Efficacy of Tuina on pain, functional activity, muscle strength and brain activity for patients with knee osteoarthritis in Shanghai: a randomised controlled trial protocol

Introduction: Knee osteoarthritis (KOA) is a common degenerative joint disease characterised by knee joint pain, functional impairment and muscle fatigue. Tuina is widely used in the treatment of KOA and has great potential in relieving pain and functional disorders. However, there is still a lack of sufficient evidence on the clinical effects of Tuina in treating KOA pain, functional activity, muscle strength and brain activity. This randomised controlled trial aims to evaluate the clinical analgesic effects and safety profile of Tuina for KOA patients, while elucidating its mechanistic basis through multimodal neuroimaging and biomechanical assessments to establish evidence-based support for Tuina.

Methods and analysis: This is a parallel design, assessor and statistician blinded, randomised controlled trial. A total of 60 patients with early-stage KOA will be recruited and randomly divided into a Tuina group (n=30) and an education group (n=30) in a 1:1 ratio, receiving either 4 weeks of Tuina intervention or education intervention. Primary outcome will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, while secondary results will include the WOMAC stiffness and function subscale, Short-Form McGill Pain Questionnaire (SF-MPQ), Visual Analogue Scale, Perceived Stress Scale, Beck Depression Scale, Pain Catastrophising Scale, Pressure Pain Threshold, Isokinetic Muscle Strength Test, functional near-infrared spectroscopy, gait analysis and MRI for comprehensive evaluation. The data will be analysed at baseline, the end of the intervention and 12, 24, 48 weeks after the intervention. Adverse events will be recorded for safety assessment.