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Corticosteroid Intra-articular Injection in Hands Osteoarthritis

NCT02102620 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-04-03

No results posted yet for this study

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.

Conditions

  • Hands Osteoarthritis

Interventions

DRUG

Intra-articular injection with corticosteroid

After rigorous antisepsis with alcoholic 0.5% chlorhexidine. Sterile insulin syringe BD ™ Ultra Fine needles 8 mm x 0.3 mm 30 G) was used in all patients. The anatomical place used for needle entry was located in the dorsal - lateral joint aspect. After the procedure, the injected joint was immobilized for 48 hours.

DRUG

Intra-articular injection with lidocaine

After rigorous antisepsis with alcoholic 0.5% chlorhexidine. Sterile insulin syringe BD ™ Ultra Fine needles 8 mm x 0.3 mm 30 G) was used in all patients. The anatomical place used for needle entry was located in the dorsal - lateral joint aspect. After the procedure, the injected joint was immobilized for 48 hours.

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Natalia O Spolidoro Paschoal · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2013-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102620 on ClinicalTrials.gov