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

NCT06626568 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-30

No results posted yet for this 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

Conditions

  • Frozen Shoulder

Interventions

DRUG

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

DRUG

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.

OTHER

Normal Saline as Placebo (ultrasound-guided subacromial injection)

ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.

OTHER

Normal Saline as Placebo (gluteal muscle inection)

gluteal injection of 5 ml normal saline at week 0,2,4.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Bin Han, Medical Doctor · The 2nd Affiliated Hospital of Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-08-21
Completion
2025-09-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06626568 on ClinicalTrials.gov