Wang Chenchen, McAlindon Timothy, Fielding Roger A, Harvey William F, Driban Jeffrey B, Price Lori Lyn, Kalish Robert, Schmid Anna, Scott Tammy M, Schmid Christopher H
Center for Complementary and Integrative Medicine/Division of Rheumatology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA.
Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, USA.
Trials. 2015 Jan 30;16:34. doi: 10.1186/s13063-015-0548-x.
Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial.
METHODS/DESIGN: A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ≥21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up.
This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short- and long-term effectiveness. The trial also explores multiple outcomes to elucidate the potential mechanisms of Tai Chi and aerobic exercise and the generalizability of these interventions across instructors. Results of this study are expected to have important public health implications for patients with a major disabling disease that incurs substantial health burdens and economic costs.
ClinicalTrials.gov identifier: NCT01420640 , registered 18 August 2011.
纤维肌痛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害，每年给美国医疗系统造成超过250亿美元的损失。目前的药物治疗可能会引起严重的不良反应，费用高昂，且无法有效改善疼痛和功能。迫切需要为纤维肌痛患者找到新的有效非药物治疗方法。我们目前正在对大量纤维肌痛患者进行太极拳与有氧运动（当前护理标准推荐的组成部分）的首次比较有效性随机试验。本文描述了该试验的设计与实施情况。
方法/设计：在马萨诸塞州波士顿的一家城市三级医疗中心进行一项为期52周的太极拳与有氧运动单中心随机对照试验。我们计划招募216名纤维肌痛患者。研究人群包括年龄≥21岁、符合美国风湿病学会1990年和2010年诊断标准的纤维肌痛成年人。参与者被随机分配到四个太极拳干预组之一：每周进行一次或两次、为期12周或24周的有监督太极拳，或每周进行两次、为期24周的有监督有氧运动对照组。主要结局是从基线到24周时修订的纤维肌痛影响问卷总分的变化。次要结局包括在12周、24周和52周随访时的广泛疼痛、症状严重程度、功能表现、平衡、肌肉力量和功率、心理功能、睡眠质量、自我效能、持续效应以及与健康相关的生活质量等指标。
本研究是在大量纤维肌痛患者中进行的太极拳与有氧运动的首次比较有效性随机试验，并进行长期随访。我们在此展示了一项设计完善且严谨的试验，以确定有监督太极拳干预在短期和长期有效性方面的最佳频率和持续时间。该试验还探讨了多个结局，以阐明太极拳和有氧运动的潜在机制以及这些干预措施在不同教练中的可推广性。预计本研究结果将对患有这种造成重大健康负担和经济成本的主要致残性疾病的患者产生重要的公共卫生影响。
ClinicalTrials.gov标识符：NCT01420640，于2011年8月18日注册。
