Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Roland-Morris Disability Questionnaire
研究概览
简要总结
Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.
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
- Single (Outcomes Assessor)
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
- •Has a VA primary care provider
- •Diagnosis of chronic low back pain > 6 months
- •Willing to attend a yoga program or be assigned to delayed treatment with yoga
- •Willing to complete 4 assessments
- •English Literacy
- •Has not begun new pain treatments or medications in the past month
- •Willing to not change pain treatments (e.g., discontinue a treatment; increase medication dose) during the 12-week intervention period unless medically necessary
排除标准
- •back surgery within the last 12 months
- •back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia)
- •morbid obesity (BMI > 40)
- •Significant sciatica or nerve compression < 3 months or chronic lumbar radicular pain > 3 months
- •Unstable, serious coexisting medical illness (eg, CHF, cancer, COPD, morbid obesity; dementia)
- •Unstable, serious psychiatric illness (e.g., unmanaged psychosis, active substance dependence)
- •Insufficient data to rule out acute, metastatic disease, (unless primary care physician approves)
- •Attended or practiced yoga > 1x in the last 12 months
- •Positive Romberg test (with or without sensory neuropathy)
研究组 & 干预措施
Yoga
The yoga intervention will consist of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
干预措施: Yoga Therapy for CLBP (Behavioral)
Delayed Treatment Control - Usual Care
Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
结局指标
主要结局
Roland-Morris Disability Questionnaire
时间窗: baseline to 6-months
The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
次要结局
- Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months(baseline to 6 months)
- Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks(baseline to 12 weeks)
- Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - SF12 PCS at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Range of Motion - Flexion at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks(baseline to 12 weeks)
- Attendance/ Home Practice(12 weeks)
- Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks(baseline to 12 weeks)
- Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - SF12 MCS at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Grip Strength at 12 Weeks(baseline to 12 weeks)
- Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks(baseline to 12 weeks)