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

Last updated: February 4, 2025
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

2

Condition

Bursitis

Treatment

Compound betamethasone Injection(Gluteal muscle injection)

home exercise

Normal Saline as Placebo (ultrasound-guided subacromial injection)

Clinical Study ID

NCT06626568
2024-0405
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. History of ≤9 months, clinically diagnosed with primary frozen shoulder (includingfrozen 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 thethree directions (forward flexion, external rotation with arm at the side, andinternal rotation with arm at the side) is reduced by 25% or more compared to thecontralateral normal shoulder.

  5. Exclusion of osteoarthritis, dislocation, and other shoulder abnormalities throughX-ray and MRI of the affected shoulder.

Exclusion

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 inpatients 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 shoulderinjections.

  5. Patients with contraindications to steroid therapy (e.g., poorly controlled bloodsugar in diabetes).

  6. Patients with frozen shoulder who have already undergone shoulder injections,manipulation under anesthesia, arthroscopic capsular release, or open surgery forcapsular 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 contralateralshoulder.

  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 orcar accidents.

Study Design

Total Participants: 40
Treatment Group(s): 5
Primary Treatment: Compound betamethasone Injection(Gluteal muscle injection)
Phase: 2
Study Start date:
October 15, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Guangde County People's Hospital

    Xuancheng, Anhui 242299
    China

    Active - Recruiting

  • Army Specialty Medical Center of the People's Liberation Army of China

    Chongqing, Chongqing 400042
    China

    Site Not Available

  • Yangpu District Central Hospital of Shanghai

    Shanghai, Shanghai 200082
    China

    Active - Recruiting

  • Jiande First People's Hospital

    Hangzhou, Zhejiang 311600
    China

    Site Not Available

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • The First People's Hospital of Linping District, Hangzhou

    Hangzhou, Zhejiang 311199
    China

    Active - Recruiting

  • First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315020
    China

    Active - Recruiting

  • Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group

    Ningbo, Zhejiang 315799
    China

    Active - Recruiting

  • Pujiang People's Hospital

    Pujiang, Zhejiang 322299
    China

    Site Not Available

  • Shengzhou People's Hospital

    Shaoxing, Zhejiang 312400
    China

    Active - Recruiting

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