Rheumatoid Arthritis
Conditions
Keywords
injection, arthritis, corticosteroid
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%.
Interventions
High dose means 40mg or 2ml of triamcinolone hexacetonide
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analog scale (VAS) | up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| chronic disease activity index (CDAI) | up to 12 weeks |
Countries
Brazil
Outcome results
None listed