Study on efficacy and safety of Tong-luo Qu-yu plaster treatment for knee osteoarthritis: study protocol for a randomised, double-blind, parallel positive control, multi-center clinical trial

Abstract Background: Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affect quality of life. Patients with KOA frequently develop one or more of the typically following symptoms: joint pain, stiffness, joint friction noise, impaired functionality. Traditional Chinese medicines (TCM) have showed a superior effect and peculiar advantage on the treatment of KOA, among TCMs, the Tong-luo Qu-yu plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high quality of clinical evidences to support the therapeutic effect that Chinese adhesive plaster can relieve pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-yu plaster in patients with KOA. Methods: This study will be a randomised, double-blind, parallel positive control, multi-center clinical trial. A total of 2000 participants older than 40 years with KOA, will be randomly allocated into a experimental group (n=1500) and a control group (n=500). All participants will receive a conventional conservative treatment lasted for 14 days as two courses, daily 1 time. Tong-luo Qu-yu plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score, visual analog scale scores will be measured during the assessment visits (baseline and 1-, 2-week follow-up). In addition, adverse events concerning clinical symptoms and signs as well as laboratory tests will be documented during clinical trials. Discussion: This study will be a randomized, double-blind, parallel positive control trial to further evaluate the effectiveness and safety of Tong-luo Qu-yu plaster for patients with KOA in nine medical centers compared with control group, it is expected that the patients with KOA will benefit from this study. Trial Registration: ClinicalTrials.gov, NCT03309501. Registered on 08 November 2017. Keywords: Clinical trials, Knee osteoarthritis, Tong-luo Qu-yu plaster, Randomized, Protocol