Chronic low back pain (CLBP) affects 5-10% of U.S. adults annually and disproportionately impacts individuals from minority and low income backgrounds due to disparities in access and treatment. Pilot data collected at one of the proposed study sites demonstrate yoga is a feasible and possibly effective intervention for CLBP in minority populations. Evidence from multiple studies supports a moderate benefit in CLBP for exercise therapy individually-delivered by a physical therapist. Moreover, physical therapy is the most common, reimbursed, non-pharmacologic treatment recommended by physicians for CLBP. Our primary study objective is to compare the effectiveness of yoga, physical therapy, and education for the treatment of CLBP in a predominantly low income minority population. A 12 week comparative effectiveness randomized controlled trial for CLBP is proposed with three treatment arms: (1) A standardized weekly hatha yoga protocol delivered in a class format;(2) a standardized evidence-based exercise therapy protocol individually delivered by a physical therapist;and (3) education delivered through a self-care book. A racially diverse population of 260 adults with CLBP will be recruited from Boston Medical Center and six affiliated community health centers and randomized in a 2:2:1 ratio to yoga, physical therapy, and education, respectively. The application's primary aim is to determine the comparative effectiveness of yoga, physical therapy, and education for three outcomes at 12 weeks: pain intensity, back-specific function, and use of pain medication. For each of these outcomes, patients randomized to the yoga group are hypothesized to demonstrate clinically and statistically greater improvements than patients in the physical therapy or education groups. After the 12 week intervention period, half of the yoga and physical therapy participants will be randomly selected to participate in a 40 week ongoing structured yoga or physical therapy maintenance program. Pain, function, and pain medication use will be compared between maintenance and non-maintenance groups. Cost and utilization data will also be collected so cost effectiveness analyses from the perspective of society, the third party payer, and the patient can be performed. Together, results from these studies will help determine whether it is justifiable for yoga, currently a "complementary" therapy, to become an acceptable "mainstream" treatment for chronic low back pain. 1

Public Health Relevance

Chronic low back pain is a substantial cause of suffering, disability, and cost in U.S. society. Individuals from low income minority backgrounds may be more affected by chronic low back pain due to disparities in health care access and treatment. Our study will compare the effectiveness of yoga to physical therapy for the treatment of chronic low back pain in 260 racially diverse adults recruited from urban community health centers. 1

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Project (R01)
Project #
5R01AT005956-04
Application #
8541949
Study Section
Musculoskeletal Rehabilitation Sciences Study Section (MRS)
Program Officer
Khalsa, Partap Singh
Project Start
2010-09-01
Project End
2015-08-31
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
4
Fiscal Year
2013
Total Cost
$551,810
Indirect Cost
$123,867
Name
Boston Medical Center
Department
Type
DUNS #
005492160
City
Boston
State
MA
Country
United States
Zip Code
02118