Ultrasound-Guided Intra-Articular Versus Systemic Corticosteroid Injection for Frozen Shoulder: A Multicenter, Blinded, Randomized Controlled Trial
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The goal of this clinical trial is to determine if a gluteal muscle injection of compound betamethasone is as effective as an ultrasound-guided intra-articular injection in treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 65. The main questions it aims to answer are: * Is gluteal injection as effective as ultrasound-guided intra-articular injection for improving shoulder function and reducing pain? * What are the side effects of each treatment method? Researchers will compare these two injection methods. Participants will: * Receive one injection at baseline and will be followed up for 12 weeks * Complete shoulder function assessments * Perform home rehabilitation exercises
• Worst shoulder pain in the past 24 hours (NRS-WP, 0-10) ≥4.
• Passive range of motion (ROM) limitation of the affected shoulder: compared with the contralateral normal shoulder, a decrease of ≥30° in at least two of the following three directions: forward flexion, abduction, and external rotation with the arm at the side.
• Radiographic exclusion of other shoulder pathology: Affected-shoulder anteroposterior (AP) radiograph excludes glenohumeral osteoarthritis, calcific tendinopathy, and other structural abnormalities; and axillary view and/or scapular Y (outlet) or transthoracic view excludes glenohumeral dislocation.
Locations
Other Locations
China
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
The First People's Hospital of Linping District, Hangzhou
NOT_YET_RECRUITING
Hangzhou
The Third Affiliated Hospital of Zhejiang Chinese Medical University
NOT_YET_RECRUITING
Hangzhou
Huzhou Central Hospital
NOT_YET_RECRUITING
Huzhou
Pujiang People's Hospital
NOT_YET_RECRUITING
Jinhua
First Affiliated Hospital of Ningbo University
NOT_YET_RECRUITING
Ningbo
Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group
At Week 0 (baseline), participants receive a single dorsogluteal intramuscular injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single ultrasound-guided intra-articular glenohumeral injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session).
Active_comparator: Local steroid / Intra-articular injection
At Week 0 (baseline), participants receive a single ultrasound-guided intra-articular glenohumeral injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single dorsogluteal intramuscular injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session).