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/NCT06005922</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar63</org_study_id>
      <nct_id>NCT06005922</nct_id>
    </id_info>
    <brief_title>The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain</brief_title>
    <official_title>Investigation of the Effectiveness of Temporomandibular Joint Mobilization and Exercise on Posture, Endurance and Functionality in Individuals With Chronic Neck Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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>
        To examine the effects of temporomandibular joint mobilization and exercises added to the&#xD;
        conventional physiotherapy program on posture, functionality and muscular endurance in&#xD;
        individuals with chronic neck pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Our research is a randomized controlled trial. 50 participants will be included in the study,&#xD;
        which will be conducted on individuals aged 18-65 years with chronic neck pain. Participants&#xD;
        will be divided into 2 groups as experimental and control groups by simple randomization&#xD;
        method. All patients will be treated with conventional physiotherapy methods for 4 weeks and&#xD;
        5 days a week. In addition to conventional treatment, temporomandibular joint mobilization&#xD;
        techniques were applied to the experimental group; exercises will be given. In the study,&#xD;
        temporomandibular dysfunction (TMD) Pain Screener, Neck Disability Index, and Visual Analog&#xD;
        Scale questionnaires will be applied to the patients twice, before and after the treatment.&#xD;
        Before and after the treatment, the cervical region's range of motion and muscular endurance&#xD;
        will be measured by the physiotherapist. Pre- and post-intervention data were statistically&#xD;
        analyzed and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 20, 2023</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>
      <intervention_model_description>temporomandibular joint mobilization and temporomandibular joint exercises</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Neck Disability Index</measure>
      <time_frame>6 weeks</time_frame>
      <description>The survey consists of 10 questions. Each question has 5 options. For each question, points are given as A:0, B:1, C:2 D:3 E:4, F:4. 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability, 35 or above points as complete disability.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Temporomandibular Joint Disorders</condition>
    <condition>Temporomandibular Joint Dysfunction Syndrome</condition>
    <condition>Neck Pain</condition>
    <condition>Chronic Pain</condition>
    <arm_group>
      <arm_group_label>conventional physiotherapy methods</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>conventional physiotherapy methods</description>
    </arm_group>
    <arm_group>
      <arm_group_label>temporomandibular joint (TMJ) group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>conventional physiotherapy methods and temporomandibular joint mobilization and temporomandibular joint exercises</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physiotherapy</intervention_name>
      <description>ultrasound hotpack electrotherapy joint range of motion exercises isometric neck exercises stretching exercises</description>
      <arm_group_label>conventional physiotherapy methods</arm_group_label>
      <arm_group_label>temporomandibular joint (TMJ) group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TMJ exercises</intervention_name>
      <description>tongue relaxation position TMJ isometric strengthening exercises Posture exercises Isometric neck extension in neutral position back extension Strengthening the abdominal muscles Supine dorsal stretch pectoral stretch</description>
      <arm_group_label>temporomandibular joint (TMJ) group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 18-65,&#xD;
  &#xD;
            -  Having neck pain lasting longer than 3 months,&#xD;
  &#xD;
            -  Absence of known systemic disease or trauma history,&#xD;
  &#xD;
            -  Volunteering to participate in the research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a history of trauma in the areas that are the subject of the study, such as&#xD;
               head and neck surgery, upper extremity, thoracic and cervical vertebrae,&#xD;
  &#xD;
            -  Disc displacement, osteoarthrosis, osteoarthritis signs and symptoms&#xD;
  &#xD;
            -  Having a neurological-psychiatric diagnosis that may affect the measurement results.&#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>Şeyma DELCEOĞLU</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Medicana Hospital</name>
        <address>
          <city>Umraniye</city>
          <state>İstanbul</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Şeyma DELCEOĞLU</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Calixtre LB, Oliveira AB, de Sena Rosa LR, Armijo-Olivo S, Visscher CM, Alburquerque-Sendin F. Effectiveness of mobilisation of the upper cervical region and craniocervical flexor training on orofacial pain, mandibular function and headache in women with TMD. A randomised, controlled trial. J Oral Rehabil. 2019 Feb;46(2):109-119. doi: 10.1111/joor.12733. Epub 2018 Oct 26.</citation>
      <PMID>30307636</PMID>
    </reference>
    <reference>
      <citation>McCarty WL Jr, Darnell MW. Rehabilitation of the temporomandibular joint through the application of motion. Cranio. 1993 Oct;11(4):298-307. doi: 10.1080/08869634.1993.11677982.</citation>
      <PMID>8118901</PMID>
    </reference>
    <reference>
      <citation>Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.</citation>
      <PMID>32723399</PMID>
    </reference>
    <reference>
      <citation>Reynolds B, Puentedura EJ, Kolber MJ, Cleland JA. Effectiveness of Cervical Spine High-Velocity, Low-Amplitude Thrust Added to Behavioral Education, Soft Tissue Mobilization, and Exercise for People With Temporomandibular Disorder With Myalgia: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2020 Aug;50(8):455-465. doi: 10.2519/jospt.2020.9175. Epub 2020 Jan 6.</citation>
      <PMID>31905097</PMID>
    </reference>
    <reference>
      <citation>Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.</citation>
      <PMID>28826164</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst. Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>endurance</keyword>
    <keyword>functionality</keyword>
    <keyword>joint range of motion</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>Chronic Pain</mesh_term>
      <mesh_term>Neck Pain</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/NCT06005922
  org study id: Uskudar63
  nct id: NCT06005922
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To examine the effects of temporomandibular joint mobilization and exercises added to the
        conventional physiotherapy program on posture, functionality and muscular endurance in
        individuals with chronic neck pain.
