RESUMEN
BACKGROUND: Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain. OBJECTIVE: To determine whether yoga is noninferior to PT for cLBP. DESIGN: 12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927). SETTING: Academic safety-net hospital and 7 affiliated community health centers. PARTICIPANTS: 320 predominantly low-income, racially diverse adults with nonspecific cLBP. INTERVENTION: Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice. MEASUREMENTS: Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life. RESULTS: One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups. LIMITATIONS: Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up. CONCLUSION: A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain. PRIMARY FUNDING SOURCE: National Center for Complementary and Integrative Health of the National Institutes of Health.
Asunto(s)
Dolor Crónico/terapia , Dolor de la Región Lumbar/terapia , Educación del Paciente como Asunto , Modalidades de Fisioterapia , Yoga , Adulto , Dolor Crónico/etnología , Investigación sobre la Eficacia Comparativa , Femenino , Estudios de Seguimiento , Humanos , Dolor de la Región Lumbar/etnología , Masculino , Persona de Mediana Edad , Cooperación del Paciente , Modalidades de Fisioterapia/efectos adversos , Pobreza , Método Simple Ciego , Resultado del TratamientoRESUMEN
OBJECTIVE: To explore the experiences of low-income minority adults taking part in a yoga dosing trial for chronic low back pain. DESIGN: Individual semi-structured interviews were conducted with nineteen participants recruited from a randomized yoga dosing trial for predominantly low-income minority adults with chronic low back pain. Interviews discussed the impact of yoga on low back pain and emotions; other perceived advantages or disadvantages of the intervention; and facilitators and barriers to practicing yoga. Interviews were audio taped and transcribed, coded using ATLAS.ti software, and analyzed with inductive and deductive thematic analysis methods. SETTING: Boston Medical Center, Boston, MA, USA. RESULTS: Participants viewed yoga as a means of pain relief and attributed improved mood, greater ability to manage stress, and enhanced relaxation to yoga. Overall, participants felt empowered to self-manage their pain. Some found yoga to be helpful in being mindful of their emotions and accepting of their pain. Trust in the yoga instructors was a commonly cited facilitator for yoga class attendance. Lack of time, motivation, and fear of injury were reported barriers to yoga practice. CONCLUSIONS: Yoga is a multidimensional treatment for low back pain that has the potential to favorably impact health in a predominantly low-income minority population.
Asunto(s)
Dolor de la Región Lumbar/terapia , Investigación Cualitativa , Yoga , Adulto , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
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.