xml: <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/NCT05993494</url>
    </required_header>
    <id_info>
      <org_study_id>KTU-FTR-2023/6</org_study_id>
      <nct_id>NCT05993494</nct_id>
    </id_info>
    <brief_title>Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction</brief_title>
    <official_title>Investigation of the Relationship Between Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karadeniz Technical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karadeniz Technical University</source>
    <oversight_info>
      <has_dmc>No</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>
        Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related&#xD;
        condition that affects the masticatory muscles, temporomandibular joint, and other related&#xD;
        structures. Recent research has focused specifically on pain catastrophe, kinesiophobia, and&#xD;
        central sensitization in individuals with TMD. Therefore, the aim of this study is to examine&#xD;
        the relationship between pain, central sensitization, kinesiophobia and stress level in&#xD;
        individuals with temporomandibular dysfunction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related&#xD;
        condition that affects the masticatory muscles, temporomandibular joint, and other related&#xD;
        structures. Psychological factors are stated as comorbid in individuals with TMD. Individuals&#xD;
        with TMD-related pain show higher levels of stress, anxiety, depression, somatic awareness,&#xD;
        pain catastrophizing, and kinesiophobia compared to controls. Therefore, recent research has&#xD;
        focused on pain catastrophe, kinesiophobia, and central sensitization, especially in&#xD;
        individuals with TMD. Therefore, the aim of this study is to examine the relationship between&#xD;
        pain, central sensitization, kinesiophobia and stress level in individuals with&#xD;
        temporomandibular dysfunction. Ninety patients aged 18-65 years, who have TME-related&#xD;
        complaints for at least 3 months, and diagnosed with TMD as a result of clinical and&#xD;
        radiological evaluation by a dentist will be included in the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Numeric Pain Scale</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Pain Assessment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tampa Scale for Kinesiophobia</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Kinesiophobia Assessment for temporomandibular joint dysfunction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Stress Scale</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Stress Assessment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Central sensitization scale</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Central sensitization Assessment</description>
    </primary_outcome>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Temporomandibular Joint Disorders</condition>
    <condition>Pain</condition>
    <eligibility>
      <study_pop>
        <textblock>
          -Patients diagnosed with Temporomandibular joint disorders&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between the ages of 18-65,&#xD;
  &#xD;
            -  Having complaints related to TMJ for at least 3 months,&#xD;
  &#xD;
            -  Patients diagnosed with TMD as a result of clinical and radiological evaluation by the&#xD;
               dentist&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cognitive problems,&#xD;
  &#xD;
            -  Any systemic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),&#xD;
  &#xD;
            -  Serious systemic diseases,&#xD;
  &#xD;
            -  Any neurological disorder (e.g. trigeminal neuralgia),&#xD;
  &#xD;
            -  Pregnancy, breastfeeding status,&#xD;
  &#xD;
            -  Previous treatment for TMJ or orofacial muscle pain&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nurhayat Korkmaz</last_name>
      <role>Principal Investigator</role>
      <affiliation>Karadeniz Technical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nurhayat Korkmaz, PhDstudent</last_name>
      <phone>+905387369062</phone>
      <email>krkmznrhyt@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Karadeniz Technical University</name>
        <address>
          <city>Trabzon</city>
          <zip>61000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nurhayat Korkmaz, PhdStudent</last_name>
        <phone>+905387369062</phone>
        <email>krkmznrhyt@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
      <investigator_full_name>Nurhayat KORKMAZ</investigator_full_name>
      <investigator_title>Research assistant</investigator_title>
    </responsible_party>
    <keyword>Temporomandibular Joint Dysfunction</keyword>
    <keyword>Pain</keyword>
    <keyword>central sensitization</keyword>
    <keyword>kinesiophobia</keyword>
    <keyword>stress</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>Kinesiophobia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993494
  org study id: KTU-FTR-2023/6
  nct id: NCT05993494
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related
        condition that affects the masticatory muscles, temporomandibular joint, and other related
        structures. Recent research has focused specifically on pain catastrophe, kinesiophobia, and
        central sensitization in individuals with TMD. Therefore, the aim of this study is to examine
        the relationship between pain, central sensitization, kinesiophobia and stress level in
        individuals with temporomandibular dysfunction.
  Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related
        condition that affects the masticatory muscles, temporomandibular joint, and other related
        structures. Psychological factors are stated as comorbid in individuals with TMD. Individuals
        with TMD-related pain show higher levels of stress, anxiety, depression, somatic awareness,
        pain catastrophizing, and kinesiophobia compared to controls. Therefore, recent research has
        focused on pain catastrophe, kinesiophobia, and central sensitization, especially in
        individuals with TMD. Therefore, the aim of this study is to examine the relationship between
        pain, central sensitization, kinesiophobia and stress level in individuals with
        temporomandibular dysfunction. Ninety patients aged 18-65 years, who have TME-related
        complaints for at least 3 months, and diagnosed with TMD as a result of clinical and
        radiological evaluation by a dentist will be included in the study.
  observational model: Case-Only
  time perspective: Prospective
  measure: Numeric Pain Scale
  time frame: through study completion, an average of 1 year
  description: Pain Assessment
  measure: Tampa Scale for Kinesiophobia
  time frame: through study completion, an average of 1 year
  description: Kinesiophobia Assessment for temporomandibular joint dysfunction
  measure: Perceived Stress Scale
  time frame: through study completion, an average of 1 year
  description: Stress Assessment
  measure: Central sensitization scale
  time frame: through study completion, an average of 1 year
  description: Central sensitization Assessment
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Nurhayat Korkmaz
  role: Principal Investigator
  affiliation: Karadeniz Technical University
  last name: Nurhayat Korkmaz, PhDstudent
  phone: +905387369062
  email: krkmznrhyt@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Karadeniz Technical University
  investigator full name: Nurhayat KORKMAZ
  investigator title: Research assistant
  mesh term: Joint Diseases
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  mesh term: Kinesiophobia
  sharing ipd: No