6, and 12 months; the yoga group had higher pain self-efficacy scores at 3 and 6 months but not at 12 months (Table 3). There was no association at all time points between pain and general health and treatment (ABPS, P ! 0.136; SF-12 physical component score, P ! 0.21; SF-12 mental component score, P ! 0.145), and the results did not vary by month of follow-up (P for interaction for ABPS ! 0.39; for SF-12 physical component score ! 0.82; for SF-12 mental component score ! 0.24). There was an association over all time points between the PSEQ score and treatment (P ! 0.022), and the effect of treatment did not vary by month of follow-up (P for interaction ! 0.36). For all secondary outcome measures, there were differential Rates of missing outcome data between the 2groups. The rates of missing data ranged from 17% to Table 3. Results of the Linear Mixed Model for the Secondary Outcome Measures*

Outcome Measure Mean

Baseline Value (SD)

Mean Change From Baseline (95% CI)

Month 3 P Value

Month 6 P Value

Month 12 P Value

ABPS†

Yoga group 25.36 (10.59) "3.62 ("5.56 to "1.69) "3.98 ("5.95 to "2.01) "3.23 ("5.20 to "1.27)

Usual care group 26.69 (10.87) "1.20 ("3.23 to 0.83) "2.24 ("4.28 to "0.20) 2.51 ("4.54 to "0.48)

Between-group difference in means

"2.42 ("4.97 to 0.12) 0.062 "1.74 ("4.32 to 0.84) 0.186 "0.73 ("3.30 to 1.84) 0.58

SF-12 PCS‡

Yoga group 44.41 (9.13) 2.65 (1.07 to 4.23) 2.89 (1.28 to 4.50) 2.99 (1.39 to 4.59) Usual care group 44.04 (9.45) 1.29 ("0.35 to 2.94) 1.64 ("0.01 to 3.29) 2.20 (0.55 to 3.84) Between-group difference

in means 1.36 ("0.70 to 3.41) 0.20 1.24 ("0.83 to 3.33) 0.24 0.80 ("1.28 to 2.87) 0.45

SF-12 MCS‡

Yoga group 45.04 (10.90) 1.94 (0.14 to 3.73) 1.64 ("0.18 to 3.46) 0.83 ("0.98 to 2.65) Usual care group 45.02 (10.66) "0.08 ("1.94 to 1.78) "0.37 (1.50 to "2.24) 0.41 ("1.45 to 2.27) Between-group difference

in means 2.02 ("0.31 to 4.35) 0.090 2.02 ("0.34 to 4.37) 0.093 0.42 ("1.92 to 2.77) 0.72

PSEQ‡

Yoga group 44.04 (10.71) 3.85 (1.85 to 5.84) 4.29 (2.27 to 6.32) 3.35 (1.33 to 5.37)

Usual care group 43.78 (11.76) 0.88 ("1.22 to 2.99) 0.97 ("1.15 to 3.08) 1.60 ("0.50 to 3.70)

Between-group difference in means 2.96 (0.35 to 5.58) 0.027 3.33 (0.68 to 5.97) 0.014 1.75 ("0.87 to 4.38) 0.190 ABPS ! Aberdeen Back Pain Scale; PSEQ ! Pain Self-Efficacy Questionnaire; SF-12 MCS ! Short Form-12, mental component score; SF-12 PCS ! Short Form-12, physical component score.

* Number of participants with missing data: ABPS—baseline (yoga, 4; usual care, 10), month 3 (yoga, 26; usual care, 21), month 6 (yoga, 30; usual care, 25), month 12

(yoga, 29; usual care, 22); SF-12 PCS and SF-12 MCS—baseline (yoga, 5; usual care, 10), month 3 (yoga, 28; usual care, 21), month 6 (yoga, 32; usual care, 24), month 12 (yoga, 32; usual care, 21); PSEQ—baseline (yoga, 4; usual care, 10), month 3 (yoga, 26; usual care, 22), month 6 (yoga, 30; usual care, 26), month 12 (yoga, 29; usual care, 21). Mean changes from baseline and between-group differences (yoga minus usual care) are predicted means and 95% CIs, estimated from the mixed effects models,and adjusted by month, age, sex, eligibility score, class preference, and duration of back pain as fixed effects and random intercepts as random effects.

