<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/NCT02991625</url>
  </required_header>
  <id_info>
    <org_study_id>1021846</org_study_id>
    <nct_id>NCT02991625</nct_id>
  </id_info>
  <brief_title>Brain Imaging Study on Biomarkers for Chronic Back Pain</brief_title>
  <official_title>Brain Imaging Study on Biomarkers for Chronic Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</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>
      Drugs used for managing chronic pain have not proven to be effective and chronic pain&#xD;
      continues to cost Canadians $60 billion a year without truly helping those who suffer. The&#xD;
      study proposes to investigate the factors related to a person that can enhance or reduce the&#xD;
      effectiveness of pain treatments in people suffering with chronic pain. Treatment response to&#xD;
      pain killers in a person may be related to their brain, genetics, social, and psychological&#xD;
      makeup. The investigators aim to study these factors to identify and develop feasible and&#xD;
      robust indicators based on a person's biological makeup (also called biomarkers). These&#xD;
      biomarkers will allow doctors and researchers to predict more accurately which treatment and&#xD;
      prevention strategies for a particular disease will work in which groups of people. These&#xD;
      measures will offer new opportunities for improving treatment such as by tailoring treatment&#xD;
      to meet the specific needs of each patient based on his/her biological and psychological&#xD;
      makeup. Towards the specific aim, data will first be collected in several experimental&#xD;
      domains for studying treatment expectations (cognitive, psychosocial, brain-related,&#xD;
      genetic). These 'experimental' data will be compared between chronic back pain (CBP) and&#xD;
      healthy participants to yield new understanding of the factors that govern treatment&#xD;
      response. At the end of experimental data collection, the investigators will collect data in&#xD;
      the 'clinical' domain. Hence, at the end of the experimental sessions, a subset of CBP&#xD;
      participants will receive a mock drug (placebo disguised as an approved pain treatment) and&#xD;
      another subset will provide pain ratings only and hence serve as a waiting list control for&#xD;
      the placebo trial. Data will be studied in steps to understand factors that mediate treatment&#xD;
      outcomes and finally the investigators will use advanced computational tools used for big&#xD;
      data analysis and aim to identify factors that can be used as biomarkers and precision&#xD;
      medicine tools.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 22, 2018</start_date>
  <completion_date type="Anticipated">January 2035</completion_date>
  <primary_completion_date type="Anticipated">January 2027</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>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain modulation - using an experimental task that tests a person's ability to form positive expectations</measure>
    <time_frame>3 days after first visit</time_frame>
    <description>Brain imaging will be used to assess each participant's capacity to endogenously adjust pain perception with changes in expectations.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>Placebos</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic Back Pain participants will enter an optional placebo trial. This phase of the study will test the clinical usefulness of the biomarkers. We will measure how expectation of starting a new treatment reduces 'clinical back pain' in each participant. Positive treatment expectations will be induced by giving them capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Back Pain. They will be requested to take two capsules twice a day and report their pain on paper forms organized as a calendar.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Chronic Back Pain participants will not be given any placebo and will be requested to report their pain on paper forms organized as a calendar.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healthy control participants will complete the main part of the study, but will not be asked to take a placebo or be placed on a waitlist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Positive treatment expectations will be induced by giving participants capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Back Pain. They will be requested to take two capsules twice a day and report their pain on paper forms organized as a calendar.</description>
    <arm_group_label>Placebos</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waitlist</intervention_name>
    <description>These Chronic Back Pain participants will not be given any placebos and will be requested to report their pain on paper forms organized as a calendar.</description>
    <arm_group_label>Waitlist</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy Controls</intervention_name>
    <description>Healthy control participants will not receive a placebo drug or be put on a waitlist.</description>
    <arm_group_label>Healthy Controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Chronic pain participant inclusion criteria:&#xD;
&#xD;
          1. 18-75 years of age&#xD;
&#xD;
          2. Right-handed&#xD;
&#xD;
          3. Meet the classification criteria of chronic low back pain (having low back pain for&#xD;
             more than 6 months), as determined by a physician and documented in the participant's&#xD;
             medical record.&#xD;
&#xD;
          4. At least 4/10 clinical pain on the Brief Pain Inventory Scale on average during the&#xD;
             two weeks prior to enrollment&#xD;
&#xD;
          5. Comfortable completing (reading and writing) questionnaires and tasks with English&#xD;
