Effectiveness Intraarticular Corticosteroid

May 9, 2013 updated by: Daniele Freitas Pereira, Federal University of São Paulo

Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04024002
        • Recruiting
        • Universidade Federal de São Paulo
        • Contact:
        • Principal Investigator:
          • Daniele F Pereira, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: high dose
intraarticular wrist injection of 40mg, 2ml
Drug: Triamcinolone hexacetonide
High dose means 40mg or 2ml of triamcinolone hexacetonide
Drug: Triamcinolone hexacetonide
Low dose means 20mg or 1 ml of triamcinolone hexacetonide
Active Comparator: low dose
intraarticular wrist injection of 20mg, 1ml.
Drug: Triamcinolone hexacetonide
High dose means 40mg or 2ml of triamcinolone hexacetonide
Drug: Triamcinolone hexacetonide
Low dose means 20mg or 1 ml of triamcinolone hexacetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analog scale (VAS)
Time Frame: up to 12 weeks
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
chronic disease activity index (CDAI)
Time Frame: up to 12 weeks
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Daniele F Pereira, MsC, Universidade Federal de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIA- 3131- AR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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