<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/NCT03233594</url>
  </required_header>
  <id_info>
    <org_study_id>17D.163</org_study_id>
    <nct_id>NCT03233594</nct_id>
  </id_info>
  <brief_title>PET Imaging of Chronic Pain Syndromes</brief_title>
  <official_title>PET Imaging of Chronic Pain Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</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>
      Central nervous system (CNS) changes associated with pain have been difficult to measure&#xD;
      until the development of functional neuroimaging techniques such as positron emission&#xD;
      tomography (PET). We have previously observed asymmetry in the thalamus associated with&#xD;
      chronic pain that altered during acupuncture therapy. Imaging studies of therapeutic&#xD;
      techniques for chronic pain in animals and humans have been quite limited. This study will be&#xD;
      the first to utilize FDG PET-MRI imaging of both the brain and body in order to assess CNS&#xD;
      changes and peripheral body changes related to chronic pain and its potential management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is based on our growing understanding of chronic pain and our ability to&#xD;
      use functional brain imaging to study in vivo neurophysiologic processes. It is important to&#xD;
      understand the brain and body mechanisms of chronic pain in order to better determine&#xD;
      therapeutic interventions to reduce pain. Part of the difficulty in treating chronic pain is&#xD;
      to determine how better to diagnose what specific issues are affecting the brain and body&#xD;
      that result in chronic pain. Participants will undergo a small battery of diagnostic tests&#xD;
      that include magnetic resonance imaging (MRI), positron emission tomography (PET). A&#xD;
      secondary goal of this study is to determine if undergoing chiropractic care alters body or&#xD;
      brain physiology in patients with chronic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 7, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Use combined PET/MRI to define pain activity pattern and inflammation.</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>To use PET-MRI to define abnormal brain and body activity and evaluate changes in inflammation in painful regions in patients with chronic pain syndromes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Patterns will be compared between those who respond and those who do not respond to chiropractic care.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Brief Pain Inventory Questionnaire</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>This validated questionnaire will be used as one of the evaluation questionnaires for the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Numeric Rating Scale for Pain Intensity for specific locations</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>This validated questionnaire will be used as one of the evaluation questionnaires for the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Profile of Mood Scale</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>The Profile of Mood States (POMS) is a validated questionnaire of 65 single word items that asks &quot;How have you been feeling in the past week including today.&quot; The subjects will select their response to each word that describes a mood or feeling on a Likert scale from 1= Not at All, 2= A Little, 3=Moderately, 4=Quite a lot, to 5=Extremely. The responses are scored to generate values for Tension, Anger, Confusion, Depression and Vigor. The higher scores indicate a greater presence of that mood or state.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) for quality of life assessment</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>This validated questionnaire will be used as one of the evaluation questionnaires for the study.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Chronic Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Chiropractic Group</arm_group_label>
    <description>Participants receiving a chiropractic care technique Neuro Emotive Technique (NET) will complete initial pain evaluations and questionnaires for chronic pain symptoms. After approximately 8 weeks participants will receive follow evaluation for pain. Pre and Post PET-MRI scan will be conducted to evaluate changes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control Group</arm_group_label>
    <description>Participants will receive initial evaluations and questionnaires followed by a PET-MRI scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chiropractic Group</intervention_name>
    <description>Participants will receive approximately 8 weeks of chiropractic care.</description>
    <arm_group_label>Chiropractic Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy Control Group</intervention_name>
    <description>Participants will not receive any interventions.</description>
    <arm_group_label>Healthy Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited only if they are already planning on receiving standard clinical&#xD;
        chiropractic care for their pain.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Chronic Pain Patients:&#xD;
&#xD;
          -  Age greater than 18 years old.&#xD;
&#xD;
          -  Have chronic pain symptoms for &gt;3 months;&#xD;
&#xD;
          -  Have moderate pain (&gt;3/10) in 2 or more areas for more than 5 out of 7 days&#xD;
&#xD;
          -  Is planning on undergoing chiropractic care for the clinical management of the chronic&#xD;
             pain.&#xD;
&#xD;
          -  May be on pain medications provided that they are on a stable dose for at least 1&#xD;
             month&#xD;
&#xD;
          -  Patients have no other pre-existing and active significant medical, neurological, or&#xD;
             psychological disorders.&#xD;
&#xD;
          -  Minor, stable health problems that should have no substantial effect on cerebral blood&#xD;
             flow will be allowed (i.e. controlled hypertension, medication controlled diabetes).&#xD;
&#xD;
          -  Patients will be allowed to be taking medications or supplements at the initial&#xD;
             intake, but they must be on a stable dose regimen for at least 1 month.&#xD;
&#xD;
