<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/NCT01664585</url>
  </required_header>
  <id_info>
    <org_study_id>R12006</org_study_id>
    <secondary_id>UKK Institute/173</secondary_id>
    <nct_id>NCT01664585</nct_id>
  </id_info>
  <brief_title>Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life</brief_title>
  <acronym>HEADEX</acronym>
  <official_title>EXERCISE TRAINING WITH PHYSICALLY ACTIVE LIFESTYLE TO REDUCE HEADACHE AND INCREASE QUALITY OF LIFE. A Randomised Controlled Trial of the Effectiveness and Cost-effectiveness of Exercise Training and Physical Activity on Chronic Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UKK Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jyväskylä Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Jyvaskyla</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UKK Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this intervention study is to examine whether tailored exercise therapy training&#xD;
      is effective and cost-effective to decrease headache frequency and intensity, reduce&#xD;
      medication used for chronic headache and patients´ absence from work, improve their neck&#xD;
      muscle force, cervical spine mobility, functional ability and quality of life, and increase&#xD;
      general physical activity in chronic headache women at regular work during a 6-month&#xD;
      intervention.&#xD;
&#xD;
      The intervention itself with pilot-tested upper-neck specific exercise regimen aims that&#xD;
      patients would independently commit to train and exercise to reduce their headache, and thus&#xD;
      increase their quality of life. In addition, reduced pain and frequency of headache may&#xD;
      increase the objectively measured daily physical activity of chronic headache patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tension-type,migraine and cervicogenic headache are the most common reasons for visits to a&#xD;
      primary care physician among working women. Headache has major economic impact due to&#xD;
      patients' absence from work, and pharmacy claims. Neck symptoms induce three percent of all&#xD;
      visits to a primary care physician and 1 % of all costs in health care, and moreover,&#xD;
      institutionalizing increase costs of treatment. Active treatment may offer cost-effective&#xD;
      option for outpatients. In addition, there is no data showing how much headache/neck pain&#xD;
      restricts participation in physical activity (PA) or other activities in society.&#xD;
&#xD;
      The purpose of this study is to investigate whether specific therapeutic exercises reduce&#xD;
      cervicogenic headache cost-effectively, and simultaneously improve neck function and quality&#xD;
      of life. The other aim is to evaluate the effect of exercises on daily PA in women with&#xD;
      chronic headache.&#xD;
&#xD;
      The following hypotheses will be tested:&#xD;
&#xD;
        1. Specific therapeutic exercises based on individual training reduce cost-effectively&#xD;
           cervicogenic headache and improve neck function, and quality of life on women at regular&#xD;
           work during a 6-month intervention&#xD;
&#xD;
        2. The intervention increases general physical activity of women with cervicogenic headache&#xD;
&#xD;
        3. The intervention assists them to manage the headache by way of exercising during the&#xD;
           follow-up.&#xD;
&#xD;
        4. Physical activity of women with chronic cervicogenic headache is lower than average in&#xD;
           Finnish population.&#xD;
&#xD;
      The HEADEX intervention study is a randomized controlled trial. Volunteers, women at regular&#xD;
      work and having ongoing status with chronic migraine and/or cervicogenic headache will be&#xD;
      recruited using newspaper advertising, from the register of Finnish Migraine Society and&#xD;
      occupational health care services in Helsinki, Tampere and Jyvaskyla. The study sample is&#xD;
      restricted to women, as the headache is much more common in women. After recruitment, the&#xD;
      eligibility of patients to participate is screened. In total, the aim is to obtain 120 women&#xD;
      to participate. The two subsequent baseline assessments and follow-up of headaches with the&#xD;
      diary between two months before the beginning of the intervention enable ensuring intensity&#xD;
      and type of the headache and that it is chronic. Randomisation is centralised but the&#xD;
      intervention will be accomplished and clustered in three study centres. Sample size has been&#xD;
      estimated for the primary outcomes. The number of participant will be 60 women in treatment&#xD;
      and 60 control group.&#xD;
&#xD;
      The 6 months exercise intervention consists of 6 supervised progressive exercise training&#xD;
      sessions and home training program, and the participants are instructed to increase their PA.&#xD;
      The main emphasis of the exercise program is to improve and relearn postural and movement&#xD;
      control of neck, and later on strengthen the postural muscles. The exercise intervention&#xD;
      consists of six supervised progressive exercise training sessions to teach rehabilitative&#xD;
      training technique with similar home training program. Before the intervention, information&#xD;
      on work ergonomics will be enquired and if needed, changes will be recommended. The control&#xD;
      group will receive Transcutaneous Nervous Stimulation treatment (6 times) as a placebo&#xD;
      treatment (intensity 0), and recommendation to maintain their PA at previous level. The&#xD;
