<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/NCT02195648</url>
  </required_header>
  <id_info>
    <org_study_id>tension type headache</org_study_id>
    <nct_id>NCT02195648</nct_id>
  </id_info>
  <brief_title>Sub-occipital Muscle Inhibition in Tension Type Headache</brief_title>
  <acronym>TTH</acronym>
  <official_title>Treatment Efficacy of Tension Type Headache After Application of Sub-occipital Muscle Inhibition Technique Associated With Interferential Electrotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to determine the effects caused in neck movement, neck&#xD;
      pain, headache in patients with tension type headache and cervicogenic headache after&#xD;
      application of sub-occipital muscle inhibition technique associated with interferential&#xD;
      electrotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is based on the combined application of sub-occipital muscle inhibition technique&#xD;
      associated with interferential electrotherapy improves symptoms in patients with tension type&#xD;
      headache and cervicogenic headache.&#xD;
&#xD;
      The purposes of this study are:&#xD;
&#xD;
        -  Evaluate the effectiveness of treatment based on the combined application of&#xD;
           sub-occipital muscle inhibition technique associated with interferential electrotherapy&#xD;
           in patients with tension type headache.&#xD;
&#xD;
        -  Evaluate the effects of treatment caused in upper cervical movement.&#xD;
&#xD;
        -  Evaluate the effects of treatment caused in neck pain.&#xD;
&#xD;
        -  Evaluate the effects of treatment caused in headache.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Outcome assessor will be blinded to group allocation. Additionally, analysis blinding will be performed to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>Pain will be assessed at baseline, before and after each session (twice a week for 4 weeks)</time_frame>
    <description>Our primary outcome will consist of changes at each session in self-reported pain, which will be measured with a visual analogic scale (VAS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>STAI will be assessed at baseline and after 4 weeks.</time_frame>
    <description>Anxiety will be assessed with the State-Trait Anxiety Inventory. This questionnaire is designed for the self-assessment of anxiety (Cronbach's α for this scale ranges from .83 to .92).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Headache Disability</measure>
    <time_frame>HDI will be assessed at baseline and after 4 weeks.</time_frame>
    <description>The Spanish version of the Headache Disability Inventory (HDI) which has shown a strong consistency/reliability will be used to measure neck disability. The HDI consists of 25 items assessing emotional (13 items) and functional aspects (12 items) with 4 possible response options, the total score ranging from 0 to 52 points and 0 to 48 points for emotional and functional aspects, respectively, with higher scores indicating more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Impact Test</measure>
    <time_frame>HIT-6 will be assessed at baseline and after 4 weeks.</time_frame>
    <description>The impact of headache on daily life will be measured by the Headache Impact Test-6 (HIT-6) (Cronbach alpha 0.89; test-retest reliability ranging from 0.78 to 0.90). The HIT-6 consists of 6 items with 4 response options. The total score of HIT-6 ranging from 36 to 78 points, where a higher score indicates a greater impact of headache on the daily life of the respondent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>ROM will be assessed at baseline and after 4 weeks.</time_frame>
    <description>Upper cervical range of motion will be measured with the CROM-device (Performance Attainment Associates. 958 Lydia Drive, Roseville, Minnesota, USA. 55113) which has demonstrated a good intra-tester reliability for cervical extension, flexion, lateral flexion and rotation. The flexion, extension and lateral flexion ranges of motion will be measured actively with the patient sit in a straight-back chair. The subject will be instructed to move their head and neck through all cardinal planes. The range of motionwill be determined either by the patient reporting the onset of pain or firm resistance met by the evaluator. Three measurements will be done, and the average will be selected for future analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index</measure>
    <time_frame>NDI will be assessed at baseline and after 4 weeks.</time_frame>
    <description>Neck Dissability Index (NDI) is a modification of the Oswestry low back pain disability index, and has the most commonly used self-report measure for neck pain. It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The tool is 5-ordinal scale from 1 (I can't) to 5 (I can), with a maximum score 50.&#xD;
The NDI has good reliability and validity in persons with mechanical neck pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 Health Survey</measure>
    <time_frame>SF-36 will be assessed at baseline and after 4 weeks.</time_frame>
    <description>The SF36 is a shortened version of a battery of 149 health status questions developed and tested on a population of over 22,000 patients as part of the medical outcome study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>BECK II will be assessed at baseline and after 4 weeks.</time_frame>
    <description>BECK II will be used to measure the participant's depression. The Beck Depression Inventory consists of 21 items, assessing depressive symptoms on a Likert scale of 0-3, ranging from 0 = &quot;rarely or not at all&quot; to 3 = &quot;most of the time or always&quot;, with overall scores ranging from 0 to a maximum of 63 points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Tension-Type Headache</condition>
  <arm_group>
    <arm_group_label>Suboccipital inhibition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention will be done to the participants during the study. After study completion, the participants will be offered to receive the therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Suboccipital inhibition</intervention_name>
    <description>Experimental: Suboccipital inhibition&#xD;
The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles.</description>
    <arm_group_label>Suboccipital inhibition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with tension type headache&#xD;
&#xD;
          -  In prophylactic regimen and with medical control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with neurological or cognitive impairments that prevent understanding the&#xD;
             questionnaires&#xD;
&#xD;
          -  Patients diagnosed with other types of headaches&#xD;
&#xD;
          -  Patients who have not signed the informed consent document&#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>Javier Meroño-Gallut, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Católica San Antonio de Murcia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad Católica San Antonio de Murcia</name>
      <address>
        <city>Murcia</city>
        <state>Guadalupe</state>
        <zip>30107</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Raúl Pérez Llanes</investigator_full_name>
    <investigator_title>Diplomado en Fisioterapia</investigator_title>
  </responsible_party>
  <keyword>Tension-Type Headache</keyword>
  <keyword>Physical Therapy Modalities</keyword>
  <keyword>Musculoskeletal Manipulations</keyword>
  <keyword>Sub-occipital muscle inhibition technique</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>


