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/NCT05972382</url>
    </required_header>
    <id_info>
      <org_study_id>CGH01</org_study_id>
      <nct_id>NCT05972382</nct_id>
    </id_info>
    <brief_title>Associations Between Neck Muscle Fatigue, Joint Position Sense, and Headache in Cervicogenic Headache</brief_title>
    <official_title>Investigating Associations Between Neck Flexor Muscle Fatigue, Cervical Joint Position Sense Errors, and Headache Pain and Disability in Individuals With Chronic Cervicogenic Headache</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ahram Canadian University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ahram Canadian University</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>
        This research study aims to better understand the relationships between neck muscle function,&#xD;
        neck joint position sense, and headache pain and disability in people with chronic&#xD;
        cervicogenic headache. Cervicogenic headache is headache originating from the neck area.&#xD;
  &#xD;
        Participants will fill out questionnaires about their headache pain and ability to do daily&#xD;
        activities. They will also do tests to measure neck muscle fatigue and neck joint position&#xD;
        sense. Researchers will analyze if those with more neck muscle fatigue and poorer joint&#xD;
        position sense have worse headache pain and disability.&#xD;
  &#xD;
        The results may improve understanding of cervical spine factors related to cervicogenic&#xD;
        headache. This could help guide more targeted treatment approaches.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic cervicogenic headache (CGH) is characterized by chronic headache originating from the&#xD;
        upper cervical spine and occipital region. CGH is associated with impairments in cervical&#xD;
        muscular control and proprioception or joint position sense. However, relationships between&#xD;
        these cervical impairments and headache symptoms are not fully elucidated.&#xD;
  &#xD;
        This cross-sectional quantitative study aims to investigate associations between neck flexor&#xD;
        muscle fatigue, cervical joint position sense, and clinical headache parameters like pain and&#xD;
        disability in individuals with CGH.&#xD;
  &#xD;
        A sample of 30 adults ages 18-65 years old with CGH longer than 3 months duration and more&#xD;
        than 15 headache days per month will be recruited from neurology clinics. Participants will&#xD;
        attend a single 2 hour study visit.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 28, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Headache Pain Intensity</measure>
      <time_frame>Baseline</time_frame>
      <description>Average headache pain over the past week rated on a 0-10 Numerical Rating Scale (NRS). Participants asked to rate their average pain level over the past week on a 0 to 10 scale, where 0 is no pain and 10 is the worst possible pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Headache Disability</measure>
      <time_frame>Baseline</time_frame>
      <description>Total score on the 25-item Headache Disability Inventory (HDI) questionnaire, assessing headache-related disability over the past month. Each item scored as yes (4 points), sometimes (2 points), or no (0 points). Total score ranges from 0 to 100, with higher scores indicating greater disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neck Flexor Fatigue</measure>
      <time_frame>baseline</time_frame>
      <description>Change in mean surface electromyography (EMG) amplitude (measured in microvolts) of the sternocleidomastoid and longus colli muscles from start to end of a 30-second craniocervical flexion contraction at 50% maximum voluntary contraction (MVC).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cervical Joint Position Sense</measure>
      <time_frame>Baseline</time_frame>
      <description>Absolute error in degrees between perceived and actual head repositioning after returning from 20 degrees of active right cervical rotation. Average error over 3 trials used.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cervicogenic Headache</condition>
    <arm_group>
      <arm_group_label>Cervicogenic Headache</arm_group_label>
      <description>Individuals with chronic cervicogenic headache (&gt;3 months duration)</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Quantitative Sensory and Neurophysiological Testing</intervention_name>
      <description>Participants will undergo the following quantitative sensory and neurophysiological diagnostic tests:&#xD;
  Surface electromyography (EMG) of the neck flexor muscles during the craniocervical flexion test to assess neck flexor muscle fatigue. EMG sensors will be placed over the sternocleidomastoid and longus colli muscles. Cervical joint position error testing to evaluate proprioceptive awareness and cervicocephalic kinesthetic sensibility. Participants will be seated upright and blindfolded.</description>
      <arm_group_label>Cervicogenic Headache</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults with chronic cervicogenic headache recruited from neurology clinics&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 18-60 years&#xD;
  &#xD;
            -  Chronic CGH (&gt;3 months duration)&#xD;
  &#xD;
            -  Headache frequency ≥15 days/month&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cervical nerve root compression or other specific pathologies explaining headache&#xD;
  &#xD;
            -  History of cervical spine surgery&#xD;
  &#xD;
            -  Botulinum toxin injections in cervical musculature in past 6 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amal Fawzy, Ph.d</last_name>
      <role>Study Chair</role>
      <affiliation>Faculty of Physical Therapy, Ahram Canadian University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mohamed M ElMeligie, Ph.d</last_name>
      <phone>+201064442032</phone>
      <email>mohamed.elmeligie@acu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Outpatient clinic of faculty of physical therapy, Ahram Canadian University</name>
        <address>
          <city>Al Ḩayy Ath Thāmin</city>
          <state>Giza</state>
          <zip>3221405</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohamed M ElMeligie, Ph.d</last_name>
        <phone>01064442032</phone>
        <email>mohamed.elmeligie@acu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ahram Canadian University</investigator_affiliation>
      <investigator_full_name>Mohamed Magdy ElMeligie</investigator_full_name>
      <investigator_title>Lecturer of Physical Therapy and Director of Electromyography Lab</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Post-Traumatic Headache</mesh_term>
      <mesh_term>Headache</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/NCT05972382
  org study id: CGH01
  nct id: NCT05972382
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This research study aims to better understand the relationships between neck muscle function,
        neck joint position sense, and headache pain and disability in people with chronic
        cervicogenic headache. Cervicogenic headache is headache originating from the neck area.
  
