Scratch Collapse Test: Prospective, Objective, Multi Multicenter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Variation in the force of external rotation of the elbow
研究概览
简要总结
Carpal tunnel syndrome and compression of the ulnar nerve at the elbow are common pathologies, which are treated surgically.
Diagnosis is usually based on an electromyogram (EMG), as well as symptomatology, etiology of typical symptoms and an evocative clinical examination. Provocative tests performed in consultation include the Tinel and Phalen sign for the carpal tunnel, and the Tinel and prolonged flexion sign for the ulnar nerve at the elbow.
The Scratch Collapse Test (SCT) has recently emerged as a new provocation test to help diagnose nerve compression in the upper limb.
This non-invasive, pain-free test looks for a reduction in the force of external rotation of the shoulder by applying resistance (the doctor's arm), before and then after a sensory stimulus by "scratching" the area of compression. Nevertheless, this test remains controversial and not based on objective measurements.
Our aim is therefore to assess shoulder external rotation force, and thus TBS, objectively with a dynamometer, before and after stimulation in cases of median nerve compression syndrome at the carpal tunnel and ulnar nerve compression syndrome at the elbow, when these are clinically and electromyographically proven.
This test has already been studied in the literature, but the results in terms of sensitivity and specificity are highly disparate. One study has already published negative results on the subject, with the limitation that the trial was monocentric.
Through this multicenter study, principal investigator wish to highlight the very probable subjectivity of the SCT when it is performed. As the resistance is applied by the physician's arm, the investigator cannot determine the force applied against the patient, unlike with a measurement object. The principal investigator expects this study to refute the notion that external shoulder rotation force decreases after trigger zone stimulation in cases of proven nerve compression syndrome.
The results of this study will thus make it possible to discontinue the use of this technique if it does not help in the diagnosis of compression.
The literature shows a lack of prospective, objective studies involving a large number of patients.
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
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient affiliated or entitled to a social security plan
- •Patient who has received informed information about the study
- •Patient of legal age
- •Patient with ulnar nerve or carpal tunnel compression confirmed by EMG during preoperative consultation
排除标准
- •Recurrence of nerve compression
- •Any history that may affect arm sensitivity
- •Infra-electromyographic nerve compression syndrome (pure ulnar nerve instability)
研究组 & 干预措施
nerve stimulation
The test in currently used to search for a nerv compression
干预措施: Scratch collapse test (Diagnostic Test)
结局指标
主要结局
Variation in the force of external rotation of the elbow
时间窗: Inclusion day
measurement taken before the test and the measurement taken immediately after nerve stimulation according to the SCT. The force is measured with a dynamometer.
次要结局
未报告次要终点
研究者
Benjamin DEGEORGE
Principal investigator
Clinique Saint Jean, France