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The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis. A Two-arm Double-blind Randomised Controlled Trial
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 72.3% of patients after a mean symptom duration of 41.8 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.
Age
35 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Start Date
August 1, 2023
Primary Completion Date
July 1, 2024
Completion Date
July 1, 2025
Last Updated
August 7, 2023
60
ESTIMATED participants
Rotator interval hydro-dissection with dextrose 5%
DRUG
Rotator interval hydro-dissection with corticosteroid solution
DRUG
Lead Sponsor
University of Malaya
NCT07484386
NCT06490172
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04831255