Analgesic effect of extracorporeal shock-wave therapy for frozen shoulder: A randomized controlled trial protocol

BACKGROUND: Till date only a few studies have reported the efficacy and clinical improvements obtained by extracorporeal shock-wave therapy (ESWT) on frozen shoulder. Limited by small number of studies and insufficient outcomes, it is important and necessary to conduct a new randomized controlled trial. The purpose of the present study is to determine whether ESWT could be more effective than oral steroid in treatment of frozen shoulder. METHODS: This randomized, single-blind, superiority clinical trial was approved by the institutional review board in The Third People's Hospital of Linyi. The inclusion criteria were patients aged >18 years with shoulder pain and restriction in range of motion. A symptom duration >3 months was required, with no radiographic findings on anteroposterior shoulder plain radiographs except for osteoporosis. Group 1 patients were given 30 mg of oral prednisolone daily for 2 weeks as a single morning dose and then 15 mg daily for another 2 weeks. Group 2 patients received 3 sessions of ESWT on the first, 14th, and 28th days. The primary outcome measure was shoulder pain score. The secondary outcomes included Disabilities of the Arm, Shoulder, and Hand score, range of motion, satisfaction rate, and complications. RESULTS: It was hypothesized that there would be a significant difference between ESWT and control groups in improving shoulder pain and functions in frozen shoulder. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5736).