drugset / Trial / NCT07183436

Intra-articular Corticosteroids Are Widely Used for Adhesive Capsulitis, But Alternatives Are Required for Patients With Contraindications. Hyaluronic Acid (HA) and Ketorolac Have Shown Individual Benefits. However, Evidence on Their Combination Remains Limited.

NCT07183436

Phase 3 Completed 56 enrolled Mahidol University
RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized, double-blind trial compared a single intra-articular injection of moderate-molecular-weight hyaluronic acid (HA) plus ketorolac with ketorolac alone in patients with adhesive capsulitis. Fifty-six participants were randomized into two equal groups and followed for 24 weeks. The primary outcome was shoulder function measured by the Thai Shoulder Pain and Disability Index (SPADI). Secondary outcomes included pain (VAS), passive range of motion (PROM), analgesic use, and adverse events. Both groups showed significant improvement in pain and function with no between-group difference in SPADI or VAS. The HA+ketorolac group demonstrated small but significant gains in external rotation and adduction. Both treatments were safe and well tolerated.

Timeline

Start
2023-11-01
Primary completion
2025-07-01
Completion
2025-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Hyaluronic Acid Other / unclassified 20 mg Other
Comparator Ketorolac Other / unclassified 30 mg Other
Background Lidocaine Other / unclassified 20 mg Other

Indications