RECRUITING Phase 4 ClinicalTrials.gov

Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder

Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine • ClinicalTrials.gov ID: NCT07416916

Registry updated: 2026-10-13

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Description

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

Interventions

Compound betamethasone injection (dorsogluteal intramuscular) (Drug)
A single dorsogluteal intramuscular injection at Week 0 (baseline): compound betamethasone 1 mL mixed with 0.9% sodium chloride 4 mL (total volume 5 mL), as part of a double-dummy design.
Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral) (Drug)
A single ultrasound-guided intra-articular glenohumeral injection at Week 0 (baseline): compound betamethasone 1 mL mixed with 0.9% sodium chloride 4 mL (total volume 5 mL), as part of a double-dummy design.
0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo) (Drug)
A single ultrasound-guided intra-articular glenohumeral placebo injection at Week 0 (baseline): 0.9% sodium chloride 5 mL, to mimic the local (intra-articular) injection in the double-dummy design.
0.9% sodium chloride injection (dorsogluteal intramuscular placebo) (Drug)
A single dorsogluteal intramuscular placebo injection at Week 0 (baseline): 0.9% sodium chloride 5 mL, to mimic the systemic (intramuscular) injection in the double-dummy design.
Standardized home-based shoulder rehabilitation exercise program (Other)
All participants perform a standardized home-based rehabilitation exercise program for 12 weeks after outpatient instruction, approximately 40 minutes per day (twice daily, 20 minutes per session), following the study-provided instructional video.

Eligibility criteria

Inclusion Criteria (all must be met): 1. Symptom duration ≤9 months; clinically diagnosed unilateral primary (idiopathic) frozen shoulder (including diabetes-associated frozen shoulder). 2. Age 18 to 65 years. 3. Worst shoulder pain in the past 24 hours (NRS-WP, 0-10) ≥4. 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. 5. 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. Exclusion Criteria (any of the following): 1. 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). 2. Confirmed or highly suspected full-thickness or massive rotator cuff tear causing functional pseudoparalysis (e.g., positive Jobe test with marked strength loss). 3. Local infection of the affected shoulder or any contraindication to shoulder injection (e.g., uncorrected bleeding risk/coagulopathy). 4. Contraindication to corticosteroid therapy (e.g., poorly controlled diabetes, systemic infection). 5. Prior manipulation under anesthesia, arthroscopic capsular release, or open surgical release for frozen shoulder on the affected shoulder. 6. Any corticosteroid treatment via any route within the past 3 months (including shoulder injection). 7. Requires long-term or intermittent corticosteroid use for other conditions (e.g., autoimmune disease such as rheumatoid arthritis, acute asthma exacerbations). 8. Bilateral frozen shoulder, or contralateral history of frozen shoulder not yet fully recovered. 9. Conditions significantly affecting upper-limb function assessment or ability to perform rehabilitation (e.g., marked limb disability). 10. Pregnant or breastfeeding. 11. Lacks the cognitive ability to comply with study procedures. 12. Does not reside in the region served by the participating hospital(s) (anticipated inability to complete follow-up). 13. Compensation claims (e.g., work-related injury, traffic accident) or ongoing legal disputes/litigation.

Conditions

Frozen Shoulder

Locations

Yangpu District Central Hospital of Shanghai — Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital — Taiyuan, Shanxi, China
The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China
Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China
The First People's Hospital of Linping District, Hangzhou — Hangzhou, Zhejiang, China
Huzhou Central Hospital — Huzhou, Zhejiang, China
Pujiang People's Hospital — Jinhua, Zhejiang, China
First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China
Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group — Ningbo, Zhejiang, China
Shengzhou People's Hospital — Shanhu, Zhejiang, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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