Ignite Creation Date:
2024-05-06 @ 2:31 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04347733
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2020-04-09
Brief Title:
Hyaluronidase in Intra-articular Steroid Injection Treating the Adhesive Capsulitis for Shoulder
Sponsor:
Veterans Health Service Medical Center Seoul Korea
Organization:
Veterans Health Service Medical Center Seoul Korea
Study Overview
Official Title:
Additive Effects of Hyaluronidase in Intra-articular Steroid Injection Treating the Initial Stage of Adhesive Capsulitis for Shoulder
Status:
COMPLETED
Status Verified Date:
2020-04
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:
None
Brief Summary:
Adhesive capsulitis AC is painful and disabling condition that is associated with a gradual loss of shoulder motion Intra-articular steroid injection is a common treatment in the initial painful stage of AC and its use in combination with hyaluronidase may offer increased therapeutic efficacy owing to synergistic effects We determined the therapeutic efficiency of the co-administration of hyaluronidase in early AC by evaluating symptomatic anthropometric and imaging changes
Detailed Description:
We enrolled eligible patients with primary adhesive capsulitis in the initial stageThe subjects were randomly assigned into 3 groups to receive ultrasound-guided intra-articular injections with 20 mg group A and 40 mg triamcinolone acetonide group B and 20 mg acetonide combined with hyaluronidase group C The outcome measures included the visual analogue scale VAS the shoulder disability questionnaire SDQ abduction and external rotation range of motion and intra-sheath fluid ISF before treatment and at 2 4 8 and 16 weeks after treatment
Study Oversight
Has Oversight DMC:
None
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?:
None