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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Assessment of the Efficacy of a Sensorimotor Approach After Maximum Three Sessions in Subjects With Symptomatic Temporomandibular Dysfunction (TMD) With Hypertonia: A Pros

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.

Detailed Summary:
Sponsor: Osteovox

Current 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) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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) ]
  3 Visual Analogic Scales (VAS) > 0 to 10. The scoring = the mean (0 to 100).
• 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) ]

  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

• 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) ]
  One question: "During the last 30 days, how many days did you have facial pain?" > 0 to 30 days
• 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) ]
  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.
• 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) ]
  20 Visual Analogic Scales (VAS) > 0 to 10. The scoring = the sum (0 to 200).
• 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) ]
  10 Visual Analogic Scales (VAS) > 0 to 4. The scoring = the sum (0 to 40).
• 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) ]
  7 Visual Analogic Scales (VAS) > 0 to 4. The scoring = the sum (0 to 28).
• 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) ]

  2 Visual Analogic Scales (VAS) about both "observation" and "exercices" > 0 to 10.

  The scoring = the sum (0 to 20).

• 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) ]

  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).

• 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) ]

  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 betwee
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Osteovox
  

  Dates:
  Date Received: December 6, 2015
  Date Started: January 2016
  Date Completion: December 31, 2017
  Last Updated: April 7, 2017
  Last Verified: April 2017
  

  

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