† A lower score indicates better health. ‡ A higher score indicates better health.

Yoga for Chronic Low Back Pain Original Research

www.annals.org 1 November 2011 Annals of Internal Medicine Volume 155 • Number 9 575

21% in the yoga group and 13% to 17% in the usual care group.

Adverse Events

Twelve of 156 (8%) yoga participants and 2 of 157 (1%) usual care participants reported adverse events (Table 4). In the yoga group, 1 adverse event was classified as serious and possibly or probably related to yoga (the participant experienced severe pain but had a history of severe pain after any physical activity); the remaining 11 were classified as nonserious and mostly related to increased pain. In the usual care group, 2 serious adverse events occurred.


DISCUSSION

This trial found that offering a 12-week yoga programto adults with chronic or recurrent low back pain led to greater improvements in back function than usual care. The improvements in back function were observed across the 12-month follow-up period but were more pronounced at 3 months, immediately after the intervention. Although there was no evidence of pain reduction at 12 months, confidence in performing normal activities despite pain improved more in the yoga group than usual care group at 3 and 6 months. We found little change in back pain and general health scores at 3, 6, and 12 months. Yoga seemedto be a safe form of activity, with only 8 participants reporting adverse events that were possibly or probably related to yoga.


Although there is no consensus, a change of 1.1 to 2.5 on the RMDQ has been recommended as clinically important (26, 27). In this trial, we found that individuals offered yoga benefited from, on average, 2.17 fewer limited activities at 3 months and by 1.57 fewer limited activities at 12 months. The activities measured by the RMDQ include, for example, walking more slowly than usual, standing for only short periods, and not doing any of the usualjobs around the house. The fact that the benefits diminished over time, after the classes had finished, may indicate that additional classes would be required to maintain the improvement in back function.


Table 4. Adverse Events

Adverse Event Usual Care Group

(n ! 157)

Yoga Group

(n ! 156)

Serious adverse events, n

Accident/injury* 1 0

Increased back pain possibly or probably related to yoga 0 1

Increased back pain unrelated to yoga 0 0

Other pain probably related to yoga† 0 0 Death 1 0

Nonserious adverse events, n

Accident/injury* 0 1

Increased back pain possibly or probably related to yoga 0 4

Increased back pain unrelated to yoga 0 3

Other pain probably related to yoga† 0 3

* Unrelated to intervention.

† All patients had a history of other pain.

Figure 3. Forest plot comparing yoga with other interventions for low back pain evaluated in high-quality randomized,

controlled trials.

Study, Year

UK BEAM, 2004 (3)

Exercise

Manipulation

Manipulation + exercise

Little et al, 2008 (26)

Alexander technique (6 sessions)

Alexander technique (24 sessions)

Lamb et al, 2010 (27)

Cognitive behavioral treatment

Yoga

Mean Difference

(95% CI)

1.36 (0.63–2.10)

1.57 (0.82–2.32)

1.87 (1.15–2.60)

1.71 (0.47–2.98)

2.91 (1.66–4.16)

1.10 (0.38–1.71)

2.17 (1.03–3.31)

–5 –4 –3 –2 –1 0 1 2 3 4 5

Mean Difference in RMDQ Scores at 3 mo

Favors Control Favors Intervention

RMDQ ! Roland–Morris Disability Questionnaire; UK BEAM ! United Kingdom Back Pain Exercise and Manipulation.

Original Research Yoga for Chronic Low Back Pain

576 1 November 2011 Annals of Internal Medicine Volume 155 • Number 9 www.annals.org

Some participants in the yoga group reported that they attended other yoga classes after the 12-week program had finished, and others reported that they continued with home practice (Appendix Tables 1 and 2, available at www.annals.org. The frequency of home practice was 82% in the first 3 months and then decreased to 65% at 6 months and 60% at 12 months; however, 13% of the yoga group did not provide home practice data at any of the follow-up points. The reported figures of home practice may explain why we observed some improvement in back function in the long term. Of note, some participants who did not adhere to the yoga program still reported home practice at 12 months.


