Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial
1 Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, 1 Boston Medical Center Place, Dowling 5 South, Boston, MA 02118, USA
2 Group Health Research Institute and Department of Epidemiology, University of Washington, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, USA
3 School of Health and Rehabilitation Sciences, University of Pittsburgh, 4028 Forbes Tower, Pittsburgh, PA 15260, USA
4 RAND Health Unit, RAND Corporation, 1776 Main Street, Santa Monica, CA 90407, USA
5 Boston University School of Social Work, 264 Bay State Road, Boston, MA 02215, USA
6 Art & Soul Yoga Studio, 220 Pearl Street, Cambridge, MA 02139, USA
7 Santosha School of Yoga, 14 Bartlett Avenue, Cranston, RI 02905, USA
8 Department of Biostatistics, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown, 3rd floor, Boston, MA 02118, USA
Trials 2014, 15:67 doi:10.1186/1745-6215-15-67Published: 26 February 2014
Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown.
This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data.
This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.