<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/NCT01725867</url>
  </required_header>
  <id_info>
    <org_study_id>201003038R</org_study_id>
    <nct_id>NCT01725867</nct_id>
  </id_info>
  <brief_title>Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain</brief_title>
  <official_title>Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      the purpose of this study is to compare the effect of physical therapy (PT) program and oral&#xD;
      appliance on patients with temporomandibular disorder (TMD)-related myofascial pain (MFP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The details of each intervention are listed as following:&#xD;
&#xD;
        -  physical therapy program group (PT): manual myofascial release over craniomandibular&#xD;
           system, chin-in exercise and self-care education&#xD;
&#xD;
        -  oral appliance group (splint): custom-made stabilization splint and self-care education&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">March 2011</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain status</measure>
    <time_frame>20 mins</time_frame>
    <description>Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>range of motion (ROM)</measure>
    <time_frame>5 mins</time_frame>
    <description>active and passive maximal mouth opening range</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle strength</measure>
    <time_frame>5 mins</time_frame>
    <description>maximal bite force</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle endurance</measure>
    <time_frame>10 mins</time_frame>
    <description>endurance of jaw closers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle stiffness</measure>
    <time_frame>10 mins</time_frame>
    <description>stiffness of masseter taut band</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL)</measure>
    <time_frame>15 mins</time_frame>
    <description>quality of life measured by Short form-36 (SF-36) Taiwanese version</description>
  </secondary_outcome>
  <other_outcome>
    <measure>stress</measure>
    <time_frame>5 mins</time_frame>
    <description>Chinese 14-item perceived stress scale (PSS-14)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Temporomandibular Disorder</condition>
  <arm_group>
    <arm_group_label>PT program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>manual myofascial release for craniomandibular system for 30~40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Splint group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PT program</intervention_name>
    <description>manual myofascial release for craniomandibular system for 30~40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks</description>
    <arm_group_label>PT program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>oral appliance</intervention_name>
    <description>custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education</description>
    <arm_group_label>Splint group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) 20-65 years old female, (2) diagnosed as MFP subtype of TMD according to Research&#xD;
             Diagnostic Criteria for TMD (RDC/TMD), (3) pain duration over 3 month, (4) palpable&#xD;
             taut band in masseter, (5) Asymmetrical pain intensity, (6) subsided symptoms of joint&#xD;
             inflammation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) traumatic TMD from external impact force, (2) history of traumatic cervical&#xD;
             injury, (3) presence of systemic disease, (4) fibromyalgia, (5) co-interventions for&#xD;
             cervical problems or TMD during study period, (6) signs of psychosomatic illness, (7)&#xD;
             unwilling to be randomized, (8) unable to wear the splint or received intraoral&#xD;
             myofascial release, (9)pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>May 30, 2010</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 8, 2012</last_update_submitted>
  <last_update_submitted_qc>November 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>National Taiwan University Hospital</investigator_full_name>
    <investigator_title>National Taiwan University Hospital</investigator_title>
  </responsible_party>
  <keyword>temporomandibular joint disorder</keyword>
  <keyword>myofascial pain</keyword>
  <keyword>manual myofascial release</keyword>
  <keyword>physical therapy</keyword>
  <keyword>oral appliance</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>
  <!-- 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/NCT01725867
org study id: 201003038R
nct id: NCT01725867
lead sponsor: 
has dmc: No
the purpose of this study is to compare the effect of physical therapy (PT) program and oral
      appliance on patients with temporomandibular disorder (TMD)-related myofascial pain (MFP).
The details of each intervention are listed as following:

        -  physical therapy program group (PT): manual myofascial release over craniomandibular
           system, chin-in exercise and self-care education

        -  oral appliance group (splint): custom-made stabilization splint and self-care education
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain status
time frame: 20 mins
description: Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands
measure: range of motion (ROM)
time frame: 5 mins
description: active and passive maximal mouth opening range
measure: muscle strength
time frame: 5 mins
description: maximal bite force
measure: muscle endurance
time frame: 10 mins
description: endurance of jaw closers
measure: muscle stiffness
time frame: 10 mins
description: stiffness of masseter taut band
measure: Quality of life (QoL)
time frame: 15 mins
description: quality of life measured by Short form-36 (SF-36) Taiwanese version
measure: stress
time frame: 5 mins
description: Chinese 14-item perceived stress scale (PSS-14)
arm group label: PT program
arm group type: Experimental
description: manual myofascial release for craniomandibular system for 30~40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks
arm group label: Splint group
arm group type: Active Comparator
description: custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education
intervention type: Other
intervention name: PT program
description: manual myofascial release for craniomandibular system for 30~40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks
arm group label: PT program
intervention type: Device
intervention name: oral appliance
description: custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education
arm group label: Splint group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: National Taiwan University Hospital
investigator title: National Taiwan University Hospital
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome