Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

Robert B Saper, Karen J Sherman, Anthony Delitto, Patricia M Herman, Joel Stevans, Ruth Paris, Julia E Keosaian, Christian J Cerrada, Chelsey M Lemaster, Carol Faulkner, Maya Breuer, Janice Weinberg, Robert B Saper, Karen J Sherman, Anthony Delitto, Patricia M Herman, Joel Stevans, Ruth Paris, Julia E Keosaian, Christian J Cerrada, Chelsey M Lemaster, Carol Faulkner, Maya Breuer, Janice Weinberg

Abstract

Background: 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.

Methods/design: 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.

Trial registration: This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.

Figures

Figure 1
Figure 1
Study flow diagram. The study will recruit 320 participants with chronic low back pain from Boston Medical Center and surrounding affiliated federally qualified community health centers. Participants are randomized after baseline data collection to yoga classes, physical therapy (PT), or education through a self-care book in a 2:2:1 ratio. This year-long study is divided into a 12-week Treatment Phase and subsequent 40-week Maintenance Phase. Yoga and PT participants who have attended at least one intervention session during the Treatment Phase are re-randomized at 12 weeks into a structured maintenance intervention or no structured maintenance intervention. For the participants, we term the no structured maintenance intervention as “Home Practice” only. Education participants continue through the study without any re-randomization.
Figure 2
Figure 2
Physical therapy intervention: the treatment-based classification algorithm. Information from the history and examination is used to place chronic low back pain participants into one of two subgroups based on the pattern of signs and symptoms. Treatment is then based upon the participant’s subgroup classification. Participants’ classification is reassessed at each visit with appropriate adjustments to recommended exercises made. Participants are also classified according to the Fear Avoidance Belief Questionnaire (FABQ). PT participants who score ≥29 on the FABQ-W subscale receive The Back Book which provides brief cognitive behavioral education aimed at lowering fear avoidance. Physical therapists reinforce these points during treatment sessions and the participant’s exercise prescription is graded.
Figure 3
Figure 3
Physical therapy intervention timeline. Participants randomized to the physical therapy arm are offered a high dose, individually-tailored exercise program by physical therapists. A total of 15 individual 60-minute sessions over the course of the initial 12-week Treatment Phase is offered. Each session is divided into approximately 30 minutes of working directly with a physical therapist followed by up to 30 minutes of a supervised aerobic exercise routine. The first visit consists of an initial comprehensive evaluation for classification. Participants re-randomized at 12 weeks into a structured physical therapy maintenance program are offered five booster sessions scheduled at months 4, 6, 8, 10, and 12. The structure and content of booster sessions is similar to the Treatment Phase where therapists classify patients according to the Treatment Based Classification algorithm, review home practice, assess progress with the Modified Oswestry, review and perform recommended exercises, and provide encouragement and guidance for further home practice. PT participants randomized into the no maintenance (a.k.a. home practice) group do not receive booster sessions; however, they are encouraged to continue with their home practice exercises.

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