Radial extracorporeal shock wave therapy for pain and function in adults with knee osteoarthritis: protocol for a placebo-controlled, randomized clinical trial.
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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.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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