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Completed

NCT Number: NCT01390454

Relationships Between 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.

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Key information

Conditions

Tennis Elbow Arm Injuries Elbow Injuries Elbow Tendinopathy Epicondylitis, Lateral Humeral Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound of the elbow 1, days 7 to 15

Procedure

The primary endpoint is evaluated a first time via an ultrasound exam.

Ultrasound of the elbow 2, days 7 to 15

Procedure

The primary endpoint is evaluated a second time by a second practitioner.

Ultrasound of the elbow 3, days 45 to 90

Procedure

A third ultrasound is performed only on tennis elbow patients between days 45 and 90.

Primary outcomes

  1. Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow)

    Time frame: Days 7 to 15

    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.

  2. Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (good elbow)

    Time frame: Days 7 to 15

    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 outcomes

  1. Visual Analog Scale for pain

    Time frame: Baseline

    A visual analog scale ranging from 0 to 100 is used to evaluate pain.

  2. Visual Analog Scale for pain

    Time frame: Between days 45 and 90

    A visual analog scale ranging from 0 to 100 is used to evaluate pain.

  3. Q-Dash Questionnaire

    Time frame: Baseline

    The Quick DASH questionnaire is used to evaluate functional changes.

  4. Q-Dash Questionnaire

    Time frame: Between 45 and 90 days

    The Quick DASH questionnaire is used to evaluate functional changes.

  5. Thickness of the ECR longus and ECR brevis interface

    Time frame: Between days 7 and 15

    The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)

  6. Thickness of the ECR longus and ECR brevis interface, tennis elbow patients only

    Time frame: Between days 45 and 90

    The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)

  7. Thickness of the ECR -supinator interface

    Time frame: Between 7 and 15 days

    The thickness of the intersection (at the base) between the Extensor Carpi Radialis (ECR) muscles and the supinator is measured during ultrasound (mm)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: EPICORE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2011
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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