<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/NCT03765879</url>
  </required_header>
  <id_info>
    <org_study_id>2018P002553</org_study_id>
    <nct_id>NCT03765879</nct_id>
  </id_info>
  <brief_title>Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back Pain</brief_title>
  <official_title>Brain Mechanisms of Video-Guided Acupuncture Imagery Treatment on Chronic Low Back 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>Yes</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>
      In this study, the investigators will examine the analgesic effects of acupuncture imagery&#xD;
      treatment in patients with chronic low back pain. The intervention used in this study is&#xD;
      &quot;video-guided acupuncture imagery treatment&quot; (VGAIT) treatment. The control used in this&#xD;
      study is sham (fake) VGAIT. Participants in each group will participate in 8 study sessions&#xD;
      (including 6 treatment sessions) over the course of 6 weeks. The primary outcome measure for&#xD;
      this study is change in low back pain severity score after each treatment session.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain is the one of the most common reasons for all physician visits in the USA and a&#xD;
      leading cause of disability. However, conventional/pharmacological treatments for chronic low&#xD;
      back pain (cLBP) have achieved limited success. Imagery is a commonly used therapeutic method&#xD;
      for many disorders, such as chronic pain and stroke. Yet, the underlying mechanism remains&#xD;
      unclear. Studies suggest that in addition to directly perceiving one's environment,&#xD;
      individuals spend considerable time recalling and/or imagining experiences. A large body of&#xD;
      literature suggests that common brain areas are activated during direct and vicarious&#xD;
      (observational) experiences. Acupuncture is an invasive treatment that involves needle&#xD;
      insertion and manipulation. Literature suggests that deqi (sensations evoked by acupuncture&#xD;
      needle manipulation, such as soreness, aching, and dull pain) are crucial for treatment&#xD;
      effects. In a recent study, the investigators examined video-guided acupuncture imagery&#xD;
      treatment (&quot;VGAIT&quot;), during which participants watch a video of acupuncture previously&#xD;
      administered on their own body while imagining it being concurrently applied. They found that&#xD;
      this treatment can produce deqi sensations and increase pain thresholds in healthy subjects.&#xD;
      In this study, the investigators will further investigate the modulation effects of VGAIT on&#xD;
      patients with chronic pain.&#xD;
&#xD;
      This study will recruit up to 80 male and female participants, ages 18-60, with a diagnosis&#xD;
      of chronic low back pain (having low back pain for more than 6 months), until 60 participants&#xD;
      have finished the study. These participants will be randomly assigned to receive VGAIT or&#xD;
      sham VGAIT, with 30 in each group.&#xD;
&#xD;
      We first performed a pilot study in which subjects (up to 25) only received real treatment to&#xD;
      ensure that the intervention has a treatment effect. In addition, we will also compare the&#xD;
      results from the pilot study with previous acupuncture studies from our lab to further&#xD;
      validate the effect of VGAIT. If a treatment effect is evident in this pilot cohort, we will&#xD;
      begin randomization.&#xD;
&#xD;
      This study consists of 8 sessions over approximately 6 weeks. These sessions include 2&#xD;
      assessment sessions (Session 1 and 8) and 6 treatment sessions (Sessions 2-7). The treatment&#xD;
      sessions will consist of verum VGAIT or sham VGAIT. Verum VGAIT will involve the use of&#xD;
      acupuncture points commonly used for chronic low back pain. Sham VGAIT will involve the use&#xD;
      of non-acupoints.&#xD;
&#xD;
      All study procedures will take place in the department of Psychiatry or the Clinical Research&#xD;
      Center at the Martinos Center for Biomedical Imaging (Charlestown Navy Yard Campus of&#xD;
      Massachusetts General Hospital).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 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>
    <intervention_model_description>In this study, participants will be randomly assigned to receive one of two interventions: verum video-guided acupuncture imagery treatment (VGAIT) or sham VGAIT.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This experiment will not be blinded. Participants will be aware if they are in the verum VGAIT or sham VGAIT group by nature of the interventions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in low back pain (LBP) severity score</measure>
    <time_frame>6 weeks</time_frame>
    <description>LBP Severity will be measured by a single-item questionnaire that asks participants to rate how bothersome their back pain has been during the past week on a visual analog scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in back-pain specific disability score</measure>
    <time_frame>6 weeks</time_frame>
    <description>Back-pain specific disability will be measured via the Owestry Low Back Pain Disability Questionnaire, an instrument that asks participants to describe their low back pain by checking statements that are most applicable to their pain. The instrument is scored based on disability severity over ten different areas (such as personal care and walking abilities). Higher scores on this instrument indicate more severe disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System-29 (PROMIS-29) score</measure>
    <time_frame>6 weeks</time_frame>
    <description>PROMIS-29 is a 29-item instrument that assesses pain, function, anxiety, and depression. Higher scores can indicate better or worse outcomes, depending on the section of this instrument being scored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System (PROMIS) Global Health score</measure>
    <time_frame>6 weeks</time_frame>
