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/NCT06037798</url>
    </required_header>
    <id_info>
      <org_study_id>CCFT-NOD</org_study_id>
      <nct_id>NCT06037798</nct_id>
    </id_info>
    <brief_title>The Cranio-cervical Flexion Test Using the NOD Device</brief_title>
    <acronym>CCFT-NOD</acronym>
    <official_title>The Cranio-cervical Flexion Test, Using the NOD. A Pilot and Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zurich University of Applied Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zurich University of Applied Sciences</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        to measure strength of the deep anterior neck muscles with a new measurement protocol and by&#xD;
        using the NOD device, a dynamometer, in subjects with and without bruxism, and compared to&#xD;
        EMG on the superficial muscles of the anterior neck and the masseter muscle.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>activation score = AS</measure>
      <time_frame>baseline</time_frame>
      <description>stepwise (5 steps) and correct (no substitution by the superficial muscles) activation of the deep neck flexors, that can be hold for 10 seconds: Each step increases by 3.4N. The scale will be offset, starting at 0N. Steps are accordingly: 3.4N, 6.8N, 10.2N, 13.6N, 17N. Higher scores denote better function</description>
    </primary_outcome>
    <primary_outcome>
      <measure>performance index= PI</measure>
      <time_frame>baseline</time_frame>
      <description>number of correctly performed 10 second holds at each incremental step. number between 1 and 10. Higher scores denote better function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Neck-Pain</measure>
      <time_frame>baseline</time_frame>
      <description>neck pain, headache or discomfort during or immediate after the test protocol, measured by a numeric rating scale from 0 to 10. Higher scores denote more pain or discomfort</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Muscle Strength</condition>
    <condition>Neck Muscle Issue</condition>
    <condition>Bruxism</condition>
    <condition>EMG</condition>
    <arm_group>
      <arm_group_label>Bruxism</arm_group_label>
      <description>subjects with known bruxism, no TMD, primary headache or neck pain</description>
    </arm_group>
    <arm_group>
      <arm_group_label>healthy</arm_group_label>
      <description>non-bruxism, no primary headache, TMD or neck pain</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>cranio-cervical flexion test with NOD</intervention_name>
      <description>testing the anterior neck muscles during a nodding movement and by using a dynamometer</description>
      <arm_group_label>Bruxism</arm_group_label>
      <arm_group_label>healthy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          adult subjects with and without bruxism&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  with or without bruxism&#xD;
  &#xD;
            -  German fluent&#xD;
  &#xD;
            -  informend consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  primary headache&#xD;
  &#xD;
            -  cranio-mandibulary disorders (CMD) in &gt;3 months within the last 12 months&#xD;
  &#xD;
            -  current neck pain intensity &gt; 2 out of 10 on Numeric rating scale&#xD;
  &#xD;
            -  known:&#xD;
  &#xD;
            -  neurological pathologies&#xD;
  &#xD;
            -  mental impairments or diseases&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  rheumatic disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Markus J Ernst, MSc</last_name>
      <phone>+41 58934</phone>
      <phone_ext>6448</phone_ext>
      <email>markus.ernst@zhaw.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zurich University of applied sciences</name>
        <address>
          <city>Winterthur</city>
          <zip>8401</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Markus J Ernst, MSc</last_name>
        <phone>+41 58 934</phone>
        <phone_ext>6448</phone_ext>
        <email>markus.ernst@zhaw.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <reference>
      <citation>Ernst MJ, Sax N, Meichtry A, Aegerter AM, Luomajoki H, Ludtke K, Gallina A, Falla D; NEXpro collaboration group. Cervical musculoskeletal impairments and pressure pain sensitivity in office workers with headache. Musculoskelet Sci Pract. 2023 Aug;66:102816. doi: 10.1016/j.msksp.2023.102816. Epub 2023 Jun 26.</citation>
      <PMID>37394322</PMID>
    </reference>
    <reference>
      <citation>Chiu TT, Law EY, Chiu TH. Performance of the craniocervical flexion test in subjects with and without chronic neck pain. J Orthop Sports Phys Ther. 2005 Sep;35(9):567-71. doi: 10.2519/jospt.2005.35.9.567.</citation>
      <PMID>16268243</PMID>
    </reference>
    <reference>
      <citation>James G, Doe T. The craniocervical flexion test: intra-tester reliability in asymptomatic subjects. Physiother Res Int. 2010 Sep;15(3):144-9. doi: 10.1002/pri.456.</citation>
      <PMID>20146239</PMID>
    </reference>
    <reference>
      <citation>Jull G, Amiri M, Bullock-Saxton J, Darnell R, Lander C. Cervical musculoskeletal impairment in frequent intermittent headache. Part 1: Subjects with single headaches. Cephalalgia. 2007 Jul;27(7):793-802. doi: 10.1111/j.1468-2982.2007.01345.x.</citation>
      <PMID>17598761</PMID>
    </reference>
    <results_reference>
