Clinical trial NCT02632643: Assessment of the Efficacy of a Sensorimotor Approach After Maximum Three Sessions in Subjects With TMD With Hypertonia
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorder
Keywords: TMD
HYPERTONIA
PARAFUNCTIONS
SENSORIMOTOR APPROACH
Lead sponsor: Osteovox
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 to 77 years old.

Subjects presenting the following 3 characteristics:

1. A TMD disorder (objectivized by the DC/TMD 2014);
2. 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));
3. 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.

Exclusion Criteria:

* 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
* 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.

Exclusion criteria after acceptance in the study:

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.

Primary outcomes:
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
timeFrame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
Secondary outcomes:
measure: 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)".
timeFrame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
measure: 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)".
timeFrame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
measure: 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.
timeFrame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
measure: 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.
timeFrame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
measure: 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)".
timeFrame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
measure: 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)".
timeFrame: Beginning (day 0); during treatment (day 30 and day 90); end (day 180)
measure: Evidence of a change from baseline in dysacusis and feelings of dizziness, on the basis of a specific questionnaire developed by the authors.
timeFrame: Beginning (day 0) and end (day 180)
measure: Evidence of a change from baseline in the patient's compliance with the treatment, on the basis of a questionnaire developed by the authors.
timeFrame: During treatment (day 30 and day 90) and end (day 180)
measure: Evidence of the patient's subjective impressions of the treatment, on the basis of a questionnaire developed by the authors.
timeFrame: end (day 180)
measure: 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).
timeFrame: Beginning (day 0)
measure: 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).
timeFrame: Beginning (day 0)
measure: 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.
timeFrame: end (day 180)
Other outcomes:
Locations:
city: Berneau
country: Belgium
facility: Cabinet de Logopédie Liesens-Denis
state: Liège
city: Beyne-Heusay
country: Belgium
facility: Cabinet d'Ostéopathie PIRON
state: Liège
city: Saive
country: Belgium
facility: Cabinet de groupe LHR
state: Liège
city: Nantes
country: France
facility: Cabinet d'Ostéopathie Garcion
state: Loire-Atlantique
city: Gussago Bs
country: Italy
facility: ANTONIO BIANCO Ortodontista e Osteopata
state: Brescia
city: Robassomero
country: Italy
facility: Osteopata MARCO SBARBARO
state: Torino
Study officials:
name: L'HOMME Sébastien, Dentist
role: PRINCIPAL_INVESTIGATOR
References: