Ulnar NeuropathiesULNECHONCT03209947
ULnar Nerve ECHographic Observation (ULNECHO)
A study testing Ulnar nerve Ultrasound in people with Ulnar Neuropathies, run by University Hospital, Brest at 1 site in France.
Trial summary
There is currently no consensus on the normal ultrasound surface of the ulnar nerve at the elbow. The goal of this study is to study the ulnar nerve surface at the elbow in a population of asymptomatic subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulnar Neuropathies
- What is being tested?
- Ulnar nerve Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2017to 15 Feb 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 -to 80 years or older
- Patient without any current or previous pathology on the ulnar nerve
- Patients would be able to consent
Who cannot join
- Patient under administrative supervision or legal guardianship
Trial locations and contacts
1 site in 1 country.
About this study
There is currently no consensus on the normal ultrasound surface of the ulnar nerve at the elbow. The goal of this study is to study the ulnar nerve surface at the elbow in a population of asymptomatic subjects
Read the detailed description
100 elbows from 50 patients will be included, from a population of asymptomatic subjects, in order to measure the frequency of ulnar nerve which surface is >8,3 mm².
The measures will be realized centered on the epicondyle : 2 cm higher, and 2 cm lower with 2 echographs (ESAOTE) and 2 observers. An inter and intra observer study will also be realized to determine the reproducibility and reliability of the measurements.
- Conditions
- Ulnar Neuropathies
- Being tested
- Ulnar nerve Ultrasound
- Keywords
- Ulnar Neuropathies, Ultrasound
- Medical subject headings
- Ulnar Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulnar nerve UltrasoundDiagnostic test
No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach by measure of ulnar nerve surface
| Study group | Role | What they receive |
|---|---|---|
| Ulnar nerve ultrasound | Experimental | Not described Receives: Diagnostic Test: Ulnar nerve Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound
Measured: 1 day
Secondary outcomes (1)
Correlation ulnar nerve surface measure of by two doctors
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start22 Sep 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulnar NeuropathiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209947
- Sponsor's protocol ID
- 29BRC17.0085 ULNECHO
- Acronym
- ULNECHO
- Status last verified
- Apr 2018
- First submitted
- 4 Jul 2017
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Letissier H, Dardenne G, Saraux A, Le Nen D, Borotikar B, Jousse-Joulin S. Ultrasound Ulnar Nerve Measurement in a Healthy Population. Rheumatol Ther. 2021 Mar;8(1):457-466. doi: 10.1007/s40744-021-00283-2. Epub 2021 Feb 4.
PubMed 33543416
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULnar Nerve ECHographic Observation (ULNECHO)
- ClinicalTrials.gov ID
- NCT03209947
- Acronym / sponsor ID
- ULNECHO / 29BRC17.0085 ULNECHO
- Conditions
- Ulnar Neuropathies
- Keywords
- Ulnar Neuropathies, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 6 Jul 2017 (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.
There is currently no consensus on the normal ultrasound surface of the ulnar nerve at the elbow. The goal of this study is to study the ulnar nerve surface at the elbow in a population of asymptomatic subjects
Detailed description
100 elbows from 50 patients will be included, from a population of asymptomatic subjects, in order to measure the frequency of ulnar nerve which surface is >8,3 mm².
The measures will be realized centered on the epicondyle : 2 cm higher, and 2 cm lower with 2 echographs (ESAOTE) and 2 observers. An inter and intra observer study will also be realized to determine the reproducibility and reliability of the measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulnar nerve ultrasound | Experimental | Diagnostic Test: Ulnar nerve Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 18 -to 80 years or older
- Patient without any current or previous pathology on the ulnar nerve
- Patients would be able to consent
Key exclusion criteria (1 listed)
- Patient under administrative supervision or legal guardianship
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 |
|---|---|---|
| Ulnar nerve UltrasoundNo drug and no placebo were used in this arm. Patients were followed by Ultrasound approach by measure of ulnar nerve surface | Diagnostic test | Ulnar nerve ultrasound |
Primary outcome
Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound
Time frame: 1 day
1 secondary outcome
Correlation ulnar nerve surface measure of by two doctors
Time frame: 1 day
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 3 Dec 2025.
- Results publication: PubMed 33543416Letissier H, Dardenne G, Saraux A, Le Nen D, Borotikar B, Jousse-Joulin S. Ultrasound Ulnar Nerve Measurement in a Healthy Population. Rheumatol Ther. 2021 Mar;8(1):457-466. doi: 10.1007/s40744-021-00283-2. Epub 2021 Feb 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulnar nerve Ultrasound in people with Ulnar Neuropathies, run by University Hospital, Brest at 1 site in France.
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 3 inclusion and 1 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 3 Dec 2025. 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 France. 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?
Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209947, which also lists 1 linked publication.
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 3 Dec 2025.