    <description>PROMIS Global Health is a 10-item instrument that assesses pain, function, depression, and anxiety. A higher score on this instrument is associated with more improved outcomes in regard to these measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in psychiatric symptoms as measured by PROMIS-29</measure>
    <time_frame>6 weeks</time_frame>
    <description>PROMIS-29 is a 29-item instrument that assesses pain, function, anxiety, and depression. Higher scores can indicate better or worse outcomes, depending on the section of this instrument being scored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in psychiatric symptoms as measured by PROMIS Global Health</measure>
    <time_frame>6 weeks</time_frame>
    <description>PROMIS Global Health is a 10-item instrument that assesses pain, function, depression, and anxiety. A higher score on this instrument is associated with more improved outcomes in regard to these measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in psychiatric symptoms as measured by Beck Depression Inventory (BDI-II)</measure>
    <time_frame>6 weeks</time_frame>
    <description>BDI-II is a 210item instrument that is used to measure major depression. Higher scores on this instrument indicate more severe depression symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Verum VGAIT Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive verum (real) acupuncture and verum video-guided acupuncture imagery treatment (VGAIT).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham VGAIT Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in this group will receive sham acupuncture and sham VGAIT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)</intervention_name>
    <description>In VGAIT treatment sessions, participants will re-watch the video of themselves receiving acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied.</description>
    <arm_group_label>Verum VGAIT Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)</intervention_name>
    <description>In sham VGAIT treatment sessions, participants will re-watch this video of themselves receiving the sham acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied.</description>
    <arm_group_label>Sham VGAIT Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers 18-60 years of age&#xD;
&#xD;
          -  Meet the Classification Criteria of the chronic low back pain (having low back pain&#xD;
             for more than 6 months), as determined by the referring physician.&#xD;
&#xD;
          -  At least 4/10 clinical pain on the 11-point low back pain intensity scale.&#xD;
&#xD;
          -  Must have had a prior evaluation of their low back pain by a health care provider,&#xD;
             which may have included radiographic studies. Documentation of this evaluation will be&#xD;
             sought from Partners or outside medical records and kept in the subject's research&#xD;
             record.&#xD;
&#xD;
          -  At least a 10th grade English-reading level; English can be a second language provided&#xD;
             that the patients feel they understand all the questions used in the assessment&#xD;
             measures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Specific causes of back pain (e.g. cancer, fractures, infections),&#xD;
&#xD;
          -  Complicated back problems (e.g. prior back surgery, medico legal issues),&#xD;
&#xD;
          -  Possible contraindications for acupuncture (e.g. coagulation disorders, cardiac&#xD;
             pacemakers, pregnancy, seizure disorder), and conditions that might confound&#xD;
             longitudinal effects or interpretation of results (e.g. severe fibromyalgia,&#xD;
             rheumatoid arthritis).&#xD;
&#xD;
          -  Conditions making study participation difficult (eg, paralysis, psychoses, or other&#xD;
             severe psychological problems as per the judgment of a study investigator during&#xD;
             Session 1)&#xD;
&#xD;
          -  The intent to undergo surgery during the time of involvement in the study.&#xD;
&#xD;
          -  History of cardiac, respiratory, or nervous system disease that, in the investigator's&#xD;
             judgment, precludes participation in the study because of a heightened potential for&#xD;
             adverse outcome. For example: asthma or claustrophobia.&#xD;
&#xD;
          -  Unresolved medical legal/disability/workers compensation claims in connection with low&#xD;
             back pain.&#xD;
&#xD;
          -  Active substance abuse disorder in the past 24 months, as determined by self-report&#xD;
             and/or urine toxicology&#xD;
&#xD;
          -  Lacking the capacity to consent for oneself&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jian Kong, MD, MS, MPH</last_name>
    <phone>617-726-7893</phone>
    <email>jkong2@mgh.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Georgia Wilson, BA</last_name>
    <phone>617-726-5004</phone>
    <email>gjwilson@mgh.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Charlestown</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Georgia Wilson, BA</last_name>
      <phone>617-726-5004</phone>
      <email>gjwilson@mgh.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</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>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Chronic Pain</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/NCT03765879
org study id: 2018P002553
nct id: NCT03765879
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators will examine the analgesic effects of acupuncture imagery
      treatment in patients with chronic low back pain. The intervention used in this study is
      "video-guided acupuncture imagery treatment" (VGAIT) treatment. The control used in this
      study is sham (fake) VGAIT. Participants in each group will participate in 8 study sessions
      (including 6 treatment sessions) over the course of 6 weeks. The primary outcome measure for
      this study is change in low back pain severity score after each treatment session.
