Painless Synovitis in Patients With Longstanding Rheumatoid Arthritis
|ClinicalTrials.gov Identifier: NCT01639287|
Recruitment Status : Unknown
Verified July 2012 by Daniele Freitas Pereira, Federal University of São Paulo.
Recruitment status was: Recruiting
First Posted : July 12, 2012
Last Update Posted : July 12, 2012
There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands.
The objective of this study is to compare painless synovitis with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings.
A sonographic examination (Gray-scale and power Doppler) will be done to evaluate metacarpophalangeal joints of patients without local painful and will be a comparison with patients with local painful.
|Condition or disease|
|- Rheumatoid Arthritis|
There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands. The mean of this is still unknown and does not exist studies in the literature that assessing the predictors of this behavior or synovial potential to cause bone erosion.
The objective of this study is to compare painless synovitis (called "cold" synovitis) with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings, articular damage (x-Ray and sonography), clinical, laboratory and demographic variables in RA patients.
Methods: Cross-sectional study with RA patients, which will be evaluated metacarpophalangeal joints of patients without local painful. Sixty RA patients will be selected in the Federal University of São Paulo ambulatory (Unifesp). The patients will be divided in two groups of thirty patients each: "painless synovitis" Group and "painful synovitis" Group. All patients will be measured through clinical evaluation, hands ultrasound and laboratory parameters (erythrocyte sedimentation rate, ESR; rheumatoid factor, RF; anti-cyclic-citrullinated peptide antibodies, CCP) on the same day. The clinical evaluation will be measured by a trained rheumatologist with experience in joint physical examination (synovitis). This measure will be done before the sonography examination and the assessment tools will be: painful joint count; swollen joint count; painful visual analogue scale (VAS 0-10); swollen VAS; activity disease VAS; measurement of grip strength and pinch with Jamar dynamometer and Preston Pinch Gauge; 28 joint Disease Activity Score (DAS 28); Stanford Health Assessment Questionnaire (HAQ); Cochin Hand Functional Scale (CHFS) and patient clinical evaluation. The level of statistical significance will be 5%.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Correlation of "Painless" Synovitis With Clinical, Laboratory and Radiological (X-ray, Sonography) Finds in Patients With Longstanding Rheumatoid Arthritis (RA).|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||July 2013|
Painless synovitis group(called "cold" synovitis)
Painful synovitis group
- Sonographic power Doppler [ Time Frame: baseline ]
- Sonographic Gray Scale [ Time Frame: baseline ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639287
|Contact: Daniele F Pereira||+55 11 email@example.com|
|Universidade Federal de Sao Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 04023900|
|Contact: Daniele Pereira 55 11 96088707 firstname.lastname@example.org|
|Principal Investigator:||Daniele F Pereira, Dr||Federal University of São Paulo|