Abstract
BACKGROUND: Knee osteoarthritis (KOA) is a progressive degeneration of the knee joint that has the potential to impair the function of the lower extremity. Tuina, as an important component of traditional Chinese medicine (TCM), is a common treatment for KOA. However, the prevailing practice often limits the therapeutic focus to the knee joint, overlooking potential coexisting hip and ankle injuries. Thus, the therapeutic efficacy may not be optimal in these instances. OBJECTIVE: This study aims to evaluate the clinical efficacy of Tuina therapy based on hip-knee-ankle synergy combined with conventional treatment in patients with KOA. It also seeks to explore the potential effects on the lower extremity kinematic chain and provide clinical practitioners with a potentially valuable therapeutic approach. METHODS: This single-blind randomized controlled trial (RCT) will involve a total of 96 participants with KOA from 1 study center (including 2 branches). Participants will be randomly divided into a conventional treatment (control) group and a Tuina+conventional treatment (intervention) group in a 1:1 ratio. Participants in the control group will receive regular health education, self-administered acupressure, and functional exercise. This routine will be completed in 4 weeks, with a total of 5 sessions planned each week. Participants in the intervention group will receive 8 sessions of Tuina therapy based on hip-knee-ankle synergy (twice a week for 4 weeks), combined with conventional treatment. The primary outcome of this study will be improvement in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores from baseline to 16 weeks. Among the secondary measures, the Key Symptoms and Signs/TCM Syndrome Classification Quantitative Evaluation of KOA and the 11-item Tampa Scale of Kinesiophobia (TSK-11) score will be evaluated from baseline to 16 weeks. The Functional Movement Screen (FMS), the Timed Up and Go (TUG) test, and the Weight Bearing Lunge Test (WBLT) scores will only be evaluated at baseline and 4 weeks. RESULTS: The trial commenced in September 2024 and is expected to conclude in September 2025. As of April 2025, key preliminary steps have been successfully completed. Specifically, the ethical review and clinical trial registration have been finalized. Participant recruitment is proceeding well, with 69 individuals having been enrolled to date. Data collection is currently ongoing, and formal data analysis has not yet been initiated. CONCLUSIONS: This RCT aims to contribute to the growing evidence base supporting the necessity of kinetic chain-based integrative diagnosis and treatment, while also evaluating the feasibility of the study protocol and exploring the benefits of manipulative therapy. TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry ITMCTR2024000293; https://tinyurl.com/4tsszfdu. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/75547.