      follow-up is identical for both groups, and information on exercise frequency is collected up&#xD;
      to 24 months follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2012</start_date>
  <completion_date type="Actual">July 3, 2015</completion_date>
  <primary_completion_date type="Actual">July 3, 2015</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in headache intensity at 6 months</measure>
    <time_frame>At baseline and follow-up after 6-months intervention</time_frame>
    <description>The intensity of pain caused by headache is measured with Visual Analogue Scale (VAS)which is a measurement instrument for subjective experience. The participants specify their level of pain by indicating a position along a continuous line between two end-points (0 to 100).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount and intensity of weekly physical activity</measure>
    <time_frame>At baseline, after 6-mo, 12-mo,and 24-mo</time_frame>
    <description>Objective assessment of daily physical activity during 7 days by accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health economics</measure>
    <time_frame>At baseline, after 6-mo, 12-mo, and 24-mo</time_frame>
    <description>To evaluate the cost-effectiveness the calculations will be based on the self-reported absence from work (off work because of headache, possible disability pension because of headache), cost of medical and pharmaceutical claims for headache, ergonomic changes at work ergonomic changes at work, and adverse events of training. Furthermore, the costs of the intervention including the salaries of the study personnel, individual grants for the members of the research team, and costs related to examination of the subjects are entered to the total costs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL)</measure>
    <time_frame>At baseline, after 6-mo, 12-mo, and 24-mo</time_frame>
    <description>The data will be collected with RAND-36 quality of life questionnaires , the FACT Fatigue scale and mood, and the Beck depression inventory (BDI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear avoidance beliefs</measure>
    <time_frame>At baseline, after 6-mo, 12-mo, and 24-mo</time_frame>
    <description>Changes in fear-avoidance behaviour will be assessed with questionnaire on fear-avoidance beliefs (FABQ) addressing the behaviour both in work and leisure (Waddell et. al 1993)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of headache</measure>
    <time_frame>At baseline, after 6-mo, 12-mo, and 24-mo</time_frame>
    <description>Participants keep diaries on daily basis in terms of number of headache periods and mail the diaries to the investigator every month,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>At baseline, after 6-mo, 12-mo, and 24-mo</time_frame>
    <description>The participants will complete the Neck Disability Index (NDI)questionnaire with questions of ADL functioning</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Headache</condition>
  <condition>Physical Activity</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The rationale and means for the exercise program are to&#xD;
Motivate and teach participants for postural and motor control and strengthening exercises&#xD;
Monitor and motivate to continue exercise training, and to increase their physical activity&#xD;
Training is organised six times as a 60-min session during six months: two individually supervised sessions, and four following training sessions will be accomplished in groups of 10 participants guided by an experienced physical therapist. Three weekly similar home training sessions are recommended for participants. Information on amount of exercise sessions per week and repetitions of each exercise will be collected via exercise diary. To perform home training, a DVD and/or booklet will be provided to participants in the training group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0), and the participants in this group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training group</intervention_name>
    <description>The 60-minute training sessions include a few mobilization techniques for upper neck. In detail, three different exercises concentrated on postural and motor control will be taught during the first two training sessions. Progressively, two additional exercise movements aiming at postural and motor control will be taught in the next session. After eight weeks, two muscle strength exercises utilising therapeutic rubber band will be included into the program. The aim of the rubber band exercises is eventually to achieve the load of 80% of maximal voluntary contraction. The participants in the training group are also instructed to increase their amount of physical activity progressively according to the current physical activity recommendations.</description>
    <arm_group_label>Training group</arm_group_label>
    <other_name>Movement control of neck</other_name>
    <other_name>Muscle training of the postural muscles of upper neck</other_name>
    <other_name>Physical activity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0) and the participants in control group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women aged 18 to 60 and currently at work and aim to continue at same work at least&#xD;
             two years&#xD;
&#xD;
          -  intensity of headache on Visual Analog Scale (VAS) has been equal or greater than 45&#xD;
             mm (scale 0-100) during last two months&#xD;
&#xD;
          -  Headache Impact Test TM [HIT-6 Scoring Interpretation Finland (Finnish) Version 1.1]&#xD;
