Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Sh… (NCT07416916) | Clinical Trial Compass
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
China528 participantsStarted 2026-02-23
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 8
Timeframe: Baseline (Week 0) to Week 8
Trial details
NCT IDNCT07416916
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
✕. Prior manipulation under anesthesia, arthroscopic capsular release, or open surgical release for frozen shoulder on the affected shoulder.
✕. Any corticosteroid treatment via any route within the past 3 months (including shoulder injection).
✕. Requires long-term or intermittent corticosteroid use for other conditions (e.g., autoimmune disease such as rheumatoid arthritis, acute asthma exacerbations).
✕. Bilateral frozen shoulder, or contralateral history of frozen shoulder not yet fully recovered.