Effectiveness of grain-sized moxibustion for rheumatoid arthritis: Study protocol for a randomized controlled trial

Abstract Introduction Rheumatoid arthritis (RA) is a common and painful autoimmune disease which impairs quality of life. The aim of the present study is to evaluate the add-on effects of grain-sized moxibustion to conventional drugs for the treatment of rheumatoid arthritis (RA). Methods The present study is a two-arm, open-labeled randomized controlled trial. A total of 126 eligible patients with RA will be randomly assigned to either the grain-sized moxibustion plus methotrexate group (Mox group) or the methotrexate group (Met group) at a 1:1 ratio. Patients in the Mox group will receive grain-sized moxibustion treatment and methotrexate, while patients in the Met group will be administered only methotrexate. Shenshu (BL32), ZuSanli (ST36) and A-shi points will be selected as the stimulation points for patients in the Mox group and will be administered in 24 sessions over a period of 12 weeks. Patients in the Met group will be administered methotrexate. The primary outcome measure will be the American College of Rheumatology 20. Secondary outcome measures will include the American College of Rheumatology 50/70, the pain visual analogue scale, DAS28 score, Health Assessment Questionnaire, rate of erythrocyte sedimentation, C-reactive protein and Rheumatoid factor. Outcomes will be assessed at baseline, the end of 12-week treatment, followed-up at the 16th, 20th and 24th week post-baseline measurements. Discussion The efficacy of moxibustion in treating rheumatoid arthritis is controversial. The experimental design of this protocol will contribute to the collection of valuable, high-quality data to evaluate the efficacy of graded moxibustion in the treatment of rheumatoid arthritis. Trial registration number ChiCTR-IOR-17012282, Prospective registration.