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

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560505
• Other study ID #: USCF
• Status: Completed
• Start date: May 16, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: June 2018
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peroneal Neuropathies
• Ultrasonography

Intervention

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).

Locations

Country	Name	City	State
Denmark	Department of Clinical Neurophysiolgy, Department of Neurology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Sándor Beniczky	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve cross-sectional area (CSA)	The nerve cross-sectional area within the hyperechoic epineurium measured with ultrasound machine software.	1 year
Primary	Common fibular nerve fascicle properties	The amount of visible fascicles and fascicle CSA of the common fibular nerve at measurement sites.	1 year