Abstract
INTRODUCTION: This study aims to compare clinical effect between Jade moxibustion and traditional moxibustion, and to determine the clinical effect of Jade moxibustion on knee osteoarthritis (KOA). METHODS/DESIGN: This is a 2-parallel-group, randomized controlled trial. A total of 148 subjects with KOA (Kellgren-Lawrence grade II or III) will be recruited and randomized to receive Jade moxibustion treatment or a traditional moxibustion treatment in a 1:1 ratio. Jade moxibustion group: The affected knee of the subjects will be covered with jade kneepad. Traditional moxibustion group: Chosen the ST35, ST34, EX-LE4, SP10 and Ashi points at the affected knee. The subjects will receive treatment three times a week, altogether 12 times in 4 weeks. The main outcomes are WOMAC knee pain score, knee function score and SF-36 quality of life questionnaire changes at the 4th week. Secondary outcomes include WOMAC knee pain score and knee function score, overall clinical efficacy evaluation, medication, safety evaluation at the 2nd, 12th, and 24th week, and cytokines related to osteoarthritis in serum. DISCUSSION: This randomized controlled trial used traditional moxibustion as a control group to provide rigorous evidence for the clinical efficacy and safety of Jade moxibustion in treatment of KOA. TRIAL REGISTRATION: ISRCTN registry, No 21174552. Registered on 28 February 2020.