Effects of Acupuncture-Combined Tuina on Patients With Knee Osteoarthritis: Protocol for a Randomized Controlled Trial

Background: Knee osteoarthritis (KOA) is a prevalent degenerative joint disease that is characterized by joint pain, stiffness, and dysfunctional impairment, imposing a substantial medical burden annually. Tuina, a widely used noninvasive traditional Chinese medicine therapy commonly used for KOA, has been used for the management of this condition; however, its additive benefit to acupuncture remains unclear. Objective: The objective of the study is to assess whether the effectiveness of acupuncture-combined Tuina is superior to that of acupuncture in the management of KOA. Methods: This single-center, parallel-group, randomized controlled trial aims to enroll 60 patients with KOA, who will be randomly assigned to either a Tuina group (acupuncture-combined Tuina) or an acupuncture group (30 patients per group). Baseline assessments will include demographic and clinical evaluations: the visual analog scale from the short-form McGill Pain Questionnaire, pain threshold, muscle tension, 10-meter walking test, Western Ontario and McMaster Universities Osteoarthritis Index, and multimodal magnetic resonance imaging. Over a 6-week intervention, the Tuina group will receive Tuina on the basis of acupuncture, that is, acupuncture-combined Tuina, while the acupuncture group will undergo just acupuncture, with both groups continuing standard care as prescribed. Posttreatment, clinical outcomes and safety will be reassessed using baseline indicators. A 12-week follow-up will include all clinical evaluations. Assessments will be conducted by blinded assessors, and statistical analyses will be conducted by independent, blinded analysts. Outcomes will evaluate clinical pain and functional differences between groups and will elucidate the underlying cerebral mechanisms. Results: This study was funded in August 2024. The experimental plan will begin on December 31, 2025, and end on May 4, 2027. Conclusions: This trial aims to verify whether acupuncture-combined Tuina receives better efficacy than single acupuncture, as well as to explore the neuroimaging mechanisms that are clinically affected, thus providing scientific evidence for the treatment of clinical patients with KOA.