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Comparison of Ultrasound-Guided Subacromial vs. Systemic Steroid Injections for Frozen Shoulder: a Multicenter Pilot Study | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Comparison of Ultrasound-Guided Subacromial vs. Systemic Steroid Injections for Frozen Shoulder: a Multicenter Pilot Study

Comparison Between Ultrasound Guided Subacromial and Systemic Injection of Steroid for Frozen Shoulder: a Double Blind Multicenter Pilot Study for Randomized Control Trial

NCT06626568•Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

The goal of this multicenter pilot study is to validate the effectiveness of extending the injection interval between betamethasone doses from one to two weeks for treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 75. This study also aims to screen potential study centers and gather data to refine the sample size calculation for a larger, future trial. The main questions it aims to answer are: * Does extending the interval between injections maintain effectiveness in improving shoulder function and reducing pain for frozen shoulder? * Which centers in this pilot study are qualified for a larger, future trial? * What is the appropriate sample size for conducting a multicenter RCT study with the same research design at the selected centers? Participants will: * Receive 3 injections over 4 weeks and will be followed up for another 8 weeks * Complete shoulder function assessments * Perform home rehabilitation exercises

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. History of ≤9 months, clinically diagnosed with primary frozen shoulder (including frozen shoulder associated with diabetes).
•2. Aged between 18 and 75 years old
•3. Pain NRS score ≥4
•4. Measured passive range of motion of the affected shoulder in at least two of the three directions (forward flexion, external rotation with arm at the side, and internal rotation with arm at the side) is reduced by 25% or more compared to the contralateral normal shoulder.
•5. Exclusion of osteoarthritis, dislocation, and other shoulder abnormalities through X-ray and MRI of the affected shoulder.

Exclusion Criteria

•1. Secondary frozen shoulder caused by thyroid disease, cardiovascular disease, cancer, stroke, radiotherapy, neurosurgery, or breast surgery (excluding diabetes); secondary frozen shoulder caused by major shoulder trauma requiring medical care (e.g., fractures, dislocations, rotator cuff tears).
•2. Full-thickness rotator cuff tear in the affected shoulder confirmed by MRI (excluding rotator cuff tendinopathy and partial-thickness rotator cuff tear in patients with frozen shoulder without a history of major shoulder trauma).
•3. Patients unable to undergo MRI due to financial reasons, claustrophobia, pacemaker, or other metallic implants in the body.
•4. Local infection in the affected shoulder or other contraindications to shoulder injections.
•5. Patients with contraindications to steroid therapy (e.g., poorly controlled blood sugar in diabetes).
•6. Patients with frozen shoulder who have already undergone shoulder injections, manipulation under anesthesia, arthroscopic capsular release, or open surgery for capsular release.
•7. Received any form of steroid treatment within the past 3 months.
•8. History of glucocorticoid use for more than 3 months.
•9. Bilateral frozen shoulder or a history of frozen shoulder in the contralateral shoulder.
•10. Pregnant or breastfeeding women.
+3 more criteria

Locations (9)

Guangde County People's Hospital

Xuancheng, Anhui, China

Yangpu District Central Hospital of Shanghai

Shanghai, Shanghai Municipality, 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&amp;#39;s Hospital

Shanhu, Zhejiang, China

Key Dates

Start Date

October 15, 2024

Primary Completion Date

August 21, 2025

Completion Date

September 2, 2025

Last Updated

January 30, 2026

Enrollment

ACTUAL participants

Conditions

Frozen Shoulder

Interventions

Compound betamethasone Injection(Gluteal muscle injection)

DRUG

Compound betamethasone Injection(Subacromial Ultrasound Guided injection)

DRUG

Normal Saline as Placebo (ultrasound-guided subacromial injection)

OTHER

Normal Saline as Placebo (gluteal muscle inection)

OTHER

home exercise

BEHAVIORAL

Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment

NCT07368751

Frozen Shoulder

View study

RECRUITINGPHASE4

Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

NCT02283996

Adhesive CapsulitisFrozen Shoulder+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of Ultrasound-Guided Subacromial vs. Systemic Steroid Injections for Frozen Shoulder: a Multicenter Pilot Study

Inclusion Criteria

Exclusion Criteria

Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment

Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

Therapeutic Effect of Shoulder Anterior Capsular Block Versus Suprascapular Nerve Block in Patients With Frozen Shoulder

3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.

Role of Modified Robbery Exercises on Scapular Dyskinesis in Frozen Shoulder

Comparison of Spencer Technique and Conventional Treatment in Adjuncts to Corticosteroid Injection in Frozen Shoulder