Effectiveness Intraarticular Corticosteroid

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Triamcinolone hexacetonide

• Registration Number: NCT01851278
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study is to compare the small and large dose of corticosteroid used in intraarticular injection of wrist.

Detailed Description

Background / Objectives: The optimal dose of corticosteroid to be used in intraarticular injection is not well established. The objective of this study is to compare the effectiveness and tolerance in the medium-term between small and large dose of triamcinolone hexacetonide (TH) used in intraarticular injection (IAI) of medium size joint of patients with rheumatoid arthritis (RA). Materials/Methods: A controlled, randomized, prospective, double-blind study will be realized in patients with RA. It will be evaluated 60 wrists joints (representing medium size joints) from the outpatient clinics at the Rheumatology Division UNIFESP, Brazil. Inclusion criteria were: patients with established RA, age between 18 and 65 years, disease modifying anti-rheumatic drugs (DMARDs) stable for at least 3 months, synovitis in wrist with pain visual analogic scale (VAS) between 4 and 8cm. Patients with overlap syndromes, polyarticular synovitis, diabetes mellitus or uncontrolled hypertension and those with suspected local or systemic infection were excluded. Patients will be randomized (Clapboard randomization) in two groups of 30 patients each: group 1 (high dose) is injected with 40mg (2ml) of TH and group 2 (small dose) was injected 20mg (1ml). Only one joint is injected by patient (IAI blindly). Evaluation will be conducted by a blinded observer at five times: baseline (T0), one week (T1), four (T4), eight (T8) and twelve (T12) weeks and the following assessment instruments were used: visual analogue scale for pain and swollen (VAS 0-10cm); wrist goniometry; chronic disease activity index (CDAI). Side effects and related events were reported in a medical questionnaire. The level of statistical significance was 5%.

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-05-09
• Last Update Submitted: 2013-05-09
• Study First Posted: 2013-05-10
• Last Update Posted: 2013-05-10
• Primary Completion: 2013-10
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with established RA
• age between 18 and 65 years
• disease modifying anti-rheumatic drugs (DMARDs) stable for at least 3 months
• synovitis in wrist with pain visual analogic scale (VAS) between 4 and 8cm

Exclusion Criteria

• patients with overlap syndromes
• polyarticular synovitis
• diabetes mellitus or uncontrolled hypertension and those with suspected local or systemic infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose	Triamcinolone hexacetonide	intraarticular wrist injection of 40mg, 2ml
low dose	Triamcinolone hexacetonide	intraarticular wrist injection of 20mg, 1ml.

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
chronic disease activity index (CDAI)	up to 12 weeks

Trial Locations

Locations (1)

Universidade Federal de São Paulo; 🇧🇷 São Paulo, SP, Brazil