<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/NCT02984826</url>
  </required_header>
  <id_info>
    <org_study_id>H-3-2009-080</org_study_id>
    <nct_id>NCT02984826</nct_id>
  </id_info>
  <brief_title>Muscle Strength in Shoulder and Neck Muscles in Tension Type Headache Patients. Effect of Specific Strength Training</brief_title>
  <official_title>Muscle Strength in Shoulder and Neck Muscles in Adult Tension Type Headache Patients, and the Effect of Specific Strength Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danish Headache Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danish Headache Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Tension Type Headache (TTH) is highly frequent and is of great socio-economic importance.&#xD;
      Andersen et al. 2008 has shown that maximal muscle strength is reduced in women with&#xD;
      trapezius myalgia. It is shown that specific strength training leads to prolonged pain&#xD;
      relief.&#xD;
&#xD;
      Aim:Test: To investigate the impact of TTH on shoulder, and neck muscle strength in patients&#xD;
      with TTH compared to healthy controls.&#xD;
&#xD;
      Intervention: To investigate the effect of specific strength training on patients with TTH&#xD;
      compared with control group, receiving training in ergonomics.&#xD;
&#xD;
      Method: Test part. 60 tension headache patients, 30 healthy. Muscle testing of neck and&#xD;
      shoulder. Testing conducted by blinded research assistant.&#xD;
&#xD;
      Intervention group: 60 patients with tension headache randomly assigned to the intervention&#xD;
      group or control group. Intervention with specific strength training program runs for 10&#xD;
      weeks. The control group will be trained in ergonomics. 3 months follow up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Headache frequency</measure>
    <time_frame>Primary outcome headache frequency at (19-22 weeks)</time_frame>
    <description>Frequency was calculated and analyzed as days with headache pr. month. primary outcome at follow up.(19-22 weeks)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Headache Duration</measure>
    <time_frame>Primary outcome duration of pain at (19-22 weeks)</time_frame>
    <description>The duration of the headache was registered in hours for each day with headache.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensity of headache</measure>
    <time_frame>Intensity of pain at (19-22 weeks)</time_frame>
    <description>The intensity was registered on a 0-10 Numeric Rating Scale (NRS) where 0 is no pain, and 10 is worst possible pain. It was calculated as intensity mean/week and a mean for 4 weeks were produced</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication intake</measure>
    <time_frame>Medication intake at (19-22 weeks)</time_frame>
    <description>Use of pain medicine was registered as days of medicine intake throughout the entire trial.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Tension-Type Headache</condition>
  <arm_group>
    <arm_group_label>Strength training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention with specific strength training program runs for 10 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ergonomic and posture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention, the control group will be trained in ergonomics and posture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strength training</intervention_name>
    <description>The specific ST group trained and fulfilled a 10 week training diary. The ST consisted of 4 shoulder exercises. During the training the relative loading was progressively increased from 12 repetitions maximum (RM) (70% of maximal intensity) at the beginning to 8 RM (80 % of the maximal intensity). ST was performed with slow concentric and eccentric muscle contractions with resistance from the elastic bands.</description>
    <arm_group_label>Strength training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ergonomic and posture</intervention_name>
    <description>The control group was instructed in ergonomics and posture correction (EP). They were instructed to pay attention to their sitting posture, and how they used a computer or other working tools. Further they were asked to do a posture correction exercise 3 times a day with 10 repetitions. The EP were seen twice during the 10 week period, and had a phone call every 2 weeks. After 10 weeks they were instructed that they should stop the exercise but continue to be conscious of their ergonomics and sitting position.</description>
    <arm_group_label>Ergonomic and posture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tension-type headache(TTH), inclusion criteria were age between 18 and 65 years and&#xD;
             for patients a diagnosis of TTH ≥8 headache days per month, and ≤3 migraine days per&#xD;
             month according to ICHD-II -criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were medication overuse headache (ICHD-II), previous whiplash or&#xD;
             head trauma, other major physical or neurological diseases, depression, other mental&#xD;
             illness, or being unable to understand and speak Danish. The patients were tested for&#xD;
             cervicogenic headache according to Jull, et al 2007, and were excluded if the test was&#xD;
             positive.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bjarne K K Madsen, phd stud.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Headache Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danish Headache Center Rigshospitalet - Glostrup</name>
      <address>
        <city>Glostrup</city>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danish Headache Center</investigator_affiliation>
    <investigator_full_name>Bjarne Kjeldgaard Madsen</investigator_full_name>
    <investigator_title>physiotherapist phd student</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02984826
org study id: H-3-2009-080
nct id: NCT02984826
lead sponsor: 
has dmc: Yes
Background:

