Clinical trial NCT01851278: Effectiveness Intraarticular Corticosteroid
Official title: Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: injection
arthritis
corticosteroid
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: chronic disease activity index (CDAI)
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
state: SP
Study officials:
affiliation: Universidade Federal de São Paulo
name: Daniele F Pereira, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Konai MS, Vilar Furtado RN, Dos Santos MF, Natour J. Monoarticular corticosteroid injection versus systemic administration in the treatment of rheumatoid arthritis patients: a randomized double-blind controlled study. Clin Exp Rheumatol. 2009 Mar-Apr;27(2):214-21.