             language instructions&#xD;
&#xD;
        Healthy participant inclusion criteria:&#xD;
&#xD;
          1. 18 - 75 years of age&#xD;
&#xD;
          2. Right-handed&#xD;
&#xD;
          3. Comfortable completing (reading and writing) questionnaires and tasks with English&#xD;
             language instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Chronic pain participant exclusion criteria:&#xD;
&#xD;
          1. History of cardiac, respiratory, or nervous system disease that may interfere with&#xD;
             participation in the study or cause heightened potential for adverse outcome. For&#xD;
             example: asthma or claustrophobia&#xD;
&#xD;
          2. Presence of any contraindications to MRI scanning. For example: cardiac pacemaker,&#xD;
             metal implants, fear of closed spaces, pregnancy&#xD;
&#xD;
        Healthy participant exclusion criteria:&#xD;
&#xD;
          1. Acute or chronic pain&#xD;
&#xD;
          2. History of cardiac, respiratory, or nervous system disease that, in the investigator's&#xD;
             judgment and by asking the participant about their comfort level and ability,&#xD;
             precludes participation in the study because of a heightened potential for adverse&#xD;
             outcome. For example: asthma or claustrophobia&#xD;
&#xD;
          3. Presence of any contraindications to MRI scanning. For example: cardiac pacemaker,&#xD;
             metal implants, fear of closed spaces, pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javeria A Hashmi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalhousie University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nova Scotia Health Authoity QEII</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Hashmi JA, Baliki MN, Huang L, Baria AT, Torbey S, Hermann KM, Schnitzer TJ, Apkarian AV. Shape shifting pain: chronification of back pain shifts brain representation from nociceptive to emotional circuits. Brain. 2013 Sep;136(Pt 9):2751-68. doi: 10.1093/brain/awt211.</citation>
    <PMID>23983029</PMID>
  </reference>
  <reference>
    <citation>Vase L, Vollert J, Finnerup NB, Miao X, Atkinson G, Marshall S, Nemeth R, Lange B, Liss C, Price DD, Maier C, Jensen TS, Segerdahl M. Predictors of the placebo analgesia response in randomized controlled trials of chronic pain: a meta-analysis of the individual data from nine industrially sponsored trials. Pain. 2015 Sep;156(9):1795-1802. doi: 10.1097/j.pain.0000000000000217.</citation>
    <PMID>25955965</PMID>
  </reference>
  <reference>
    <citation>Hashmi JA, Kong J, Spaeth R, Khan S, Kaptchuk TJ, Gollub RL. Functional network architecture predicts psychologically mediated analgesia related to treatment in chronic knee pain patients. J Neurosci. 2014 Mar 12;34(11):3924-36. doi: 10.1523/JNEUROSCI.3155-13.2014.</citation>
    <PMID>24623770</PMID>
  </reference>
  <reference>
    <citation>Hashmi JA, Baria AT, Baliki MN, Huang L, Schnitzer TJ, Apkarian VA. Brain networks predicting placebo analgesia in a clinical trial for chronic back pain. Pain. 2012 Dec;153(12):2393-2402. doi: 10.1016/j.pain.2012.08.008. Epub 2012 Sep 15.</citation>
    <PMID>22985900</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02991625
org study id: 1021846
nct id: NCT02991625
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Drugs used for managing chronic pain have not proven to be effective and chronic pain
      continues to cost Canadians $60 billion a year without truly helping those who suffer. The
      study proposes to investigate the factors related to a person that can enhance or reduce the
      effectiveness of pain treatments in people suffering with chronic pain. Treatment response to
      pain killers in a person may be related to their brain, genetics, social, and psychological
      makeup. The investigators aim to study these factors to identify and develop feasible and
      robust indicators based on a person's biological makeup (also called biomarkers). These
      biomarkers will allow doctors and researchers to predict more accurately which treatment and
      prevention strategies for a particular disease will work in which groups of people. These
      measures will offer new opportunities for improving treatment such as by tailoring treatment
      to meet the specific needs of each patient based on his/her biological and psychological
      makeup. Towards the specific aim, data will first be collected in several experimental
      domains for studying treatment expectations (cognitive, psychosocial, brain-related,
      genetic). These 'experimental' data will be compared between chronic back pain (CBP) and
      healthy participants to yield new understanding of the factors that govern treatment
      response. At the end of experimental data collection, the investigators will collect data in
      the 'clinical' domain. Hence, at the end of the experimental sessions, a subset of CBP
      participants will receive a mock drug (placebo disguised as an approved pain treatment) and
      another subset will provide pain ratings only and hence serve as a waiting list control for
      the placebo trial. Data will be studied in steps to understand factors that mediate treatment
      outcomes and finally the investigators will use advanced computational tools used for big
      data analysis and aim to identify factors that can be used as biomarkers and precision
      medicine tools.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pain modulation - using an experimental task that tests a person's ability to form positive expectations
time frame: 3 days after first visit
description: Brain imaging will be used to assess each participant's capacity to endogenously adjust pain perception with changes in expectations.
