Masseter Muscle SpasmEVERESTNCT02425839
Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter
A study testing Ultrasound exam by Supersonic Shear Imaging® technique and EMG examination by electromyograph Keypoint system in people with Masseter Muscle Spasm, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Masseter Muscle Spasm
- What is being tested?
- Ultrasound exam by Supersonic Shear Imaging® technique and EMG examination by electromyograph Keypoint system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People with social security.
- People aged 20 to 40 years, of both sexes.
- People that gave and signed consent to participate in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter, in Rest and Maximal Voluntary Contraction
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
- Being tested
- Ultrasound exam by Supersonic Shear Imaging® technique, EMG examination by electromyograph Keypoint system
- Keywords
- shear wave elastography, surface electromyogram, masseter
- Medical subject headings
- Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound exam by Supersonic Shear Imaging® techniqueDevice
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 systemDevice
Experimented neurologist performs EMG examination.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | * ultrasound exam by Supersonic Shear Imaging® technique
* EMG examination by electromyograph Keypoint system. Receives: Device: Ultrasound exam by Supersonic Shear Imaging® technique; Device: EMG examination by electromyograph Keypoint system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastic modulus using Supersonic Shear Imaging® technique on superficial and deep masseter parts at rest and maximal voluntary contraction.
Measured: Day 1 (inclusion day)
Secondary outcomes (3)
Thickness of the whole masseter mesured by Supersonic Shear Imaging® technique
Measured: Day 1 (inclusion day)
Thickness of the masseter superficial part mesured by Supersonic Shear Imaging® technique
Measured: Day 1 (inclusion day)
Thickness of the masseter deep part mesured by Supersonic Shear Imaging® technique
Measured: Day 1 (inclusion day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masseter Muscle SpasmStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire BOUTET, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425839
- Sponsor's protocol ID
- 1408203
- Other IDs
- 2015-A00073-46
- Acronym
- EVEREST
- Status last verified
- Nov 2015
- First submitted
- 9 Apr 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter, in Rest and Maximal Voluntary Contraction
- ClinicalTrials.gov ID
- NCT02425839
- Acronym / sponsor ID
- EVEREST / 1408203
- Conditions
- Masseter Muscle Spasm
- Keywords
- shear wave elastography, surface electromyogram, masseter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Ultrasound exam by Supersonic Shear Imaging® technique, Device: EMG examination by electromyograph Keypoint system* ultrasound exam by Supersonic Shear Imaging® technique * EMG examination by electromyograph Keypoint system. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- People with social security.
- People aged 20 to 40 years, of both sexes.
- People that gave and signed consent to participate in the study.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound exam by Supersonic Shear Imaging® techniqueEach of the two observers performs twice ultrasound examination and measures of the masseter thickness and its elastic modulus, at rest and maximal voluntary contraction. | Device | Experimental group |
| EMG examination by electromyograph Keypoint systemExperimented neurologist performs EMG examination. | Device | Experimental group |
Primary outcome
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)
3 secondary outcomes
Thickness of the whole masseter mesured by Supersonic Shear Imaging® technique
Time frame: Day 1 (inclusion day)
Thickness of the masseter superficial part mesured by Supersonic Shear Imaging® technique
Time frame: Day 1 (inclusion day)
Thickness of the masseter deep part mesured by Supersonic Shear Imaging® technique
Time frame: Day 1 (inclusion day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
Related trials for Masseter Muscle Spasm
Recruiting
Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal
Neuromuscular Blockade Reversal Agent, Perioperative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire BOUTET, MD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound exam by Supersonic Shear Imaging® technique and EMG examination by electromyograph Keypoint system in people with Masseter Muscle Spasm, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.