Sixty percent of participants offered yoga adhered tothe program: Of the remaining participants, 26% attended at least 1 class but did not fully adhere, and 15% did not attend any classes. Reasons for nonattendance varied: withdrawal by physician, work commitments, child care, and other health problems. For 21 of the 40 participants who partially adhered, we could not ascertain reasons for nonattendance. There were missing data for all outcomes, and differential rates of missing data were observed for secondary outcome measures. Hence, it is possible that such imbalances may have biased the results. When departures from the missing-at-random assumption were assessed in the primary outcome model, the results were consistent with those of our primary analysis under the best-case scenario but were inconsistent under the worst-case scenario. These analyses are useful because they demonstrate the largest and smallest effect estimates compatible with the observed data; however, they are both unlikely scenarios. Unfortunately, the implications of missing data for the analysis depend on the missing-value mechanism, and this is rarely known. Ours was a large randomized trial with long-term follow-up, including multiple teachers (n ! 12) delivering classes in 5 geographic areas.


The program was acceptable to and taught by teachers from 2 yoga associations. Checks were made to ensure fidelity to the program. A recent review identified 7 other randomized, controlled trials evaluating yoga for low back pain (6 –12), but all had design limitations, including small sample sizes, a single yoga teacher delivering the program, and short-term follow-up. Most of the studies found differences in favor of yoga, and our results are consistent with their findings.

Other interventions for low back pain that have been evaluated in high-quality randomized, controlled trials include exercise and manipulation (3), the Alexander technique (26), and cognitive behavioral treatment (27). Comparing the findings of this study with these other interventions suggests that group yoga may improve back function (as measured by the RMDQ) more than exercise and manipulation, cognitive behavioral treatment, and 6 sessions of 1-to-1 Alexander technique but not as much as24 sessions (Figure 3). However, we must be cautious about overanalyzing these results because the comparisons are indirect. Future research should compare yoga directly with these other treatments. In summary, we found that offering a 12-week yoga program to adults with chronic or recurrent low back pain Led to greater improvements in back function than usual care for up to 12 months. Yoga seems to be a safe and effective activity that clinicians could consider recommending for patients with a history of low back pain.

From the University of York, Heslington, York, United Kingdom; University of Manchester, St. Mary’s Hospital, Manchester, United Kingdom; Yoga in York, York, United Kingdom; and SBRCP-Yoga Walsingham Clinic, Truro, Cornwall, United Kingdom.

Grant Support: By Arthritis Research UK.

Acknowledgment: The authors thank Jennifer Klaber-Moffett for her contribution to the development of the original trial protocol and contribution of her expertise in low back pain during the early phase of the trial. They also thank all the yoga teachers who participated in delivering and assessing the intervention.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline .org/authors/icmje/ConflictOfInterestForms.do?msNum!M10-2577.

Reproducible Research Statement: Study protocol: Available at Cox H,

Tilbrook H, Aplin J, et al. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: trial protocol. Complement Ther Clin Pract. 2010;16:76-80. Statistical code and data set: Availability of certain portions of the analytic data set and statistical code to approved individuals through written agreements with Dr. Torgerson (e-mail, david.torgerson@york.ac.uk).

Requests for Single Reprints: Helen E. Tilbrook, BSc, MSc, York

Trials Unit, Department of Health Sciences, Lower Ground Floor, ARRC Building, University of York, Heslington, York YO10 5DD, United Kingdom; e-mail, helen.tilbrook@york.ac.uk. Current author addresses and author contributions are available at www.annals.org.


References

1. Savigny P, Kuntze S, Watson P, Underwood M, Ritchie G, Cotterell M, et al. Low back pain: early management of persistent non-specific low back pain. London: National Collaborating Centre for Primary Care and Royal College of General Practitioners; May 2009.

2. Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain. 2000;84:95-103. [PMID: 10601677]

3. UK BEAM Trial Team. United Kingdom Back Pain Exercise and Manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care. BMJ. 2004;329:1377. [PMID: 15556955]

4. Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005;142:765- 75. [PMID: 15867409]

5. Johnson RE, Jones GT, Wiles NJ, Chaddock C, Potter RG, Roberts C, et al. Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2007; 32:1578-85. [PMID: 17621203] Yoga for Chronic Low Back Pain Original Research

www.annals.org

November 2011 Annals of Internal Medicine Volume 155 • Number 9 577 6. Williams K, Abildso C, Steinberg L, Doyle E, Epstein B, Smith D, et al. Evaluation of the effectiveness and efficacy of Iyengar yoga therapy on chronic low back pain. Spine (Phila Pa 1976). 2009;34:2066-76. [PMID: 19701112]

7. Saper RB, Sherman KJ, Cullum-Dugan D, Davis RB, Phillips RS, Culpepper L. Yoga for chronic low back pain in a predominantly minority population:

a pilot randomized controlled trial. Altern Ther Health Med. 2009;15:18-27. [PMID: 19943573]

8. Tekur P, Singphow C, Nagendra HR, Raghuram N. Effect of short-term intensive yoga program on pain, functional disability and spinal flexibility in chronic low back pain: a randomized control study. J Altern Complement Med.2008;14:637-44. [PMID: 18673078]

9. Sherman KJ, Cherkin DC, Erro J, Miglioretti DL, Deyo RA. Comparing yoga, exercise, and a self-care book for chronic low back pain: a randomized, controlled trial. Ann Intern Med. 2005;143:849-56. [PMID: 16365466]

10. Williams KA, Petronis J, Smith D, Goodrich D, Wu J, Ravi N, et al. Effect of Iyengar yoga therapy for chronic low back pain. Pain. 2005;115:107-17. [PMID: 15836974]

11. Galantio ML, Bzdewka TM, Eissler-Russo JL, Holbrook ML, Mogck EP, Geigle P, et al. The impact of modified hatha yoga on chronic low back pain: a pilot study. Alternative Therapies. 2004;10:56-63.

12. Jacobs BP, Mehling W, Goldberg H, Eppel E, Acree M, Lasater J, et al. Feasibility of conducting a clinical trial on hatha yoga for chronic low back pain: methodological lessons. Alternative Therapies. 2004;10:80-3.

13. Cox H, Tilbrook H, Aplin J, Chuang LH, Hewitt C, Jayakody S, et al. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: trial protocol. Complement Ther Clin Pract. 2010;16:76-80. [PMID: 20347837]

14. 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-back pain. Spine (Phila Pa 1976). 1983;8:141-4. [PMID: 6222486]

15. Burton K, Klaber Moffett J, Main C, Roland M, Waddell G. The Back Book. 2nd ed. Norwich: TSO; 2002.

16. Man MS, Tilbrook HE, Jayakody S, Hewitt CE, Cox H, Cross B, et al. Electronic reminders did not improve postal questionnaire response rates or response times: a randomized controlled trial. J Clin Epidemiol. 2011;64:1001-4. [PMID: 21292441]

17. Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care.1996;34:220-33. [PMID: 8628042]

18. Jenkinson C, Layte R. Development and testing of the UK SF-12 (short form health survey). J Health Serv Res Policy. 1997;2:14-8. [PMID: 10180648]

19. Ruta DA, Garratt AM, Wardlaw D, Russell IT. Developing a valid and reliable measure of health outcome for patients with low back pain. Spine (Phila PA 1976). 1994;19:1887-96. [PMID: 7997920]

20. Nicholas MK. Self-efficacy and chronic pain. Proceedings of the AnnualConference of the British Psychological Society. St. Andrews, United Kingdom:British Psychological Society; 1989.

21. Brook R. EuroQol: the current state of play. Health Policy. 1996;37:53-72.

22. Torgerson DJ, Klaber-Moffett J, Russell IT. Patient preferences in randomised trials: threat or opportunity? J Health Serv Res Policy. 1996;1:194-7. [PMID: 10180870]

23. Torgerson DJ, Sibbald B. Understanding controlled trials. What is a patient preference trial? BMJ. 1998;316:360. [PMID: 9487173]

24. Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. Springer Series in Statistics. New York: Springer; 2000

25. Fitzmaurice GM, Laird NM, Ware JH. Applied Longitudinal Analysis.Hoboken, NJ: Wiley; 2004.

26. Little P, Lewith G, Webley F, Evans M, Beattie A, Middleton K, et al. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain. BMJ. 2008;337:a884. [PMID:18713809]

27. Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, et al; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and costeffectiveness analysis. Lancet. 2010;375:916-23. [PMID: 20189241]


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Original Research Yoga for Chronic Low Back Pain

578 1 November 2011 Annals of Internal Medicine Volume 155 • Number 9 www.annals.org

Current Author Addresses: Ms. Tilbrook, Ms. Cox, Dr. Hewitt, Mr.Kang’ombe, Dr. Chuang, and Ms. Jayakody: University of York, Heslington,York YO10 5DD, UK. Dr. Aplin: Manchester Academic Health Science Centre, University of Manchester, St. Mary’s Hospital, Manchester M13 9WL, UK.

Ms. Semlyen: Yoga in York, 24 Grange Street, York YO10 4BH, United Kingdom.Ms. Trewhela: SBRCP-Yoga Walsingham Clinic, 2 Walsingham Place,Truro, Cornwall TR1 2RP, United Kingdom. Dr. Watt: Department of Health Sciences, University of York, Area 2, Seebohm Rowntree Building, Heslington, York YO10 5DD, United Kingdom.Dr. Torgerson: Hull York Medical School, York Trials Unit, Lower Ground Floor, ARRC Building, Department of Health Sciences, Universityof York, Heslington, York YO10 5DD, United Kingdom.


Author Contributions: Conception and design: H.E. Tilbrook, H. Cox, J.D. Aplin, A. Semlyen, A. Trewhela, I. Watt, D.J. Torgerson Analysis and interpretation of the data: H.E. Tilbrook, C.E. Hewitt, A.R. Kang’ombe, J.D. Aplin, A. Semlyen, A. Trewhela, I. Watt, D.J. Torgerson.

Drafting of the article: H.E. Tilbrook, C.E. Hewitt, A.R. Kang’ombe, I. Watt, D.J. Torgerson.

Critical revision of the article for important intellectual content: C.E. Hewitt, L.H. Chuang, J.D. Aplin, A. Semlyen, A. Trewhela, I. Watt, D.J. Torgerson.Final approval of the article: H.E. Tilbrook, H. Cox, C.E. Hewitt, A.R. Kang’ombe, J.D. Aplin, A. Semlyen, A. Trewhela, I. Watt, D.J. Torgerson.

Provision of study materials or patients: A. Semlyen, A. Trewhela.

Statistical expertise: C.E. Hewitt, A.R. Kang’ombe.

Obtaining of funding: J.D. Aplin, A. Semlyen, I. Watt, D.J. Torgerson.

Administrative, technical, or logistic support: H. Cox, J.D. Aplin, A. Semlyen.

Collection and assembly of data: H.E. Tilbrook, H. Cox, D.J. Torgerson.


Appendix Table 1. Summary Data on Whether Participants Practiced Yoga at Home and How Often They Practiced Over Time

Variable Yoga Group, n/n (%) Usual Care Group

(n ! 157), n/n (%)

Offered Yoga

(n ! 156)*

Adherent

(n ! 93)*

Partial Attenders

(n ! 40)*

Nonattenders

(n ! 23)*

– – –

Month 3

Practicing yoga at home 102/125 (82) 83/89 (93) 15/27 (56) 4 (50) 3/19 (16)

Not practicing yoga at home 23/125 (18) 6/89 (7) 12/27 (44) 4 (50) 16/19 (84)

Missing data on use of yoga at home 31/156 (20) 4/93 (4) 13/40 (33) 15/23 (65) 138/157 (88)

How often practicing yoga at home?

Daily 9/101 (9) 7/82 (9) 2/15 (13) – 1/3 (33)

Every other day 21/101 (21) 17/82 (21) 2/15 (13) 2/4 (50) –

Twice a week 40/101 (40) 35/82 (43) 5/15 (33) – –

Once a week 23/101 (23) 18/82 (22) 3/15 (20) 2/4 (50) 1/3 (33)

Less than once a week 8/101 (8) 5/82 (6) 3/15 (20) – 1/3 (33)

Missing (did not provide frequency of yoga

home use)

1/102 (1) 1/83 (1)

– – –

Month 6

Practicing yoga at home 82/126 (65) 72/88 (82) 7/26 (27) 3 (27) 17/128 (13)

Not practicing yoga at home 44/126 (35) 16/88 (18) 19/26 (73) 8 (73) 111/128 (87)

Missing data on use of yoga at home 30/156 (19) 5/93 (5) 14/40 (35) 10/23 (43) 29/157 (19)

How often practicing yoga at home?

