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

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ClinicalTrials.gov Identifier: NCT03560505
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Sándor Beniczky, Aarhus University Hospital

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.

Condition or disease Intervention/treatment
Ultrasonography Peroneal Neuropathies Diagnostic Test: Ultrasound protocol

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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
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.
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


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).




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

  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560505


Contacts
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Contact: Selim Kilic, MS-V +4541578461 selim.kilic@post.au.dk

Locations
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Denmark
Department of Clinical Neurophysiolgy, Department of Neurology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Selim Kilic, MS-V    +4541578461    selim.kilic@post.au.dk   
Sponsors and Collaborators
Sándor Beniczky
Aarhus University Hospital
Investigators
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Study Director: Erisela Qerama Montvilas, MD, PhD Department of Clinical Neurophysiology, Aarhus University Hospital

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Responsible Party: Sándor Beniczky, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03560505     History of Changes
Other Study ID Numbers: USCF
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sándor Beniczky, Aarhus University Hospital:
Ultrasound reference material
Sensitivity
Specificity
Common fibular compression neuropathy
Type 2 diabetes polyneuropathy
Intra-rater reliability
Inter-rater reliability

Additional relevant MeSH terms:
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Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Peripheral Nervous System Diseases
Peroneal Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn
Mononeuropathies