<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/NCT02974166</url>
  </required_header>
  <id_info>
    <org_study_id>InstitutoBOsteopatia</org_study_id>
    <nct_id>NCT02974166</nct_id>
  </id_info>
  <brief_title>Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders</brief_title>
  <official_title>Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Brasileiro de Osteopatia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Brasileiro de Osteopatia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether osteopathic manipulative treatment&#xD;
      associated to Dentistry care and speech therapy improves pain and function in individuals&#xD;
      with temporomandibular disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A standardized TMD examination was executed in all patients by a dentist following the&#xD;
      Research Diagnostic Criteria for Temporomandibular Disorders (RDC/ TMD) questionnaire, Axis I&#xD;
      and II, portuguese version. The RDC/ TMD is compound by a 31 items questionnaire and a ten&#xD;
      items clinical exam. All these items are related to patients symptoms and signs; to&#xD;
      mandibular functional impairment; and social-demographics, social-economics, psychological e&#xD;
      psychosocial data. The first part as Axis I tend to clinical assess and classify the TMD and&#xD;
      the second, as Axis II propose a chronic pain score that could quantify the psychosocial&#xD;
      impairment and present a subjects profile.&#xD;
&#xD;
      Others assessment instruments utilized on the research were the VAS consists in a 10 cm&#xD;
      horizontal line with &quot;no pain&quot; on the left side and &quot;worst pain&quot; on right side, then the&#xD;
      subjects were instructed to vertical risk the level of pain. The digital caliper with a 0,03&#xD;
      mm precision was used to measure the maximal mouth opening (MMO) as the maximal inter-incisal&#xD;
      vertical distance of the incisors. The subjects were seated at 90° with neutral head position&#xD;
      and solicited to open their mouths the maximum they can unassisted and without pain, maximum&#xD;
      unassisted opening and maximum assisted opening. Also, a portable digital pressure algometer&#xD;
      for measuring sensitivity to pressure before it became painful. The masseters and temporalis&#xD;
      muscles trigger point location were used as reference to guarantee the reproducibility of the&#xD;
      proceeding as well as to assess the always the same site. The statistical analysis was&#xD;
      performed using the means comparisons for the parametric tests through Student T test and for&#xD;
      the non-parametrical data, Wilcoxon. Also, it was made the descriptive statistical with&#xD;
      frequencies analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">November 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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>4 weeks</time_frame>
    <description>Pain assessed by visual analogue scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>(RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Temporomandibular Disorder</condition>
  <arm_group>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with temporomandibular disorder were used rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions during four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteopathic Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals with temporomandibular disorder received the same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week until the end of dental and speech therapy treatments (4 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Group</intervention_name>
    <description>Rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) were made and prescribed under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions.</description>
    <arm_group_label>Conventional Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Osteopathic Group</intervention_name>
    <description>Same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week during four weeks. The osteopathic treatment consisted in an individualized assessment of mobility restrictions of myofascial tissues and joints and the application of smooth techniques such myofascial release, membranous strain and counterstrain, muscle energy, cranial and high velocity and low amplitude.</description>
    <arm_group_label>Osteopathic Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.</description>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_label>Osteopathic Group</arm_group_label>
    <other_name>anti-inflammatory drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclobenzaprine Hydrochloride</intervention_name>
    <description>The medication was prescribed by the dentist as muscle relaxer if necessary.</description>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_label>Osteopathic Group</arm_group_label>
    <other_name>muscle relaxer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects of both genders with TMD diagnosed and minimum pain intensity of 40 mm on a&#xD;
             visual analogue scale (VAS) who need dental treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  continuous use of analgesic medication, mouth opening above 40 mm, presence of any&#xD;
             other orofacial pain not related to TMD and being under orthodontic or TMD treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thiago B Susin</last_name>
    <role>Principal Investigator</role>
    <affiliation>IBO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brazilian Institute of Osteopathy</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Brasileiro de Osteopatia</investigator_affiliation>
    <investigator_full_name>Thiago Boeira Susin, PT, DO</investigator_full_name>
    <investigator_title>PT, DO</investigator_title>
  </responsible_party>
  <keyword>Temporomandibular Disorder</keyword>
  <keyword>Osteopathic Manipulative Treatment</keyword>
  <keyword>Rigid Splint</keyword>
  <keyword>Speech Therapy</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
    <mesh_term>Anti-Inflammatory Agents</mesh_term>
    <mesh_term>Cyclobenzaprine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02974166
org study id: InstitutoBOsteopatia
nct id: NCT02974166
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether osteopathic manipulative treatment
      associated to Dentistry care and speech therapy improves pain and function in individuals
      with temporomandibular disorders.
