Tai Chi and Fibromyalgia

描述（由申请人提供）：纤维肌痛（FM）是一种慢性肌肉骨骼疼痛综合征，导致严重的身体和心理损害，每年花费超过250亿美元。目前的药物治疗可能是昂贵的，造成严重的不良反应，并不能有效地改善疼痛和功能。因此，寻找新的有效的非药物治疗方法是迫切需要的。以前的研究表明，太极拳，一种传统的中国身心运动，可以改善FM患者的身心健康。然而，没有临床试验证明其与标准有氧运动疗法相比的临床有效性，也没有确定其作为FM治疗的最佳剂量（频率或持续时间）。因此，我们建议进行太极拳与有氧运动（当前护理标准的推荐组成部分）的第一次比较效果试验，并评估在不同太极拳剂量计划下在大型FM人群中的有效性。我们的目标是(1)证明，与有氧运动相比，太极拳是一种更有效的干预措施，可以控制疼痛和改善影响FM患者生活质量的功能限制，以及(2)确定与短期和长期有效性相关的监督太极拳干预的最佳频率和持续时间。为了实现这一目标，我们将对216名符合美国风湿病学会FM标准的患者进行太极拳与有氧运动的单盲、随机对照试验。患者将被随机分为四个太极干预组：12或24周，每周进行一次或两次监督太极拳，或进行监督有氧运动控制（每周2次，持续24周）。所有组将进行52周的随访。主要结果将是24周时FM影响问卷的总分。次要结局包括12,24和52周时的广泛疼痛、功能表现、心理功能、自我效能、睡眠质量和生活质量。这项研究的成功完成将确定太极的理想疗法，并证明太极拳可以是一种简单、有效和持久的治疗这种治疗上具有挑战性的疾病的方法。我们相信，我们的工作将说服临床社区将太极拳作为数百万FM患者的一线治疗方法。

DESCRIPTION (provided by applicant): Fibromyalgia (FM) is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs over $25 billion annually. Current pharmacological therapies may be expensive, cause serious adverse effects, and fail to effectively improve pain and function. Thus, finding new and effective non-pharmacological treatments for FM patients is urgently needed. Previous research has demonstrated that Tai Chi, a traditional Chinese mind-body exercise, can improve both physical and mental health for FM patients. However, no clinical trials have demonstrated its clinical effectiveness compared to standard aerobic exercise therapy, or determined its optimum dose (frequency or duration) as a treatment for FM. We therefore propose to conduct the first comparative effectiveness trial of Tai Chi vs. aerobic exercise (a recommended component of the current standard of care) and to evaluate effectiveness under different Tai Chi dosing schedules in a large FM population. We aim to (1) demonstrate that, compared to aerobic exercise, Tai Chi is a more effective intervention for managing the pain and improving the functional limitations that impact quality of life for FM patients, and 2) determine the optimal frequency and duration of a supervised Tai Chi intervention in relation to short and long-term effectiveness. To achieve this goal, we will conduct a single-blind, randomized controlled trial of Tai Chi vs. aerobic exercise in 216 patients who meet the American College of Rheumatology criteria for FM. Patients will be randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi given once or twice per week, or a supervised aerobic exercise control (2x/week for 24 weeks). All groups will have a 52-week follow-up. The primary outcome will be the FM Impact Questionnaire total score at 24 weeks. Secondary outcomes include the measures of widespread pain, functional performance, psychological functioning, self-efficacy, sleep quality, and quality of life at 12, 24, and 52 weeks. Successful completion of the proposed study will determine the ideal regimen of Tai Chi and demonstrate that Tai Chi can be a simple, effective, and durable treatment for this therapeutically challenging disorder. We believe that our work will convince the clinical community to implement Tai Chi as a first-line treatment for the millions of individuals with FM.