Abstract
Background
Knee osteoarthritis(KOA) is the type of osteoarthritis with the highest incidence, the most common clinical, and the greatest damage to individuals and society. The combination of traditional Chinese decoction and manipulation has been proved to be effective in the treatment of KOA. However, no evidence-based medical research has been organized to assess the effectiveness and safety of traditional Chinese medicine(TCM) treatment of KOA.
Methods
In this multicenter randomized positive controlled clinical trial, 144 eligible patients from four clinical trial centers will be randomly divided into a treatment group (Qubi Yangge Decoction combined with three steps and nine methods of whole knee) and a control group (oral western medicine and physiotherapy). Before and after the intervention, the main efficacy indicators included WOMAC osteoarthritis index questionnaire; VAS visual analogue pain score; Sf-36 score of quality of Life Evaluation Scale. The above indexes were recorded once before treatment, 2 weeks, 4 weeks and 12 weeks after treatment. During the treatment period, any signs of acute adverse eventswill be recorded at each visit.
Discussion
Although Qubi Yangge Decoction combined with three steps and nine methods of whole knee in treating of KOA has been used in China for many years, there is no consensus on its effectiveness. This experiment will provide convincing evidence of the efficacy of Qubi Yangge Decoction combined with three steps and nine methods of whole knee in the treatment of KOA.
Trial registration:
The clinical trial has been registered in the Chinese Clinical Trial Database (registration number ChiCTR2000036077).