Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter

NCT ID: NCT02425839

Last Updated: 2015-11-06

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-05-31

Brief Summary

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Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory dysfunction and follow up of treatment effectiveness is currently based only on clinical features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in order to study its viscoelastic properties.

In this study, the investigators study the correlation between changes of shear wave elastography modulus and surface electromyogram features of the masseters between rest and maximal voluntary contraction.

Detailed Description

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Conditions

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Masseter Muscle Spasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Experimental group

* ultrasound exam by Supersonic Shear Imaging® technique
* EMG examination by electromyograph Keypoint system.

Group Type EXPERIMENTAL

Ultrasound exam by Supersonic Shear Imaging® technique

Intervention Type DEVICE

Each of the two observers performs twice ultrasound examination and measures of the masseter thickness and its elastic modulus, at rest and maximal voluntary contraction.

EMG examination by electromyograph Keypoint system

Intervention Type DEVICE

Experimented neurologist performs EMG examination.

Interventions

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Ultrasound exam by Supersonic Shear Imaging® technique

Each of the two observers performs twice ultrasound examination and measures of the masseter thickness and its elastic modulus, at rest and maximal voluntary contraction.

Intervention Type DEVICE

EMG examination by electromyograph Keypoint system

Experimented neurologist performs EMG examination.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* People with social security.
* People aged 20 to 40 years, of both sexes.
* People that gave and signed consent to participate in the study.

Exclusion Criteria

* Any concomitant muscle disease (myopathy, myositis…)
* Botulinum toxin injections in the masseter in the last 3 months preceding the study.
* Any treatment that induces muscular effect (baclofen, benzodiazepine)
* Bruxism or any masticatory apparatus disease
* Any surgery of the masticatory apparatus
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire BOUTET, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00073-46

Identifier Type: OTHER

Identifier Source: secondary_id

1408203

Identifier Type: -

Identifier Source: org_study_id

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