<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/NCT04401501</url>
  </required_header>
  <id_info>
    <org_study_id>N14/2020</org_study_id>
    <nct_id>NCT04401501</nct_id>
  </id_info>
  <brief_title>Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.</brief_title>
  <official_title>Short- and Mid-Term Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Zaragoza</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Cervicogenic headache is defined as unilateral headache associated with neck pain. Effect of&#xD;
      manual translatoric therapy of the upper cervical spine associated with cervical exercises in&#xD;
      these patients is currently unknown. Our aim was to determine if adding manual therapy to an&#xD;
      exercise and home-exercise program improved effects on symptoms and function in short- and&#xD;
      mid-term in patients with cervicogenic headache.&#xD;
&#xD;
      A randomized controlled study will be conducted with 40 subjects with cervicogenic headache.&#xD;
      Each group will receive four 20-minute sessions weekly and a home-exercise program. Upper&#xD;
      cervical flexion, flexion-rotation test, Impact Headache Test-6 (HIT-6), headache intensity,&#xD;
      craniocervical flexion test, pain pressure thresholds and Global Rating of Change&#xD;
      (GROC)-Scale will be assessed at end of the intervention, at 3- and at 6-month follow-ups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Headache Intensity (HIT-6)</measure>
    <time_frame>Change between baseline and post intervention (1 month), after 3 months and after 6 months</time_frame>
    <description>Test-6 questionnaire (HIT-6) will be used to describe the degree of pain and disability caused by the headache, with a reliability higher than 0.70. The results are classified into four categories that score daily life impact of headache (little or none, some, substantial and severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flexion-rotation test</measure>
    <time_frame>Change between baseline and post intervention (1 month), after 3 months and after 6 months</time_frame>
    <description>This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32º</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Upper cervical flexion range of motion</measure>
    <time_frame>Change between baseline and post intervention (1 month), after 3 months and after 6 months</time_frame>
    <description>Active flexion of the upper cervical spine will be measured in standing position using a CROM device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Intensity</measure>
    <time_frame>Change between baseline and post intervention (1 month), after 3 months and after 6 months</time_frame>
    <description>Headache intensity will be assessed on a visual analogue scale from 0 to 10 cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craniocervical flexion test</measure>
    <time_frame>Change between baseline and post intervention (1 month), after 3 months and after 6 months</time_frame>
    <description>This test will be used to measure the strength of the deep flexor muscles. The activation and resistance of the deep flexor muscles will be evaluated in five progressive pressure increases of 2 mmHg up to a maximum of 30 mmHg. The patient will pass to the next level after reaching one certain level three times.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Pressure Thresholds</measure>
    <time_frame>Change between baseline and post intervention (1 month), after 3 months and after 6 months</time_frame>
    <description>Pain pressure thresholds will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2. Pressure will be applied at a rate of 1 kg/cm2/s, perpendicular to the skin. Pressure pain thresholds will be assessed over six points bilaterally with the subject in supine position: suboccipital region, C2-3, C5-6, elevator of scapula, trapezius and first metacarpal joint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Raiting of Scale (GROC-Scale)</measure>
    <time_frame>Change between baseline and post intervention (1 month), after 3 months and after 6 months</time_frame>
    <description>GROC-Scale will be used to measure the personal evolution that the patient had experienced. This scale is considered to be an efficient way to score patients' perceived clinical change and test-reliability has shown to be excellent (ICC=0.90).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to self-treatment scale</measure>
    <time_frame>Change between baseline and post intervention (1 month), after 3 months and after 6 months</time_frame>
    <description>This scale will be used in order to measure the adherence to self-treatment at home. Patients will be asked to choose between the following answers: &quot;I have done the exercises every day&quot;; &quot;I have performed the exercises 4-6 days a week&quot;; &quot;I have performed the exercises 1-3 days a week&quot;; &quot;I have performed the exercises less than 1 day a week&quot;; or &quot;I have not performed them&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cervicogenic Headache</condition>
  <condition>Headache</condition>
  <arm_group>
    <arm_group_label>Manual Therapy + Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of manual therapy and exercises for cervicogenic headache</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Only exercises for cervicogenic headache</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy and Exercises</intervention_name>
    <description>Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache</description>
    <arm_group_label>Manual Therapy + Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Exercises for cervicogenic headache</description>
    <arm_group_label>Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cervicogenic headache according to Sjaastad et al. Subjects will have to&#xD;
             fulfill both parts I and III of the major criteria for diagnosis (pain aggravated by&#xD;
             neck movement, sustained position or external pressure, restricted cervical range of&#xD;
