A Prospective, Randomized-controlled Study to Evaluate the Effect of a Standardized Yoga Practice on Chronic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in VAS(visual analog scale)
研究概览
简要总结
Chronic low back pain is notoriously difficult to treat and is a primary contributor to lost work days and excessive health expenditures, and whose treatment has, in part, contributed to the opioid crisis. Surgery is only an option in a minority of these patients, usually confined to those with structural instability. Yoga is an ancient modality whose benefits are currently being studied.
详细描述
The purpose of this research study is to determine whether a 6 week standardized yoga practice is superior to usual conservative therapies in the treatment of chronic back pain at 6 months. There is enough data that the most recent ACP guidelines have included yoga as a treatment for chronic back pain, but more data needs to be generated regarding the efficacy of this modality in treating the chronic back pain population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to and ability to participate in study procedures
- •Chronic back pain (pain above the gluteal cleft of at least 3 months duration)
排除标准
- •Indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis)
- •Cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice
研究组 & 干预措施
Control arm
The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections
Yoga Arm
The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.
干预措施: Yoga program (Behavioral)
结局指标
主要结局
Changes in VAS(visual analog scale)
时间窗: Enrollment visit, 6 months after enrollment visit
The visual analogue scale or visual analog scale (VAS) is designed to measure pain intensity with less pain being experienced by those in the intervention group in comparison to the control group.
Changes in ODI (Oswestry Disability Index)
时间窗: Enrollment visit, 6 months after enrollment visit
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Improvement will be measured by the lower score out of a 100, which reflects less disability.
Changes in SF-36 (Short Form (36) Health Survey )
时间窗: Enrollment visit, 6 months after enrollment visit
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. Improvement with those with Yoga will be seen by higher scores in SF-36 which indicate lower disability.
次要结局
- Long term changes in SF-36 after intervention(Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit)
- Long term changes in ODI after intervention(Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit)
- Long term changes in VAS after intervention(Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit)