NCT00865358

Yoga for Chronic Low Back Pain

Yoga for Chronic Low Back Pain in a Predominantly Minority Population: A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Chronic low back pain is the most common cause of pain in the United States. Common treatments such as medication, physical therapy, and surgery often do not provide adequate relief. Yoga has shown promise for improving low back pain in studies of predominantly middle class white individuals. We will assess the feasibility and collect preliminary data on yoga for chronic low back pain in predominantly minority individuals in a community health center setting in a low income neighborhood of Boston, Massachusetts. We hypothesize that offering yoga for this population is feasible and will show promising efficacy and safety data.

Detailed description

Promising therapies for chronic low back pain such as yoga need to be studied because conventional treatments such as medication, physical therapy, and surgery frequently do not provide lasting relief. We will use a standardized yoga protocol, developed specifically for this trial by a consensus panel of yoga experts, in a pilot randomized controlled trial for subjects with chronic low back pain. We will recruit 30 predominantly English-speaking minority adults from Boston Medical Center (BMC) and its affiliated clinics with low back pain lasting \>12 weeks and an average pain level in the previous week of 4 or more on a scale of 0 to 10 (0 = no pain, 10 = worst possible pain). Subjects will be randomized to a yoga class once per week for 12 weeks (Group 1) or a wait-list control group (Group 2). All subjects will receive their usual medical care and an educational booklet designed for low back pain patients. Primary outcomes are 12 week pain intensity and functional status measured by the Roland Morris Disability scale. Secondary outcomes include analgesic use, health-related quality of life (SF-36), global improvement, subject satisfaction, adverse events, compliance, work status, and health expenditures. Group 2 will be offered yoga classes at 26 weeks. To refine estimates of effect size and further confirm safety of the protocol, we will also collect data from Group 2 during their yoga classes. This pilot will provide preliminary feasibility and efficacy data to plan a future adequately powered randomized controlled trial of yoga for chronic low back pain in predominantly minority subjects.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Yoga Group	Reproducible standardized 12 week series of hatha yoga classes specifically developed for patients with chronic low back pain and little or no experience with yoga

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-07-01
• Completion: 2008-01-01
• First posted: 2009-03-19
• Last updated: 2012-12-05

Locations

2 sites across 1 country: United States