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/NCT05999201</url>
    </required_header>
    <id_info>
      <org_study_id>p.t.REC/012/003179</org_study_id>
      <nct_id>NCT05999201</nct_id>
    </id_info>
    <brief_title>Effect of Craniocervical Neural Mobilization on Quality of Life in Patients With Primary Tension Headache</brief_title>
    <acronym>TTH</acronym>
    <official_title>Effect of Craniocervical Neural Mobilization on Quality of Life in Patients With Primary Tension Headache</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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 study will be conducted to investigate the effect of craniocervical neural mobilization&#xD;
        on quality of life in patients with primary tension headache.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The World Health Organization estimates that the three most prevalent neurologic disorders&#xD;
        worldwide are tension-type headache (1.5 billion), migraine (958.8 million), and medication&#xD;
        overuse headache (58.5 million). Collectively, these three disorders contribute approximately&#xD;
        17% to the global burden of neurologic diseases, with migraine the second most disabling&#xD;
        disease overall. TTH (Tension Type of Headache) is defined as mild to moderate band-like&#xD;
        pressure headache with few associated symptoms. It varies considerably in frequency and&#xD;
        duration, from rare, short-lasting episodes of discomfort to frequent, long-lasting, or even&#xD;
        continuous disabling headaches.Physiotherapy treatment based on manual therapy achieved&#xD;
        positive outcomes in pain intensity and frequency, disability, impact of headache, quality of&#xD;
        life, and craniocervical range of motion in adults with TTH. Although pervious findings&#xD;
        showed a clinical improvement, there is no clear evidence that one technique is superior to&#xD;
        another.Neurodynamic techniques can improve mechanical functions in nerve structures, such as&#xD;
        tension and sliding functions. When the nerve structure experiences clamping and disrupts&#xD;
        mobility, pain occurs along the nerve. Neurodynamic sliding techniques play a major role in&#xD;
        improving blood circulation and axonal transport, as well as increasing nerve integrity and&#xD;
        reducing the pressure caused by intraneural and extraneural fibrosis. thirty patients with&#xD;
        tension headache will be allocated randomly into two equal groups. the first one will receive&#xD;
        craniocervical mobilization and a selected physiotherapy program and the control group will&#xD;
        receive selected physiotherapy program for one month.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 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>Craniocervical Neural Mobilization and selected physiotherapy program</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>opaque sealed envelope</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>life disability</measure>
      <time_frame>up to four weeks</time_frame>
      <description>Headache Impact Test-6 scale will be used to assess life disability.It is a six-item, self-report, retrospective questionnaire. The six items in the HIT-6 address such aspects of quality of life as pain, social functioning, cognitive functioning, and psychological distress.The HIT-6 is scored by giving these responses a value of 6, 8, 10, 11, and 13, respectively. The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>frequency and severity of headache</measure>
      <time_frame>up to four weeks</time_frame>
      <description>headache disability index will be used to assess the frequency and severity of headache. The questionnaire begins with two items that assess pain severity (mild, moderate, and severe) and frequency (once month, from 1 to 4 times a month, and more than once a week). It also includes 25 question on functional sub-scale (12 items) and emotional subscale (13 items) with three possible response option (No=0 points; Sometimes=2 points; Yes=4 points). The maximum score is 100 points, ranging from 0=no disability to 100=severe disability. A total score of 10-28 is considered o indicate mild disability; 30-48 is moderate disability; 50-68 is sever disability; 72 or more is complete disability</description>
    </primary_outcome>
    <primary_outcome>
      <measure>pain intensity</measure>
      <time_frame>up to four weeks</time_frame>
      <description>visaul analogue scale will be used to assess pain intensity. Patients will be informed about visual analog scale that has two ends ; 0: no pain; 10: maximum pain.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Tension-Type Headache</condition>
    <arm_group>
      <arm_group_label>craniocervical neural mobilization</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>the patients will receive craniocervical neural mobilization and a selected physiotherapy program twice a week for four weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>selected physiotherapy program</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the patients will receive a selected physiotherapy program twice a week for four weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>craniocervical neural mobilization</intervention_name>
      <description>the patients will receive The craniocervical neural mobilization in the form of passive craniocervical flexion in which An anterior rotation of the head will be done which stimulates the meninges.To increase mechanical stress in the nervous system, patients will be asked to do a descent and retropulsion of the shoulders while gradually extending both elbows. in addition to Passive lateral cervical sliding and Craniocervical flexion with mouth opening.The neural mobilization should be mild, progressive, and slow. The protocol lasted 15 minutes and also the patients will receive selected physiotherapy program</description>
      <arm_group_label>craniocervical neural mobilization</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>selected physiotherapy program</intervention_name>
      <description>the patients will receive selected physiotherapy program in the form of Suboccibital muscles inhibition suboccipital inhibition technique (SIT), from supine lying position, the therapist will sit at the patient's head head with the elbows rested on the surface of the table. Then, the therapist will place both hands behind the head of the patient with the palms facing upwards, the fingers flexed, and the finger pads positioned on the posterior arch of the atlas to allow the occiput to rest in the palm of the hands. the patients will receive also trigger point release technique in the form of An ischemic compression for sternocleidomastoid muscle, temporal muscle, upper trapezius muscle and splines muscles</description>
      <arm_group_label>craniocervical neural mobilization</arm_group_label>
      <arm_group_label>selected physiotherapy program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The type of headache will be primary tension type of headache.&#xD;
  &#xD;
            -  Age of subjects will range from 25-40 years.&#xD;
  &#xD;
            -  The duration of headaches swill be one years ago.&#xD;
  &#xD;
            -  Body mass index from 25 to less than 30.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Major neurological conditions (e.g. stroke, multiple sclerosis, epilepsy, brain tumor,&#xD;
               meningitis, and hypertension).&#xD;
  &#xD;
            -  Patients with cervical spinal cord injury, recent trauma of head.&#xD;
  &#xD;
            -  Patients with auditory and visual impairments.&#xD;
  &#xD;
            -  Smoker and addicted subjects.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Amira Mohammed Abdul Hamid Elgendy</investigator_full_name>
      <investigator_title>principle investigator amira mohamed abdul hamid</investigator_title>
    </responsible_party>
    <keyword>craniocervical neural mobilization</keyword>
    <keyword>quality of life</keyword>
    <keyword>primary tension headache</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tension-Type Headache</mesh_term>
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <!-- 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/NCT05999201
  org study id: p.t.REC/012/003179
  nct id: NCT05999201
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  this study will be conducted to investigate the effect of craniocervical neural mobilization
        on quality of life in patients with primary tension headache.
