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

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

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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Bin Han, Medical Doctor · The 2nd Affiliated Hospital of Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-23

Primary Completion

2030-10-31

Completion

2031-01-31

Countries

• China

Study Locations