Skip to main content
OpenTrials
Completed

NCT Number: NCT03560505

High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Neurophysiolgy, Department of Neurology, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ultrasound protocol

Diagnostic Test

High-resolution ultrasound protocol at pre-defined sites bilaterally. Pre-defined sites: Sciatic nerve (proximal and distal), tibial nerve (proximal and distal), common fibular nerve (proximal and distal), superficial fibular nerve (proximal and distal) and sural nerve (proximal and distal).

Primary outcomes

  1. Nerve cross-sectional area (CSA)

    Time frame: 1 year

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

  2. Common fibular nerve fascicle properties

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Sándor Beniczky

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2018
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.