A standardized TMD examination was executed in all patients by a dentist following the
      Research Diagnostic Criteria for Temporomandibular Disorders (RDC/ TMD) questionnaire, Axis I
      and II, portuguese version. The RDC/ TMD is compound by a 31 items questionnaire and a ten
      items clinical exam. All these items are related to patients symptoms and signs; to
      mandibular functional impairment; and social-demographics, social-economics, psychological e
      psychosocial data. The first part as Axis I tend to clinical assess and classify the TMD and
      the second, as Axis II propose a chronic pain score that could quantify the psychosocial
      impairment and present a subjects profile.

      Others assessment instruments utilized on the research were the VAS consists in a 10 cm
      horizontal line with "no pain" on the left side and "worst pain" on right side, then the
      subjects were instructed to vertical risk the level of pain. The digital caliper with a 0,03
      mm precision was used to measure the maximal mouth opening (MMO) as the maximal inter-incisal
      vertical distance of the incisors. The subjects were seated at 90° with neutral head position
      and solicited to open their mouths the maximum they can unassisted and without pain, maximum
      unassisted opening and maximum assisted opening. Also, a portable digital pressure algometer
      for measuring sensitivity to pressure before it became painful. The masseters and temporalis
      muscles trigger point location were used as reference to guarantee the reproducibility of the
      proceeding as well as to assess the always the same site. The statistical analysis was
      performed using the means comparisons for the parametric tests through Student T test and for
      the non-parametrical data, Wilcoxon. Also, it was made the descriptive statistical with
      frequencies analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Pain intensity
time frame: 4 weeks
description: Pain assessed by visual analogue scale.
measure: (RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders
time frame: 4 weeks
arm group label: Conventional Group
arm group type: Active Comparator
description: Individuals with temporomandibular disorder were used rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions during four weeks.
arm group label: Osteopathic Group
arm group type: Experimental
description: Individuals with temporomandibular disorder received the same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week until the end of dental and speech therapy treatments (4 weeks).
intervention type: Other
intervention name: Conventional Group
description: Rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) were made and prescribed under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions.
arm group label: Conventional Group
intervention type: Other
intervention name: Osteopathic Group
description: Same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week during four weeks. The osteopathic treatment consisted in an individualized assessment of mobility restrictions of myofascial tissues and joints and the application of smooth techniques such myofascial release, membranous strain and counterstrain, muscle energy, cranial and high velocity and low amplitude.
arm group label: Osteopathic Group
intervention type: Drug
intervention name: Ibuprofen
description: The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.
arm group label: Conventional Group
arm group label: Osteopathic Group
other name: anti-inflammatory drug
intervention type: Drug
intervention name: Cyclobenzaprine Hydrochloride
description: The medication was prescribed by the dentist as muscle relaxer if necessary.
arm group label: Conventional Group
arm group label: Osteopathic Group
other name: muscle relaxer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Thiago B Susin
role: Principal Investigator
affiliation: IBO
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto Brasileiro de Osteopatia
investigator full name: Thiago Boeira Susin, PT, DO
investigator title: PT, DO
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Ibuprofen
mesh term: Anti-Inflammatory Agents
mesh term: Cyclobenzaprine
sharing ipd: No