      Tension Type Headache (TTH) is highly frequent and is of great socio-economic importance.
      Andersen et al. 2008 has shown that maximal muscle strength is reduced in women with
      trapezius myalgia. It is shown that specific strength training leads to prolonged pain
      relief.

      Aim:Test: To investigate the impact of TTH on shoulder, and neck muscle strength in patients
      with TTH compared to healthy controls.

      Intervention: To investigate the effect of specific strength training on patients with TTH
      compared with control group, receiving training in ergonomics.

      Method: Test part. 60 tension headache patients, 30 healthy. Muscle testing of neck and
      shoulder. Testing conducted by blinded research assistant.

      Intervention group: 60 patients with tension headache randomly assigned to the intervention
      group or control group. Intervention with specific strength training program runs for 10
      weeks. The control group will be trained in ergonomics. 3 months follow up.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Headache frequency
time frame: Primary outcome headache frequency at (19-22 weeks)
description: Frequency was calculated and analyzed as days with headache pr. month. primary outcome at follow up.(19-22 weeks)
measure: Headache Duration
time frame: Primary outcome duration of pain at (19-22 weeks)
description: The duration of the headache was registered in hours for each day with headache.
measure: Intensity of headache
time frame: Intensity of pain at (19-22 weeks)
description: The intensity was registered on a 0-10 Numeric Rating Scale (NRS) where 0 is no pain, and 10 is worst possible pain. It was calculated as intensity mean/week and a mean for 4 weeks were produced
measure: Medication intake
time frame: Medication intake at (19-22 weeks)
description: Use of pain medicine was registered as days of medicine intake throughout the entire trial.
arm group label: Strength training
arm group type: Active Comparator
description: Intervention with specific strength training program runs for 10 weeks.
arm group label: Ergonomic and posture
arm group type: Active Comparator
description: Intervention, the control group will be trained in ergonomics and posture.
intervention type: Other
intervention name: Strength training
description: The specific ST group trained and fulfilled a 10 week training diary. The ST consisted of 4 shoulder exercises. During the training the relative loading was progressively increased from 12 repetitions maximum (RM) (70% of maximal intensity) at the beginning to 8 RM (80 % of the maximal intensity). ST was performed with slow concentric and eccentric muscle contractions with resistance from the elastic bands.
arm group label: Strength training
intervention type: Other
intervention name: Ergonomic and posture
description: The control group was instructed in ergonomics and posture correction (EP). They were instructed to pay attention to their sitting posture, and how they used a computer or other working tools. Further they were asked to do a posture correction exercise 3 times a day with 10 repetitions. The EP were seen twice during the 10 week period, and had a phone call every 2 weeks. After 10 weeks they were instructed that they should stop the exercise but continue to be conscious of their ergonomics and sitting position.
arm group label: Ergonomic and posture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bjarne K K Madsen, phd stud.
role: Principal Investigator
affiliation: Danish Headache Center
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Danish Headache Center
investigator full name: Bjarne Kjeldgaard Madsen
investigator title: physiotherapist phd student
mesh term: Tension-Type Headache
mesh term: Headache
sharing ipd: No