          -  Able to give informed consent and willing to complete the study at Thomas Jefferson&#xD;
             University and Marcus Institute of Integrative Health.&#xD;
&#xD;
        Inclusion Criteria for Healthy Controls:&#xD;
&#xD;
          -  No significant current active medical conditions.&#xD;
&#xD;
          -  Stable medical conditions as determined by the PI are allowed.&#xD;
&#xD;
          -  No brain or body abnormalities that would affect the acquisition or analysis of the&#xD;
             scan.&#xD;
&#xD;
        Exclusion Criteria for Chronic Pain Patients and Healthy Controls:&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Enrollment in active clinical trial/ experimental therapy within the prior 30 days.&#xD;
&#xD;
          -  Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia&#xD;
             or weight)&#xD;
&#xD;
          -  Subject has metal in their body or other reason that they cannot undergo magnetic&#xD;
             resonance imaging.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew B. Newberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University, Marcus Institute of Integrative Health Centers</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University, Marcus Institute of Integrative Health Centers</name>
      <address>
        <city>Villanova</city>
        <state>Pennsylvania</state>
        <zip>19085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 29, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Pain Syndrome</keyword>
  <keyword>Chronic Pain</keyword>
  <keyword>Chiropractic</keyword>
  <keyword>PET</keyword>
  <keyword>MRI</keyword>
  <keyword>Positron emission tomography</keyword>
  <keyword>Magnetic resonance imaging</keyword>
  <keyword>Neuro Emotive Technique (NET)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03233594/ICF_005.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03233594
org study id: 17D.163
nct id: NCT03233594
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Central nervous system (CNS) changes associated with pain have been difficult to measure
      until the development of functional neuroimaging techniques such as positron emission
      tomography (PET). We have previously observed asymmetry in the thalamus associated with
      chronic pain that altered during acupuncture therapy. Imaging studies of therapeutic
      techniques for chronic pain in animals and humans have been quite limited. This study will be
      the first to utilize FDG PET-MRI imaging of both the brain and body in order to assess CNS
      changes and peripheral body changes related to chronic pain and its potential management.
The proposed study is based on our growing understanding of chronic pain and our ability to
      use functional brain imaging to study in vivo neurophysiologic processes. It is important to
      understand the brain and body mechanisms of chronic pain in order to better determine
      therapeutic interventions to reduce pain. Part of the difficulty in treating chronic pain is
      to determine how better to diagnose what specific issues are affecting the brain and body
      that result in chronic pain. Participants will undergo a small battery of diagnostic tests
      that include magnetic resonance imaging (MRI), positron emission tomography (PET). A
      secondary goal of this study is to determine if undergoing chiropractic care alters body or
      brain physiology in patients with chronic pain.
observational model: Other
time perspective: Prospective
measure: Use combined PET/MRI to define pain activity pattern and inflammation.
time frame: Baseline and 8 weeks
description: To use PET-MRI to define abnormal brain and body activity and evaluate changes in inflammation in painful regions in patients with chronic pain syndromes.
measure: Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.
time frame: Baseline and 8 weeks
description: Patterns will be compared between those who respond and those who do not respond to chiropractic care.
measure: Brief Pain Inventory Questionnaire
time frame: Baseline and 8 weeks
description: This validated questionnaire will be used as one of the evaluation questionnaires for the study.
measure: Numeric Rating Scale for Pain Intensity for specific locations
time frame: Baseline and 8 weeks
description: This validated questionnaire will be used as one of the evaluation questionnaires for the study.
measure: Profile of Mood Scale
time frame: Baseline and 8 weeks
description: The Profile of Mood States (POMS) is a validated questionnaire of 65 single word items that asks "How have you been feeling in the past week including today." The subjects will select their response to each word that describes a mood or feeling on a Likert scale from 1= Not at All, 2= A Little, 3=Moderately, 4=Quite a lot, to 5=Extremely. The responses are scored to generate values for Tension, Anger, Confusion, Depression and Vigor. The higher scores indicate a greater presence of that mood or state.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) for quality of life assessment
time frame: Baseline and 8 weeks
description: This validated questionnaire will be used as one of the evaluation questionnaires for the study.
arm group label: Chiropractic Group
description: Participants receiving a chiropractic care technique Neuro Emotive Technique (NET) will complete initial pain evaluations and questionnaires for chronic pain symptoms. After approximately 8 weeks participants will receive follow evaluation for pain. Pre and Post PET-MRI scan will be conducted to evaluate changes.
arm group label: Healthy Control Group
description: Participants will receive initial evaluations and questionnaires followed by a PET-MRI scan.
intervention type: Other
intervention name: Chiropractic Group
description: Participants will receive approximately 8 weeks of chiropractic care.
arm group label: Chiropractic Group
intervention type: Other
intervention name: Healthy Control Group
description: Participants will not receive any interventions.
arm group label: Healthy Control Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew B. Newberg, MD
role: Principal Investigator
affiliation: Thomas Jefferson University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Chronic Pain
mesh term: Somatoform Disorders
sharing ipd: No
provided document: 