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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03560505

Enrollment

Registered

2018-06-18

Start date

2018-05-16

Completion date

2020-02-28

Last updated

2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasonography, Peroneal Neuropathies

Keywords

Ultrasound reference material, Sensitivity, Specificity, Common fibular compression neuropathy, Type 2 diabetes polyneuropathy, Intra-rater reliability, Inter-rater reliability

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.

Interventions

DIAGNOSTIC_TESTUltrasound 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).

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026