drugset / Trial / NCT02102620

Corticosteroid Intra-articular Injection in Hands Osteoarthritis

NCT02102620

Phase 4 Completed 60 enrolled Federal University of São Paulo
RandomizedParallel-groupTriple-blindTreatment

Summary

Objective - to evaluate the effectiveness and tolerance of intra-articular injections (IAI) of hexacetonide triamcinolone (HT) for the treatment of osteoarthritis (OA) in interphalangeal joints. Design:randomized, controlled, double-blinded study Materials and methods: sixty patients were randomized into: the TH / lidocaine (LD) group (n=30) who underwent IAI at the most symptomatic interphalangeal joint with HT (20mg/ml) and LD 2% or the LD group (n=30) who received IAI with just LD. Patients were assessed at baseline, 1, 4, 8 and 12 weeks by a blinded observer. The following parameters regarding the affected joint were assessed: pain at rest (VASr); pain at movement (VASm); pain (VAS) during the 48 hours after the procedure; swelling (VASs); goniometry; grip and pinch strength; hand function; treatment improvement; daily requirement of paracetamol and incidence and types of local side effects after the procedure.

Timeline

Start
2011-08
Primary completion
2012-08
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 0.1 ml Other
Subject Triamcinolone Hexacetonide Other / unclassified 4 mg Other
Subject Triamcinolone Hexacetonide Other / unclassified 6 mg Other

Indications