<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/NCT02264340</url>
  </required_header>
  <id_info>
    <org_study_id>F(EFP)-003/2010</org_study_id>
    <nct_id>NCT02264340</nct_id>
  </id_info>
  <brief_title>Effects of Exercise and Relaxation Techniques on Tension Headache Pain Parameters of University Students</brief_title>
  <acronym>ERTTHU</acronym>
  <official_title>EFFECTS OF EXERCISE AND RELAXATION TECHNIQUES ON TENSION-TYPE HEADACHE PAIN PARAMETERS OF UNIVERSITY STUDENTS; A RANDOMIZED AND CONTROLLED CLINICAL TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Complutense de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Complutense de Madrid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tension headache is a common disabling disease and a worldwide public health problem. This&#xD;
      research tries to demonstrate the efficacy of physical therapy, based on cervical training&#xD;
      and postural self-correction instructions, which aims to increase the positive results&#xD;
      obtained from traditional relaxation techniques (Schultz Autogenic Training). University&#xD;
      students are selected, because headaches are very common in this sector of the population.&#xD;
      The design is a non-pharmacological randomized controlled trial, with blinded evaluation of&#xD;
      the response variables. The investigators compare two independent samples. One of them&#xD;
      receives an only treatment (Autogenic Training) and the other group receives a combined&#xD;
      program (Autogenic Training + specific cervical exercises and postural correction). Pain&#xD;
      parameters (frequency, intensity and duration) and drug consumption are measured before&#xD;
      treatment, and then, at 4 weeks and 3 months, to value the results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">December 2010</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>Frequency</measure>
    <time_frame>4 weeks</time_frame>
    <description>Days with headache, during 4 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensity</measure>
    <time_frame>4 weeks</time_frame>
    <description>Pain intensity (VAS: 1-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Hours a day with headache</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication</measure>
    <time_frame>4 weeks</time_frame>
    <description>Days in which person takes drugs for pain, during 4 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">152</enrollment>
  <condition>Tension-Type Headache</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Relaxation technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combined treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation technique Autogenic Training</intervention_name>
    <description>Autogenic Training</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Combined treatment Autogenic Training + Cervical exercises and postural correction</intervention_name>
    <description>Autogenic Training + Cervical exercises and postural correction</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  College students of Complutense University of Madrid, diagnosed with frequent episodic&#xD;
             or chronic tension-type headache (according to the criteria of International Headache&#xD;
             Society (IHS)).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cases with other headaches&#xD;
&#xD;
          -  Students with excessive state anxiety and / or trait anxiety (≥ 85 percentile,&#xD;
             State-Trait Anxiety Inventory )&#xD;
&#xD;
          -  Students that had received treatment for tension headache, based on physical exercise&#xD;
             or relaxation techniques, in the last 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ángela Álvarez Melcón, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Complutense de Madrid</affiliation>
  </overall_official>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Complutense de Madrid</investigator_affiliation>
    <investigator_full_name>Ángela Álvarez Melcón</investigator_full_name>
    <investigator_title>Physiotherapist (Doctor)</investigator_title>
  </responsible_party>
  <keyword>Tension-type headache</keyword>
  <keyword>relaxation techniques</keyword>
  <keyword>physiotherapy</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/NCT02264340
org study id: F(EFP)-003/2010
nct id: NCT02264340
lead sponsor: 
has dmc: No
Tension headache is a common disabling disease and a worldwide public health problem. This
      research tries to demonstrate the efficacy of physical therapy, based on cervical training
      and postural self-correction instructions, which aims to increase the positive results
      obtained from traditional relaxation techniques (Schultz Autogenic Training). University
      students are selected, because headaches are very common in this sector of the population.
      The design is a non-pharmacological randomized controlled trial, with blinded evaluation of
      the response variables. The investigators compare two independent samples. One of them
      receives an only treatment (Autogenic Training) and the other group receives a combined
      program (Autogenic Training + specific cervical exercises and postural correction). Pain
      parameters (frequency, intensity and duration) and drug consumption are measured before
      treatment, and then, at 4 weeks and 3 months, to value the results.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Frequency
time frame: 4 weeks
description: Days with headache, during 4 weeks
measure: Intensity
time frame: 4 weeks
description: Pain intensity (VAS: 1-10)
measure: Duration
time frame: 4 weeks
description: Hours a day with headache
measure: Medication
time frame: 4 weeks
description: Days in which person takes drugs for pain, during 4 weeks
arm group label: Control
arm group type: Active Comparator
description: Relaxation technique
arm group label: Experimental
arm group type: Experimental
description: Combined treatment
intervention type: Behavioral
intervention name: Relaxation technique Autogenic Training
description: Autogenic Training
arm group label: Control
intervention type: Behavioral
intervention name: Combined treatment Autogenic Training + Cervical exercises and postural correction
description: Autogenic Training + Cervical exercises and postural correction
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
last name: Ángela Álvarez Melcón, Doctor
role: Principal Investigator
affiliation: Universidad Complutense de Madrid
responsible party type: Principal Investigator
investigator affiliation: Universidad Complutense de Madrid
investigator full name: Ángela Álvarez Melcón
investigator title: Physiotherapist (Doctor)
mesh term: Tension-Type Headache
mesh term: Headache