Assessment of the Efficacy of a Sensorimotor Approach After Maximum Three Sessions in Subjects With TMD With Hypertonia

NCT02632643 | Unknown

• 1 other identifier: B707201525923
• Study Type: interventional
• Target: 110
• Locations: 3 countries
• Sites: 6

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.

Conditions

Temporomandibular Disorder

Keywords

TMD; HYPERTONIA; PARAFUNCTIONS; SENSORIMOTOR APPROACH

Outcome Measures

Primary Outcomes (1)

• 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)

  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)".

  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)".

  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.

  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.

  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)".

  Beginning (day 0); during treatment (day 30 and day 90); end (day 180)

Study Arms (1)

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.

Interventions

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. BEHAVIORAL

lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osteovox: lead

Study Sites (6)

Cabinet de Logopédie Liesens-Denis

Berneau, Liège, 4607, Belgium

Location

Cabinet d'Ostéopathie PIRON

Beyne-Heusay, Liège, 4610, Belgium

Location

Cabinet de groupe LHR

Saive, Liège, 4671, Belgium

Location

Cabinet d'Ostéopathie Garcion

Nantes, Loire-Atlantique, 44100, France

Location

ANTONIO BIANCO Ortodontista e Osteopata

Gussago Bs, Brescia, 25064, Italy

Location

Osteopata MARCO SBARBARO

Robassomero, Torino, 10070, Italy

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Muscle Hypertonia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• L'HOMME Sébastien, Dentist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: December 17, 2015
• Study Start: January 1, 2016
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

BE (3); IT (2); FR (1)