Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain

NCT ID: NCT01390454

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-05

Study Completion Date

2013-06-18

Brief Summary

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

Detailed Description

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Conditions

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Tennis Elbow Epicondylitis, Lateral Humeral

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tennis elbow patients

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

Group Type EXPERIMENTAL

Ultrasound of the elbow 1, days 7 to 15

Intervention Type PROCEDURE

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

Ultrasound of the elbow 2, days 7 to 15

Intervention Type PROCEDURE

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

Ultrasound of the elbow 3, days 45 to 90

Intervention Type PROCEDURE

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

Healthy volunteers

Healthy volunteers are selected and paired according to age, sex, socio-professional category and left- or right-handedness.

Group Type ACTIVE_COMPARATOR

Ultrasound of the elbow 1, days 7 to 15

Intervention Type PROCEDURE

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

Ultrasound of the elbow 2, days 7 to 15

Intervention Type PROCEDURE

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

Interventions

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Ultrasound of the elbow 1, days 7 to 15

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

Intervention Type PROCEDURE

Ultrasound of the elbow 2, days 7 to 15

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud Dupeyron, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Centre Hospitalier Universitaire de Nîmes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2011-A00769-32

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2010/AD-03b

Identifier Type: -

Identifier Source: org_study_id

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