<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/NCT01687881</url>
  </required_header>
  <id_info>
    <org_study_id>CEH-K34KSF-AHUS</org_study_id>
    <secondary_id>2829002</secondary_id>
    <nct_id>NCT01687881</nct_id>
  </id_info>
  <brief_title>Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache</brief_title>
  <official_title>Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache? A Randomized Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Foundation for Health and Rehabilitation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Chiropractic Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Akershus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for&#xD;
      cervicogenic headache (CEH). If the method proves to be effective, it will provide a new&#xD;
      non-pharmacological treatment option for CEH. This is especially important since&#xD;
      pharmacological management has minor effect in CEH, and alternative treatment options are&#xD;
      warranted. The applied methodology of the study will aim towards the highest possible&#xD;
      research standards. This international study is a collaboration between Akershus University&#xD;
      Hospital, Innlandet Hospital and University of Oslo (UiO), Norway and Macquarie University,&#xD;
      Australia. The multidisciplinary professional backgrounds are physiotherapy, chiropractic and&#xD;
      medicine. By increasing the methodological quality of the investigators research to a very&#xD;
      high level, the investigators see the method to work as a guide to increase the quality of&#xD;
      chiropractic research in the future, as previous randomized clinical trials (RCTs) of CEH&#xD;
      used methodology showing room for improvement.&#xD;
&#xD;
      Study hypothesis:&#xD;
&#xD;
      CSMT using the Gonstead method reduces days with CEH by at least 25% as compared to placebo&#xD;
      (sham manipulation, i.e. broad non-specific contact, non-directional, low velocity and low&#xD;
      amplitude) and no intervention (control group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervicogenic headache (CEH) is a symptomatic headache characterized by chronic unilateral&#xD;
      headache and symptoms and signs of neck involvement. CEH is often worsened by neck movement,&#xD;
      sustained awkward head position, external pressure over the upper cervical or occipital&#xD;
      region on the symptomatic side. Abolition of the headache following diagnostic anesthetic&#xD;
      blocks of cervical structures or local factors in neck give evidence that the pain is&#xD;
      attributed to a neck disorder or lesion. The prevalence of CEH is 0.2% in the general&#xD;
      population of Akershus County, i.e. 9,000 Norwegians have CEH. However, the prevalence varies&#xD;
      between 0.4-4.1% in studies applying less rigorous diagnostic criteria. The efficacy of&#xD;
      pharmacological management in CEH is poor. Patients suffering from CEH are commonly treated&#xD;
      with CSMT, but the methodology has one or more shortcomings in all studies. In addition, the&#xD;
      RCTs mostly included participant with infrequent CEH and did not follow the recommended&#xD;
      clinical guidelines by the International Headache Society (IHS) of intervention of at least&#xD;
      three months. An analysis of the literature as well as a recent pilot study suggests that&#xD;
      CSMT has an effect on headache intensity and duration, and medication intake. However, a&#xD;
      randomized controlled clinical trial with high methodological quality on CEH still remains to&#xD;
      be conducted.&#xD;
&#xD;
      The RCT is single blinded, placebo-controlled trial of CSMT using the Gonstead method vs.&#xD;
      sham manipulation and control group. If the treatment shows to be effective, the participants&#xD;
      whom receive sham manipulation or control will be offered true intervention after the&#xD;
      follow-up period and free of charge. This study will follow the recommendations set by the&#xD;
      clinical trial guidelines from the IHS, while the methodological quality control will in&#xD;
      general follow previous suggested criteria and the CONSORT statements.&#xD;
&#xD;
      Patients will be recruited through Akershus University Hospital and Innlandet Hospital,&#xD;
      Norway as well as through media advertising in Akershus and Oslo County. The diagnose is set&#xD;
      by a chiropractor and a neurologist with experience in headache.&#xD;
&#xD;
      The clinical trials consist of three stages: Run-in, intervention (treatment) and follow-up.&#xD;
&#xD;
      One month of base line data collection where participants will fill-in a diagnostic headache&#xD;
      diary. Baseline demographics and clinical characteristics will be presented in tables with&#xD;
      mean and standard deviation (SD) for each group.&#xD;
&#xD;
      The participants will be randomized by drawing prepared sealed lots. Each lot includes three&#xD;
      different interventions, i.e active treatment, sham manipulation and control group. The first&#xD;
      three participants will draw from the same lot until all three interventions are used. The&#xD;
      next lot with three interventions is then followed by the next three participants.&#xD;
&#xD;
      The RCTs will be conducted by an experienced chiropractor. Active treatment consists of CSMT&#xD;
      using the Gonstead method. A specific contact, high velocity, low amplitude, short lever,&#xD;
      with no recoil post adjustment directed to spinal biomechanical dysfunction diagnosed by&#xD;
      standard chiropractic tests.&#xD;
&#xD;
      Follow-up at 3, 6 and 12 months post-treatment. During this period participants continue to&#xD;
      fill in a diagnostic headache diary. The control group will also be included in this phase of&#xD;
      the study.&#xD;
&#xD;
      The data will be analyzed with SPSS using standard statistical techniques.&#xD;
&#xD;
      The investigators based our calculation of sample size on migraine days from recent group&#xD;
      comparison studies of topiramate (38). The investigators calculated that a sample size of 16&#xD;
      patients was required to detect a difference in mean reduction in monthly headache days of&#xD;
      2.5 with 80% power, with p=0.05 as level of significance, and assuming a common SD of 2.5 for&#xD;
      active treatment and broad-based treatment groups.&#xD;
&#xD;
      Insurance is through &quot;The Norwegian System of Compensation to Patients&quot; (NPE) which is an&#xD;
      independent national body, set up to process compensation claims from patients who have&#xD;
