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

Primary Purpose

Tennis Elbow, Epicondylitis, Lateral Humeral

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound of the elbow 1, days 7 to 15
Ultrasound of the elbow 2, days 7 to 15
Ultrasound of the elbow 3, days 45 to 90
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tennis Elbow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tennis elbow patients

Healthy volunteers

Arm Description

These patients have tennis elbow, according to stated inclusion criteria.

Healthy volunteers are selected and paired according to age, sex, socio-professional category and left- or right-handedness.

Outcomes

Primary Outcome Measures

Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow)
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.
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (good elbow)
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.

Secondary Outcome Measures

Visual Analog Scale for pain
A visual analog scale ranging from 0 to 100 is used to evaluate pain.
Visual Analog Scale for pain
A visual analog scale ranging from 0 to 100 is used to evaluate pain.
Q-Dash Questionnaire
The Quick DASH questionnaire is used to evaluate functional changes.
Q-Dash Questionnaire
The Quick DASH questionnaire is used to evaluate functional changes.
Thickness of the ECR longus and ECR brevis interface
The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)
Thickness of the ECR longus and ECR brevis interface, tennis elbow patients only
The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)
Thickness of the ECR -supinator interface
The thickness of the intersection (at the base) between the Extensor Carpi Radialis (ECR) muscles and the supinator is measured during ultrasound (mm)

Full Information

First Posted
July 7, 2011
Last Updated
March 29, 2018
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01390454
Brief Title
Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain
Acronym
EPICORE
Official Title
Study of the Relationship Between Functional Ultrasound Data and the Impact of Lateral Epicondylar Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 5, 2012 (Actual)
Primary Completion Date
June 18, 2013 (Actual)
Study Completion Date
June 18, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Epicondylitis, Lateral Humeral

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tennis elbow patients
Arm Type
Experimental
Arm Description
These patients have tennis elbow, according to stated inclusion criteria.
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Healthy volunteers are selected and paired according to age, sex, socio-professional category and left- or right-handedness.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound of the elbow 1, days 7 to 15
Intervention Description
The primary endpoint is evaluated a first time via an ultrasound exam.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound of the elbow 2, days 7 to 15
Intervention Description
The primary endpoint is evaluated a second time by a second practitioner.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound of the elbow 3, days 45 to 90
Intervention Description
A third ultrasound is performed only on tennis elbow patients between days 45 and 90.
Primary Outcome Measure Information:
Title
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow)
Description
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.
Time Frame
Days 7 to 15
Title
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (good elbow)
Description
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.
Time Frame
Days 7 to 15
Secondary Outcome Measure Information:
Title
Visual Analog Scale for pain
Description
A visual analog scale ranging from 0 to 100 is used to evaluate pain.
Time Frame
Baseline
Title
Visual Analog Scale for pain
Description
A visual analog scale ranging from 0 to 100 is used to evaluate pain.
Time Frame
Between days 45 and 90
Title
Q-Dash Questionnaire
Description
The Quick DASH questionnaire is used to evaluate functional changes.
Time Frame
Baseline
Title
Q-Dash Questionnaire
Description
The Quick DASH questionnaire is used to evaluate functional changes.
Time Frame
Between 45 and 90 days
Title
Thickness of the ECR longus and ECR brevis interface
Description
The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)
Time Frame
Between days 7 and 15
Title
Thickness of the ECR longus and ECR brevis interface, tennis elbow patients only
Description
The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)
Time Frame
Between days 45 and 90
Title
Thickness of the ECR -supinator interface
Description
The thickness of the intersection (at the base) between the Extensor Carpi Radialis (ECR) muscles and the supinator is measured during ultrasound (mm)
Time Frame
Between 7 and 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Dupeyron, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain

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