Painless Synovitis in Patients With Longstanding Rheumatoid Arthritis
NCT ID: NCT01639287
Last Updated: 2012-07-12
Study Results
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Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2012-07-31
2013-07-31
Brief Summary
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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.
Detailed Description
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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%.
Conditions
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Study Design
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RETROSPECTIVE
Study Groups
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Painless
Painless synovitis group(called "cold" synovitis)
No interventions assigned to this group
Painful
Painful synovitis group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* chronically painless synovitis in the hands or painful
Exclusion Criteria
* change of basic drug in the last 3 months
18 Years
FEMALE
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Federal University of São Paulo
OTHER
Responsible Party
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Daniele Freitas Pereira
Dr, Principal Investigator
Principal Investigators
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Daniele F Pereira, Dr
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Universidade Federal de Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Daniele Pereira
Role: primary
Other Identifiers
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USG-3131-AR
Identifier Type: -
Identifier Source: org_study_id