Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain (EPICORE)

March 29, 2018 updated by: Centre Hospitalier Universitaire de Nīmes

Study of the Relationship Between Functional Ultrasound Data and the Impact of Lateral Epicondylar Pain

Our primary objective is to study the relationship between ultra sound data and the pain associated with tennis elbow.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Nîmes, France, 30029
        • Centre Hospitalier Universitaire de Nîmes

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for Tennis Elbow patients:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 90 days of follow up
  • Pain when pressure applied to the epicondyl
  • Pain upon forced movement of both epicondylien muscles
  • Absence of pain upon forced movement of an epitrochlear muscle
  • Absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow
  • at least one consult for pain treatment associated with tennis elbow (on the same elbow)

Inclusion Criteria for healthy volunteers:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • No pain when pressure applied to the epicondyl
  • No pain upon forced movement of both epicondylien muscles
  • No neck pain
  • No skeletal-muscle problems in the arms during the 3 months preceding the study

Exclusion Criteria for Tennis Elbow patients:

  • The patient is included in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant
  • The patient is breastfeeding
  • Absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow

Exclusion Criteria for Health Volunteers:

  • The subject is included in another study
  • The subject is in an exclusion period determined by a previous study
  • The subject is under judicial protection, under tutorship or curatorship
  • The subject refuses to sign the consent
  • It is impossible to correctly inform the subject
  • Presence of one or more skeletal-muscle problems in the arms within the 3 months preceding the study
  • Pain when pressure applied to the epicondyl
  • Pain upon forced movement of both epicondylien muscles
  • Consultation for any kind of treatment for elbow pain

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Tennis elbow patients
These patients have tennis elbow, according to stated inclusion criteria.
Procedure: Ultrasound of the elbow 1, days 7 to 15
The primary endpoint is evaluated a first time via an ultrasound exam.
Procedure: Ultrasound of the elbow 2, days 7 to 15
The primary endpoint is evaluated a second time by a second practitioner.
Procedure: Ultrasound of the elbow 3, days 45 to 90
A third ultrasound is performed only on tennis elbow patients between days 45 and 90.
ACTIVE_COMPARATOR: Healthy volunteers
Healthy volunteers are selected and paired according to age, sex, socio-professional category and left- or right-handedness.
Procedure: Ultrasound of the elbow 1, days 7 to 15
The primary endpoint is evaluated a first time via an ultrasound exam.
Procedure: Ultrasound of the elbow 2, days 7 to 15
The primary endpoint is evaluated a second time by a second practitioner.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow)
Time Frame: Days 7 to 15
The movement of the superficial epicondyliens relative to the supinator is studied via ultrasound and classified as follows: A) good interface movement in both directions; B) good movement in only 1 direction; C) bad movement over less than half of the interface; D) bad movement over a majority of the interface; E) no movement along the interface.
Days 7 to 15
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (good elbow)
Time Frame: Days 7 to 15
The movement of the superficial epicondyliens relative to the supinator is studied via ultrasound and classified as follows: A) good interface movement in both directions; B) good movement in only 1 direction; C) bad movement over less than half of the interface; D) bad movement over a majority of the interface; E) no movement along the interface.
Days 7 to 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale for pain
Time Frame: Baseline
A visual analog scale ranging from 0 to 100 is used to evaluate pain.
Baseline
Visual Analog Scale for pain
Time Frame: Between days 45 and 90
A visual analog scale ranging from 0 to 100 is used to evaluate pain.
Between days 45 and 90
Q-Dash Questionnaire
Time Frame: Baseline
The Quick DASH questionnaire is used to evaluate functional changes.
Baseline
Q-Dash Questionnaire
Time Frame: Between 45 and 90 days
The Quick DASH questionnaire is used to evaluate functional changes.
Between 45 and 90 days
Thickness of the ECR longus and ECR brevis interface
Time Frame: Between days 7 and 15
The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)
Between days 7 and 15
Thickness of the ECR longus and ECR brevis interface, tennis elbow patients only
Time Frame: Between days 45 and 90
The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)
Between days 45 and 90
Thickness of the ECR -supinator interface
Time Frame: Between 7 and 15 days
The thickness of the intersection (at the base) between the Extensor Carpi Radialis (ECR) muscles and the supinator is measured during ultrasound (mm)
Between 7 and 15 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2010/AD-03b
  • 2011-A00769-32 (OTHER: RBC number)

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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