NCT07416916

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

Ultrasound-Guided Intra-Articular Versus Systemic Corticosteroid Injection for Frozen Shoulder: A Multicenter, Blinded, Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 528 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Frozen Shoulder

Interventions

Type	Name	Description
DRUG	Compound betamethasone injection (dorsogluteal intramuscular)	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.
DRUG	Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral)	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.
DRUG	0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo)	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.
DRUG	0.9% sodium chloride injection (dorsogluteal intramuscular placebo)	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.
OTHER	Standardized home-based shoulder rehabilitation exercise program	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.

Timeline

• Start date: 2026-02-23
• Primary completion: 2030-10-01
• Completion: 2031-01-01
• First posted: 2026-02-18
• Last updated: 2026-02-25

Locations

9 sites across 1 country: China