|Wang, Chenchen - Tufts University|
|Iversen, Maura - Northeastern University|
|Mcalindon, Timothy - Tufts University|
|Harvey, William - Tufts University|
|Wong, John - Tufts University|
|Fielding, Roger - Jean Mayer Human Nutrition Research Center On Aging At Tufts University|
|Driban, Jeffrey - Tufts University|
|Price, Lori Lyn - Tufts University|
|Rones, Ramel - The Center For Mind-Body Therapies|
|Gamache, Tressa - Tufts University|
|Schmid, Chrostopher - Brown University|
Submitted to: BMC Complementary and Alternative Medicine
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 8/27/2014
Publication Date: 9/8/2014
Citation: Wang, C., Iversen, M.D., McAlindon, T., Harvey, W.F., Wong, J.B., Fielding, R.A., Driban, J.B., Price, L., Rones, R., Gamache, T.C., Schmid, C. 2014. Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial. BMC Complementary and Alternative Medicine. 14:333. https://doi.org/10.1186/1472-6882-14-333.
DOI: https://doi.org/10.1186/1472-6882-14-333 Interpretive Summary: This study describes the design of a study that we are completing which compared the effects of a mind-body therapy, Tai Chi, to traditional physical therapy in patients with osteoarthritis of the knee. Subjects were assigned by a computerized algorithm equivalent to the flip of a coin to one of two groups and will be followed up to one year. The main outcome of this study will be to determine which intervention causes the greatest reduction in knee pain.
Technical Abstract: Background: Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. Methods/Design: A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults >/= 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. Discussion: This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind-body effect for a major disabling disease with substantial health burdens and economic costs. Results of this study are expected to have important public health implications for the large and growing population with knee OA.