        Participants will fill out questionnaires about their headache pain and ability to do daily
        activities. They will also do tests to measure neck muscle fatigue and neck joint position
        sense. Researchers will analyze if those with more neck muscle fatigue and poorer joint
        position sense have worse headache pain and disability.
  
        The results may improve understanding of cervical spine factors related to cervicogenic
        headache. This could help guide more targeted treatment approaches.
  Chronic cervicogenic headache (CGH) is characterized by chronic headache originating from the
        upper cervical spine and occipital region. CGH is associated with impairments in cervical
        muscular control and proprioception or joint position sense. However, relationships between
        these cervical impairments and headache symptoms are not fully elucidated.
  
        This cross-sectional quantitative study aims to investigate associations between neck flexor
        muscle fatigue, cervical joint position sense, and clinical headache parameters like pain and
        disability in individuals with CGH.
  
        A sample of 30 adults ages 18-65 years old with CGH longer than 3 months duration and more
        than 15 headache days per month will be recruited from neurology clinics. Participants will
        attend a single 2 hour study visit.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Headache Pain Intensity
  time frame: Baseline
  description: Average headache pain over the past week rated on a 0-10 Numerical Rating Scale (NRS). Participants asked to rate their average pain level over the past week on a 0 to 10 scale, where 0 is no pain and 10 is the worst possible pain.
  measure: Headache Disability
  time frame: Baseline
  description: Total score on the 25-item Headache Disability Inventory (HDI) questionnaire, assessing headache-related disability over the past month. Each item scored as yes (4 points), sometimes (2 points), or no (0 points). Total score ranges from 0 to 100, with higher scores indicating greater disability.
  measure: Neck Flexor Fatigue
  time frame: baseline
  description: Change in mean surface electromyography (EMG) amplitude (measured in microvolts) of the sternocleidomastoid and longus colli muscles from start to end of a 30-second craniocervical flexion contraction at 50% maximum voluntary contraction (MVC).
  measure: Cervical Joint Position Sense
  time frame: Baseline
  description: Absolute error in degrees between perceived and actual head repositioning after returning from 20 degrees of active right cervical rotation. Average error over 3 trials used.
  arm group label: Cervicogenic Headache
  description: Individuals with chronic cervicogenic headache (>3 months duration)
  intervention type: Diagnostic Test
  intervention name: Quantitative Sensory and Neurophysiological Testing
  description: Participants will undergo the following quantitative sensory and neurophysiological diagnostic tests:
  Surface electromyography (EMG) of the neck flexor muscles during the craniocervical flexion test to assess neck flexor muscle fatigue. EMG sensors will be placed over the sternocleidomastoid and longus colli muscles. Cervical joint position error testing to evaluate proprioceptive awareness and cervicocephalic kinesthetic sensibility. Participants will be seated upright and blindfolded.
  arm group label: Cervicogenic Headache
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Amal Fawzy, Ph.d
  role: Study Chair
  affiliation: Faculty of Physical Therapy, Ahram Canadian University
  last name: Mohamed M ElMeligie, Ph.d
  phone: +201064442032
  email: mohamed.elmeligie@acu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ahram Canadian University
  investigator full name: Mohamed Magdy ElMeligie
  investigator title: Lecturer of Physical Therapy and Director of Electromyography Lab
  mesh term: Post-Traumatic Headache
  mesh term: Headache
  sharing ipd: No