<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/NCT03837587</url>
  </required_header>
  <id_info>
    <org_study_id>77082166-604.01.02-</org_study_id>
    <nct_id>NCT03837587</nct_id>
  </id_info>
  <brief_title>Reliability, Validity of The Turkish Version of Craniofacial Pain and Disability Inventory</brief_title>
  <official_title>Reliability, Validity of The Turkish Version of Craniofacial Pain and Disability Inventory</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study, we are aim to make the Turkish version validity and reliability of the&#xD;
      Cranifacial Pain and Disability Inventory, Jaw Functional Limitation Scale-20, and Jaw&#xD;
      Functional Limitation Scale-8.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 60% of individuals with temporomandibular disorders (TMD) reported increased&#xD;
      pain intensity from midlevel to severe. This was seen at the end of the intervention or work&#xD;
      related activities in the quarter of individuals. Therefore, the correct diagnosis of TMD is&#xD;
      very important to reduce the economic cost. Craniofacial Pain and Disability Inventory&#xD;
      (CF-PDI) is designed based on a biopsychosocial approach. Evidence has shown that CF-PDI is&#xD;
      an well-structured, internal consistency, repeatable and valid, and that an objective outcome&#xD;
      for the evaluation of pain and discomfort in patients with craniofacial pain. There is no&#xD;
      Turkish version and validity study of CF-PDI. Each item is scored between 0-3. The total&#xD;
      score ranged from 0 to 63, and a high score indicate a high level of discomfort. The aim of&#xD;
      this study was to evaluate the validity and reliability of the Turkish version of CF-PDI. The&#xD;
      study of validity and reliability is planned with 105 individuals with TMD. The&#xD;
      sociodemographic characteristics of the individuals will be questioned by the investigators&#xD;
      and then the patients will be evaluated with CF-PDI, Neck Disability Index (NDI), Tampa Scale&#xD;
      for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Headache Impact Test-6 (HIT-6),&#xD;
      Jaw Functional Limitation Scale (JFLS) (Turkish version) and Visual Analogue Scale (VAS). The&#xD;
      test-retest will be re-administered by face-to-face interview technique after 1 week. The&#xD;
      results will be analyzed using the SPSS version 22.0 computer package program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Craniofacial Pain and Disability Inventory</measure>
    <time_frame>10 minutes</time_frame>
    <description>Craniofacial Pain and Disability Inventory is a questionnaire that development to individuals with temporomandibular disorders. Each item is scored between 0-3. The total score range from 0 to 63, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Jaw Functional Limitation Scale-20</measure>
    <time_frame>10 minutes</time_frame>
    <description>Jaw Functional Limitation Scale-20 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. Each item is scored between 0-10. It mean that &quot;0= no limitation&quot; and &quot;10= severe limitation&quot;.The total score range from 0 to 200, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Jaw Functional Limitation Scale-8</measure>
    <time_frame>5 minutes</time_frame>
    <description>Jaw Functional Limitation Scale-8 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. It is short form of Jaw Functional Limitation Scale-20. Each item is scored between 0-10. It mean that &quot;0= no limitation&quot; and &quot;10= severe limitation&quot;.The total score range from 0 to 80, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">221</enrollment>
  <condition>Temporomandibular Joint Disorders</condition>
  <arm_group>
    <arm_group_label>Patients group</arm_group_label>
    <description>Patients with temporomandibular disorders</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with temporomandibular disorders between the ages of 18-50&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a temporomandibular disorder&#xD;
&#xD;
          -  Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria&#xD;
             classification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant,&#xD;
&#xD;
          -  Canser,&#xD;
&#xD;
          -  Trauma,&#xD;
&#xD;
          -  Neurologic disorder,&#xD;
&#xD;
          -  Infection,&#xD;
&#xD;
          -  Trigeminal or postherpatic neuralgia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seyit ÇITAKER, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gazi University</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>May 29, 2022</last_update_submitted>
  <last_update_submitted_qc>May 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Halime ARIKAN</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Validity</keyword>
  <keyword>Reliability</keyword>
  <keyword>Temporomandibular Joint Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
    <mesh_term>Facial Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT03837587
org study id: 77082166-604.01.02-
nct id: NCT03837587
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study, we are aim to make the Turkish version validity and reliability of the
      Cranifacial Pain and Disability Inventory, Jaw Functional Limitation Scale-20, and Jaw
      Functional Limitation Scale-8.
Approximately 60% of individuals with temporomandibular disorders (TMD) reported increased
      pain intensity from midlevel to severe. This was seen at the end of the intervention or work
      related activities in the quarter of individuals. Therefore, the correct diagnosis of TMD is
      very important to reduce the economic cost. Craniofacial Pain and Disability Inventory
      (CF-PDI) is designed based on a biopsychosocial approach. Evidence has shown that CF-PDI is
      an well-structured, internal consistency, repeatable and valid, and that an objective outcome
      for the evaluation of pain and discomfort in patients with craniofacial pain. There is no
      Turkish version and validity study of CF-PDI. Each item is scored between 0-3. The total
      score ranged from 0 to 63, and a high score indicate a high level of discomfort. The aim of
      this study was to evaluate the validity and reliability of the Turkish version of CF-PDI. The
      study of validity and reliability is planned with 105 individuals with TMD. The
      sociodemographic characteristics of the individuals will be questioned by the investigators
      and then the patients will be evaluated with CF-PDI, Neck Disability Index (NDI), Tampa Scale
      for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Headache Impact Test-6 (HIT-6),
      Jaw Functional Limitation Scale (JFLS) (Turkish version) and Visual Analogue Scale (VAS). The
      test-retest will be re-administered by face-to-face interview technique after 1 week. The
      results will be analyzed using the SPSS version 22.0 computer package program.
observational model: Case-Only
time perspective: Prospective
measure: Craniofacial Pain and Disability Inventory
time frame: 10 minutes
description: Craniofacial Pain and Disability Inventory is a questionnaire that development to individuals with temporomandibular disorders. Each item is scored between 0-3. The total score range from 0 to 63, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.
measure: Jaw Functional Limitation Scale-20
time frame: 10 minutes
description: Jaw Functional Limitation Scale-20 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. Each item is scored between 0-10. It mean that "0= no limitation" and "10= severe limitation".The total score range from 0 to 200, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.
measure: Jaw Functional Limitation Scale-8
time frame: 5 minutes
description: Jaw Functional Limitation Scale-8 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. It is short form of Jaw Functional Limitation Scale-20. Each item is scored between 0-10. It mean that "0= no limitation" and "10= severe limitation".The total score range from 0 to 80, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.
arm group label: Patients group
description: Patients with temporomandibular disorders
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Seyit ÇITAKER, Prof. Dr.
role: Study Chair
affiliation: Gazi University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Halime ARIKAN
investigator title: Research Assistant
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Facial Pain
sharing ipd: Yes
ipd info type: Clinical Study Report (CSR)