drugset / Trial / NCT05977985

The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis.

NCT05977985

Phase 4 Unknown 60 enrolled University of Malaya
RandomizedParallel-groupTriple-blindTreatment

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 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.

Timeline

Start
2023-08-01
Primary completion
2024-07-01
Completion
2025-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextrose Unknown 5 % Other
Comparator Triamcinolone Other / unclassified 40 mg Other

Indications