  Our research is a randomized controlled trial. 50 participants will be included in the study,
        which will be conducted on individuals aged 18-65 years with chronic neck pain. Participants
        will be divided into 2 groups as experimental and control groups by simple randomization
        method. All patients will be treated with conventional physiotherapy methods for 4 weeks and
        5 days a week. In addition to conventional treatment, temporomandibular joint mobilization
        techniques were applied to the experimental group; exercises will be given. In the study,
        temporomandibular dysfunction (TMD) Pain Screener, Neck Disability Index, and Visual Analog
        Scale questionnaires will be applied to the patients twice, before and after the treatment.
        Before and after the treatment, the cervical region's range of motion and muscular endurance
        will be measured by the physiotherapist. Pre- and post-intervention data were statistically
        analyzed and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: temporomandibular joint mobilization and temporomandibular joint exercises
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Neck Disability Index
  time frame: 6 weeks
  description: The survey consists of 10 questions. Each question has 5 options. For each question, points are given as A:0, B:1, C:2 D:3 E:4, F:4. 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability, 35 or above points as complete disability.
  arm group label: conventional physiotherapy methods
  arm group type: Active Comparator
  description: conventional physiotherapy methods
  arm group label: temporomandibular joint (TMJ) group
  arm group type: Experimental
  description: conventional physiotherapy methods and temporomandibular joint mobilization and temporomandibular joint exercises
  intervention type: Other
  intervention name: physiotherapy
  description: ultrasound hotpack electrotherapy joint range of motion exercises isometric neck exercises stretching exercises
  arm group label: conventional physiotherapy methods
  arm group label: temporomandibular joint (TMJ) group
  intervention type: Other
  intervention name: TMJ exercises
  description: tongue relaxation position TMJ isometric strengthening exercises Posture exercises Isometric neck extension in neutral position back extension Strengthening the abdominal muscles Supine dorsal stretch pectoral stretch
  arm group label: temporomandibular joint (TMJ) group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Şeyma DELCEOĞLU
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Calixtre LB, Oliveira AB, de Sena Rosa LR, Armijo-Olivo S, Visscher CM, Alburquerque-Sendin F. Effectiveness of mobilisation of the upper cervical region and craniocervical flexor training on orofacial pain, mandibular function and headache in women with TMD. A randomised, controlled trial. J Oral Rehabil. 2019 Feb;46(2):109-119. doi: 10.1111/joor.12733. Epub 2018 Oct 26.
  PMID: 30307636
  citation: McCarty WL Jr, Darnell MW. Rehabilitation of the temporomandibular joint through the application of motion. Cranio. 1993 Oct;11(4):298-307. doi: 10.1080/08869634.1993.11677982.
  PMID: 8118901
  citation: Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.
  PMID: 32723399
  citation: Reynolds B, Puentedura EJ, Kolber MJ, Cleland JA. Effectiveness of Cervical Spine High-Velocity, Low-Amplitude Thrust Added to Behavioral Education, Soft Tissue Mobilization, and Exercise for People With Temporomandibular Disorder With Myalgia: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2020 Aug;50(8):455-465. doi: 10.2519/jospt.2020.9175. Epub 2020 Jan 6.
  PMID: 31905097
  citation: Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
  PMID: 28826164
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  mesh term: Joint Diseases
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  mesh term: Chronic Pain
  mesh term: Neck Pain
  sharing ipd: No