             motion, and unilateral pain starting in the neck and radiating to the frontotemporal&#xD;
             region)&#xD;
&#xD;
          -  Hypomobility in one or more segments of C0-1, C1-2, C2-3 through manual evaluation.&#xD;
&#xD;
          -  A positive result in the flexion-rotation test.&#xD;
&#xD;
          -  A failure to pass stage 2 (24 mmHg) of the craniocervical flexion test.&#xD;
&#xD;
          -  Be at least 18 years old.&#xD;
&#xD;
          -  Have signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for manual therapy or exercise.&#xD;
&#xD;
          -  Participation in exercise or manual therapy programs in the last three months.&#xD;
&#xD;
          -  Inability to maintain supine position.&#xD;
&#xD;
          -  The use of pacemakers (the magnets in the CROM device could alter their signal).&#xD;
&#xD;
          -  Inability to perform the flexion-rotation test.&#xD;
&#xD;
          -  Language difficulties.&#xD;
&#xD;
          -  Pending litigation or lawsuits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad de Zaragoza</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Zaragoza</investigator_affiliation>
    <investigator_full_name>Jacobo Rodríguez-Sanz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cervicogenic headache</keyword>
  <keyword>exercise</keyword>
  <keyword>manual therapy</keyword>
  <keyword>upper cervical spine</keyword>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04401501
org study id: N14/2020
nct id: NCT04401501
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cervicogenic headache is defined as unilateral headache associated with neck pain. Effect of
      manual translatoric therapy of the upper cervical spine associated with cervical exercises in
      these patients is currently unknown. Our aim was to determine if adding manual therapy to an
      exercise and home-exercise program improved effects on symptoms and function in short- and
      mid-term in patients with cervicogenic headache.

      A randomized controlled study will be conducted with 40 subjects with cervicogenic headache.
      Each group will receive four 20-minute sessions weekly and a home-exercise program. Upper
      cervical flexion, flexion-rotation test, Impact Headache Test-6 (HIT-6), headache intensity,
      craniocervical flexion test, pain pressure thresholds and Global Rating of Change
      (GROC)-Scale will be assessed at end of the intervention, at 3- and at 6-month follow-ups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Headache Intensity (HIT-6)
time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
description: Test-6 questionnaire (HIT-6) will be used to describe the degree of pain and disability caused by the headache, with a reliability higher than 0.70. The results are classified into four categories that score daily life impact of headache (little or none, some, substantial and severe.
measure: Flexion-rotation test
time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
description: This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32º
measure: Upper cervical flexion range of motion
time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
description: Active flexion of the upper cervical spine will be measured in standing position using a CROM device
measure: Headache Intensity
time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
description: Headache intensity will be assessed on a visual analogue scale from 0 to 10 cm.
measure: Craniocervical flexion test
time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
description: This test will be used to measure the strength of the deep flexor muscles. The activation and resistance of the deep flexor muscles will be evaluated in five progressive pressure increases of 2 mmHg up to a maximum of 30 mmHg. The patient will pass to the next level after reaching one certain level three times.
measure: Pain Pressure Thresholds
time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
description: Pain pressure thresholds will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2. Pressure will be applied at a rate of 1 kg/cm2/s, perpendicular to the skin. Pressure pain thresholds will be assessed over six points bilaterally with the subject in supine position: suboccipital region, C2-3, C5-6, elevator of scapula, trapezius and first metacarpal joint.
measure: Global Raiting of Scale (GROC-Scale)
time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
description: GROC-Scale will be used to measure the personal evolution that the patient had experienced. This scale is considered to be an efficient way to score patients' perceived clinical change and test-reliability has shown to be excellent (ICC=0.90).
measure: Adherence to self-treatment scale
time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
description: This scale will be used in order to measure the adherence to self-treatment at home. Patients will be asked to choose between the following answers: "I have done the exercises every day"; "I have performed the exercises 4-6 days a week"; "I have performed the exercises 1-3 days a week"; "I have performed the exercises less than 1 day a week"; or "I have not performed them".
arm group label: Manual Therapy + Exercise Group
arm group type: Experimental
description: Combination of manual therapy and exercises for cervicogenic headache
arm group label: Exercise Group
arm group type: Active Comparator
description: Only exercises for cervicogenic headache
intervention type: Other
intervention name: Manual Therapy and Exercises
description: Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache
arm group label: Manual Therapy + Exercise Group
intervention type: Other
intervention name: Exercise
description: Exercises for cervicogenic headache
arm group label: Exercise Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Zaragoza
investigator full name: Jacobo Rodríguez-Sanz
investigator title: Principal Investigator
mesh term: Post-Traumatic Headache
mesh term: Headache