NCT06626568

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-08-21
• Completion: 2025-09-02
• First posted: 2024-10-04
• Last updated: 2026-01-30

Locations

9 sites across 1 country: China