Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain

NCT01390454 | Completed

• 2 other identifiers: LOCAL/2010/AD-03b2011-A00769-32
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tennis Elbow; Epicondylitis, Lateral Humeral

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Visual Analog Scale for pain

  Baseline

• Visual Analog Scale for pain

  Between days 45 and 90

• Q-Dash Questionnaire

  Baseline

• Q-Dash Questionnaire

  Between 45 and 90 days

• Thickness of the ECR longus and ECR brevis interface

  Between days 7 and 15

Study Arms (2)

Tennis elbow patients

EXPERIMENTAL

These patients have tennis elbow, according to stated inclusion criteria.

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

Healthy volunteers

ACTIVE COMPARATOR

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; Procedure: Ultrasound of the elbow 2, days 7 to 15

Interventions

Ultrasound of the elbow 1, days 7 to 15 PROCEDURE

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

Healthy volunteers; Tennis elbow patients

Ultrasound of the elbow 2, days 7 to 15 PROCEDURE

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

Healthy volunteers; Tennis elbow patients

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.

Tennis elbow patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• The patient is included in another 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
• The subject is included in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Arnaud Dupeyron, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 11, 2011
• Study Start: March 5, 2012
• Primary Completion: June 18, 2013
• Study Completion: June 18, 2013
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

FR (1)