      <citation>Carrasco-Uribarren A, Marimon X, Portela A, Cabanillas-Barea S, Rodriguez-Rubio PR, Perez RA. A Novel Device for Assessment and Treatment of Upper Cervical Spine: Test-Retest Reliability Study. J Clin Med. 2023 Mar 1;12(5):1954. doi: 10.3390/jcm12051954.</citation>
      <PMID>36902739</PMID>
    </results_reference>
    <results_reference>
      <citation>Romeo A, Baccini M, Carreras G, Sagripanti M, Ruggeri M, Pillastrini P, Di Bari M. Reliability, Validity, and Responsiveness of the Craniocervical Flexion Test in People Who Are Asymptomatic and Patients With Nonspecific Neck Pain: A Systematic Review and Meta-Analysis. Phys Ther. 2022 Jul 4;102(7):pzac054. doi: 10.1093/ptj/pzac054.</citation>
      <PMID>35554598</PMID>
    </results_reference>
    <results_reference>
      <citation>Selistre LFA, Melo CS, Noronha MA. Reliability and Validity of Clinical Tests for Measuring Strength or Endurance of Cervical Muscles: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2021 Jun;102(6):1210-1227. doi: 10.1016/j.apmr.2020.11.018. Epub 2020 Dec 28.</citation>
      <PMID>33383030</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zurich University of Applied Sciences</investigator_affiliation>
      <investigator_full_name>Markus J. Ernst</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bruxism</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>data can be shared on demand</ipd_description>
    </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/NCT06037798
  org study id: CCFT-NOD
  nct id: NCT06037798
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  to measure strength of the deep anterior neck muscles with a new measurement protocol and by
        using the NOD device, a dynamometer, in subjects with and without bruxism, and compared to
        EMG on the superficial muscles of the anterior neck and the masseter muscle.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: activation score = AS
  time frame: baseline
  description: stepwise (5 steps) and correct (no substitution by the superficial muscles) activation of the deep neck flexors, that can be hold for 10 seconds: Each step increases by 3.4N. The scale will be offset, starting at 0N. Steps are accordingly: 3.4N, 6.8N, 10.2N, 13.6N, 17N. Higher scores denote better function
  measure: performance index= PI
  time frame: baseline
  description: number of correctly performed 10 second holds at each incremental step. number between 1 and 10. Higher scores denote better function.
  measure: Neck-Pain
  time frame: baseline
  description: neck pain, headache or discomfort during or immediate after the test protocol, measured by a numeric rating scale from 0 to 10. Higher scores denote more pain or discomfort
  arm group label: Bruxism
  description: subjects with known bruxism, no TMD, primary headache or neck pain
  arm group label: healthy
  description: non-bruxism, no primary headache, TMD or neck pain
  intervention type: Other
  intervention name: cranio-cervical flexion test with NOD
  description: testing the anterior neck muscles during a nodding movement and by using a dynamometer
  arm group label: Bruxism
  arm group label: healthy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  last name: Markus J Ernst, MSc
  phone: +41 58934
  phone ext: 6448
  email: markus.ernst@zhaw.ch
  facility: 
  contact: 
  country: Switzerland
  citation: Ernst MJ, Sax N, Meichtry A, Aegerter AM, Luomajoki H, Ludtke K, Gallina A, Falla D; NEXpro collaboration group. Cervical musculoskeletal impairments and pressure pain sensitivity in office workers with headache. Musculoskelet Sci Pract. 2023 Aug;66:102816. doi: 10.1016/j.msksp.2023.102816. Epub 2023 Jun 26.
  PMID: 37394322
  citation: Chiu TT, Law EY, Chiu TH. Performance of the craniocervical flexion test in subjects with and without chronic neck pain. J Orthop Sports Phys Ther. 2005 Sep;35(9):567-71. doi: 10.2519/jospt.2005.35.9.567.
  PMID: 16268243
  citation: James G, Doe T. The craniocervical flexion test: intra-tester reliability in asymptomatic subjects. Physiother Res Int. 2010 Sep;15(3):144-9. doi: 10.1002/pri.456.
  PMID: 20146239
  citation: Jull G, Amiri M, Bullock-Saxton J, Darnell R, Lander C. Cervical musculoskeletal impairment in frequent intermittent headache. Part 1: Subjects with single headaches. Cephalalgia. 2007 Jul;27(7):793-802. doi: 10.1111/j.1468-2982.2007.01345.x.
  PMID: 17598761
  citation: Carrasco-Uribarren A, Marimon X, Portela A, Cabanillas-Barea S, Rodriguez-Rubio PR, Perez RA. A Novel Device for Assessment and Treatment of Upper Cervical Spine: Test-Retest Reliability Study. J Clin Med. 2023 Mar 1;12(5):1954. doi: 10.3390/jcm12051954.
  PMID: 36902739
  citation: Romeo A, Baccini M, Carreras G, Sagripanti M, Ruggeri M, Pillastrini P, Di Bari M. Reliability, Validity, and Responsiveness of the Craniocervical Flexion Test in People Who Are Asymptomatic and Patients With Nonspecific Neck Pain: A Systematic Review and Meta-Analysis. Phys Ther. 2022 Jul 4;102(7):pzac054. doi: 10.1093/ptj/pzac054.
  PMID: 35554598
  citation: Selistre LFA, Melo CS, Noronha MA. Reliability and Validity of Clinical Tests for Measuring Strength or Endurance of Cervical Muscles: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2021 Jun;102(6):1210-1227. doi: 10.1016/j.apmr.2020.11.018. Epub 2020 Dec 28.
  PMID: 33383030
  responsible party type: Principal Investigator
  investigator affiliation: Zurich University of Applied Sciences
  investigator full name: Markus J. Ernst
  investigator title: Principal investigator
  mesh term: Bruxism
  sharing ipd: No
  ipd description: data can be shared on demand