  The World Health Organization estimates that the three most prevalent neurologic disorders
        worldwide are tension-type headache (1.5 billion), migraine (958.8 million), and medication
        overuse headache (58.5 million). Collectively, these three disorders contribute approximately
        17% to the global burden of neurologic diseases, with migraine the second most disabling
        disease overall. TTH (Tension Type of Headache) is defined as mild to moderate band-like
        pressure headache with few associated symptoms. It varies considerably in frequency and
        duration, from rare, short-lasting episodes of discomfort to frequent, long-lasting, or even
        continuous disabling headaches.Physiotherapy treatment based on manual therapy achieved
        positive outcomes in pain intensity and frequency, disability, impact of headache, quality of
        life, and craniocervical range of motion in adults with TTH. Although pervious findings
        showed a clinical improvement, there is no clear evidence that one technique is superior to
        another.Neurodynamic techniques can improve mechanical functions in nerve structures, such as
        tension and sliding functions. When the nerve structure experiences clamping and disrupts
        mobility, pain occurs along the nerve. Neurodynamic sliding techniques play a major role in
        improving blood circulation and axonal transport, as well as increasing nerve integrity and
        reducing the pressure caused by intraneural and extraneural fibrosis. thirty patients with
        tension headache will be allocated randomly into two equal groups. the first one will receive
        craniocervical mobilization and a selected physiotherapy program and the control group will
        receive selected physiotherapy program for one month.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Craniocervical Neural Mobilization and selected physiotherapy program
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: opaque sealed envelope
  measure: life disability
  time frame: up to four weeks
  description: Headache Impact Test-6 scale will be used to assess life disability.It is a six-item, self-report, retrospective questionnaire. The six items in the HIT-6 address such aspects of quality of life as pain, social functioning, cognitive functioning, and psychological distress.The HIT-6 is scored by giving these responses a value of 6, 8, 10, 11, and 13, respectively. The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).
  measure: frequency and severity of headache
  time frame: up to four weeks
  description: headache disability index will be used to assess the frequency and severity of headache. The questionnaire begins with two items that assess pain severity (mild, moderate, and severe) and frequency (once month, from 1 to 4 times a month, and more than once a week). It also includes 25 question on functional sub-scale (12 items) and emotional subscale (13 items) with three possible response option (No=0 points; Sometimes=2 points; Yes=4 points). The maximum score is 100 points, ranging from 0=no disability to 100=severe disability. A total score of 10-28 is considered o indicate mild disability; 30-48 is moderate disability; 50-68 is sever disability; 72 or more is complete disability
  measure: pain intensity
  time frame: up to four weeks
  description: visaul analogue scale will be used to assess pain intensity. Patients will be informed about visual analog scale that has two ends ; 0: no pain; 10: maximum pain.
  arm group label: craniocervical neural mobilization
  arm group type: Experimental
  description: the patients will receive craniocervical neural mobilization and a selected physiotherapy program twice a week for four weeks
  arm group label: selected physiotherapy program
  arm group type: Active Comparator
  description: the patients will receive a selected physiotherapy program twice a week for four weeks
  intervention type: Other
  intervention name: craniocervical neural mobilization
  description: the patients will receive The craniocervical neural mobilization in the form of passive craniocervical flexion in which An anterior rotation of the head will be done which stimulates the meninges.To increase mechanical stress in the nervous system, patients will be asked to do a descent and retropulsion of the shoulders while gradually extending both elbows. in addition to Passive lateral cervical sliding and Craniocervical flexion with mouth opening.The neural mobilization should be mild, progressive, and slow. The protocol lasted 15 minutes and also the patients will receive selected physiotherapy program
  arm group label: craniocervical neural mobilization
  intervention type: Other
  intervention name: selected physiotherapy program
  description: the patients will receive selected physiotherapy program in the form of Suboccibital muscles inhibition suboccipital inhibition technique (SIT), from supine lying position, the therapist will sit at the patient's head head with the elbows rested on the surface of the table. Then, the therapist will place both hands behind the head of the patient with the palms facing upwards, the fingers flexed, and the finger pads positioned on the posterior arch of the atlas to allow the occiput to rest in the palm of the hands. the patients will receive also trigger point release technique in the form of An ischemic compression for sternocleidomastoid muscle, temporal muscle, upper trapezius muscle and splines muscles
  arm group label: craniocervical neural mobilization
  arm group label: selected physiotherapy program
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 40 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Amira Mohammed Abdul Hamid Elgendy
  investigator title: principle investigator amira mohamed abdul hamid
  mesh term: Tension-Type Headache
  mesh term: Headache