<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/NCT03261505</url>
  </required_header>
  <id_info>
    <org_study_id>2017P000820</org_study_id>
    <nct_id>NCT03261505</nct_id>
  </id_info>
  <brief_title>Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain</brief_title>
  <official_title>Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate brain response and connectivity changes evoked by&#xD;
      video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in knee&#xD;
      osteoarthritis patients to elucidate the underlying brain mechanisms of mind-body&#xD;
      interaction, imagery, and acupuncture.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fMRI signal increases</measure>
    <time_frame>4 days; Sessions 2-5</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>VGAIT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>VGAIT Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Real Acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Acupuncture</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.</description>
    <arm_group_label>Real Acupuncture</arm_group_label>
    <arm_group_label>Sham Acupuncture</arm_group_label>
    <arm_group_label>VGAIT</arm_group_label>
    <arm_group_label>VGAIT Control</arm_group_label>
    <other_name>Video of Acupuncture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Knee osteoarthritis patients&#xD;
&#xD;
          -  Ages 40 to 70 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindications to MRI scanning (claustrophobia, metal implants)&#xD;
&#xD;
          -  Current or past history of major medical, neurological, or psychiatric illness other&#xD;
             than knee osteoarthritis (including high blood pressure, heart disorders, impaired&#xD;
             elimination, stomach problems, major kidney or liver problems, bleeding problems,&#xD;
             severe dehydration, history of diabetes, history of asthma or other respiratory&#xD;
             condition)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Non fluent English speaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jian Kong, MD, MPH</last_name>
    <phone>617-726-7893</phone>
    <email>jkong2@mgh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Athinoula A. Martinos Center for Biomedical Imaging</name>
      <address>
        <city>Charlestown</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>December 29, 2022</last_update_submitted>
  <last_update_submitted_qc>December 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Jian Kong</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>fMRI</keyword>
  <keyword>acupuncture</keyword>
  <keyword>osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT03261505
org study id: 2017P000820
nct id: NCT03261505
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate brain response and connectivity changes evoked by
      video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in knee
      osteoarthritis patients to elucidate the underlying brain mechanisms of mind-body
      interaction, imagery, and acupuncture.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: fMRI signal increases
time frame: 4 days; Sessions 2-5
arm group label: VGAIT
arm group type: Experimental
arm group label: VGAIT Control
arm group type: Sham Comparator
arm group label: Real Acupuncture
arm group type: Active Comparator
arm group label: Sham Acupuncture
arm group type: Placebo Comparator
intervention type: Device
intervention name: Acupuncture
description: Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
arm group label: Real Acupuncture
arm group label: Sham Acupuncture
arm group label: VGAIT
arm group label: VGAIT Control
other name: Video of Acupuncture
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jian Kong, MD, MPH
phone: 617-726-7893
email: jkong2@mgh.harvard.edu
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jian Kong
investigator title: Assistant Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No