Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493656
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-06-24
Brief Title:
Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation
Sponsor:
Chuncheon Sacred Heart Hospital
Organization:
Chuncheon Sacred Heart Hospital
Study Overview
Official Title:
The Efficacy of Single-shot Capsule-preserving Hydrodilatation With Corticosteroids in Treating Adhesive Capsulitis of the Shoulder A Randomized Controlled Trial Versus Isolated Corticosteroid Injection
Status:
COMPLETED
Status Verified Date:
2024-07
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:
CSvsCSHD
Brief Summary:
This clinical trial investigates whether concomitant capsule-preserving hydrodilatation CSHD is more effective than isolated glenohumeral corticosteroid injection CS in treating shoulder adhesive capsulitis The main questions it aims to answer are
Is CSHD inferior to CS in immediate pain relief as the solution is diluted
Is CSHD superior to CS in improving the range of motion as the contracted capsule is dilated
Group CS will receive an ultrasound-guided glenohumeral corticosteroid injection only with a solution of 5 mL
Group CSHD will receive an ultrasound-guided glenohumeral corticosteroid with hydrodilatation with a solution of 20 mL
Clinical scores and range of motion will be compared between the groups up to six months post-injection
Is CSHD inferior to CS in immediate pain relief as the solution is diluted
Is CSHD superior to CS in improving the range of motion as the contracted capsule is dilated
Group CS will receive an ultrasound-guided glenohumeral corticosteroid injection only with a solution of 5 mL
Group CSHD will receive an ultrasound-guided glenohumeral corticosteroid with hydrodilatation with a solution of 20 mL
Clinical scores and range of motion will be compared between the groups up to six months post-injection
Detailed Description:
A single-centre double-blinded prospective randomised controlled trial involving patients diagnosed with adhesive capsulitis of the shoulder AC
Patients were randomly allocated to either corticosteroid injection with hydrodilatation group CSHD or corticosteroid injection only group CS
For the CS group a solution of 1 mL triamcinolone 40mg and 4 mL 1 lidocaine 5 mL in total was injected intraarticularly through the posterior approach using ultrasound guidance
The CSHD group received an injection of 20 mL with 15 mL of normal saline added to the abovementioned 5 mL solution The dilatation of the joint capsule was confirmed by the increase in distance between the capsule and the humeral head
Patients underwent the following assessments just before the injection and at post-injection three weeks seven weeks three months and six months
Range of motion in forward elevation external rotation and internal rotation Clinical scores include the pain visual analogue scale pVAS the American Shoulder and Elbow Surgeons score and the Constant-Murley score
Subjective patient satisfaction was recorded on a scale from 0 to 100 with 100 being the most satisfied
The recorded data were compared within each group before and after the injection and also between the groups
Patients were randomly allocated to either corticosteroid injection with hydrodilatation group CSHD or corticosteroid injection only group CS
For the CS group a solution of 1 mL triamcinolone 40mg and 4 mL 1 lidocaine 5 mL in total was injected intraarticularly through the posterior approach using ultrasound guidance
The CSHD group received an injection of 20 mL with 15 mL of normal saline added to the abovementioned 5 mL solution The dilatation of the joint capsule was confirmed by the increase in distance between the capsule and the humeral head
Patients underwent the following assessments just before the injection and at post-injection three weeks seven weeks three months and six months
Range of motion in forward elevation external rotation and internal rotation Clinical scores include the pain visual analogue scale pVAS the American Shoulder and Elbow Surgeons score and the Constant-Murley score
Subjective patient satisfaction was recorded on a scale from 0 to 100 with 100 being the most satisfied
The recorded data were compared within each group before and after the injection and also between the groups
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?:
False
Is an FDA AA801 Violation?:
None