The Impact of Musculoskeletal Ultrasound-added to Clinical Evaluations- on Patient Reported Outcomes: A Prospective Study of Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity (ULTRAPRO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change from Baseline of the Patient Reported Outcome (HAQ)
研究概览
简要总结
Evaluate the impact of MusculoSkeletal Ultrasound added to Rheumatoid Arthritis patients classified in remission/low disease activity in terms of Patient Reported Outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of RA made at the discretion of the attending experienced rheumatologist.
- •Patients classified in remission/low disease activity
排除标准
- •<16 years old.
- •Patient with recent trauma in the evaluated joints.
- •Luxation in the MCP, PIP or MTP joints.
研究组 & 干预措施
Ultrasound shared
Patient will be assessed with ultrasound (GUS-7 score)
干预措施: MusculoSkeletal Ultrasound (Diagnostic Test)
Ultrasound not shared
Patient will be assessed with ultrasound (GUS-7 score)
干预措施: MusculoSkeletal Ultrasound (Diagnostic Test)
结局指标
主要结局
Change from Baseline of the Patient Reported Outcome (HAQ)
时间窗: From baseline at 6 months
Minimal Clinically Significant change in HAQ
Change from Baseline of the Patient Reported Outcome (RADAI)
时间窗: from baseline at 6 months
Minimal Clinically Significant change in RADAI
Change from Baseline of the Patient Reported Outcome (SF-36)
时间窗: from baseline at 6 months
Minimal Clinically Significant change in SF-36
Change from Baseline of the Patient Reported Outcome (VAS-Patient)
时间窗: from baseline at 6 months
Minimal Clinically Significant change in VAS-Patient
次要结局
- Ultrasound findings in Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity(Baseline)
- Clinical relapse: Proportion of patients with relapse after the intervention in both groups(baseline and 6 months)
- Change from Baseline of the Patient Reported Outcome (HAQ)(from baseline at 12 months)
- Change from Baseline of the Patient Reported Outcome (RADAI)(from baseline at 12 months)
- Change from Baseline of the Patient Reported Outcome (SF-36)(from baseline at 12 months)
- Change from Baseline of the Patient Reported Outcome (VAS-Patient)(from baseline at 12 months)