<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/NCT01687660</url>
  </required_header>
  <id_info>
    <org_study_id>2012CB518501-2</org_study_id>
    <nct_id>NCT01687660</nct_id>
  </id_info>
  <brief_title>Acupuncture for Migraine Prophylaxis</brief_title>
  <acronym>AMP</acronym>
  <official_title>A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Li ying</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hunan University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chengdu University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A&#xD;
      open-label randomized controlled trial. 249 participants will be included. Three arms:&#xD;
      acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis&#xD;
      Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and&#xD;
      Chongqing province. Two hundred and forty-three participants will be randomly assign to&#xD;
      acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each&#xD;
      participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30&#xD;
      minutes in a session. After all the treatments was accomplished, there will be 5 times&#xD;
      follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine&#xD;
      attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at&#xD;
      the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire&#xD;
      MSQ Version2.1), etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>frequency of migraine attacks</measure>
    <time_frame>16th week after inclusion</time_frame>
    <description>to assess the frequency of migraine attacks at the 16th week after inclusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>frequency of migraine attacks</measure>
    <time_frame>4th and 24th week after inclusion</time_frame>
    <description>to assess the frequency of migraine attacks at the 4th and 24th week respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>headache severity</measure>
    <time_frame>0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion</time_frame>
    <description>to evaluate the change of severity of headache</description>
  </secondary_outcome>
  <other_outcome>
    <measure>MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1)</measure>
    <time_frame>the day of inclusion and 4th week after inclusion</time_frame>
    <description>to observe the change of MSQ</description>
  </other_outcome>
  <other_outcome>
    <measure>acupuncture expectation scale</measure>
    <time_frame>1 day</time_frame>
    <description>an outcome to indicate the expectation of patient towards acupuncture treatment for migraine</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">249</enrollment>
  <condition>Migraine Without Aura</condition>
  <condition>Unilateral Headache</condition>
  <arm_group>
    <arm_group_label>acupoint-meridian group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apply traditional acupuncture to prevent the migraine attack according to TCM theory</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham-acupoint group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>sham-acupoint will be penetrated for migraine prophylaxis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>waiting list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No acupuncture nor other methods will be conducted in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>apply acupuncture to prevent the migraine attack</description>
    <arm_group_label>acupoint-meridian group</arm_group_label>
    <arm_group_label>sham-acupoint group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of a subject is between 18 and 65 years old(initially occured beneath the age of&#xD;
             50), male or female;&#xD;
&#xD;
          -  in accordance with diagnosis of migraine without aura in International Classification&#xD;
             of Headache Disorders, ICHD-2, by IHS;&#xD;
&#xD;
          -  2 to 8 times attack per month in recent 3 months, with each period beyond 15 days;&#xD;
&#xD;
          -  with migraine history for over 1 year;&#xD;
&#xD;
          -  be able and willing to finish the headache diary in baseline ;&#xD;
&#xD;
          -  informed consent form must be signed by patient or lineal relative;&#xD;
&#xD;
        Exclusion Criteria：&#xD;
&#xD;
          -  Patients who are unconscious, psychotic.&#xD;
&#xD;
          -  Patients with aggravating tumor and other serious consumptive disease, and who are&#xD;
             subject to infection and bleeding.&#xD;
&#xD;
          -  With serious primary illness or disease of cardiovascular, liver, renal,&#xD;
             gastrointestinal, hematological systems and so on.&#xD;
&#xD;
          -  Pregnant women or women in lactation.&#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>Fanrong Liang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chengdu University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chengdu University of TCM</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610075</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Chengdu University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Li ying</investigator_full_name>
    <investigator_title>Chengdu University of Traditional Chinese Medicine</investigator_title>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>migraine prophylaxis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Migraine without Aura</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/NCT01687660
org study id: 2012CB518501-2
nct id: NCT01687660
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A
      open-label randomized controlled trial. 249 participants will be included. Three arms:
      acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.
Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis
      Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and
      Chongqing province. Two hundred and forty-three participants will be randomly assign to
      acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each
      participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30
      minutes in a session. After all the treatments was accomplished, there will be 5 times
      follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine
      attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at
      the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire
      MSQ Version2.1), etc.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: frequency of migraine attacks
time frame: 16th week after inclusion
description: to assess the frequency of migraine attacks at the 16th week after inclusion
measure: frequency of migraine attacks
time frame: 4th and 24th week after inclusion
description: to assess the frequency of migraine attacks at the 4th and 24th week respectively
measure: headache severity
time frame: 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion
description: to evaluate the change of severity of headache
measure: MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1)
time frame: the day of inclusion and 4th week after inclusion
description: to observe the change of MSQ
measure: acupuncture expectation scale
time frame: 1 day
description: an outcome to indicate the expectation of patient towards acupuncture treatment for migraine
arm group label: acupoint-meridian group
arm group type: Experimental
description: Apply traditional acupuncture to prevent the migraine attack according to TCM theory
arm group label: sham-acupoint group
arm group type: Other
description: sham-acupoint will be penetrated for migraine prophylaxis.
arm group label: waiting list
arm group type: No Intervention
description: No acupuncture nor other methods will be conducted in this group.
intervention type: Other
intervention name: acupuncture
description: apply acupuncture to prevent the migraine attack
arm group label: acupoint-meridian group
arm group label: sham-acupoint group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fanrong Liang, Professor
role: Principal Investigator
affiliation: Chengdu University of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Chengdu University of Traditional Chinese Medicine
investigator full name: Li ying
investigator title: Chengdu University of Traditional Chinese Medicine
mesh term: Migraine Disorders
mesh term: Migraine without Aura
mesh term: Headache