Clinical trial NCT03560505: High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Peroneal Neuropathies
Keywords: Ultrasound reference material
Sensitivity
Specificity
Common fibular compression neuropathy
Type 2 diabetes polyneuropathy
Intra-rater reliability
Inter-rater reliability
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2018-06-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nerve cross-sectional area (CSA)
timeFrame: 1 year
measure: Common fibular nerve fascicle properties
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Clinical Neurophysiolgy, Department of Neurology, Aarhus University Hospital
Study officials:
affiliation: Department of Clinical Neurophysiology, Aarhus University Hospital
name: Erisela Qerama Montvilas, MD, PhD
role: STUDY_DIRECTOR
References: