UltrasonographyNCT03560505
High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.
An observational study of Ultrasonography and Peroneal Neuropathies, run by Sándor Beniczky at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Peroneal Neuropathies
- What is being tested?
- Ultrasound protocol
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 16 May 2018to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with common fibular compression neuropathy and patients with type 2 diabetes polyneuropathy involving the common fibular nerve
Who may be able to join
- Type 2 diabetes polyneuropathy common fibular nerve affection or
- Common fibular nerve compression neuropathy
Who cannot join
- Lumbar radiculopathy
- Other competing lower extremity peripheral neuropathy
- Peripheral vascular disease
- Hypothyroidism
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Neurophysiolgy, Department of Neurology, Aarhus University Hospital
Aarhus, 8000
About this study
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.
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.
Read the 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.
- Conditions
- Ultrasonography, Peroneal Neuropathies
- Being tested
- Ultrasound protocol
- Keywords
- Ultrasound reference material, Sensitivity, Specificity, Common fibular compression neuropathy, Type 2 diabetes polyneuropathy, Intra-rater reliability, Inter-rater reliability
- Medical subject headings
- Peroneal Neuropathies, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound protocolDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Common fibular compression neuropathy | Patients referred for electrophysiological assessment of common fibular compression neuropathy with subsequent confirmation of referral diagnosis.
Intervention: Ultrasound protocol. Receives: Diagnostic Test: Ultrasound protocol | |
| 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. Receives: Diagnostic Test: Ultrasound protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve cross-sectional area (CSA)
The nerve cross-sectional area within the hyperechoic epineurium measured with ultrasound machine software.
Measured: 1 year
Common fibular nerve fascicle properties
The amount of visible fascicles and fascicle CSA of the common fibular nerve at measurement sites.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start16 May 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sándor Beniczky
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Sándor Beniczky, Aarhus University Hospital
- Investigators
- Erisela Qerama Montvilas, MD, PhD, Study director, Department of Clinical Neurophysiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560505
- Sponsor's protocol ID
- USCF
- Status last verified
- Jun 2018
- First submitted
- 7 Jun 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03560505
- Acronym / sponsor ID
- USCF
- Conditions
- Ultrasonography, Peroneal Neuropathies
- Keywords
- Ultrasound reference material, Sensitivity, Specificity, Common fibular compression neuropathy, Type 2 diabetes polyneuropathy, Intra-rater reliability, Inter-rater reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sándor BeniczkyUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 16 May 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common fibular compression neuropathy | – | Diagnostic Test: Ultrasound protocolPatients referred for electrophysiological assessment of common fibular compression neuropathy with subsequent confirmation of referral diagnosis. Intervention: Ultrasound protocol. |
| Type 2 diabetes polyneuropathy | – | Diagnostic Test: Ultrasound protocolPatients with type 2 diabetes referred for polyneuropathy involving the common fibular nerve with subsequent confirmation of referral diagnosis. Intervention: Ultrasound protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with common fibular compression neuropathy and patients with type 2 diabetes polyneuropathy involving the common fibular nerve
Key inclusion criteria (2 listed)
- Type 2 diabetes polyneuropathy common fibular nerve affection or
- Common fibular nerve compression neuropathy
Key exclusion criteria (4 listed)
- Lumbar radiculopathy
- Other competing lower extremity peripheral neuropathy
- Peripheral vascular disease
- Hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound protocolHigh-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). | Diagnostic test | Common fibular compression neuropathy, Type 2 diabetes polyneuropathy |
Primary outcome
Nerve cross-sectional area (CSA)
Time frame: 1 year
The nerve cross-sectional area within the hyperechoic epineurium measured with ultrasound machine software.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erisela Qerama Montvilas, MD, PhD study director
Department of Clinical Neurophysiology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography and Peroneal Neuropathies, run by Sándor Beniczky at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve cross-sectional area (CSA) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.