The Clinical Efficacy, Safety and Biomechanical Mechanism of Tai Chi in Patients with Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial

Abstract Background: Knee osteoarthritis (KOA), one of the most common degenerative joint disease, is the leading cause of disability among elder people. Many previous studies demonstrated that Tai chi is an effective treatment in the management of KOA, but there has been a lack of study evaluated the effect of Tai chi on both clinical and biomechanical outcomes in individuals with KOA. The purpose of the study is to identify the clinical and biomechanical effect of the Tai chi, the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi. Methods: We will conduct a prospective, randomized controlled trials of 72 individuals with medial KOA. The participants with medial KOA will be randomly divided into Tai chi group or a control group. The Tai chi group will participant in Tai chi twice a week for eight weeks. The control group will receive health care education. After the 8-week intervention period there will be a 16-week follow-period with no active intervention in either group. The primary and secondary outcomes will be assessed at baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks. The primary measure will be Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcome measures will include the kinetics, kinematics changing of the knee joint at sagittal, frontal, and transverse plane, the muscle co-contraction.Discussion: This study aims to investigate the clinical and biomechanical effect of the Tai chi, and the results will help to improve the understanding of possible underlying biomechanical effects of the Tai chi in the management of KOA. Trail Registration: The study was approved by China registered clinical trial ethics review committee with No.ChiECRCT20200335. The study plan was registered on the website of China Registered Clinical Trial Registration Center with No.ChiCTR2000040769 .Registered 09 December 2020, http://www.chictr.org.cn/showprojen.aspx?proj=65571