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

NCT02425839 | Completed

• 2 other identifiers: 14082032015-A00073-46
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Masseter Muscle Spasm

Keywords

shear wave elastography; surface electromyogram; masseter

Outcome Measures

Primary Outcomes (1)

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

  Day 1 (inclusion day)

Secondary Outcomes (3)

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

  Day 1 (inclusion day)

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

  Day 1 (inclusion day)

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

  Day 1 (inclusion day)

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Device: Ultrasound exam by Supersonic Shear Imaging® technique; Device: EMG examination by electromyograph Keypoint system

Interventions

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.

Experimental group

EMG examination by electromyograph Keypoint system DEVICE

Experimented neurologist performs EMG examination.

Experimental group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Trismus

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire BOUTET, MD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 24, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

FR (1)