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

Study Protocol

Timothy McAlindon¹  Jeffrey B Driban¹  William F Harvey¹  Tressa Gamache¹  Chenchen Wang¹  Ramel Rones²  Christopher H Schmid³  Maura D Iversen⁴  John B Wong⁵  Roger A Fielding⁶  Lori Lyn Price⁷ 

[1] Center for Integrative Medicine and Division of Rheumatology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA;Center for Mind–Body Therapies, Providence, RI, USA;Department of Biostatistics and Center for Evidence Based Medicine, Brown University School of Public Health, Providence, RI, USA;Department of Physical Therapy, Movement and Rehabilitation Sciences, Northeastern University, Boston, MA, USA;Division of Rheumatology, Immunology & Allergy, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA, USA;Division of Clinical Decision Making, Department of Medicine, Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Tufts Clinical and Translational Science Institute, Tufts University, Boston, Medford, MA, USA;Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, USA;The Institute for Clinical Research and Health Policy Studies, Tufts Clinical and Translational Science Institute Tufts Medical Center, Tufts University, Boston, MA, USA;

关键词: Tai Chi;    Physical therapy;    Knee osteoarthritis;    Comparative effectiveness research;    Randomized controlled trial;   

DOI  :  10.1186/1472-6882-14-333

 received in 2014-07-18, accepted in 2014-08-27,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundKnee 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/DesignA 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 stkiffness 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.DiscussionThis 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.Trial registrationClinicalTrials.gov identifier:NCT01258985

【 授权许可】

CC BY   
© Wang et al.; licensee BioMed Central Ltd. 2014