Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626568
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Comparison of Ultrasound-Guided Subacromial Vs Systemic Steroid Injections for Frozen Shoulder a Multicenter Pilot Study
Sponsor:
None
Organization:
None
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:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None