Effectiveness Intraarticular Corticosteroid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-04-30

Brief Summary

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

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Detailed Description

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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%.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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high dose

intraarticular wrist injection of 40mg, 2ml

Group Type ACTIVE_COMPARATOR

Triamcinolone hexacetonide

Intervention Type DRUG

High dose means 40mg or 2ml of triamcinolone hexacetonide

low dose

intraarticular wrist injection of 20mg, 1ml.

Group Type ACTIVE_COMPARATOR

Triamcinolone hexacetonide

Intervention Type DRUG

Low dose means 20mg or 1 ml of triamcinolone hexacetonide

Interventions

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Triamcinolone hexacetonide

High dose means 40mg or 2ml of triamcinolone hexacetonide

Intervention Type DRUG

Triamcinolone hexacetonide

Low dose means 20mg or 1 ml of triamcinolone hexacetonide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No