跳至主要内容
临床试验/NCT03556449
NCT03556449已完成不适用

High Resolution Ultrasound of Scapulae Alatae - Correlation With Electrophysiological Measurements - a Prospective Case Control Study

Sándor Beniczky1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Thickness of musculus trapezius

研究概览

简要总结

Scapula alata, caused by disturbance in the scapulothoracic stabilizer muscles due to nerve injury, is a relatively rare but also underreported disease. It can lead to years of invalidity of the affected upper extremity, considerable pain and social and emotional consequences for the patients. Unrecognized and misdiagnosed scapula alata and, consequently, wrong or delayed treatment is a general problem in this patient group. Today the diagnosis is based on the clinical examination and the electrophysiological examination. One of the problems is that the electrophysiological examination in a fair part of the patients is not showing any pathology even though the history of the patient and the clinical evaluation are indicating scapula alata.

This study is a single-blinded, prospective, controlled multicentre study. The aim of the study is to investigate whether ultrasound can be used as a supplement to the electrophysiological examination when diagnosing scapula alata. Ultrasound will be used to visualize possible thickening of the cross-sectional area of nerves and the degree and pattern of muscle involvement in patients with scapula alata. By comparing measurements from scapula alata patients with the measurements from healthy controls, we are able to see if ultrasound can distinguish these two groups from each other. Furthermore, we will examine whether the ultrasound measurements correlate with the electrophysiological findings in patients and, when available, compare the ultrasound measurements of muscle thickness with MRI (magnetic resonance Imaging) findings. The use of ultrasound in scapula alata patients may help determine the presence and severity of a nerve lesion and the subsequent degree of muscle involvement and may therefore serve as a supplement to the clinical diagnosis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Clinical suspicion of scapula alata

排除标准

  • Winged scapula due to other cause than nerve damage. eg. myopathy
  • Healthy subjects
  • Exclusion Criteria:
  • History of Shoulder trauma or shoulder disease
  • History of cervical radiculopathy
  • History of upper extremity peripheral neuropathy/plexopathy
  • Peripheral vascular disease

结局指标

主要结局

Thickness of musculus trapezius

时间窗: 10-15 minuttes

Thickness of musculus rhomboideus

时间窗: 10-15 minuttes

Cross sectional area of nervus thoracicus longus

时间窗: 10-15 minuttes

Cross sectional area of nervus dorsalis scapularis

时间窗: 10-15 minuttes

Thickness of musculus serratus anterior

时间窗: 10-15 minuttes

Cross sectional area of nervus accesorius

时间窗: 10-15 minuttes

次要结局

未报告次要终点

研究者

发起方
Sándor Beniczky
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sándor Beniczky

Professor

Aarhus University Hospital

研究点 (1)

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