Effectiveness Intraarticular Corticosteroid

F

Federal University of São Paulo

Status

Unknown

Conditions

Rheumatoid Arthritis

Treatments

Drug: Triamcinolone hexacetonide

Study type

Interventional

Funder types

Other

Identifiers

NCT01851278
IIA- 3131- AR

Details and patient eligibility

About

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

Full 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%.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

high dose
Active Comparator group
Description:
intraarticular wrist injection of 40mg, 2ml
Treatment:
Drug: Triamcinolone hexacetonide
low dose
Active Comparator group
Description:
intraarticular wrist injection of 20mg, 1ml.
Treatment:
Drug: Triamcinolone hexacetonide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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