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临床试验/NCT01639287
NCT01639287Unknown不适用

Correlation of "Painless" Synovitis With Clinical, Laboratory and Radiological (X-ray, Sonography) Finds in Patients With Longstanding Rheumatoid Arthritis (RA).

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Sonographic power Doppler

研究概览

简要总结

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.

详细描述

Introduction/Objectives:

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%.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • longstanding rheumatoid arthritis
  • chronically painless synovitis in the hands or painful

排除标准

  • uncompensated systemic disease, e.g. diabetes mellitus, hypothyroidism
  • change of basic drug in the last 3 months

结局指标

主要结局

Sonographic power Doppler

时间窗: baseline

次要结局

  • Sonographic Gray Scale(baseline)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniele Freitas Pereira

Dr, Principal Investigator

Federal University of São Paulo

研究点 (1)

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