Yoga, Physical Therapy, or Education for Chronic Low Back Pain

A Randomized Noninferiority Trial

Published in: Annals of Internal Medicine, Volume 167, Issue 2 (June 2017), pages 85-94. doi: 10.7326/M16-2579

Posted on RAND.org on August 02, 2017

by Robert B. Saper, Chelsey M. Lemaster, Anthony M. Delitto, Karen J. Sherman, Patricia M. Herman, Ekaterina Sadikova, Joel Stevans, Julia E. Keosaian, Christian J. Cerrada, Alexandra L. Femia, Eric J. Roseen, Paula Gardiner, Katherine Gergen Barnett, Carol Faulkner, Janice Weinberg

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Background

Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain.

Objective

To determine whether yoga is noninferior to PT for cLBP.

Design

12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927)

Setting

Academic safety-net hospital and 7 affiliated community health centers.

Participants

320 predominantly low-income, racially diverse adults with nonspecific cLBP.

Intervention

Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice.

Measurements

Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life.

Results

One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups.

Limitations

Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up.

Conclusion

A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain.

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