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Completed

NCT Number: NCT02425839

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

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.

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Key information

Conditions

Masseter Muscle Spasm Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Trismus

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ultrasound exam by Supersonic Shear Imaging® technique

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

Device

Experimented neurologist performs EMG examination.

Primary outcomes

  1. Elastic modulus using Supersonic Shear Imaging® technique on superficial and deep masseter parts at rest and maximal voluntary contraction.

    Time frame: Day 1 (inclusion day)

Secondary outcomes

  1. Thickness of the whole masseter mesured by Supersonic Shear Imaging® technique

    Time frame: Day 1 (inclusion day)

  2. Thickness of the masseter superficial part mesured by Supersonic Shear Imaging® technique

    Time frame: Day 1 (inclusion day)

  3. Thickness of the masseter deep part mesured by Supersonic Shear Imaging® technique

    Time frame: Day 1 (inclusion day)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter, in Rest and Maximal Voluntary Contraction

Acronym: EVEREST

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 24, 2015
Registry last updated
Nov 6, 2015

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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