Low back pain is the one of the most common reasons for all physician visits in the USA and a
      leading cause of disability. However, conventional/pharmacological treatments for chronic low
      back pain (cLBP) have achieved limited success. Imagery is a commonly used therapeutic method
      for many disorders, such as chronic pain and stroke. Yet, the underlying mechanism remains
      unclear. Studies suggest that in addition to directly perceiving one's environment,
      individuals spend considerable time recalling and/or imagining experiences. A large body of
      literature suggests that common brain areas are activated during direct and vicarious
      (observational) experiences. Acupuncture is an invasive treatment that involves needle
      insertion and manipulation. Literature suggests that deqi (sensations evoked by acupuncture
      needle manipulation, such as soreness, aching, and dull pain) are crucial for treatment
      effects. In a recent study, the investigators examined video-guided acupuncture imagery
      treatment ("VGAIT"), during which participants watch a video of acupuncture previously
      administered on their own body while imagining it being concurrently applied. They found that
      this treatment can produce deqi sensations and increase pain thresholds in healthy subjects.
      In this study, the investigators will further investigate the modulation effects of VGAIT on
      patients with chronic pain.

      This study will recruit up to 80 male and female participants, ages 18-60, with a diagnosis
      of chronic low back pain (having low back pain for more than 6 months), until 60 participants
      have finished the study. These participants will be randomly assigned to receive VGAIT or
      sham VGAIT, with 30 in each group.

      We first performed a pilot study in which subjects (up to 25) only received real treatment to
      ensure that the intervention has a treatment effect. In addition, we will also compare the
      results from the pilot study with previous acupuncture studies from our lab to further
      validate the effect of VGAIT. If a treatment effect is evident in this pilot cohort, we will
      begin randomization.

      This study consists of 8 sessions over approximately 6 weeks. These sessions include 2
      assessment sessions (Session 1 and 8) and 6 treatment sessions (Sessions 2-7). The treatment
      sessions will consist of verum VGAIT or sham VGAIT. Verum VGAIT will involve the use of
      acupuncture points commonly used for chronic low back pain. Sham VGAIT will involve the use
      of non-acupoints.

      All study procedures will take place in the department of Psychiatry or the Clinical Research
      Center at the Martinos Center for Biomedical Imaging (Charlestown Navy Yard Campus of
      Massachusetts General Hospital).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, participants will be randomly assigned to receive one of two interventions: verum video-guided acupuncture imagery treatment (VGAIT) or sham VGAIT.
primary purpose: Treatment
masking: None (Open Label)
masking description: This experiment will not be blinded. Participants will be aware if they are in the verum VGAIT or sham VGAIT group by nature of the interventions.
measure: Changes in low back pain (LBP) severity score
time frame: 6 weeks
description: LBP Severity will be measured by a single-item questionnaire that asks participants to rate how bothersome their back pain has been during the past week on a visual analog scale.
measure: Changes in back-pain specific disability score
time frame: 6 weeks
description: Back-pain specific disability will be measured via the Owestry Low Back Pain Disability Questionnaire, an instrument that asks participants to describe their low back pain by checking statements that are most applicable to their pain. The instrument is scored based on disability severity over ten different areas (such as personal care and walking abilities). Higher scores on this instrument indicate more severe disability.
measure: Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System-29 (PROMIS-29) score
time frame: 6 weeks
description: PROMIS-29 is a 29-item instrument that assesses pain, function, anxiety, and depression. Higher scores can indicate better or worse outcomes, depending on the section of this instrument being scored.
measure: Changes in dysfunction, as measured by Patient Reported Outcomes Measurement System (PROMIS) Global Health score
time frame: 6 weeks
description: PROMIS Global Health is a 10-item instrument that assesses pain, function, depression, and anxiety. A higher score on this instrument is associated with more improved outcomes in regard to these measures.
measure: Changes in psychiatric symptoms as measured by PROMIS-29
time frame: 6 weeks
description: PROMIS-29 is a 29-item instrument that assesses pain, function, anxiety, and depression. Higher scores can indicate better or worse outcomes, depending on the section of this instrument being scored.
measure: Changes in psychiatric symptoms as measured by PROMIS Global Health
time frame: 6 weeks
description: PROMIS Global Health is a 10-item instrument that assesses pain, function, depression, and anxiety. A higher score on this instrument is associated with more improved outcomes in regard to these measures.
measure: Changes in psychiatric symptoms as measured by Beck Depression Inventory (BDI-II)
time frame: 6 weeks
description: BDI-II is a 210item instrument that is used to measure major depression. Higher scores on this instrument indicate more severe depression symptoms.
arm group label: Verum VGAIT Group
arm group type: Experimental
description: Participants in this group will receive verum (real) acupuncture and verum video-guided acupuncture imagery treatment (VGAIT).
arm group label: Sham VGAIT Group
arm group type: Placebo Comparator
description: Participants in this group will receive sham acupuncture and sham VGAIT.
intervention type: Other
intervention name: Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)
description: In VGAIT treatment sessions, participants will re-watch the video of themselves receiving acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied.
arm group label: Verum VGAIT Group
intervention type: Other
intervention name: Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)
description: In sham VGAIT treatment sessions, participants will re-watch this video of themselves receiving the sham acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied.
arm group label: Sham VGAIT Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jian Kong, MD, MS, MPH
phone: 617-726-7893
email: jkong2@mgh.harvard.edu
last name: Georgia Wilson, BA
phone: 617-726-5004
email: gjwilson@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jian Kong
investigator title: Associate Professor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Chronic Pain