Tai Chi and Fibromyalgia

描述(申请人提供)：纤维肌痛(FM)是一种慢性肌肉骨骼疼痛综合征，会导致严重的身体和心理损伤，每年造成超过250亿美元的损失。目前的药物治疗可能昂贵，引起严重的不良反应，并且不能有效地改善疼痛和功能。因此，迫切需要为FM患者寻找新的有效的非药物治疗方法。之前的研究表明，太极，一种传统的中国心身锻炼方式，可以改善FM患者的身心健康。然而，还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，我们建议进行太极与有氧运动(当前护理标准的推荐组成部分)的第一次有效性比较试验，并在大量FM人群中评估不同太极剂量计划下的有效性。我们的目的是(1)证明，与有氧运动相比，太极是一种更有效的干预措施，可以控制疼痛并改善影响FM患者生活质量的功能限制，以及2)根据短期和长期效果，确定有监督的太极干预的最佳频率和持续时间。为了实现这一目标，我们将在216名符合美国风湿病学会FM标准的患者中进行太极和有氧运动的单盲随机对照试验。患者将被随机分到四个太极干预组中的一个：12或24周的监督太极拳，每周一次或两次，或监督有氧运动对照组(24周，每周2次)。所有小组都将进行为期52周的随访。主要结果将是FM影响问卷在24周时的总分。次要结果包括12、24和52周的广泛性疼痛、功能表现、心理功能、自我效能、睡眠质量和生活质量的测量。这项拟议研究的成功完成将确定理想的太极养生法，并证明太极可以成为这种具有治疗挑战性的疾病的一种简单、有效和持久的治疗方法。我们相信，我们的工作将说服临床社区将太极作为数百万FM患者的一线治疗。 公共卫生相关性：纤维肌痛(FM)是美国第二常见的风湿病，目前还没有令人满意的治疗方法。迫切需要创新有效的战略。太极提供了一种新颖的、在后勤上可行的锻炼方案和一种互补的心身结合的方法来管理疼痛，并增强FM患者的身心健康。成功完成建议的研究将证明太极是一种简单、有效和持久的治疗FM的方法。1

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. PUBLIC HEALTH RELEVANCE: Fibromyalgia (FM) is the second most common rheumatologic condition in the United States and there are currently no satisfactory treatments. Innovative effective strategies are urgently needed. Tai Chi offers a novel and logistically feasible exercise regimen and a complementary mind-body approach to manage pain as well as enhance physical and mental health and wellness in patients with FM. Successful completion of the proposed study will demonstrate that Tai Chi is a simple, effective and durable treatment for FM. 1