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RECRUITING
NCT07416916
PHASE4

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

528

Start Date

2026-02-23

Completion Date

2031-01

Last Updated

2026-02-25

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (9)

Yangpu District Central Hospital of Shanghai

Shanghai, Shanghai Municipality, 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