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临床试验/NCT03560505
NCT03560505已完成不适用

A Prospective Study of High-resolution Ultrasonography in Examination of Lower Extremity Peripheral Nerves in Patients With Compression Neuropathies and in Healthy Controls.

Sándor Beniczky1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年5月16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
90
试验地点
1
主要终点
Nerve cross-sectional area (CSA)

研究概览

简要总结

This study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls. High-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.

详细描述

The usual diagnostic work-up of patients referred for lower-extremity neuropathy includes clinical examination, biochemical tests (blood and cerebrospinal fluid), electrophysiological assessment and if necessary nerve biopsy. The electrophysiological assessment usually consists of nerve conduction studies (NCS) and electromyography (EMG). While electrophysiological measurements generally give information about the function of nerves, high-resolution ultrasound may provide information about the structure of nerves.

High-resolution ultrasound examination has shown promising results as a supplementary tool in the diagnostic work-up of various peripheral neuropathies. The clinical utility of ultrasound in the diagnosis of common fibular neuropathies, however, calls for further elucidation.

This study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls, as well as each other. High-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes polyneuropathy common fibular nerve affection or
  • Common fibular nerve compression neuropathy

排除标准

  • Lumbar radiculopathy
  • Other competing lower extremity peripheral neuropathy
  • Peripheral vascular disease
  • Hypothyroidism

结局指标

主要结局

Nerve cross-sectional area (CSA)

时间窗: 1 year

The nerve cross-sectional area within the hyperechoic epineurium measured with ultrasound machine software.

Common fibular nerve fascicle properties

时间窗: 1 year

The amount of visible fascicles and fascicle CSA of the common fibular nerve at measurement sites.

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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