Clinical trial NCT01390454: Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain
Official title: Study of the Relationship Between Functional Ultrasound Data and the Impact of Lateral Epicondylar Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Epicondylitis, Lateral Humeral
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow)
timeFrame: Days 7 to 15
measure: Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (good elbow)
timeFrame: Days 7 to 15
Secondary outcomes:
measure: Visual Analog Scale for pain
timeFrame: Baseline
measure: Visual Analog Scale for pain
timeFrame: Between days 45 and 90
measure: Q-Dash Questionnaire
timeFrame: Baseline
measure: Q-Dash Questionnaire
timeFrame: Between 45 and 90 days
measure: Thickness of the ECR longus and ECR brevis interface
timeFrame: Between days 7 and 15
measure: Thickness of the ECR longus and ECR brevis interface, tennis elbow patients only
timeFrame: Between days 45 and 90
measure: Thickness of the ECR -supinator interface
timeFrame: Between 7 and 15 days
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: