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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Epicondylitis, Lateral Humeral; Tennis Elbow

Treatments: Procedure: Ultrasound of the elbow 3, days 45 to 90; Procedure: Ultrasound of the elbow 1, days 7 to 15; Procedure: Ultrasound of the elbow 2, days 7 to 15

Study type: Interventional

Funder types: Other

Identifiers

NCT01390454

2011-A00769-32 (Other Identifier)

LOCAL/2010/AD-03b

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Tennis elbow patients

Experimental group

Description:

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

Treatment:

Procedure: Ultrasound of the elbow 1, days 7 to 15

Procedure: Ultrasound of the elbow 3, days 45 to 90

Procedure: Ultrasound of the elbow 2, days 7 to 15

Healthy volunteers

Active Comparator group

Description:

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

Treatment:

Procedure: Ultrasound of the elbow 1, days 7 to 15

Procedure: Ultrasound of the elbow 2, days 7 to 15