Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial

Abstract

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.

Primary funding source: National Center for Complementary and Integrative Health of the National Institutes of Health.

Figure. Primary outcomes from baseline to 52 weeks.

The study was divided into a treatment phase (baseline to 12 weeks) and maintenance phase (12 to 52 weeks). Intention-to-treat analyses are shown. Plotted values in the treatment phase derive from models using multiple imputation to handle missing data. Values in the maintenance phase derive from longitudinal models using all available data. 95% CIs are shown. Data points are slightly offset from each other to aid interpretation. RMDQ = Roland Morris Disability Questionnaire. Top. Mean RMDQ scores adjusted for baseline scores and anchored at the study population mean at baseline. Bottom. Mean unadjusted back pain scores.