Influence of Manual Therapy in Temporomandibular Joint Disorder

NCT02880774 | Completed DMC

• 1 other identifier: Uninove_Reabilitação
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Temporomandibular joint dysfunction (TMD) is characterized for being a complex and multifactorial pathology, where functional and pathological changes commit temporomandibuar articulation, masticatory muscles, and other associated structures. In the light of the whole complexity of the DTM noted the necessity of interdisciplinary treatment, including physical therapy with the use of manual features, has been excelling. Objective: The aim of this study is to evaluate the influence of mandibular nonspecific mobilization on the mandibular movement and lateralidades, through the three-dimensional kinematics in subjects with diagnosis of TMD, as well as analyze the behavior of pain, quality of life and functionality of individuals with DTM pre, immediately after and 30 days of 12 treatment sessions. Method: This is a clinical trial randomised, placebo-controlled and blind, designed to study the effects of Mandibular Nonspecific Mobilization x Placebo (detuned ultrasound). Individuals will be randomised controlled trials and allocated into two groups: Group A (intervention) and Group B (placebo) and evaluated by the Research Diagnostic Criteria for Temporomandibular joint Disorders (RDC/TMD) for diagnosis of TMD, numeric scale of Pain (END), quality of life questionnaire (WHOQOL-BREF), Patient specific Functional Scale and Kinematic Analysis Tridiemsnional. Statistical Analysis: Mandibular movement will be the primary outcome and will be quantified by three-dimensional kinematic analysis. The pain, Functionality and quality of life will be the secondary outcomes. Initially the distribution of data will be checked by the Shapiro-Wilk test. In comparisons between the groups, if the data present normal distribution will be used a repeated measures ANOVA to two factors, being these: Group (intervention and placebo) and treatment (pre and post-intervention), with Bonferrone correction. If the data do not show normal distribution, a logarithmic function is used to correct striping. As level of significance will be used p \< 0.05.

Conditions

Musculoskeletal Diseases

Keywords

Temporomandibular Joint Disorders; Mandibular Movement; Músculoesqueléticas Manipulations; Modalities of Physiotherapy.

Outcome Measures

Primary Outcomes (1)

• Mandibular Movement

  Mandiblulares movements will be quantified by 3D kinematics using the Vicon system ®. Markers, will be willing us participants at strategic points. The collections will be carried out before treatment, post 12 treatment sessions and follow up to a month. Static test: the volunteer will remain motionless, with his mouth shut, for 5 seconds while maintaining contact between the arches. Then a pointer is positioned in the right mandibular first Premolar and the individual in isometry is done collecting, this form will be collected the left side, upper left and right and between the upper and lower central incisors. Dynamics: will be held 6 repetitions in opening and closing freestyle to touch your teeth and will be carried out six straight tours and six excursions lefts of the mandible (laterality).

  45 minutes

Secondary Outcomes (3)

• WHOQOL-BREF for the evaluation of quality of life

  15 minutes

• Functional range Specifies the Patient to evaluate the functionality.

  5 minutes

• END to evaluate pain intensity

  5 minutes

Study Arms (2)

Mandibular Nonspecific mobilization

EXPERIMENTAL

GA: Mandibular Nonspecific mobilization on the region of the face with presence of TMD.

Other: mandibular nonspecific mobilization

ultrasound detuned

PLACEBO COMPARATOR

Group B: Used ultrasound equipment detuned on the region of the face with presence of TMD.

Other: Ultrasound detuned,

Interventions

mandibular nonspecific mobilization OTHER

The mobilization will be held with the individual in supine position, by a trained and experienced therapist, where using disposable gloves, will position the first finger on the last molar, performing intermittently mobilization during 1 minute, will be held five repetitions. Going on a break during the repetition, in that the individual will carry out 15 times language exercises on the palate. With regard to mobilizing joint side, this will be previously set by means of the RDC/TMD and may be unilateral or bilateral basis, depending on the diagnosis. The therapist will remain in orthostatic in opposite side the mobilization to prevent any pressure on the jaw. The treatment will last for 4 weeks, 3 times a week, for a total of 12 sessions.

Also known as: mandibular mobilization

Mandibular Nonspecific mobilization

Ultrasound detuned, OTHER

Will be held the identical positioning to group A with the individual supine on the stretcher, used ultrasound equipment detuned on the region of the face with the presence of TMD. The procedures of this group will have a duration of 4 weeks, 3 times a week, for a total of 12 sessions.

ultrasound detuned

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Will be included in the study, women with TMD, diagnosed by the RDC/TMD, with diversion and/or mandibular dentition full deflection (except third molars)

You may not qualify if:

• Not participate of the study subjects without TMD, TMD sufferers who have systemic diseases that affect the joints and/or masticatory muscles
• Over bite (bite deep) greater than 3 mm, tooth failures, neuromuscular diseases
• With hypo/condylar hyperplasia
• Making use of any type of dental prosthesis; in orthodontic treatment and/or physiotherapy
• Neurological or behavioural disorders that present that prevent the realization of kinematic analysis and/or with a history of prior surgery or orthognathic ATM.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, São Paulo, 01415000, Brazil

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Ana Paula Amaral

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniela Aparecida Biasotto-Gonzalez

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)