Discriminative Validity of Real-time Sonoelastography of the Supraspinatus Tendon: Comparison of Findings Between Patients With Supraspinatus Tendinopathy and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tendon quality (SEL)
研究概览
简要总结
This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy
详细描述
The case-control trial will include 96 participants. 48 of them diagnosed with supraspinatus tendinopathy by MRI and 48 healthy subjects.
In this study the investigators will compare the outcome of tissue elasticity measured by sonoelastography, with MRI and conventional ultrasound.
Patients will be recruited through different radiology department and healthy volunteers will be recruited primarily through advertising in local newspapers and social media.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index < 30
- •Symptomatic: Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins.
- •Asymptomatic: No shoulder pain in the last year, negative on 5/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins).
排除标准
- •Shoulder-fracture, operation and luxation, known-neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondyloarthropathy and psychiatric disorders, pregnancy and inability to read and understand Danish. Biceps rupture, labrum lesions, supraspinatus tears (> 1/3 of the vertical tendon height) and calcifications (> 2 mm in length) (MRI).
研究组 & 干预措施
Diagnostic
All participants will be exposed to shoulder- MRI, ultrasound and sonoelastography.
干预措施: Diagnostic (Diagnostic Test)
结局指标
主要结局
Tendon quality (SEL)
时间窗: Baseline
Sonoelastography - strain elasticity
次要结局
- Tendon quality (US)(Baseline)
- Disability(Baseline)
- Pain on a VAS scale(Baseline)
- Quality of life on the E!-5D-3L questionnaire(Baseline)
- Tendon quality (MRI)(Baseline)
研究者
Karen Brage
Ph.D-student
University of Southern Denmark