Temporomandibular DisorderNCT02632643
Assessment of the Efficacy of a Sensorimotor Approach After Maximum Three Sessions in Subjects With TMD With Hypertonia
A study testing Sensorimotor education with a view to obtaining an optimal FWS further to the relaxation of the masticatory, lingual and labial system. Learning of mandibular micro-movements in 5 directions. in people with Temporomandibular Disorder, run by Osteovox at 6 sites in 3 countries.
Trial summary
The study aims to demonstrate the efficacy of the sensorimotor approach developed by A. Piron (taught to the patient in three sessions) regarding three parameters related to TMD: facial pain, functional incapacities and hypertonia. Read more about this study
- Who is it for?
- Ages 18 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Sensorimotor education with a view to obtaining an optimal FWS further to the relaxation of the masticatory, lingual and labial system. Learning of mandibular micro-movements in 5 directions.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jan 2016to 31 Dec 2017
- 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 18 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 to 77 years old.
- Subjects presenting the following 3 characteristics:
- A TMD disorder (objectivized by the DC/TMD 2014);
- Facial pain in the last 30 days (objectivized by the Graded Chronic Pain Scale version 2.0 (GCPS v2.0)) and/or functional incapacity (chewing, mobility, verbal and emotional communication) in the last 30 days (objectivized by the Jaw Functional Limitation Scale 20 (JFLS-20));
- Hypertonia (objectivized by the Oral Behaviors Checklist (OBC) short version and the Explanatory Model Scale).
- Subjects who agree to comply with the requirements of the study. Subjects who are of age (and know how to read and write) who have given their informed, explicit consent in advance to any procedure related to the trial, the study or the investigation conducted on human beings, with the objective of developing knowledge specific to the exercise of health care professions, as set out in Royal Decree No. 78 of 10 November 1967 on the practice of the health care professions (Act of 27 December 2005).
- Subjects insured under social security.
Who cannot join
- Any subject presenting at least one of the following criteria may not be included:
- Significant medical problems involving the following conditions:
- Severe or progressive pathology (psychiatric, neurological, cardiopulmonary, renal, hepatic, endocrinological, hematological, neoplastic, infectious, metabolic or allergic).
- Any acute trauma of the temporomandibular joint (trauma within the last 72 hours).
- Severe anxiety or severe depression, as defined by a score greater than or equal to 15 on the HAD.
- Pregnant women
Show all 20Show fewer
- Criteria related to prior or concurrent treatments:
- Treatment with antipsychotics, anxiolytics, soporifics or muscle relaxants started within the two months preceding the study.
- Treatment with intraoral implants during the study or in the two months preceding the study.
- Criteria related to lifestyle: Excessive alcohol consumption (WHO definition: more than two glasses per day for a woman and more than three for a man).
- Subjects undergoing withdrawal or taking a replacement substance.
- Criteria related to the subject: Subjects unlikely, in the investigator's view, to comply with the instructions in the protocol.
- Subjects unlikely, on the basis of a score <2 to question "C" of the Explanatory Model Scale, to comply with the therapy.
- Subjects who had participated in a clinical trial in the previous month or were participating at the time of selection.
- Subjects without the linguistic or psychological capacity to understand and sign the informed consent form and complete the psychometric questionnaires and psychological tests.
- In addition to becoming aware a posteriori of an error related to the inclusion or exclusion criteria defined above, the therapist may decide to remove a subject before completion of the study.
- The motivations for early exit are as follows:
- Subject who no longer agrees to comply with the requirements of the study.
- Occurrence of a major life stressor (score greater than 40 on the Holmes and Rahe Stress Scale).
- Need to redirect the subject to a different treatment. Any early exit from the study, whether decided on by the subject, the therapist or both together, will be recorded on a specific document, indicating the date and the reasons for the early exit.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Belgium3 sites
Cabinet de Logopédie Liesens-Denis
Berneau, Liège, 4607
Cabinet d'Ostéopathie PIRON
Beyne-Heusay, Liège, 4610
Cabinet de groupe LHR
Saive, Liège, 4671
Italy2 sites
ANTONIO BIANCO Ortodontista e Osteopata
Gussago Bs, Brescia, 25064
Osteopata MARCO SBARBARO
Robassomero, Torino, 10070
About this study
Official title: Assessment of the Efficacy of a Sensorimotor Approach After Maximum Three Sessions in Subjects With Symptomatic Temporomandibular Dysfunction (TMD) With Hypertonia: A Prospective, Multicenter Case Study.
The study aims to demonstrate the efficacy of the sensorimotor approach developed by A. Piron (taught to the patient in three sessions) regarding three parameters related to TMD: facial pain, functional incapacities and hypertonia.
