Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders (TMD)

September 5, 2016 updated by: Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara

Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders: A Randomized Clinical Trial

The Temporomandibular Joint (TMJ) is one of the most complex joints in the individual. It is composed of the mandibular condyle is positioned within the glenoid fossa of the temporal bone, and the articular disk that separates these two bones. The normal biomechanics of the TMJ is the concave / convex relationship between the condyles and the articular disc. The movements of the TMJ joint are: mandibular depression and elevation (opening and closing of the mouth), mandibular protrusion and retraction, and lateral deviations. The DTM is a musculoskeletal disorder of the masticatory system that affects over 25% of the population. Physical therapy can be adopted this treatment in order to relieve musculoskeletal pain, reduce inflammation and restore normal motor functions. The physical therapy interventions taken include electrotherapy, exercise therapy, acupuncture and manual therapy. Overall objective is to assess the immediate effects of previous mobilization versus flow amplitude of mandibular depression in patients with temporomandibular dysfunction. The type of study will be a randomized study of two parallel groups balanced distribution (1: 1) and double-blind. The research will be conducted in the Laboratory of Human Movement Analysis of Physiotherapy, Faculty of Medicine, Federal University of Ceará. The study population will consist of residents in the city of Fortaleza-CE individuals who voluntarily seek to participate in the study due to symptoms of TMD. Data, anthropometry, application of Research Diagnostic Criteria for Temporomandibular Disorders will be collected. The physiotherapist responsible for the assessment before and after the interventions will be blind with respect to the distribution of the treatment groups. The patient will also be blind, because you will not know whether or caudal anterior mobilization was performed. Randomization codes are generated by computer using Random Allocation Software (version 1.0.0) at a ratio of 1: 1 by a researcher not involved in the data collection. These codes will be placed in sealed, opaque envelopes being numbered consecutively, which will ensure the covert allocation of study participants. Our data are considered confidential as joint property of the parties involved.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-160
        • Federal University of Ceará

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals have not received the last 3 months treatment for TMD, who are not taking anti-inflammatory and / or analgesic for at least two weeks, you are not in the period of postoperative head and / or neck and to accept the participation in the study and signed the Instrument of Consent

Exclusion Criteria:

  • Subjects with no teeth, history of metabolic diseases (such as hyper / hypothyroidism), neurological disorders, history of cancer in the last five years, active inflammatory arthritis, fractures, dislocations of the jaw or neck.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Posterior Mobilization
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower lateral incisors and canines. Applies a force previous distraction grade III and performs oscillating for 1 minute.
Procedure: CAUDAL MOBILIZATION
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower molars of patients. Apply simultaneous flow and force the previous direction, and performs the degree of oscillation III for 1 minute.
Active Comparator: Caudal Mobilization
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower molars of patients. Apply simultaneous flow and force the previous direction, and performs the degree of oscillation III for 1 minute.
Procedure: POSTERIOR MOBILIZATION
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower lateral incisors and canines. Applies a force previous distraction grade III and performs oscillating for 1 minute.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mandibular range of motion
Time Frame: Five minutes after mobilization
The caliper is a measuring instrument that inform the millimetric values of mandibular depression, as measured the distance between the edges of the incisors of the maxilla and mandible. Three measurements of the active mouth opening will be held, where the individual experiencing pain, the measurement will be the beginning of it, if he does not feel pain, be gauged from the maximum amplitude of movement. Soon after the arithmetic mean of the measurements will be made.
Five minutes after mobilization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Five minutes after mobilization
Numeric Ratig Scale for Pain - 0 (no pain) and 10 (worst pain)
Five minutes after mobilization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Ceara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UFCeara

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