Comparison of Ultrasound-Guided Subacromial vs. Systemic Steroid Injections for Frozen Shoulder: a Multicenter Pilot Study
NCT ID: NCT06626568
Last Updated: 2025-11-28
Study Results
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Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2024-10-15
2025-09-02
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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gluteal injection
gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4, ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
Compound betamethasone Injection(Gluteal muscle injection)
gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4
Normal Saline as Placebo (ultrasound-guided subacromial injection)
ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.
home exercise
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
subacromial injection
gluteal injection of 5 ml normal saline at week 0,2,4, ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
Compound betamethasone Injection(Subacromial Ultrasound Guided injection)
ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.
Normal Saline as Placebo (gluteal muscle inection)
gluteal injection of 5 ml normal saline at week 0,2,4.
home exercise
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
Interventions
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Compound betamethasone Injection(Gluteal muscle injection)
gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4
Compound betamethasone Injection(Subacromial Ultrasound Guided injection)
ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.
Normal Saline as Placebo (ultrasound-guided subacromial injection)
ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.
Normal Saline as Placebo (gluteal muscle inection)
gluteal injection of 5 ml normal saline at week 0,2,4.
home exercise
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Bin Han, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
The 2nd Affiliated Hospital of Zhejiang University
Locations
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Guangde County People's Hospital
Xuancheng, Anhui, China
Army Specialty Medical Center of the People's Liberation Army of China
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital, Fujian Medical University
Quanzhou, Fujian, China
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
Ningbo Ninth Hospital
Ningbo, Zhejiang, China
Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group
Ningbo, Zhejiang, China
Shengzhou People's Hospital
Shanhu, Zhejiang, China
Countries
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Other Identifiers
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2024-0405
Identifier Type: -
Identifier Source: org_study_id
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