drugset / Trial / NCT06626568

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

NCT06626568

RandomizedParallel-groupDouble-blindTreatment

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject BETAMETHASONE DIPROPIONATE Small molecule 1 ml Intramuscular

Indications