The subjects in the study are 18 to 77 years old and present the following conditions: a TMD disorder caused or aggravated by hypertonia and responsible for cervico-maxillo-facial pain and/or a functional incapacity in the last 30 days.
- Conditions
- Temporomandibular Disorder
- Being tested
- Sensorimotor education with a view to obtaining an optimal FWS further to the relaxation of the masticatory, lingual and labial system. Learning of mandibular micro-movements in 5 directions.
- Keywords
- TMD, HYPERTONIA, PARAFUNCTIONS, SENSORIMOTOR APPROACH
- Medical subject headings
- Temporomandibular Joint Disorders, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor education with a view to obtaining an optimal FWS further to the relaxation of the masticatory, lingual and labial system. Learning of mandibular micro-movements in 5 directions.Behavioural
| Study group | Role | What they receive |
|---|---|---|
| lifestyle counseling | Experimental | Not described Receives: Behavioral: Sensorimotor education with a view to obtaining an optimal FWS further to the relaxation of the masticatory, lingual and labial system. Learning of mandibular micro-movements in 5 directions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall relief (from 0% to 100%) based on the ratio of "complaint after treatment" to "complaint before treatment". Multiple measurements related to both pain and functional incapacity are aggregated to arrive at one reported value: complaint
Patient's complaint is calculated:
- By integrating the weighting of both pain (P) and functional incapacity (FI) parameters in the complaint. 11 possibilities: [100% P - 0% FI] OR [90% P - 10% FI] OR [80% P - 20% FI] etc.
- Patient's complaint = Pain and/or functional incapacity
- Assessement of pain integrates 2 or 3 or 4 parameters: 2 are constant (intensity and frequency), 2 are optional (quality of life and drugs) because some painful patient don't take drug or don't have an altered quality of life. If there are 2 parameters, each = 50%; if 3 parameters, each = 33,3%; if 4 parameters, each = 25%
- The scoring of the 4 pain parameters is based on questionnaires: Intensity: GCPS v2.0 (part 1): Score 0 to 100; Frequency (last month): Score 0 to 30; Drug: number of gram of the most specific medication (last month); Quality of life: GCPS v2.0 (part 2): score 0 to 6
- Assessement of functional incapacity integrates 1 parameter: the JFLS-20 questionnaire (score from 0 to 200)
Measured: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Secondary outcomes (12)
Evidence of a change from baseline in the "intensity" component of cervico-maxillo-facial pain (a component of the primary outcome measure), on the basis of a questionnaire called "the Graded Chronic Pain Scale Version 2 (GCPS v2.0) (part 1)".
3 Visual Analogic Scales (VAS) > 0 to 10. The scoring = the mean (0 to 100).
Measured: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in the "impact on quality of life" component of facial pain (a component of the primary outcome measure), on the basis of questionnaire called "the Graded Chronic Pain Scale Version 2 (GCPS v2.0) (part 2)".
3 Visual Analogic Scales (VAS) > 0 to 10 and a 4th question about "how many days did pain keep the patient from doing usual activities" > 0 to 30 days.
These 4 questions lead to a incapacity score from 0 to 6
Measured: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in the "frequency" component of facial pain (a component of the primary outcome measure), on the basis of a questionnaire developed by the authors.
One question: "During the last 30 days, how many days did you have facial pain?" > 0 to 30 days
Measured: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in the "taking the most specific medication for painful attacks" component of facial pain (a component of the primary outcome measure), on the basis of a questionnaire developed by the authors.
One question: "During the last 30 days, which drugs did you take to improve your facial pain?". Only one drug is taken into account: the most specific one used for facial pain > number of gram for the last month.
Measured: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in functional incapacity (a component of the primary outcome measure), on the basis of a questionnaire called " the Jaw Functional Limitation Scale (JFLS-20)".
20 Visual Analogic Scales (VAS) > 0 to 10. The scoring = the sum (0 to 200).
Measured: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in oral behaviors induced by hypertonia, on the basis of a questionnaire developed by the authors and called "the short version of the Oral Behavior Checklist (OBC)".
10 Visual Analogic Scales (VAS) > 0 to 4. The scoring = the sum (0 to 40).
Measured: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in dysacusis and feelings of dizziness, on the basis of a specific questionnaire developed by the authors.
7 Visual Analogic Scales (VAS) > 0 to 4. The scoring = the sum (0 to 28).
Measured: Beginning (day 0) and end (day 180)
Evidence of a change from baseline in the patient's compliance with the treatment, on the basis of a questionnaire developed by the authors.
