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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01390454
First received: July 7, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Tennis Elbow
Epicondylitis, Lateral Humeral
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
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of the Relationship Between Functional Ultrasound Data and the Impact of Lateral Epicondylar Pain

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow) [ Time Frame: Days 7 to 15 ] [ Designated as safety issue: No ]
    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.

  • Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (good elbow) [ Time Frame: Days 7 to 15 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Visual Analog Scale for pain [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A visual analog scale ranging from 0 to 100 is used to evaluate pain.

  • Visual Analog Scale for pain [ Time Frame: Between days 45 and 90 ] [ Designated as safety issue: No ]
    A visual analog scale ranging from 0 to 100 is used to evaluate pain.

  • Q-Dash Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Quick DASH questionnaire is used to evaluate functional changes.

  • Q-Dash Questionnaire [ Time Frame: Between 45 and 90 days ] [ Designated as safety issue: No ]
    The Quick DASH questionnaire is used to evaluate functional changes.

  • Thickness of the ECR longus and ECR brevis interface [ Time Frame: Between days 7 and 15 ] [ Designated as safety issue: No ]
    The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)

  • Thickness of the ECR longus and ECR brevis interface, tennis elbow patients only [ Time Frame: Between days 45 and 90 ] [ Designated as safety issue: No ]
    The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)

  • Thickness of the ECR -supinator interface [ Time Frame: Between 7 and 15 days ] [ Designated as safety issue: No ]
    The thickness of the intersection (at the base) between the Extensor Carpi Radialis (ECR) muscles and the supinator is measured during ultrasound (mm)


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390454

Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Arnaud Dupeyron, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01390454     History of Changes
Other Study ID Numbers: LOCAL/2010/AD-03b, 2011-A00769-32
Study First Received: July 7, 2011
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014