About this trial
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
Eligibility criteria
Qualifiers
Symptom duration ≤9 months; clinically diagnosed unilateral primary (idiopathic) frozen shoulder (including diabetes-associated frozen shoulder).
Age 18 to 65 years.
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.
Disqualifiers
Secondary frozen shoulder due to thyroid disease, cardiovascular disease, stroke, radiotherapy, prior neurosurgical or breast surgery, etc. (diabetes excluded from this item); or frozen shoulder secondary to major shoulder trauma requiring medical care (e.g., fracture, dislocation, rotator cuff tear).
Confirmed or highly suspected full-thickness or massive rotator cuff tear causing functional pseudoparalysis (e.g., positive Jobe test with marked strength loss).
Local infection of the affected shoulder or any contraindication to shoulder injection (e.g., uncorrected bleeding risk/coagulopathy).
Contraindication to corticosteroid therapy (e.g., poorly controlled diabetes, systemic infection).
Trial design
Treatments tested in this trial
- Compound betamethasone injection (dorsogluteal intramuscular)
- Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral)
- 0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo)
- 0.9% sodium chloride injection (dorsogluteal intramuscular placebo)
- Standardized home-based shoulder rehabilitation exercise program
Treatment groups
Locations
9Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor