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

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

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

Study Overview

• Status: Completed
• Conditions: Tennis Elbow; Epicondylitis, Lateral Humeral
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2012
• Primary Completion (ACTUAL): June 18, 2013
• Study Completion (ACTUAL): June 18, 2013

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (ESTIMATE): July 11, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 29, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: LOCAL/2010/AD-03b; 2011-A00769-32 (OTHER: RBC number)