             58/78 points&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe degenerative changes at cervical vertebra or discus (including discus prolapse)&#xD;
&#xD;
          -  whiplash injury or injury, which is contraindication for exercise and active lifestyle&#xD;
&#xD;
          -  treated with manual therapy or physiotherapy within a previous month&#xD;
&#xD;
          -  changed medication known to affect headaches during a previous month&#xD;
&#xD;
          -  changed bifocals during previous month&#xD;
&#xD;
          -  athletic trainees (3 or more times per week)&#xD;
&#xD;
          -  alcoholic and/or drug addicts/ AUDIT The Alcohol Use Disorders Identification Test,&#xD;
             Finnish version&#xD;
&#xD;
          -  mental depression&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marjo B Rinne, PhD</last_name>
    <role>Study Director</role>
    <affiliation>UKK Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Riku P Nikander, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Jyvaskyla</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arja H Häkkinen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Jyvaskyla</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jari J Ylinen, MD, DO, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jyväskylä Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katriina Kukkonen-Harjula, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitation, South Karelia Social and Health Care District (Eksote)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kari Tokola, MSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>UKK Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sanna Garam, MSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki Metropolia University of Applied Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Jyväskylä</name>
      <address>
        <city>Jyväskylä</city>
        <zip>40014</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jyväskylä Central Hospital, Department of Physical and Rehabilitation Medicine</name>
      <address>
        <city>Jyväskylä</city>
        <zip>40620</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKK Institute</name>
      <address>
        <city>Tampere</city>
        <zip>33500</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <reference>
    <citation>De Hertogh W, Vaes P, Devroey D, Louis P, Carpay H, Truijen S, Duquet W, Oostendorp R. Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain. BMC Musculoskelet Disord. 2009 Sep 23;10:115. doi: 10.1186/1471-2474-10-115.</citation>
    <PMID>19775434</PMID>
  </reference>
  <reference>
    <citation>Fricton J, Velly A, Ouyang W, Look JO. Does exercise therapy improve headache? a systematic review with meta-analysis. Curr Pain Headache Rep. 2009 Dec;13(6):413-9. doi: 10.1007/s11916-009-0081-2. No abstract available.</citation>
    <PMID>19889280</PMID>
  </reference>
  <reference>
    <citation>Fuller G, Kaye C. Headaches. BMJ. 2007 Feb 3;334(7587):254-6. doi: 10.1136/bmj.39090.652847.DE. No abstract available.</citation>
    <PMID>17272568</PMID>
  </reference>
  <reference>
    <citation>Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manipulation or mobilisation for neck pain. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004249. doi: 10.1002/14651858.CD004249.pub3.</citation>
    <PMID>20091561</PMID>
  </reference>
  <reference>
    <citation>Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.</citation>
    <PMID>12221344</PMID>
  </reference>
  <reference>
    <citation>Ylinen J, Takala EP, Nykanen M, Hakkinen A, Malkia E, Pohjolainen T, Karppi SL, Kautiainen H, Airaksinen O. Active neck muscle training in the treatment of chronic neck pain in women: a randomized controlled trial. JAMA. 2003 May 21;289(19):2509-16. doi: 10.1001/jama.289.19.2509.</citation>
    <PMID>12759322</PMID>
  </reference>
  <reference>
    <citation>Ylinen J, Kautiainen H, Wiren K, Hakkinen A. Stretching exercises vs manual therapy in treatment of chronic neck pain: a randomized, controlled cross-over trial. J Rehabil Med. 2007 Mar;39(2):126-32. doi: 10.2340/16501977-0015.</citation>
    <PMID>17351694</PMID>
  </reference>
  <reference>
    <citation>Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.</citation>
    <PMID>8455963</PMID>
  </reference>
  <results_reference>
    <citation>British Association for the Study of Headache Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type, Cluster and Medication-Overuse Headache Writing Committee: EA MacGregor, TJ Steiner, PTG Davies 3rd edition (1st revision). 2010.</citation>
  </results_reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UKK Institute</investigator_affiliation>
    <investigator_full_name>Marjo Rinne, PhD</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>headache</keyword>
  <keyword>women</keyword>
  <keyword>exercise</keyword>
  <keyword>fear avoidance</keyword>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01664585
org study id: R12006
secondary id: UKK Institute/173
nct id: NCT01664585
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of this intervention study is to examine whether tailored exercise therapy training
      is effective and cost-effective to decrease headache frequency and intensity, reduce
      medication used for chronic headache and patients´ absence from work, improve their neck
      muscle force, cervical spine mobility, functional ability and quality of life, and increase
      general physical activity in chronic headache women at regular work during a 6-month
      intervention.

