Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-02 @ 5:18 PM
Study NCT ID:
NCT06626568
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2024-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Ultrasound-Guided Subacromial vs. Systemic Steroid Injections for Frozen Shoulder: a Multicenter Pilot Study
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CUSIS-FS-Pilot
Brief 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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: