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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different ways to give steroid injections for treating frozen shoulder, a condition that causes stiffness and pain in the shoulder. The researchers want to find out if giving injections every two weeks instead of every week can still help improve shoulder movement and reduce pain. This study is also testing which clinics can participate in a larger future trial and figuring out how many patients will be needed for that study.

To take part, you need to be between 18 and 75 years old and have been diagnosed with frozen shoulder within the last nine months. You should be experiencing moderate pain and have limited movement in your shoulder. If you join the study, you will receive three injections over four weeks and follow up for another two months. During this time, you’ll also do some home exercises to help improve your shoulder function. Keep in mind that certain medical conditions or past treatments may prevent you from participating, so it’s best to check with the study team if you have any questions about your eligibility.

Gender

ALL

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.