ULnar Nerve ECHographic Observation (ULNECHO) (ULNECHO)

April 20, 2018 updated by: University Hospital, Brest
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient under administrative supervision or legal guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ulnar nerve ultrasound
Diagnostic test: Ulnar nerve Ultrasound
No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach by measure of ulnar nerve surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation ulnar nerve surface measure of by two doctors
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2017

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 20, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC17.0085 ULNECHO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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