BACKGROUND: Several studies suggest yoga may be effective for chronic low back pain; however, trials targeting minorities have not been conducted. PRIMARY STUDY OBJECTIVES: Assess the feasibility of studying yoga in a predominantly minority population with chronic low back pain. Collect preliminary data to plan a larger powered study. STUDY DESIGN: Pilot randomized controlled trial. SETTING:Two community health centers in a racially diverse neighborhood of Boston, Massachusetts. PARTICIPANTS: Thirty English-speaking adults (mean age 44 years, 83% female, 83% racial/ethnic minorities; 48% with incomes < or = $30,000) with moderate-to-severe chronic low back pain. INTERVENTIONS: Standardized series of weekly hatha yoga classes for 12 weeks compared to a waitlist usual care control. OUTCOME MEASURES: Feasibility measured by time to complete enrollment, proportion of racial/ethnic minorities enrolled, retention rates, and adverse events. Primary efficacy outcomes were changes from baseline to 12 weeks in pain score (0=no pain to 10=worst possible pain) and back-related function using the modified Roland-Morris Disability Questionnaire (0-23 point scale, higher scores reflect poorer function). Secondary efficacy outcomes were analgesic use, global improvement, and quality of life (SF-36). RESULTS: Recruitment took 2 months. Retention rates were 97% at 12 weeks and 77% at 26 weeks. Mean pain scores for yoga decreased from baseline to 12 weeks (6.7 to 4.4) compared to usual care, which decreased from 7.5 to 7.1 (P=.02). Mean Roland scores for yoga decreased from 14.5 to 8.2 compared to usual care, which decreased from 16.1 to 12.5 (P=.28). At 12 weeks, yoga compared to usual care participants reported less analgesic use (13% vs 73%, P=.003), less opiate use (0% vs 33%, P=.04), and greater overall improvement (73% vs 27%, P=.03). There were no differences in SF-36 scores and no serious adverse events. CONCLUSION: A yoga study intervention in a predominantly minority population with chronic low back pain was moderately feasible and may be more effective than usual care for reducing pain and pain medication use.
RCT Entities:
BACKGROUND: Several studies suggest yoga may be effective for chronic low back pain; however, trials targeting minorities have not been conducted. PRIMARY STUDY OBJECTIVES: Assess the feasibility of studying yoga in a predominantly minority population with chronic low back pain. Collect preliminary data to plan a larger powered study. STUDY DESIGN: Pilot randomized controlled trial. SETTING: Two community health centers in a racially diverse neighborhood of Boston, Massachusetts. PARTICIPANTS: Thirty English-speaking adults (mean age 44 years, 83% female, 83% racial/ethnic minorities; 48% with incomes < or = $30,000) with moderate-to-severe chronic low back pain. INTERVENTIONS: Standardized series of weekly hatha yoga classes for 12 weeks compared to a waitlist usual care control. OUTCOME MEASURES: Feasibility measured by time to complete enrollment, proportion of racial/ethnic minorities enrolled, retention rates, and adverse events. Primary efficacy outcomes were changes from baseline to 12 weeks in pain score (0=no pain to 10=worst possible pain) and back-related function using the modified Roland-Morris Disability Questionnaire (0-23 point scale, higher scores reflect poorer function). Secondary efficacy outcomes were analgesic use, global improvement, and quality of life (SF-36). RESULTS: Recruitment took 2 months. Retention rates were 97% at 12 weeks and 77% at 26 weeks. Mean pain scores for yoga decreased from baseline to 12 weeks (6.7 to 4.4) compared to usual care, which decreased from 7.5 to 7.1 (P=.02). Mean Roland scores for yoga decreased from 14.5 to 8.2 compared to usual care, which decreased from 16.1 to 12.5 (P=.28). At 12 weeks, yoga compared to usual care participants reported less analgesic use (13% vs 73%, P=.003), less opiate use (0% vs 33%, P=.04), and greater overall improvement (73% vs 27%, P=.03). There were no differences in SF-36 scores and no serious adverse events. CONCLUSION: A yoga study intervention in a predominantly minority population with chronic low back pain was moderately feasible and may be more effective than usual care for reducing pain and pain medication use.
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