Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, 1 Boston Medical Center Place, Dowling 5 South, Boston, MA 02118, USA.
Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.
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.
This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.
慢性下腰痛给社会带来了巨大的发病率和成本，而低收入和少数族裔成年人的影响不成比例。几项随机对照试验表明瑜伽是一种有效的治疗方法。然而，瑜伽和物理治疗的比较效果，这是一种治疗慢性下腰痛的常见主流治疗方法，尚不清楚。
方法/设计：这是一项针对 320 名主要为低收入少数族裔成年人的慢性下腰痛的随机对照试验，比较瑜伽、物理治疗和教育。纳入标准为年龄在 18-64 岁之间的成年人，有持续时间≥ 12 周的非特异性下腰痛，且自我报告的平均疼痛强度为 0-10 刻度上的≥ 4。招募工作在波士顿医疗中心进行，这是一家城市学术性安全网医院和位于不同社区的七家联邦合格社区卫生中心。这项为期 52 周的研究有一个初始的 12 周治疗阶段，在此期间，参与者以 2:2:1 的比例随机分为 i）每周一次标准的哈他瑜伽课程，辅以家庭练习；ii）一种标准化的基于证据的运动疗法方案，根据治疗分类方法改编，由物理治疗师单独提供，并辅以家庭练习；iii）通过自我保健书籍提供教育。主要结果测量是 12 周的疼痛强度，用 11 点数字评分量表测量，背部特定功能用改良的 Roland Morris 残疾问卷测量。在随后的 40 周维持阶段，瑜伽参与者以 1:1 的比例重新随机分为结构化维持瑜伽课程或仅家庭练习。物理治疗参与者也同样重新随机分为五组强化课程或仅家庭练习。教育参与者继续遵循教育材料的建议。我们还将使用索赔数据库、电子病历、自我报告的成本数据和研究记录，从个人、保险公司和社会的角度评估成本效益。访谈中的定性数据将补充定量数据，提供主观细节。
这项试验在 ClinicalTrials.gov 注册，编号为 NCT01343927。
