Joint Ultrasound Evaluation of Asymptomatic Feet in Patients With Rheumatoid Arthritis: A Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Presence of synovial effusion and/or synovial hypertrophy
研究概览
简要总结
Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of patients with rheumatoid arthritis (RA) and normal controls, determine the association between ultrasound and global disease activity, function and goniometric measures in patients with RA and determine the correlation between ultrasound and radiography in the detection of bone erosion.
Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform, calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal [MTP] joints) of 50 healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Rheumatoid Arthritis Group:
- •RA with at least one year since diagnosis
- •Asymptomatic feet
- •Age between 18 and 65 years Control group
- •absence of known osteoarticular disease
- •Exclusion Criteria for both groups:
- •Peripheral venous insufficiency with retrograde venous flow and/or ochre dermatitis
- •Previous surgical intervention and/or fracture in feet/ankles
- •Intra-articular corticosteroid injection in previous three months in any of the joints evaluated
- •Foot neuropathy
- •Pain and swelling in feet or ankles
排除标准
- 未提供
结局指标
主要结局
Presence of synovial effusion and/or synovial hypertrophy
时间窗: Baseline
Ultrasound evaluation - quantitative measurement considered the distance between the joint capsule and subchondral bone of the joints studied (talocrural, talocalcaneal (medial, lateral and posterior windows); dorsal face of calcaneocuboid, talonavicular, medial naviculocuneiform, 5th tarsometatarsal and metatarsophalangeal (MTP) (dorsal and volar faces of 1st to 5th MTP joints and lateral face of 1st and 5th MTP joints). A modified score was used for the semi-quantitative measurement, ranging from 0 to 3: 0-no synovial thickening; 1-minimal synovial thickening in joint recess; 2-synovial thickening in entire joint recess causing bulging of joint capsule; and 3-synovial thickening in joint recess with bulging of joint capsule and extending to at least one bone diaphysis. "Presence of synovitis" was defined as synovial hypertrophy of at least Grade 1 in the semi-quantitative analysis (gray scale - ultrasound)
Presence of bone erosion
时间窗: Baseline
defined based on the preliminary OMERACT criteria: intra-articular discontinuity of the bone surface observed on two perpendicular planes. A previously established semi-quantitative score (0-3) was employed: 0-uniform bone surface; 1-irregular bone surface; 2-bone surface defect on two planes; 3-bone defect causing extensive bone destruction. The "presence of erosion" was defined as the presence of at least Grade 2 erosion.
次要结局
- Radiographic evaluation(Baseline)
- Intraobserver and interobserver agreement(Baseline)
- Presence of synovial blood flow(Baseline)
研究者
Anamaria Jones
Principal Investigator
Federal University of São Paulo