Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain

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

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

Conditions
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Tennis Elbow, Epicondylitis, Lateral Humeral

Intervention / Treatment
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* Procedure: Ultrasound of the elbow 1, days 7 to 15
* Procedure: Ultrasound of the elbow 2, days 7 to 15
* Procedure: Ultrasound of the elbow 3, days 45 to 90


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tennis elbow patients<br>These patients have tennis elbow, according to stated inclusion criteria. | Procedure: Ultrasound of the elbow 1, days 7 to 15<br>* The primary endpoint is evaluated a first time via an ultrasound exam.<br>Procedure: Ultrasound of the elbow 2, days 7 to 15<br>* The primary endpoint is evaluated a second time by a second practitioner.<br>Procedure: Ultrasound of the elbow 3, days 45 to 90<br>* A third ultrasound is performed only on tennis elbow patients between days 45 and 90.<br>|
| Active Comparator: Healthy volunteers<br>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<br>* The primary endpoint is evaluated a first time via an ultrasound exam.<br>Procedure: Ultrasound of the elbow 2, days 7 to 15<br>* The primary endpoint is evaluated a second time by a second practitioner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Days 7 to 15 | 
| 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. | Days 7 to 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for pain | A visual analog scale ranging from 0 to 100 is used to evaluate pain. | Baseline | 
| Visual Analog Scale for pain | A visual analog scale ranging from 0 to 100 is used to evaluate pain. | Between days 45 and 90 | 
| Q-Dash Questionnaire | The Quick DASH questionnaire is used to evaluate functional changes. | Baseline | 
| Q-Dash Questionnaire | The Quick DASH questionnaire is used to evaluate functional changes. | Between 45 and 90 days | 
| 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) | Between days 7 and 15 | 
| 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) | Between days 45 and 90 | 
| 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) | Between 7 and 15 days |