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Proprioceptive Treatment for Temporomandibular Dysfunction

Primary Purpose

Facial Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
hyperbolid combined with tongue exercises on the palate
hyperbolid
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Pain focused on measuring Facial Pain, Physical Therapy Modalities, Temporomandibular Joint Disorders, Exercise Therapy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Temporomandibular Joint Disorders according to the RDC / TMD questionnaire,
  • 18 to 40 years

Exclusion Criteria:

  • History of neurological disorders
  • Submit dental flaws,
  • Sull or partial denture,
  • Systemic diseases, neuromuscular,
  • History of trauma to the face and or ATM
  • History of TMJ luxation.
  • Being in orthodontic treatment or medication that affects the musculoskeletal system.

Sites / Locations

  • University of Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Hyperbolid combined with tongue exercises on the palate

Hyperbolid

Control

Arm Description

The proprioceptive treatment protocol if run in the use of exercises with hyperboloid based on studies of Biasotto-Gonzalez (2005), for each exercise will be held 6 sets of 6 reps. Between exercises, 1 minute will be established for rest of the volunteer, in order to avoid muscle fatigue and possible exacerbation of pain, and after that period you will be asked to volunteer the proprioceptive exercise of ´ ´ tongue on the hard palate ´ ´ Biasotto-Gonzalez-based (2005), which consists of the language supported in the hard palate, you must open and close the mouth, having as the principle language as a physical reference.

The proprioceptive treatment protocol if run in the use of the hyperboloid, based on studies of Biasotto-Gonzalez (2005), but without the proprioceptive exercise of language in ´ ´ hard palate ´ ´. For each exercise will be held 6 series of 6 repetitions, and between exercises, 1 minute will be established for rest of the volunteer, in order to avoid muscle fatigue and possible exacerbation of pain.

The individuals in control group did not receive any type of intervention, being offered proprioceptive treatment after the study period.

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensity was assessed using the visual analog scale, RDC/TMD Pain Index.

Secondary Outcome Measures

Electromyographic Activity
Muscle activity was assessed using the EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment

Full Information

First Posted
December 19, 2013
Last Updated
May 11, 2022
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02021357
Brief Title
Proprioceptive Treatment for Temporomandibular Dysfunction
Official Title
The Influence of Proprioceptive Treatment for the Intensity of Pain, Muscle Activity, Level of Severity and Mandible Mobility in Individuals With Temporomandibular Dysfunction: Clinical Trial, Randomized, Controlled, Double-Blind
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The project aims to assess the effects of proprioceptive treatment through the use of hyperbolid mastication apparatus on pain intensity, muscle activity and joint mobility in subjects with TMD. A randomized, blind, clinical trial will be conducted. Volunteers aged between 18 and 40 years will be recruited, with a diagnosis of muscle- and joint-related TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly divided in three different groups: Group 1 (G1) - treated with HB device combined with tongue exercises on the palate; Group 2 (G2) - treated HB alone and Group 3 (G3) - control. Treatment protocols will be applied for 12 sessions, the volunteers will be evaluated in two stages: before applying the treatment and after the last session.
Detailed Description
The temporomandibular disorder (TMD) are characterized by a set of clinical abnormalities involving the masticatory muscles, the temporomandibular joint (TMJ) and other associated structures. Several studies have supported the use of physical therapy in the treatment of this condition, especially electrotherapy, laser therapy and manual resources. However, despite advances in the search for scientific evidence, it is necessary to prove to other commonly used clinical measures in subjects with TMD, such as the use of hyperbolid, which is a feature that stimulates the proprioceptive function. Thus, this project aims to assess the effects of proprioceptive treatment through the use of hyperbolid on pain intensity, muscle activity and joint mobility in subjects with TMD. A randomized, blind, clinical trial will be conducted. Volunteers aged between 18 and 40 years will be recruited, with a diagnosis of muscle- and joint-related TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly divided in three different groups, the first group constituted by treatment with hyperbolid associated with tongue exercises on the palate, the second group consists of treatment with hyperbolid alone and the third group will not receive any type of intervention (proprioceptive treatment will be offered after the study period). Treatment protocols will be applied for 12 sessions, the volunteers will be evaluated in two stages: before applying the treatment and after the last session. The variables that will be investigated are: pain assessed using visual analog scale and algometry; muscle activity, investigated by electromyography of masticatory muscles; and joint mobility, measured by the use of a caliper. Regarding the analysis of the data will be held intragroup comparisons, considering the pre-treatment and after twelve sessions, and comparisons between groups. To this end it will be applied the Shapiro-Wilk test for checking the normality of data, and the statistical test applied consistent, then parametric or nonparametric. Is assumed a significance level of 5%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Pain
Keywords
Facial Pain, Physical Therapy Modalities, Temporomandibular Joint Disorders, Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperbolid combined with tongue exercises on the palate
Arm Type
Experimental
Arm Description
The proprioceptive treatment protocol if run in the use of exercises with hyperboloid based on studies of Biasotto-Gonzalez (2005), for each exercise will be held 6 sets of 6 reps. Between exercises, 1 minute will be established for rest of the volunteer, in order to avoid muscle fatigue and possible exacerbation of pain, and after that period you will be asked to volunteer the proprioceptive exercise of ´ ´ tongue on the hard palate ´ ´ Biasotto-Gonzalez-based (2005), which consists of the language supported in the hard palate, you must open and close the mouth, having as the principle language as a physical reference.
Arm Title
Hyperbolid
Arm Type
Active Comparator
Arm Description
The proprioceptive treatment protocol if run in the use of the hyperboloid, based on studies of Biasotto-Gonzalez (2005), but without the proprioceptive exercise of language in ´ ´ hard palate ´ ´. For each exercise will be held 6 series of 6 repetitions, and between exercises, 1 minute will be established for rest of the volunteer, in order to avoid muscle fatigue and possible exacerbation of pain.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The individuals in control group did not receive any type of intervention, being offered proprioceptive treatment after the study period.
Intervention Type
Behavioral
Intervention Name(s)
hyperbolid combined with tongue exercises on the palate
Intervention Type
Other
Intervention Name(s)
hyperbolid
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity was assessed using the visual analog scale, RDC/TMD Pain Index.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Electromyographic Activity
Description
Muscle activity was assessed using the EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Temporomandibular Joint Disorders according to the RDC / TMD questionnaire, 18 to 40 years Exclusion Criteria: History of neurological disorders Submit dental flaws, Sull or partial denture, Systemic diseases, neuromuscular, History of trauma to the face and or ATM History of TMJ luxation. Being in orthodontic treatment or medication that affects the musculoskeletal system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Arruda
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nove de Julho
City
Sao Paulo
ZIP/Postal Code
02117-020
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.uninove.br
Description
University web site

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Proprioceptive Treatment for Temporomandibular Dysfunction

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