2 Visual Analogic Scales (VAS) about both "observation" and "exercices" > 0 to 10.
The scoring = the sum (0 to 20).
Measured: During treatment (day 30 and day 90) and end (day 180)
Evidence of the patient's subjective impressions of the treatment, on the basis of a questionnaire developed by the authors.
3 Visual Analogic Scales (VAS) about "difficulty of the treatment", "impact of the treatment on the long term" and "treatment easy to use in case of recurrence > 0 to 10.
The scoring = the sum (0 to 30).
Measured: end (day 180)
Evidence of correlations between the patient's psychological state (assessed with the HAD and SCL-90R) and the therapeutic efficacy of the approach (assessed by the patient's overall relief).
2 questionnaires:
- Hospital Anxiety and Depression Scale (HADS): 7 questions about anxiety (0 to 3) > Scoring = sum (0 to 21) and 7 questions about depression (0 to 3) > Scoring = sum (0 to 21).
- Symptom Check-List (SCL 90 R): 90 questions about personality (0 to 4) > Scoring = 9 dimensions of the personality.
See if there is a correlation between psychological state and therapeutic efficacy
Measured: Beginning (day 0)
Evidence of correlations between the patient's psychological state (assessed with the HAD and SCL-90R) and compliance with the treatment (assessed with a numerical scale created by the team in anticipation of the study).
2 questionnaires:
- Hospital Anxiety and Depression Scale (HADS): 7 questions about anxiety (0 to 3) > Scoring = sum (0 to 21) and 7 questions about depression (0 to 3) > Scoring = sum (0 to 21).
- Symptom Check-List (SCL 90 R): 90 questions about personality (0 to 4) > Scoring = 9 dimensions of the personality.
See if there is a correlation between psychological state and compliance
Measured: Beginning (day 0)
Evidence of the percentage of subjects diagnosed as hypertonic among all the patients diagnosed as having TMD (whether or not included in the study) by tracking the patients with a flowchart developed by the authors.
flowchart filled in by all investigators. At the top of the flowchart: all patients diagnosed TMD. The flowchart integrates all hypertonic patients. See the ratio: hypertonic TMD patients / All TMD patients.
Measured: end (day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion31 Oct 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osteovox
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L'HOMME Sébastien, Osteovox
- Investigators
- L'HOMME Sébastien, Dentist, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632643
- Sponsor's protocol ID
- B707201525923
- Status last verified
- Apr 2017
- First submitted
- 6 Dec 2015
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of a Sensorimotor Approach After Maximum Three Sessions in Subjects With Symptomatic Temporomandibular Dysfunction (TMD) With Hypertonia: A Prospective, Multicenter Case Study.
- ClinicalTrials.gov ID
- NCT02632643
- Acronym / sponsor ID
- B707201525923
- Conditions
- Temporomandibular Disorder
- Keywords
- TMD, HYPERTONIA, PARAFUNCTIONS, SENSORIMOTOR APPROACH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- OsteovoxUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 31 Oct 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 17 Dec 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.
The study aims to demonstrate the efficacy of the sensorimotor approach developed by A. Piron (taught to the patient in three sessions) regarding three parameters related to TMD: facial pain, functional incapacities and hypertonia.
The subjects in the study are 18 to 77 years old and present the following conditions: a TMD disorder caused or aggravated by hypertonia and responsible for cervico-maxillo-facial pain and/or a functional incapacity in the last 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle counseling | Experimental | Behavioral: Sensorimotor education with a view to obtaining an optimal FWS further to the relaxation of the masticatory, lingual and labial system. Learning of mandibular micro-movements in 5 directions. |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged 18 to 77 years old.
- A TMD disorder (objectivized by the DC/TMD 2014);
- Facial pain in the last 30 days (objectivized by the Graded Chronic Pain Scale version 2.0 (GCPS v2.0)) and/or functional incapacity (chewing, mobility, verbal and emotional communication) in the last 30 days (objectivized by the Jaw Functional Limitation Scale 20 (JFLS-20));
- Hypertonia (objectivized by the Oral Behaviors Checklist (OBC) short version and the Explanatory Model Scale).
- Subjects who agree to comply with the requirements of the study. Subjects who are of age (and know how to read and write) who have given their informed, explicit consent in advance to any procedure related to the trial, the study or the investigation conducted on human beings, with the objective of developing knowledge specific to the exercise of health care professions, as set out in Royal Decree No. 78 of 10 November 1967 on the practice of the health care professions (Act of 27 December 2005).