      The intervention itself with pilot-tested upper-neck specific exercise regimen aims that
      patients would independently commit to train and exercise to reduce their headache, and thus
      increase their quality of life. In addition, reduced pain and frequency of headache may
      increase the objectively measured daily physical activity of chronic headache patients.
Tension-type,migraine and cervicogenic headache are the most common reasons for visits to a
      primary care physician among working women. Headache has major economic impact due to
      patients' absence from work, and pharmacy claims. Neck symptoms induce three percent of all
      visits to a primary care physician and 1 % of all costs in health care, and moreover,
      institutionalizing increase costs of treatment. Active treatment may offer cost-effective
      option for outpatients. In addition, there is no data showing how much headache/neck pain
      restricts participation in physical activity (PA) or other activities in society.

      The purpose of this study is to investigate whether specific therapeutic exercises reduce
      cervicogenic headache cost-effectively, and simultaneously improve neck function and quality
      of life. The other aim is to evaluate the effect of exercises on daily PA in women with
      chronic headache.

      The following hypotheses will be tested:

        1. Specific therapeutic exercises based on individual training reduce cost-effectively
           cervicogenic headache and improve neck function, and quality of life on women at regular
           work during a 6-month intervention

        2. The intervention increases general physical activity of women with cervicogenic headache

        3. The intervention assists them to manage the headache by way of exercising during the
           follow-up.

        4. Physical activity of women with chronic cervicogenic headache is lower than average in
           Finnish population.

      The HEADEX intervention study is a randomized controlled trial. Volunteers, women at regular
      work and having ongoing status with chronic migraine and/or cervicogenic headache will be
      recruited using newspaper advertising, from the register of Finnish Migraine Society and
      occupational health care services in Helsinki, Tampere and Jyvaskyla. The study sample is
      restricted to women, as the headache is much more common in women. After recruitment, the
      eligibility of patients to participate is screened. In total, the aim is to obtain 120 women
      to participate. The two subsequent baseline assessments and follow-up of headaches with the
      diary between two months before the beginning of the intervention enable ensuring intensity
      and type of the headache and that it is chronic. Randomisation is centralised but the
      intervention will be accomplished and clustered in three study centres. Sample size has been
      estimated for the primary outcomes. The number of participant will be 60 women in treatment
      and 60 control group.