Daily 6/82 (7) 6/72 (8) – – 1/7 (6)

Every other day 10/82 (12) 9/72 (13) 1/7 (14) – 3/7 (18)

Twice a week 25/82 (31) 21/72 (29) 2/7 (29) 2/3 (67) 6/7 (35)

Once a week 21/82 (26) 16/72 (22) 4/7 (57) 1/3 (33) 4/7 (24)

Less than once a week 20/82 (24) 20/72 (28) – – 3/7 (18)

Missing (did not provide frequency of yoga

home use)

– – – – –

Month 12

Practicing yoga at home 76/126 (60) 61/89 (69) 10/25 (40) 4 (36) 16/136 (12)

Not practicing yoga at home 50/126 (40) 28/89 (31) 15/25 (60) 7 (64) 120/136 (88)

Missing data on use of yoga at home 30/156 (19) 4/89 (4) 15/40 (38) 12/23 (52) 21/157 (13)

How often practicing yoga at home?

Daily 5/76 (7) 5/62 (8) – – –

Every other day 8/76 (11) 7/62 (11) 1/10 (10) – 3/16 (18)

Twice a week 28/76 (37) 21/62 (34) 6/10 (60) – 3/16 (18)

Once a week 17/76 (22) 12/62 (19) 2/10 (20) 1/4 (25) 5/16 (31)

Less than once a week 18/76 (24) 17/62 (27) 1/10 (10) 3/4 (75) 5/16 (31)

Missing (did not provide frequency of yoga home use)

– – – – –

* Total number in each group. Offered yoga: all participants randomly assigned to yoga; adherent: participants who attended at least 3 of the first 6 classes and at least 3 other classes; partial attenders: participants who attended at least 1 class but did not meet the definition of adherent; nonattenders: participants who did not attend any of the yoga classes offered. Annals of Internal Medicine W-166 1 November 2011 Annals of Internal Medicine Volume 155 • Number 9 www.annals.org

Appendix Table 2. Summary Data on Whether Participants Regularly Attended Yoga Classes After the Intervention* Variable Yoga Group Usual Care GroupMonth 3

Attending a regular yoga class, n/n (%) 1/17 (6) 4/132 (3)

Not attending a regular yoga class, n/n (%) 16/17 (94) 128/132 (97)

Mean classes attended over past 12 wk (SD), n 7.14 (3.70) 3.50 (3.89)

Median classes attended over past 12 wk (range), n 7.50 (1.00–12.00) 3.00 (0.00–8.00)

Missing (did not provide attendance data at 3 mo), n† 119 9

– – –

Month 6

Attending a regular yoga class, n/n (%) 19/125 (15) 5/134 (4)

Not attending a regular yoga class, n/n (%) 106/125 (85) 129/134 (96)

Mean classes attended over past 12 wk (SD), n 5.52 (4.17) 3.80 (5.90)

Median classes attended over past 12 wk (range), n 5.00 (0.00–12.00) 1.50 (0.00–18.00)

Missing (did not provide attendance data at 6 mo), n† 13 3

– – –

Month 12

Attending a regular yoga class, n/n (%) 11/126 (9) 7/136 (5)

Not attending a regular yoga class, n/n (%) 115/126 (91) 129/136 (95)

Mean classes attended over past 12 wk (SD), n 9.89 (10.24) 5.53 (7.23)

Median classes attended over past 12 wk (range), n 10.00 (0.00–30.00) 1.00 (0.00–20.00)

Missing (did not provide attendance data at 12 mo), n

† 9 4 * Only self-reported postintervention class attendance is summarized.

† These participants completed the questionnaires but did not provide the attendance data; 36, 38, and 38 participants did not complete the 3-, 6-, and 12-monthquestionnaires, respectively.

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Research on the Systematic Therapeutic Methodology of Shri B.K.S. Iyengar