Chuna manual therapy combined with acupuncture and cupping for frozen shoulder (adhesive capsulitis): Study protocol for a multicenter, randomized, patient-assessor blind, clinical trial

Abstract

IntroductionFrozen shoulder, also called adhesive capsulitis is an obstinate disease involving severe shoulder pain and limitation of range of motion. The aim of this study is to establish a protocol to carry out research which evaluates the effectiveness, safety, and economic efficiency of Chuna manual therapy on frozen shoulder by combining treatments with acupuncture, cupping, and self-exercise. Methods/designA multicenter, randomized, patient-assessor blind, parallel clinical trial will be carried out. Eligible subjects will be allocated to one of two groups with randomized sampling. The experimental group will receive acupuncture, cupping and real Chuna manual therapy, and control group will receive acupuncture, cupping and sham Chuna manual therapy. During the 8-weeks treatment period, effectiveness and safety evaluations will be carried out and evaluation of satisfaction and economic efficiency will be performed at the end of the trial (20-week). The primary outcome is shoulder pain and disability index. The secondary outcomes are 100 mm pain VAS, passive range of motion of the shoulder, Korean shoulder scoring system score, quality of life score, use of relief medicine, evaluation of patient satisfaction, safety, and economic efficiency. Discussion/conclusionThis is the first trial evaluating the effectiveness, safety, and economic efficiency of Chuna manual therapy for frozen shoulder. The results of this trial will be used to underpin basis for the use of Chuna manual therapy for pain relief, improvement in range of motion and shoulder joint function for people with frozen shoulder. Trial registrationClinical Research Information Service Registration Number is KCT0002300. Registered on 6 April 2017.