Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Fibromyalgia Impact Questionnaire Revised (FIQR)
研究概览
简要总结
Fibromyalgia is a common, costly and debilitating illness which affects mostly women. Fibromyalgia patients report widespread musculoskeletal pain, fatigue, stiffness, and distress. Several consensus statements indicate that optimal care combines medication, exercise, and psychology. Yoga is a popular mind/body discipline which holds promise for reducing fibromyalgia symptoms. The aim of this pilot study is to evaluate the effects of an innovative program, Yoga of Awareness, in which yoga poses are complemented by meditation and breathing exercises, presentations on healthy coping, and group discussions. Fifty-six women with fibromyalgia will be recruited and randomly divided into two groups. One group will receive the yoga program right away, and the other group will wait 3 months before receiving the program. Information about fibromyalgia symptoms and functioning will be collected from both groups before and immediately after the first group receives the yoga program. When results from the 2 groups are compared, the investigators expect patients who received the yoga program will have greater gains in fibromyalgia symptoms, physical function and pain coping capacities then those waiting to receive the program. If this study shows the yoga program is effective, the investigators will use this data in 2010 to apply to the National Institutes of Health for a more complete study of its benefits.
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
- 21 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women ≥21 years of age
- •diagnosed with fibromyalgia by ACR criteria for at least 1 year
- •on a stable regimen of pharmacologic and/or non-pharmacologic treatment for FM ≥3 months
排除标准
- •reside >70 miles from the research site
- •unavailable to attend the intervention at one of the scheduled times
- •currently engaged in intensive yoga practice (practice >3 days/wk)
- •score >29 on the Beck depression scale modified for fibromyalgia
- •currently undergoing disability application or involved in litigation
- •elective surgery scheduled during the study period
- •physically disabled in a manner that precludes meaningful participation in the intervention (eg, quadriplegic paralysis)
- •do not speak English
研究组 & 干预措施
yoga condition
assigned to start the yoga program right away
干预措施: Yoga of Awareness Program (Behavioral)
wait-list control condition
This condition will control for any effects of symptom measurement reactivity in patients receiving routine fibromyalgia medical care. After the 3-month assessment, the yoga intervention program will be provided to these patients.
结局指标
主要结局
Fibromyalgia Impact Questionnaire Revised (FIQR)
时间窗: baseline, 3 months, 6 months
次要结局
- Chronic Pain Acceptance Questionnaire (CPAQ)(baseline, 3 months, 6 months)
- Vanderbilt Multidimensional Pain Coping Inventory (VMPCI)(baseline, 3 months, 6 months)
- Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT)(baseline, 3 months, 6 months)
研究者
James W Carson, PhD
Associate Professor
Oregon Health and Science University
