Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain

Tennis Elbow Clinical Trial

— EPICORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390454
• Other study ID #: LOCAL/2010/AD-03b
• Secondary ID: 2011-A00769-32
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: March 29, 2018
• Start date: March 5, 2012
• Est. completion date: June 18, 2013

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 18, 2013
• Est. primary completion date: June 18, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epicondylitis, Lateral Humeral
• Tennis Elbow

Intervention

Procedure:
• Ultrasound of the elbow 1, days 7 to 15
The primary endpoint is evaluated a first time via an ultrasound exam.
• Ultrasound of the elbow 2, days 7 to 15
The primary endpoint is evaluated a second time by a second practitioner.
• Ultrasound of the elbow 3, days 45 to 90
A third ultrasound is performed only on tennis elbow patients between days 45 and 90.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Visual Analog Scale for pain	A visual analog scale ranging from 0 to 100 is used to evaluate pain.	Baseline
Secondary	Visual Analog Scale for pain	A visual analog scale ranging from 0 to 100 is used to evaluate pain.	Between days 45 and 90
Secondary	Q-Dash Questionnaire	The Quick DASH questionnaire is used to evaluate functional changes.	Baseline
Secondary	Q-Dash Questionnaire	The Quick DASH questionnaire is used to evaluate functional changes.	Between 45 and 90 days
Secondary	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
Secondary	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
Secondary	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