Clinical Trial: Influence of Manual Therapy in Temporomandibular Joint Disorder

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Influence of Manual Therapy in Temporomandibular Joint on the Mandibular Movement: Clinical Trial, Randomised, Placebo-controlled and Blind

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

Detailed Summary:

Contextualization:Temporomandibular joint dysfunction (TMD) is defined as a group of heterogeneous changes affect a temporomandibular joint (TMJ), affecting anatomical and functional elements, is characterized as a complex and multifactorial disease. The most common signs are joint noises and limitations on the extent of the mandibular movements, associated or not to the articular disc displacement during a mandibular function and predominant symptoms are pain pre-Auricular, on ATM and/or masticatory muscles. A study of an urban brazilian population shows that 39.2% of evaluated feature at least one sign or symptom of TMD.

Its development can be related to the traumatic acometimentos of the jaw or occlusal interference or TMJ, malocclusion, changes in masticatory muscles, microtrauma caused by parafunctional habits, rheumatic diseases, emotional stress, anxiety and postural abnormalities, thus creating a major impact on quality of life and sleep of patients with this disease.

When there is a breakdown between anatomical condyle and articular eminence, disk, drift to occur for the most part, are characterized as previous joint disc displacement, with or without reduction. In both cases, the disk is presented prior to the mandibular condyle with mouth closed, and can resume his position, featuring a disc displacement with reduction (DDCR), having as main feature the snap during an opening. The disc may get introduced before the condyle during the entire opening movement, made a previous offset oral disc without reduction (DDSR), characterized by the presence of clicks, including, in the most serious cases, cause a limitation of motion and functional changes of the mandible, the adaptation of the retrodiscais tissue.

In the light of the whole complexity of the DTM it is necess
Sponsor: University of Nove de Julho

Current Primary Outcome: Mandibular Movement [ Time Frame: 45 minutes ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • WHOQOL-BREF for the evaluation of quality of life [ Time Frame: 15 minutes ]
    The questionnaire is self-explanatory and can be applied in 3 ways: self administered, assisted by the interviewer or administered by the interviewer and will be applied before treatment, post 12 treatment sessions and follow up to a month.
  • Functional range Specifies the Patient to evaluate the functionality. [ Time Frame: 5 minutes ]
    Asked to identify the patient until 3 activities that are unable to perform or presents any difficulty and may incorporate issues that were not addressed in a generic scale, but it's important for the patient's problem. The scale will be performed before treatment, post 12 treatment sessions and follow up to a month.
  • END to evaluate pain intensity [ Time Frame: 5 minutes ]
    The degree of pain will be evaluated when an individual is at rest, before treatment, before and after each treatment session and folow up to a month.


Original Secondary Outcome: Same as current

Information By: University of Nove de Julho

Dates:
Date Received: August 23, 2016
Date Started: August 2015
Date Completion: August 2016
Last Updated: August 25, 2016
Last Verified: August 2016