Key exclusion criteria (20 listed)
- Any subject presenting at least one of the following criteria may not be included:
- Significant medical problems involving the following conditions:
- Severe or progressive pathology (psychiatric, neurological, cardiopulmonary, renal, hepatic, endocrinological, hematological, neoplastic, infectious, metabolic or allergic).
- Any acute trauma of the temporomandibular joint (trauma within the last 72 hours).
- Severe anxiety or severe depression, as defined by a score greater than or equal to 15 on the HAD.
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 |
|---|---|---|
| Sensorimotor education with a view to obtaining an optimal FWS further to the relaxation of the masticatory, lingual and labial system. Learning of mandibular micro-movements in 5 directions. | Behavioural | lifestyle counseling |
Primary outcome
Overall relief (from 0% to 100%) based on the ratio of "complaint after treatment" to "complaint before treatment". Multiple measurements related to both pain and functional incapacity are aggregated to arrive at one reported value: complaint
Time frame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Patient's complaint is calculated: * By integrating the weighting of both pain (P) and functional incapacity (FI) parameters in the complaint. 11 possibilities: [100% P - 0% FI] OR [90% P - 10% FI] OR [80% P - 20% FI] etc. * Patient's complaint = Pain and/or functional incapacity * Assessement of pain integrates 2 or 3 or 4 parameters: 2 are constant (intensity and frequency), 2 are optional (quality of life and drugs) because some painful patient don't take drug or don't have an altered quality of life. If there are 2 parameters, each = 50%; if 3 parameters, each = 33,3%; if 4 parameters, each = 25% * The scoring of the 4 pain parameters is based on questionnaires: Intensity: GCPS v2.0 (part 1): Score 0 to 100; Frequency (last month): Score 0 to 30; Drug: number of gram of the most specific medication (last month); Quality of life: GCPS v2.0 (part 2): score 0 to 6 * Assessement of functional incapacity integrates 1 parameter: the JFLS-20 questionnaire (score from 0 to 200)
12 secondary outcomes
Evidence of a change from baseline in the "intensity" component of cervico-maxillo-facial pain (a component of the primary outcome measure), on the basis of a questionnaire called "the Graded Chronic Pain Scale Version 2 (GCPS v2.0) (part 1)".
Time frame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in the "impact on quality of life" component of facial pain (a component of the primary outcome measure), on the basis of questionnaire called "the Graded Chronic Pain Scale Version 2 (GCPS v2.0) (part 2)".
Time frame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in the "frequency" component of facial pain (a component of the primary outcome measure), on the basis of a questionnaire developed by the authors.
Time frame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in the "taking the most specific medication for painful attacks" component of facial pain (a component of the primary outcome measure), on the basis of a questionnaire developed by the authors.
Time frame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in functional incapacity (a component of the primary outcome measure), on the basis of a questionnaire called " the Jaw Functional Limitation Scale (JFLS-20)".
Time frame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in oral behaviors induced by hypertonia, on the basis of a questionnaire developed by the authors and called "the short version of the Oral Behavior Checklist (OBC)".
Time frame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Evidence of a change from baseline in dysacusis and feelings of dizziness, on the basis of a specific questionnaire developed by the authors.
Time frame: Beginning (day 0) and end (day 180)
Evidence of a change from baseline in the patient's compliance with the treatment, on the basis of a questionnaire developed by the authors.
Time frame: During treatment (day 30 and day 90) and end (day 180)
Evidence of the patient's subjective impressions of the treatment, on the basis of a questionnaire developed by the authors.
Time frame: end (day 180)
Evidence of correlations between the patient's psychological state (assessed with the HAD and SCL-90R) and the therapeutic efficacy of the approach (assessed by the patient's overall relief).
Time frame: Beginning (day 0)
Evidence of correlations between the patient's psychological state (assessed with the HAD and SCL-90R) and compliance with the treatment (assessed with a numerical scale created by the team in anticipation of the study).
Time frame: Beginning (day 0)
Evidence of the percentage of subjects diagnosed as hypertonic among all the patients diagnosed as having TMD (whether or not included in the study) by tracking the patients with a flowchart developed by the authors.
Time frame: end (day 180)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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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.
L'HOMME Sébastien, Dentist principal investigator
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorimotor education with a view to obtaining an optimal FWS further to the relaxation of the masticatory, lingual and labial system. Learning of mandibular micro-movements in 5 directions. in people with Temporomandibular Disorder, run by Osteovox at 6 sites in 3 countries.
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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Italy, 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?
Results are not available in the source record.
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?
Overall relief (from 0% to 100%) based on the ratio of "complaint after treatment" to "complaint before treatment". Multiple measurements related to both pain and functional incapacity are aggregated to arrive at one reported value: complaint (time frame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)). 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 10 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.