NCT07416916 Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
| NCT ID | NCT07416916 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Frozen Shoulder |
| Study Type | INTERVENTIONAL |
| Enrollment | 528 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2030-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 528 participants in total. It began in 2026-02-23 with a primary completion date of 2030-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Bin Han, Medical Doctor
PRINCIPAL INVESTIGATOR
The 2nd Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT07416916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Frozen Shoulder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07416916 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07416916 currently recruiting?
Yes, NCT07416916 is actively recruiting participants. Contact the research team at icydoctor@zju.edu.cn for enrollment information.
Where is the NCT07416916 trial being conducted?
This trial is being conducted at Shanghai, China, Hangzhou, China, Hangzhou, China, Hangzhou, China and 5 additional locations.
Who is sponsoring the NCT07416916 clinical trial?
NCT07416916 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Bin Han, Medical Doctor at The 2nd Affiliated Hospital of Zhejiang University. The trial plans to enroll 528 participants.