A Randomized, Parallel Control And Multicenter Clinical Trial of Evidence-Based Traditional Chinese Medicine Massage Treatment VS External Diclofenac Diethylamine Emulgel For The Treatment of Knee Osteoarthritis

Abstract Background: Both massage and topically administered NSAIDs are safe and effective treatment for knee osteoarthritis (KOA); however, different massage technique sects in China caused assessment difficulties for the treatment of KOA. In order to standardize massage techniques and procedures, we organized multi-disciplinary experts in China to acquire an evidence-based traditional Chinese medicine massage treatment of knee osteoarthritis. The purposes of this study are to evaluate the efficacy and safety of evidence-based traditional Chinese medicine massage treatment of KOA compared to External Diclofenac Diethylamine Emulgel.Methods and design: 300 participants diagnosed with KOA will be randomly divided into the experimental group, control group, and waiting list group in a ratio of 2:1. The participants will receive evidence-based traditional Chinese medicine massage 2 sessions per week for 10 weeks or External Diclofenac Diethylamine Emulgel 3-4 times per day for 10 weeks respectively. The MRI scans and X-ray will be performed at baseline and the end of the intervention period. The main evaluation index will include the Western Ontario and McMaster Osteoarthritis Index (WOMAC). The secondary evaluation index will include：(1) WOMAC each dimension; (2) the PRO scale for knee osteoarthritis based on the concept of Traditional Chinese Medicine（Chinese scale for knee osteoarthritis, CSKO）; (3) MRI scan and X-ray evaluation.Discussion: The results of our study will help to evaluate efficacy and safety of evidence-based traditional Chinese medicine massage treatment of KOA compared with External Diclofenac Diethylamine Emulgel combined with clinical, X-ray and MRI changes. Trial registration: Chinese Clinical Trial Registry ChiCTR1800014400. Registered on 10 January 2018.