Simplified Tai Chi for Reducing Fibromyalgia Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire
研究概览
简要总结
Data from two recent Tai chi studies have found that Tai Chi yields symptomatic benefit in patients with fibromyalgia (FM). The purpose of this study is to confirm those findings in a larger randomized, controlled clinical trial in a community-based setting. We also sought to extend this line of inquiry by closely examining Tai chi's effect on physical function, specifically postural stability. Towards these ends, we conducted a single-blind, randomized controlled clinical trial of an FM modified 8-form Yang-style Tai chi program compared to standard education. Subjects in both conditions meet in small groups two times weekly for 60 minutes over 12 weeks.
详细描述
120 males and females with fibromyalgia were randomized to participate in a modified 8 form Yang-Style Tai Chi program or a standard group education program. Both programs met in a small group format for twice weekly 60 minute sessions lasting for 12 weeks. 99 subjects completed the protocol. Primary outcomes from the Fibromyalgia Impact Questionnaire were assessed at baseline and 12 weeks. Secondary measures included pain intensity and interference, sleep, coping, and fitness tests.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects included adults over 40 years of age or older who met 1990 ACR criteria for the classification of FM. Those criteria include pain in three or more body quadrants (above the waist, below the waist, left of midline and right of midline) including axial pain by self-report for a minimum of three consecutive months.
- •Additionally at least 11 of 18 muscle/tendon junction tender points were found to be painful via digital palpation of 4kg over 4 seconds by a trained examiner (Wolfe 1990).
排除标准
- •Individuals were excluded if they practiced Tai chi within the past 6 months; - were exercising more than 30 minutes, three times weekly for past 3 months;
- •could not independently ambulate without assistive devices;
- •were unable to attain MD clearance for exercise within past 3 months;
- •were unwilling to undergo random assignment; had cognitive impairment based on score >3 Pfeiffer Mental Status;
- •had significant depressive symptoms based on a score of >27 on Beck Depression Inventory;
- •had BPI pain severity scores less than 3/10, had planned elective surgery during the study period;
- •were unwilling to keep all treatments/medications steady throughout the study period;
- •were currently enrolled in another study.
结局指标
主要结局
Fibromyalgia Impact Questionnaire
时间窗: Assessed following 12 week intervention
次要结局
- Brief Pain Inventory(Assessed following 12 week intervention)