Comparing two types of steroid injections for treating frozen shoulder

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

This study is testing if giving steroid injections for frozen shoulder every two weeks instead of every week helps adults feel better and move their shoulder more easily.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 9 sites (Xuancheng, Anhui and 8 other locations)
• Trial ID: NCT06626568 on ClinicalTrials.gov

What this trial studies

This multicenter pilot study aims to evaluate the effectiveness of extending the injection interval between betamethasone doses from one to two weeks for treating frozen shoulder in adults aged 18 to 75. Participants will receive three injections over four weeks and will be monitored for shoulder function and pain reduction over an additional eight weeks. The study also seeks to identify qualified centers for a larger future trial and refine the sample size for that trial. Assessments will include shoulder function evaluations and home rehabilitation exercises.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a clinically diagnosed primary frozen shoulder and significant pain and reduced shoulder mobility.

Not a fit: Patients with secondary frozen shoulder due to other medical conditions or those with full-thickness rotator cuff tears may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment regimen for patients suffering from frozen shoulder, potentially improving their recovery and quality of life.

How similar studies have performed: While this approach is being tested in this pilot study, similar studies have shown promise in using steroid injections for frozen shoulder, but the specific interval extension is novel.

Eligibility criteria

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.
11. Patients lacking the cognitive ability to comply with the study protocol.
12. Patients not residing in the area where the study is being conducted.
13. Patients with compensation claims or legal disputes related to workplace injury or car accidents.

Where this trial is running

Xuancheng, Anhui and 8 other locations

• Guangde County People's Hospital — Xuancheng, Anhui, China (Recruiting)
• Army Specialty Medical Center of the People's Liberation Army of China — Chongqing, Chongqing, China (Not_yet_recruiting)
• Yangpu District Central Hospital of Shanghai — Shanghai, Shanghai, China (Recruiting)
• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• The First People's Hospital of Linping District, Hangzhou — Hangzhou, Zhejiang, China (Recruiting)
• First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
• Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group — Ningbo, Zhejiang, China (Recruiting)
• Pujiang People's Hospital — Pujiang, Zhejiang, China (Not_yet_recruiting)
• Shengzhou People's Hospital — Shaoxing, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Bin Han, Medical Doctor

Conditions Frozen Shoulder; frozen shoulder; intramuscular injection; subacromial injection; compound betamethasone; ultrasound guidance