      The 6 months exercise intervention consists of 6 supervised progressive exercise training
      sessions and home training program, and the participants are instructed to increase their PA.
      The main emphasis of the exercise program is to improve and relearn postural and movement
      control of neck, and later on strengthen the postural muscles. The exercise intervention
      consists of six supervised progressive exercise training sessions to teach rehabilitative
      training technique with similar home training program. Before the intervention, information
      on work ergonomics will be enquired and if needed, changes will be recommended. The control
      group will receive Transcutaneous Nervous Stimulation treatment (6 times) as a placebo
      treatment (intensity 0), and recommendation to maintain their PA at previous level. The
      follow-up is identical for both groups, and information on exercise frequency is collected up
      to 24 months follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from baseline in headache intensity at 6 months
time frame: At baseline and follow-up after 6-months intervention
description: The intensity of pain caused by headache is measured with Visual Analogue Scale (VAS)which is a measurement instrument for subjective experience. The participants specify their level of pain by indicating a position along a continuous line between two end-points (0 to 100).
measure: Amount and intensity of weekly physical activity
time frame: At baseline, after 6-mo, 12-mo,and 24-mo
description: Objective assessment of daily physical activity during 7 days by accelerometer
measure: Health economics
time frame: At baseline, after 6-mo, 12-mo, and 24-mo
description: To evaluate the cost-effectiveness the calculations will be based on the self-reported absence from work (off work because of headache, possible disability pension because of headache), cost of medical and pharmaceutical claims for headache, ergonomic changes at work ergonomic changes at work, and adverse events of training. Furthermore, the costs of the intervention including the salaries of the study personnel, individual grants for the members of the research team, and costs related to examination of the subjects are entered to the total costs.
measure: Quality of Life (QoL)
time frame: At baseline, after 6-mo, 12-mo, and 24-mo
description: The data will be collected with RAND-36 quality of life questionnaires , the FACT Fatigue scale and mood, and the Beck depression inventory (BDI).
measure: Fear avoidance beliefs
time frame: At baseline, after 6-mo, 12-mo, and 24-mo
description: Changes in fear-avoidance behaviour will be assessed with questionnaire on fear-avoidance beliefs (FABQ) addressing the behaviour both in work and leisure (Waddell et. al 1993)
measure: Frequency of headache
time frame: At baseline, after 6-mo, 12-mo, and 24-mo
description: Participants keep diaries on daily basis in terms of number of headache periods and mail the diaries to the investigator every month,
measure: Disability
time frame: At baseline, after 6-mo, 12-mo, and 24-mo
description: The participants will complete the Neck Disability Index (NDI)questionnaire with questions of ADL functioning
arm group label: Training group
arm group type: Experimental
description: The rationale and means for the exercise program are to
Motivate and teach participants for postural and motor control and strengthening exercises
Monitor and motivate to continue exercise training, and to increase their physical activity
Training is organised six times as a 60-min session during six months: two individually supervised sessions, and four following training sessions will be accomplished in groups of 10 participants guided by an experienced physical therapist. Three weekly similar home training sessions are recommended for participants. Information on amount of exercise sessions per week and repetitions of each exercise will be collected via exercise diary. To perform home training, a DVD and/or booklet will be provided to participants in the training group.
arm group label: Control
arm group type: Sham Comparator
description: The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0), and the participants in this group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.
intervention type: Behavioral
intervention name: Training group
description: The 60-minute training sessions include a few mobilization techniques for upper neck. In detail, three different exercises concentrated on postural and motor control will be taught during the first two training sessions. Progressively, two additional exercise movements aiming at postural and motor control will be taught in the next session. After eight weeks, two muscle strength exercises utilising therapeutic rubber band will be included into the program. The aim of the rubber band exercises is eventually to achieve the load of 80% of maximal voluntary contraction. The participants in the training group are also instructed to increase their amount of physical activity progressively according to the current physical activity recommendations.
arm group label: Training group
other name: Movement control of neck
other name: Muscle training of the postural muscles of upper neck
other name: Physical activity
intervention type: Behavioral
intervention name: Control
description: The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0) and the participants in control group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Marjo B Rinne, PhD
role: Study Director
affiliation: UKK Institute
last name: Riku P Nikander, PhD
role: Principal Investigator
affiliation: University of Jyvaskyla
last name: Arja H Häkkinen, PhD
role: Principal Investigator
affiliation: University of Jyvaskyla
last name: Jari J Ylinen, MD, DO, PhD
role: Principal Investigator
affiliation: Jyväskylä Central Hospital
last name: Katriina Kukkonen-Harjula, MD
role: Principal Investigator
affiliation: Rehabilitation, South Karelia Social and Health Care District (Eksote)
last name: Kari Tokola, MSci
role: Principal Investigator
affiliation: UKK Institute
last name: Sanna Garam, MSci
role: Principal Investigator
affiliation: Helsinki Metropolia University of Applied Sciences
facility: 
facility: 
facility: 
country: Finland
citation: De Hertogh W, Vaes P, Devroey D, Louis P, Carpay H, Truijen S, Duquet W, Oostendorp R. Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain. BMC Musculoskelet Disord. 2009 Sep 23;10:115. doi: 10.1186/1471-2474-10-115.
PMID: 19775434
citation: Fricton J, Velly A, Ouyang W, Look JO. Does exercise therapy improve headache? a systematic review with meta-analysis. Curr Pain Headache Rep. 2009 Dec;13(6):413-9. doi: 10.1007/s11916-009-0081-2. No abstract available.
PMID: 19889280
citation: Fuller G, Kaye C. Headaches. BMJ. 2007 Feb 3;334(7587):254-6. doi: 10.1136/bmj.39090.652847.DE. No abstract available.
PMID: 17272568
citation: Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manipulation or mobilisation for neck pain. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004249. doi: 10.1002/14651858.CD004249.pub3.
PMID: 20091561
citation: Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
PMID: 12221344
citation: Ylinen J, Takala EP, Nykanen M, Hakkinen A, Malkia E, Pohjolainen T, Karppi SL, Kautiainen H, Airaksinen O. Active neck muscle training in the treatment of chronic neck pain in women: a randomized controlled trial. JAMA. 2003 May 21;289(19):2509-16. doi: 10.1001/jama.289.19.2509.
PMID: 12759322
citation: Ylinen J, Kautiainen H, Wiren K, Hakkinen A. Stretching exercises vs manual therapy in treatment of chronic neck pain: a randomized, controlled cross-over trial. J Rehabil Med. 2007 Mar;39(2):126-32. doi: 10.2340/16501977-0015.
PMID: 17351694
citation: Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
PMID: 8455963
citation: British Association for the Study of Headache Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type, Cluster and Medication-Overuse Headache Writing Committee: EA MacGregor, TJ Steiner, PTG Davies 3rd edition (1st revision). 2010.
responsible party type: Principal Investigator
investigator affiliation: UKK Institute
investigator full name: Marjo Rinne, PhD
investigator title: Researcher
mesh term: Headache
sharing ipd: No