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/NCT02195648
org study id: tension type headache
nct id: NCT02195648
lead sponsor: 
has dmc: No
The main objective of this study is to determine the effects caused in neck movement, neck
      pain, headache in patients with tension type headache and cervicogenic headache after
      application of sub-occipital muscle inhibition technique associated with interferential
      electrotherapy.
This study is based on the combined application of sub-occipital muscle inhibition technique
      associated with interferential electrotherapy improves symptoms in patients with tension type
      headache and cervicogenic headache.

      The purposes of this study are:

        -  Evaluate the effectiveness of treatment based on the combined application of
           sub-occipital muscle inhibition technique associated with interferential electrotherapy
           in patients with tension type headache.

        -  Evaluate the effects of treatment caused in upper cervical movement.

        -  Evaluate the effects of treatment caused in neck pain.

        -  Evaluate the effects of treatment caused in headache.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Outcome assessor will be blinded to group allocation. Additionally, analysis blinding will be performed to group allocation.
measure: Pain
time frame: Pain will be assessed at baseline, before and after each session (twice a week for 4 weeks)
description: Our primary outcome will consist of changes at each session in self-reported pain, which will be measured with a visual analogic scale (VAS).
measure: Anxiety
time frame: STAI will be assessed at baseline and after 4 weeks.
description: Anxiety will be assessed with the State-Trait Anxiety Inventory. This questionnaire is designed for the self-assessment of anxiety (Cronbach's α for this scale ranges from .83 to .92).
measure: Headache Disability
time frame: HDI will be assessed at baseline and after 4 weeks.
description: The Spanish version of the Headache Disability Inventory (HDI) which has shown a strong consistency/reliability will be used to measure neck disability. The HDI consists of 25 items assessing emotional (13 items) and functional aspects (12 items) with 4 possible response options, the total score ranging from 0 to 52 points and 0 to 48 points for emotional and functional aspects, respectively, with higher scores indicating more disability.
measure: Headache Impact Test
time frame: HIT-6 will be assessed at baseline and after 4 weeks.
description: The impact of headache on daily life will be measured by the Headache Impact Test-6 (HIT-6) (Cronbach alpha 0.89; test-retest reliability ranging from 0.78 to 0.90). The HIT-6 consists of 6 items with 4 response options. The total score of HIT-6 ranging from 36 to 78 points, where a higher score indicates a greater impact of headache on the daily life of the respondent.
measure: Range of Motion
time frame: ROM will be assessed at baseline and after 4 weeks.
description: Upper cervical range of motion will be measured with the CROM-device (Performance Attainment Associates. 958 Lydia Drive, Roseville, Minnesota, USA. 55113) which has demonstrated a good intra-tester reliability for cervical extension, flexion, lateral flexion and rotation. The flexion, extension and lateral flexion ranges of motion will be measured actively with the patient sit in a straight-back chair. The subject will be instructed to move their head and neck through all cardinal planes. The range of motionwill be determined either by the patient reporting the onset of pain or firm resistance met by the evaluator. Three measurements will be done, and the average will be selected for future analysis.
measure: Neck Disability Index
time frame: NDI will be assessed at baseline and after 4 weeks.
description: Neck Dissability Index (NDI) is a modification of the Oswestry low back pain disability index, and has the most commonly used self-report measure for neck pain. It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The tool is 5-ordinal scale from 1 (I can't) to 5 (I can), with a maximum score 50.
The NDI has good reliability and validity in persons with mechanical neck pain.
measure: SF-36 Health Survey
time frame: SF-36 will be assessed at baseline and after 4 weeks.
description: The SF36 is a shortened version of a battery of 149 health status questions developed and tested on a population of over 22,000 patients as part of the medical outcome study.
measure: Depression
time frame: BECK II will be assessed at baseline and after 4 weeks.
description: BECK II will be used to measure the participant's depression. The Beck Depression Inventory consists of 21 items, assessing depressive symptoms on a Likert scale of 0-3, ranging from 0 = "rarely or not at all" to 3 = "most of the time or always", with overall scores ranging from 0 to a maximum of 63 points.
arm group label: Suboccipital inhibition
arm group type: Experimental
description: The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles.
arm group label: Control
arm group type: No Intervention
description: No intervention will be done to the participants during the study. After study completion, the participants will be offered to receive the therapy.
intervention type: Other
intervention name: Suboccipital inhibition
description: Experimental: Suboccipital inhibition
The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles.
arm group label: Suboccipital inhibition
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Javier Meroño-Gallut, PhD
role: Study Director
affiliation: Universidad Católica San Antonio de Murcia
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Raúl Pérez Llanes
investigator title: Diplomado en Fisioterapia
mesh term: Tension-Type Headache
mesh term: Headache