<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02263053</url>
  </required_header>
  <id_info>
    <org_study_id>UFCeara</org_study_id>
    <nct_id>NCT02263053</nct_id>
  </id_info>
  <brief_title>Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders</brief_title>
  <acronym>TMD</acronym>
  <official_title>Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Ceara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Ceara</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Temporomandibular Joint (TMJ) is one of the most complex joints in the individual. It is&#xD;
      composed of the mandibular condyle is positioned within the glenoid fossa of the temporal&#xD;
      bone, and the articular disk that separates these two bones. The normal biomechanics of the&#xD;
      TMJ is the concave / convex relationship between the condyles and the articular disc. The&#xD;
      movements of the TMJ joint are: mandibular depression and elevation (opening and closing of&#xD;
      the mouth), mandibular protrusion and retraction, and lateral deviations. The DTM is a&#xD;
      musculoskeletal disorder of the masticatory system that affects over 25% of the population.&#xD;
      Physical therapy can be adopted this treatment in order to relieve musculoskeletal pain,&#xD;
      reduce inflammation and restore normal motor functions. The physical therapy interventions&#xD;
      taken include electrotherapy, exercise therapy, acupuncture and manual therapy. Overall&#xD;
      objective is to assess the immediate effects of previous mobilization versus flow amplitude&#xD;
      of mandibular depression in patients with temporomandibular dysfunction. The type of study&#xD;
      will be a randomized study of two parallel groups balanced distribution (1: 1) and&#xD;
      double-blind. The research will be conducted in the Laboratory of Human Movement Analysis of&#xD;
      Physiotherapy, Faculty of Medicine, Federal University of Ceará. The study population will&#xD;
      consist of residents in the city of Fortaleza-CE individuals who voluntarily seek to&#xD;
      participate in the study due to symptoms of TMD. Data, anthropometry, application of Research&#xD;
      Diagnostic Criteria for Temporomandibular Disorders will be collected. The physiotherapist&#xD;
      responsible for the assessment before and after the interventions will be blind with respect&#xD;
      to the distribution of the treatment groups. The patient will also be blind, because you will&#xD;
      not know whether or caudal anterior mobilization was performed. Randomization codes are&#xD;
      generated by computer using Random Allocation Software (version 1.0.0) at a ratio of 1: 1 by&#xD;
      a researcher not involved in the data collection. These codes will be placed in sealed,&#xD;
      opaque envelopes being numbered consecutively, which will ensure the covert allocation of&#xD;
      study participants. Our data are considered confidential as joint property of the parties&#xD;
      involved.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mandibular range of motion</measure>
    <time_frame>Five minutes after mobilization</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>Five minutes after mobilization</time_frame>
    <description>Numeric Ratig Scale for Pain - 0 (no pain) and 10 (worst pain)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Temporomandibular Disorders</condition>
  <arm_group>
    <arm_group_label>Posterior Mobilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caudal Mobilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>POSTERIOR MOBILIZATION</intervention_name>
    <description>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.</description>
    <arm_group_label>Caudal Mobilization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CAUDAL MOBILIZATION</intervention_name>
    <description>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.</description>
    <arm_group_label>Posterior Mobilization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals have not received the last 3 months treatment for TMD, who are not taking&#xD;
             anti-inflammatory and / or analgesic for at least two weeks, you are not in the period&#xD;
             of postoperative head and / or neck and to accept the participation in the study and&#xD;
             signed the Instrument of Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with no teeth, history of metabolic diseases (such as hyper /&#xD;
             hypothyroidism), neurological disorders, history of cancer in the last five years,&#xD;
             active inflammatory arthritis, fractures, dislocations of the jaw or neck.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriel PL Almeida, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Ceara</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Ceara</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceará</state>
        <zip>60430-160</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>September 5, 2016</last_update_submitted>
  <last_update_submitted_qc>September 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Ceara</investigator_affiliation>
    <investigator_full_name>Gabriel Peixoto Leão Almeida</investigator_full_name>
    <investigator_title>Gabriel Peixoto Leão Almeida</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02263053
org study id: UFCeara
nct id: NCT02263053
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Mandibular range of motion
time frame: Five minutes after mobilization
description: 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.
measure: Pain Intensity
time frame: Five minutes after mobilization
description: Numeric Ratig Scale for Pain - 0 (no pain) and 10 (worst pain)
arm group label: Posterior Mobilization
arm group type: Active Comparator
description: 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.
arm group label: Caudal Mobilization
arm group type: Active Comparator
description: 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.
intervention type: Procedure
intervention name: POSTERIOR MOBILIZATION
description: 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.
arm group label: Caudal Mobilization
intervention type: Procedure
intervention name: CAUDAL MOBILIZATION
description: 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.
arm group label: Posterior Mobilization
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gabriel PL Almeida, MSc
role: Principal Investigator
affiliation: Universidade Federal do Ceara
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Ceara
investigator full name: Gabriel Peixoto Leão Almeida
investigator title: Gabriel Peixoto Leão Almeida
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome