Relationships Between Ultrasound Data and the Impact of L... | NCT01390454

ID	Type	Description	Link
2011-A00769-32	Other Identifier	RBC number

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tennis elbow patients	Experimental	These patients have tennis elbow, according to stated inclusion criteria.	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
Healthy volunteers	Active Comparator	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 Procedure: Ultrasound of the elbow 2, days 7 to 15

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound of the elbow 1, days 7 to 15	Procedure	The primary endpoint is evaluated a first time via an ultrasound exam.	Healthy volunteers Tennis elbow patients

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

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:

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