Abstract
BACKGROUND: Knee osteoarthritis (KOA) is the most common degenerative joint disease. It is characterized by pain, stiffness, reduced joint motion, and muscle weakness. It also has the potential for long-term disability. Radial extracorporeal shock wave therapy (rESWT) is a noninvasive therapeutic modality widely used for the treatment of musculoskeletal disorders. However, the role of rESWT in the treatment of knee osteoarthritis remains controversial in previous clinical trials. This trial will investigate the efficacy of rESWT in improving the symptoms, function, and bone metabolic status of participants with knee osteoarthritis. METHODS: The study is a randomized, double-blind, controlled trial. Thirty participants with knee osteoarthritis will be randomized to receive either rESWT or sham rESWT on the affected knee once per week for 4 weeks. All participants will undergo professional physiotherapy once a week during the treatment period. The primary outcome is the visual analogue scale score for pain. Secondary outcomes include the Western Ontario and McMaster Universities Osteoarthritis Index score, knee range of motion, the 10-m walk test results, and bone metabolism biochemical indicators. Outcomes will be measured at baseline (T0), 5 weeks post-intervention (T1), and 8 weeks post-intervention (T2). DISCUSSION: This study will investigate the effects of rESWT on pain, physical function, and bone metabolism biochemical indicators in participants with knee osteoarthritis, which is expected to reduce the pain of participants, improve the function of participants, and improve bone metabolism biochemical indicators. The information obtained will enhance our understanding of rESWT for the treatment of knee osteoarthritis and may be used to standardize clinical treatment protocols for knee osteoarthritis. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2300069997. Registered on 30 March 2023.