arm group label: Placebos
arm group type: Experimental
description: Chronic Back Pain participants will enter an optional placebo trial. This phase of the study will test the clinical usefulness of the biomarkers. We will measure how expectation of starting a new treatment reduces 'clinical back pain' in each participant. Positive treatment expectations will be induced by giving them capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Back Pain. They will be requested to take two capsules twice a day and report their pain on paper forms organized as a calendar.
arm group label: Waitlist
arm group type: Other
description: Chronic Back Pain participants will not be given any placebo and will be requested to report their pain on paper forms organized as a calendar.
arm group label: Healthy Controls
arm group type: Other
description: Healthy control participants will complete the main part of the study, but will not be asked to take a placebo or be placed on a waitlist.
intervention type: Drug
intervention name: Placebos
description: Positive treatment expectations will be induced by giving participants capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Back Pain. They will be requested to take two capsules twice a day and report their pain on paper forms organized as a calendar.
arm group label: Placebos
intervention type: Other
intervention name: Waitlist
description: These Chronic Back Pain participants will not be given any placebos and will be requested to report their pain on paper forms organized as a calendar.
arm group label: Waitlist
intervention type: Other
intervention name: Healthy Controls
description: Healthy control participants will not receive a placebo drug or be put on a waitlist.
arm group label: Healthy Controls
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Javeria A Hashmi, PhD
role: Principal Investigator
affiliation: Dalhousie University
facility: 
country: Canada
citation: Hashmi JA, Baliki MN, Huang L, Baria AT, Torbey S, Hermann KM, Schnitzer TJ, Apkarian AV. Shape shifting pain: chronification of back pain shifts brain representation from nociceptive to emotional circuits. Brain. 2013 Sep;136(Pt 9):2751-68. doi: 10.1093/brain/awt211.
PMID: 23983029
citation: Vase L, Vollert J, Finnerup NB, Miao X, Atkinson G, Marshall S, Nemeth R, Lange B, Liss C, Price DD, Maier C, Jensen TS, Segerdahl M. Predictors of the placebo analgesia response in randomized controlled trials of chronic pain: a meta-analysis of the individual data from nine industrially sponsored trials. Pain. 2015 Sep;156(9):1795-1802. doi: 10.1097/j.pain.0000000000000217.
PMID: 25955965
citation: Hashmi JA, Kong J, Spaeth R, Khan S, Kaptchuk TJ, Gollub RL. Functional network architecture predicts psychologically mediated analgesia related to treatment in chronic knee pain patients. J Neurosci. 2014 Mar 12;34(11):3924-36. doi: 10.1523/JNEUROSCI.3155-13.2014.
PMID: 24623770
citation: Hashmi JA, Baria AT, Baliki MN, Huang L, Schnitzer TJ, Apkarian VA. Brain networks predicting placebo analgesia in a clinical trial for chronic back pain. Pain. 2012 Dec;153(12):2393-2402. doi: 10.1016/j.pain.2012.08.008. Epub 2012 Sep 15.
PMID: 22985900
responsible party type: Sponsor
mesh term: Back Pain
sharing ipd: Undecided