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

Masseter Muscle Spasm Clinical Trial

— EVEREST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425839
• Other study ID #: 1408203
• Secondary ID: 2015-A00073-46
• Status: Completed
• Phase: N/A
• First received: April 9, 2015
• Last updated: November 5, 2015
• Start date: May 2015
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Masseter Muscle Spasm
• Spasm

Intervention

Device:
• 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.
• EMG examination by electromyograph Keypoint system
Experimented neurologist performs EMG examination.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elastic modulus using Supersonic Shear Imaging® technique on superficial and deep masseter parts at rest and maximal voluntary contraction.		Day 1 (inclusion day)	No
Secondary	Thickness of the whole masseter mesured by Supersonic Shear Imaging® technique		Day 1 (inclusion day)	No
Secondary	Thickness of the masseter superficial part mesured by Supersonic Shear Imaging® technique		Day 1 (inclusion day)	No
Secondary	Thickness of the masseter deep part mesured by Supersonic Shear Imaging® technique		Day 1 (inclusion day)	No