A pragmatic multicentered randomized controlled trial of yoga for chronic low back pain: economic evaluation.

STUDY DESIGN: Multicentered randomized controlled trial with quality of life and resource use data collected. OBJECTIVE: The objective of this study was to evaluate the cost-effectiveness of yoga intervention plus usual care compared with usual care alone for chronic or recurrent low back pain. SUMMARY OF BACKGROUND DATA: Yoga has been shown as an effective intervention for treating chronic or recurrent low back pain. However, there is little evidence on its cost-effectiveness. The data are extracted from a pragmatic, multicentered, randomized controlled trial that has been conducted to evaluate the effectiveness and cost-effectiveness of a 12-week progressive program of yoga plus usual care in patients with chronic or recurrent low back pain. METHODS: With this trial data, a cost-effectiveness analysis during the time period of 12 months from both perspectives of the UK National Health Service and the societal is presented. Main outcome measure is an incremental cost per quality-adjusted life-year (QALY). RESULTS: From the perspective of the U.K. National Health Service, yoga intervention yields an incremental cost-effectiveness ratio of £13,606 per QALY. Given a willingness to pay for an additional QALY of £20,000, the probability of yoga intervention being cost-effective is 72%. From the perspective of the society, yoga intervention is a dominant treatment compared with usual care alone. This result is surrounded by fewer uncertainties-the probability of yoga being cost-effective reaches 95% at a willingness to pay for an additional QALY of £20,000. Sensitive analyses suggest the same results that yoga intervention is likely to be cost-effective in both perspectives. CONCLUSION: On the basis of this trial, 12 weekly group classes of specialized yoga are likely to be a cost-effective intervention for treating patients with chronic or recurrent low back pain.

Yoga for chronic low back pain: a randomized trial.

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 the United Kingdom. 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.

A randomised controlled trial of yoga for the treatment of chronic low back pain: results of a pilot study.

OBJECTIVE: To conduct a pilot trial of yoga for the treatment of chronic low back pain (LBP) to inform the feasibility and practicality of conducting a full-scale trial in the UK; and to assess the efficacy of yoga for the treatment of chronic low back pain. DESIGN: A pragmatic randomised controlled trial was undertaken comparing yoga to usual care. PARTICIPANTS: Twenty participants who had presented to their GP with chronic low back pain in the previous 18 months were recruited via GP records from one practice in York, UK. INTERVENTIONS: Twenty patients were randomised to either 12 weekly 75-min sessions of specialised yoga plus written advice, or usual care plus written advice. Allocation was 50/50. MAIN OUTCOME MEASURES: Recruitment rate, levels of intervention attendance, and loss to follow-up were the main non-clinical outcomes. Change as measured by the Roland and Morris disability questionnaire was the primary clinical outcome. Changes in the Aberdeen back pain scale, SF-12, EQ-5D, and pain self-efficacy were secondary clinical outcomes. Data were collected via postal questionnaire at baseline, 4 weeks, and 12 weeks follow-up. RESULTS: Of the 286 patients identified from the GP database, 52 (18%) consented and returned the eligibility questionnaire, out of these 20 (6.9%) were eligible and randomised. The total percentage of patients randomised from the GP practice population was 0.28%. Ten patients were randomised to yoga, receiving an average of 1.7 sessions (range 0-5), and 10 were randomised to usual care. At 12 weeks follow-up data was received from 60% of patients in the yoga group and 90% of patients in the usual care group (75% overall). No significant differences were seen between groups in clinical outcomes apart from on the Aberdeen back pain scale at four weeks follow-up where the yoga group reported significantly less pain. CONCLUSION: This pilot study provided useful data and information to inform the design and development of a full-scale trial of yoga for CLBP in the UK. A key finding is the calculation of GP practice total list size required for patient recruitment in a full-scale trial, and the need to implement methods to increase class attendance.

A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: trial protocol.

UNLABELLED: A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is funded by Arthritis Research Campaign (arc) and is being conducted by the University of York. 262 patients will be recruited from GP practices in 5 centres in England. Patients will be randomised to receive usual care or 12 weekly classes of yoga. A yoga programme will be devised that can be delivered by yoga teachers of the two main national yoga organisations in the UK (British Wheel of Yoga and Iyengar Yoga Association (UK)). TRIAL REGISTRATION: Current controlled trials registry ISRCTN81079604 (date registered 30/03/2007).