Tuina on knee pain and physical function for patients with mild-moderate knee osteoarthritis in Shanghai: protocol for a multicenter, assessor-blinded, randomized controlled trial

Abstract Background Knee osteoarthritis (KOA) is one of the most common osteoarthritis, imposing substantial economic and medical burdens on both individuals and society. In China, Tuina has been chosen as a complementary and alternative therapy to relieve symptoms of knee pain and dysfunction. However, current evidence is insufficient to support the efficacy of Tuina therapy in addressing knee pain and improving physical function. The purpose of this trial was to investigate the efficacy of Tuina compared to celecoxib, by observing changes in outcome measures and assessing its level of effectiveness as an alternative treatment. Methods and analysis A total of 360 patients with KOA aged between 40 and 70 years and classified as Kellgren and Lawrence Grade I-II will be recruited from eight sub-central hospitals. The participants will be randomly assigned to either the treatment group (Tuina, Biw) or the control group (Celecoxib, Qd), with both groups undergoing a 4-week intervention phase followed by an 8-week follow-up phase. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale at week 4 compared with baseline. Secondary outcomes including WOMAC stiffness and function subscales, WOMAC total score, 36-item short form health survey (SF-36), timed up and go test (TUG), short physical performance battery (SPPB), gait analysis parameters, and pain medication records will be assessed at weeks 4, 8, and 12. Any adverse events occurring during the trial will be promptly recorded. Discussion This multicenter randomized trial aims to evaluate the effectiveness of Tuina on relieving pain and increasing physical function of KOA patients. This protocol, if proven effective, will present more compelling evidence supporting the value of Tuina and contribute to providing a promising alternative therapy for patients with mild-moderate KOA. Trial registration number: This trial has been registered in the China Clinical Trials Registry (registration number: ChiCTR2300069416).