      suffered an injury as a result of treatment under the Norwegian health service.&#xD;
&#xD;
      The Regional Committee for Medical Research Ethics (REK) in Norway and Norwegian Social&#xD;
      Science Data Services approved the full PhD research protocol. The declaration of Helsinski&#xD;
      is followed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of headache days</measure>
    <time_frame>Change from baseline to post-treatment, 3, 6, 12 months follow-up</time_frame>
    <description>25% reduction in number of headache days between active treatment and sham.&#xD;
25% reduction in number of headache days between active treatment and control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Headache duration</measure>
    <time_frame>Change from baseline to post-treatment, 3, 6, 12 months follow-up</time_frame>
    <description>25% reduction in headache duration in hours between active treatment and sham.&#xD;
25% reduction in headache duration in hours between active treatment and control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self reported VAS</measure>
    <time_frame>Change from baseline to post-treatment, 3, 6, 12 months follow-up</time_frame>
    <description>25% self-reported improvement on VAS between active treatment and sham.&#xD;
25% self-reported improvement on VAS between active treatment and control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache index</measure>
    <time_frame>Change from baseline to post-treatment, 3, 6, 12 months follow-up</time_frame>
    <description>25% reduction in headache index (frequency x duration x intensity) between active treatment and sham.&#xD;
25% reduction in headache index between active treatment and control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache medication</measure>
    <time_frame>Change from baseline to post-treatment, 3, 6, 12 months follow-up</time_frame>
    <description>50% reduction in headache medication between active treatment and sham.&#xD;
50% reduction in headache medication between active treatment and control group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sub-analysis on x-ray findings</measure>
    <time_frame>Change formbaseline to post-treatment, 3, 6, 12 months follow-up</time_frame>
    <description>Sub-analysis will be done on participants with structural deformities vs. normal x-ray findings.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Cervicogenic Headache</condition>
  <arm_group>
    <arm_group_label>Sham Chiropractic</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Chiropractic manipulative therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention: Control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chiropractic Spinal Manipulative Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active intervention: Chiropractic Spinal Manipulative Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chiropractic</intervention_name>
    <description>Chiropractic Spinal Manipulative Therapy</description>
    <arm_group_label>Chiropractic Spinal Manipulative Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Chiropractic</intervention_name>
    <description>Sham manipulation</description>
    <arm_group_label>Sham Chiropractic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CEH according to at least three major criteria of the CHISG not including occipital&#xD;
             nerve blockage&#xD;
&#xD;
          -  Age 18-70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to spinal manipulation&#xD;
&#xD;
          -  Chiropractic treatment within the last 12 months&#xD;
&#xD;
          -  Radiculopathy&#xD;
&#xD;
          -  Depression&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Participants whom become pregnant during the migraine trial will also be excluded from&#xD;
             analysis from the time of pregnancy&#xD;
&#xD;
          -  Participants who change their prophylactic medical regime for headaches will be&#xD;
             excluded in the analysis from the time of change&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael B Russell, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Head and Neck research Group, Research Centre, Akershus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Centre, Akershus University Hospital</name>
      <address>
        <city>Lørenskog</city>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30.</citation>
    <PMID>22460941</PMID>
  </reference>
  <reference>
    <citation>Chaibi A, Benth JS, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for cervicogenic headache: a study protocol of a single-blinded placebo-controlled randomized clinical trial. Springerplus. 2015 Dec 16;4:779. doi: 10.1186/s40064-015-1567-5. eCollection 2015.</citation>
    <PMID>26697289</PMID>
  </reference>
  <results_reference>
    <citation>Chaibi A, Knackstedt H, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for cervicogenic headache: a single-blinded, placebo, randomized controlled trial. BMC Res Notes. 2017 Jul 24;10(1):310. doi: 10.1186/s13104-017-2651-4.</citation>
    <PMID>28738895</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Akershus</investigator_affiliation>
    <investigator_full_name>Aleksander Chaibi</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <keyword>Chiropractic</keyword>
  <keyword>Manipulative therapy</keyword>
  <keyword>Cervicogenic headache</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/NCT01687881
org study id: CEH-K34KSF-AHUS
secondary id: 2829002
nct id: NCT01687881
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for
      cervicogenic headache (CEH). If the method proves to be effective, it will provide a new
      non-pharmacological treatment option for CEH. This is especially important since
      pharmacological management has minor effect in CEH, and alternative treatment options are
      warranted. The applied methodology of the study will aim towards the highest possible
      research standards. This international study is a collaboration between Akershus University
      Hospital, Innlandet Hospital and University of Oslo (UiO), Norway and Macquarie University,
      Australia. The multidisciplinary professional backgrounds are physiotherapy, chiropractic and
      medicine. By increasing the methodological quality of the investigators research to a very
      high level, the investigators see the method to work as a guide to increase the quality of
      chiropractic research in the future, as previous randomized clinical trials (RCTs) of CEH
      used methodology showing room for improvement.

