Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977985
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-07
First Post:
2023-07-19
Brief Title:
The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis
Sponsor:
University of Malaya
Organization:
University of Malaya
Study Overview
Official Title:
The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis A Two-arm Double-blind Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
None
Brief Summary:
Adhesive capsulitis AC is a significant cause of chronic shoulder pain and disability Non-surgical option consisting of intraarticular corticosteroid IA CS injection with structured physiotherapy PT is the current standard of care More recent randomized controlled trials have found that rotator interval RI hydro-dissection approach leads to better improvement in pain as compared to IA approach Despite being non-inferior to surgical management long-term outcome studies of patients treated with IA CS injection and PT have shown that patients only achieve satisfactory outcomes in 723 of patients after a mean symptom duration of 418 months Furthermore CS injections are associated with significant systemic and local adverse effects such as Cushing syndrome osteopenia osteoporosis infection and hyperglycemia In recent years dextrose injection has emerged as an effective alternative to CS-based injections to treat chronic painful musculoskeletal conditions such as chronic low back pain peripheral nerve entrapment and lateral epicondylitis
The investigators aim to study the effects of RI hydro-dissection with dextrose 5 D5 on pain relief shoulder ROM and shoulder function in patients with primary AC
The investigators aim to study the effects of RI hydro-dissection with dextrose 5 D5 on pain relief shoulder ROM and shoulder function in patients with primary AC
Detailed Description:
None
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