A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia study protocol for a randomized controlled trial

Authors: WANG, CHENCHEN - Tufts Medical Center; MCALINDON, TIMOTHY - Tufts Medical Center; FIELDING, ROGER - Jean Mayer Human Nutrition Research Center On Aging At Tufts University; HARVEY, WILLIAM - Tufts Medical Center; DRIBAN, JEFFREY - Tufts Medical Center; PRICE, LORI LYN - Tufts Medical Center; KALISH, ROBERT - Tufts Medical Center; SCHMID, ANNA - Tufts Medical Center; SCOTT, TAMMY - Jean Mayer Human Nutrition Research Center On Aging At Tufts University; SCHMID, CHRISTOPHER - Tufts Medical Center

Submitted to: Trials
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 1/8/2015
Publication Date: 1/30/2015
Citation: Wang, C., McAlindon, T., Fielding, R.A., Harvey, W.F., Driban, J., Price, L., Kalish, R., Schmid, A., Scott, T., Schmid, C.H. 2015. A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial. Trials. 16:34. https://doi.org/10.1186/s13063-015-0548-x.
DOI: https://doi.org/10.1186/s13063-015-0548-x

Interpretive Summary: Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Finding new and effective treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized study of Tai Chi (a traditional mind body exercise program) versus aerobic exercise (a recommended component of the current standard of care) in patients with fibromyalgia. This article describes the design and conduct of this trial. A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted. We plan to study 216 patients with fibromyalgia. 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 the Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Other measures include measures of pain, symptom severity, functional performance, balance, muscle strength and power. This is the first study comparing Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. 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.

Technical Abstract: BACKGROUND: 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. DISCUSSION: 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.