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

Completed

• Conditions: Peroneal Neuropathies; Ultrasonography
• Interventions: Diagnostic Test: Ultrasound protocol

• Registration Number: NCT03560505
• Lead Sponsor: Sándor Beniczky

Brief 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.

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 Timeline

• Study Start: 2018-05-16
• Status Verified: 2018-06
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-18
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Common fibular compression neuropathy	Ultrasound protocol	Patients referred for electrophysiological assessment of common fibular compression neuropathy with subsequent confirmation of referral diagnosis. Intervention: Ultrasound protocol.
Type 2 diabetes polyneuropathy	Ultrasound protocol	Patients with type 2 diabetes referred for polyneuropathy involving the common fibular nerve with subsequent confirmation of referral diagnosis. Intervention: Ultrasound protocol.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Neurophysiolgy, Department of Neurology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark