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

January 13, 2021 updated by: Sándor Beniczky

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Clinical Neurophysiolgy, Department of Neurology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with common fibular compression neuropathy and patients with type 2 diabetes polyneuropathy involving the common fibular nerve

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Common fibular compression neuropathy

Patients referred for electrophysiological assessment of common fibular compression neuropathy with subsequent confirmation of referral diagnosis.

Intervention: Ultrasound protocol.
Diagnostic test: Ultrasound protocol
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).
Type 2 diabetes polyneuropathy

Patients with type 2 diabetes referred for polyneuropathy involving the common fibular nerve with subsequent confirmation of referral diagnosis.

Intervention: Ultrasound protocol.
Diagnostic test: Ultrasound protocol
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve cross-sectional area (CSA)
Time Frame: 1 year
The nerve cross-sectional area within the hyperechoic epineurium measured with ultrasound machine software.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sándor Beniczky

Collaborators

Aarhus University Hospital

Investigators

  • Study Director: Erisela Qerama Montvilas, MD, PhD, Department of Clinical Neurophysiology, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2018

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USCF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ultrasonography

Clinical Trials on Ultrasound protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe