Intradermal acupuncture for rheumatoid arthritis: study protocol for a randomised controlled trial

BACKGROUND: Rheumatoid arthritis (RA) is a common autoimmune disease that severely impacts quality of life. Currently available medications for the treatment of RA have adverse side effects. Emerging evidence suggests that intradermal acupuncture (IA) is feasible and safe for patients, but its application in RA patients has not been examined. Our study aims to explore the efficacy and safety of IA for the treatment of RA. METHODS: This study is a randomised, sham-controlled, patient-outcome assessor-statistician blind trial that aims to evaluate the effects of IA in patients with RA. We will recruit 132 patients aged ≥ 18 years with a diagnosis of RA. Patients will be randomly allocated with a 1:1 ratio to IA or sham IA groups. Both groups will receive basic treatment and nursing routines for RA. The experimental group will receive actual IA treatment, whereas the control group will receive sham IA treatment. All patients will receive one course of treatment (i.e., four consecutive treatment sessions with an intervening 1-day interval). Primary outcomes will be traditional Chinese medicine (TCM) syndromes before and after a treatment course and Health Assessment Questionnaire (HAQ) scores. Secondary outcomes will be disease activity score 28 (DAS28) and levels of serum C-reactive protein (CRP). Outcome measures will be collected pre- and post-treatment. DISCUSSION: This study aims to provide high-quality evidence for the efficacy and safety of IA for treating RA. In addition, the results will provide references for selection of acupoints for other syndromes in clinical practice. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000038028. Registered on 8 September 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05416-0.