ClinicalTrials.gov
ClinicalTrials.gov Menu

Influence of Manual Therapy in Temporomandibular Joint Disorder (THERAPY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02880774
Recruitment Status : Unknown
Verified August 2016 by Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho.
Recruitment status was:  Recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho

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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Diseases Other: mandibular nonspecific mobilization Other: Ultrasound detuned, Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Influence of Manual Therapy in Temporomandibular Joint on the Mandibular Movement: Clinical Trial, Randomised, Placebo-controlled and Blind
Study Start Date : August 2015
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mandibular Nonspecific mobilization
GA: Mandibular Nonspecific mobilization on the region of the face with presence of TMD.
Other: mandibular nonspecific mobilization
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.
Other Name: mandibular mobilization

Placebo Comparator: ultrasound detuned
Group B: Used ultrasound equipment detuned on the region of the face with presence of TMD.
Other: Ultrasound detuned,
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880774


Contacts
Contact: Daniela Biasotto-Gonzalez 11 26339312 ext 55 dani_atm@uninove.br

Locations
Brazil
University of Nove de Julho Recruiting
Sao Paulo, São Paulo, Brazil, 01415000
Contact: Daniela Ap Biasotto-Gonzalez, Doctor    +5511999063166    dani_atm@ig.com.br   
Sponsors and Collaborators
University of Nove de Julho
Investigators
Principal Investigator: Ana Paula Amaral University of Nove de Julho

Responsible Party: Daniela Ap. Biasotto-Gonzalez, Daniela Aparecida Biasotto-Gonzalez, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02880774     History of Changes
Other Study ID Numbers: Uninove_Reabilitação
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho:
Temporomandibular Joint Disorders
Mandibular Movement
Músculoesqueléticas Manipulations
Modalities of Physiotherapy.

Additional relevant MeSH terms:
Musculoskeletal Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes