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Recruiting Phase 4 NCT07416916

NCT07416916 Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder

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Clinical Trial Summary
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

Trial Parameters

Condition Frozen Shoulder
Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 528
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2026-02-23
Completion 2030-10
Interventions
Compound betamethasone injection (dorsogluteal intramuscular)Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral)0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo)

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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 neurosurgi

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