      Study hypothesis:

      CSMT using the Gonstead method reduces days with CEH by at least 25% as compared to placebo
      (sham manipulation, i.e. broad non-specific contact, non-directional, low velocity and low
      amplitude) and no intervention (control group).
Cervicogenic headache (CEH) is a symptomatic headache characterized by chronic unilateral
      headache and symptoms and signs of neck involvement. CEH is often worsened by neck movement,
      sustained awkward head position, external pressure over the upper cervical or occipital
      region on the symptomatic side. Abolition of the headache following diagnostic anesthetic
      blocks of cervical structures or local factors in neck give evidence that the pain is
      attributed to a neck disorder or lesion. The prevalence of CEH is 0.2% in the general
      population of Akershus County, i.e. 9,000 Norwegians have CEH. However, the prevalence varies
      between 0.4-4.1% in studies applying less rigorous diagnostic criteria. The efficacy of
      pharmacological management in CEH is poor. Patients suffering from CEH are commonly treated
      with CSMT, but the methodology has one or more shortcomings in all studies. In addition, the
      RCTs mostly included participant with infrequent CEH and did not follow the recommended
      clinical guidelines by the International Headache Society (IHS) of intervention of at least
      three months. An analysis of the literature as well as a recent pilot study suggests that
      CSMT has an effect on headache intensity and duration, and medication intake. However, a
      randomized controlled clinical trial with high methodological quality on CEH still remains to
      be conducted.

      The RCT is single blinded, placebo-controlled trial of CSMT using the Gonstead method vs.
      sham manipulation and control group. If the treatment shows to be effective, the participants
      whom receive sham manipulation or control will be offered true intervention after the
      follow-up period and free of charge. This study will follow the recommendations set by the
      clinical trial guidelines from the IHS, while the methodological quality control will in
      general follow previous suggested criteria and the CONSORT statements.

      Patients will be recruited through Akershus University Hospital and Innlandet Hospital,
      Norway as well as through media advertising in Akershus and Oslo County. The diagnose is set
      by a chiropractor and a neurologist with experience in headache.

