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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014