Chinese medicine packet plus wax therapy for periarthritis of the shoulder: study protocol for a multi-center, randomized controlled trial

Background: Periarthritis of the shoulder clinically manifests as pain and functional disorder of the shoulder joint. Although there is a tendency to self-heal, results are unsatisfactory. Nonsurgical treatments often used for clinical treatment of periarthritis, including simple closure, massage and acupuncture, do not improve symptoms. Chinese medicine packets and wax treatment effectively improves the local micro-circulation and regulates body functions. Therefore, this study aims to develop a new Chinese medicine wax treatment for periarthritis of the shoulder using these two techniques, and to observe its safety and efficacy. Methods/Design: A prospective, multi-center randomized, double-blind, placebo-controlled clinical trial will enroll patients with periarthritis of the shoulder who will be randomized into treatment and control groups. In the treatment group, packets will be immersed in a decoction of Chinese medicine. Prepared packets will be placed onto the shoulder joint followed by warm paraffin cake, once a day for 20 minutes, for 4 weeks. In the control group, Chinese medicine packets will be replaced by placebo; all other procedures will be identical. Outcome measures will be assessed at baseline and 1, 2, and 4 weeks after treatment. Primary outcome is the McGill Pain Questionnaire score. Secondary outcomes include shoulder disability questionnaire score, Oxford shoulder score, American Shoulder and Elbow Surgeons score, University of California, Los Angeles shoulder score, the efficacy in treating Traditional Chinese Medicine syndromes, visual analog scale score, and Constant-Murley shoulder score. Discussion: This trial will provide a quantitative basis to establish therapeutic guidelines and technical standards for Chinese medicine packet plus wax therapy for the treatment of periarthritis of the shoulder. Trial registration: Chictr.org.cn identifier: ChiCTR-IOR-15006149; registered on 11 March 2015. Written approval for this protocol was obtained from the Ethics Committee of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine in China (approval No. 2014ZX (KT)-010-02).