      The clinical trials consist of three stages: Run-in, intervention (treatment) and follow-up.

      One month of base line data collection where participants will fill-in a diagnostic headache
      diary. Baseline demographics and clinical characteristics will be presented in tables with
      mean and standard deviation (SD) for each group.

      The participants will be randomized by drawing prepared sealed lots. Each lot includes three
      different interventions, i.e active treatment, sham manipulation and control group. The first
      three participants will draw from the same lot until all three interventions are used. The
      next lot with three interventions is then followed by the next three participants.

      The RCTs will be conducted by an experienced chiropractor. Active treatment consists of CSMT
      using the Gonstead method. A specific contact, high velocity, low amplitude, short lever,
      with no recoil post adjustment directed to spinal biomechanical dysfunction diagnosed by
      standard chiropractic tests.

      Follow-up at 3, 6 and 12 months post-treatment. During this period participants continue to
      fill in a diagnostic headache diary. The control group will also be included in this phase of
      the study.

      The data will be analyzed with SPSS using standard statistical techniques.

      The investigators based our calculation of sample size on migraine days from recent group
      comparison studies of topiramate (38). The investigators calculated that a sample size of 16
      patients was required to detect a difference in mean reduction in monthly headache days of
      2.5 with 80% power, with p=0.05 as level of significance, and assuming a common SD of 2.5 for
      active treatment and broad-based treatment groups.

      Insurance is through "The Norwegian System of Compensation to Patients" (NPE) which is an
      independent national body, set up to process compensation claims from patients who have
      suffered an injury as a result of treatment under the Norwegian health service.

      The Regional Committee for Medical Research Ethics (REK) in Norway and Norwegian Social
      Science Data Services approved the full PhD research protocol. The declaration of Helsinski
      is followed.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of headache days
time frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up
description: 25% reduction in number of headache days between active treatment and sham.
25% reduction in number of headache days between active treatment and control group.
measure: Headache duration
time frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up
description: 25% reduction in headache duration in hours between active treatment and sham.
25% reduction in headache duration in hours between active treatment and control group.
measure: Self reported VAS
time frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up
description: 25% self-reported improvement on VAS between active treatment and sham.
25% self-reported improvement on VAS between active treatment and control group.
measure: Headache index
time frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up
description: 25% reduction in headache index (frequency x duration x intensity) between active treatment and sham.
25% reduction in headache index between active treatment and control group.
measure: Headache medication
time frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up
description: 50% reduction in headache medication between active treatment and sham.
50% reduction in headache medication between active treatment and control group.
measure: Sub-analysis on x-ray findings
time frame: Change formbaseline to post-treatment, 3, 6, 12 months follow-up
description: Sub-analysis will be done on participants with structural deformities vs. normal x-ray findings.
arm group label: Sham Chiropractic
arm group type: Sham Comparator
description: Sham Chiropractic manipulative therapy.
arm group label: Control group
arm group type: No Intervention
description: No intervention: Control group.
arm group label: Chiropractic Spinal Manipulative Therapy
arm group type: Active Comparator
description: Active intervention: Chiropractic Spinal Manipulative Therapy
intervention type: Other
intervention name: Chiropractic
description: Chiropractic Spinal Manipulative Therapy
arm group label: Chiropractic Spinal Manipulative Therapy
intervention type: Other
intervention name: Sham Chiropractic
description: Sham manipulation
arm group label: Sham Chiropractic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Michael B Russell, Professor
role: Study Director
affiliation: Head and Neck research Group, Research Centre, Akershus University Hospital
facility: 
country: Norway
citation: Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30.
PMID: 22460941
citation: Chaibi A, Benth JS, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for cervicogenic headache: a study protocol of a single-blinded placebo-controlled randomized clinical trial. Springerplus. 2015 Dec 16;4:779. doi: 10.1186/s40064-015-1567-5. eCollection 2015.
PMID: 26697289
citation: Chaibi A, Knackstedt H, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for cervicogenic headache: a single-blinded, placebo, randomized controlled trial. BMC Res Notes. 2017 Jul 24;10(1):310. doi: 10.1186/s13104-017-2651-4.
PMID: 28738895
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Akershus
investigator full name: Aleksander Chaibi
investigator title: PhD student
mesh term: Post-Traumatic Headache
mesh term: Headache