<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/NCT03294148</url>
  </required_header>
  <id_info>
    <org_study_id>16-0544</org_study_id>
    <nct_id>NCT03294148</nct_id>
  </id_info>
  <brief_title>Mind-body Treatments for Chronic Back Pain</brief_title>
  <official_title>Mind-body Treatments for Chronic Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Boulder</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Radiological Society of North America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Psychophysiologic Disorders Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Therapeutic Encouter Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Boulder</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>
      Participants with chronic back pain will complete an online prescreen. They will then be&#xD;
      randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy&#xD;
      vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid&#xD;
      use. Participants will then complete an in-person eligibility session, and eligible&#xD;
      participants will be scheduled for the baseline assessment session. Following the baseline&#xD;
      assessment session, participants will then be randomized to the treatment group or the&#xD;
      waitlist group (with a ratio of 2:1 treatment:waitlist), using a computer-generated random&#xD;
      sequence.&#xD;
&#xD;
      This scheme will result in three equally sized groups-placebo, psychotherapy, and waitlist-as&#xD;
      the investigators will collapse data from the waitlist arms in the two studies for analyses.&#xD;
      The investigators do not use a standard three-way randomization because the investigators do&#xD;
      not want placebo participants to think they are in a control condition. Thus, the&#xD;
      investigators constrain participant's expectations to either injection vs. waitlist or to&#xD;
      psychotherapy vs. waitlist.&#xD;
&#xD;
      The placebo treatment is a subcutaneous injection of saline into the back. Participants will&#xD;
      know that the treatment is a placebo, i.e., it is an &quot;open label&quot; placebo. Psychotherapy (8&#xD;
      sessions) will be supervised by Alan Gordon and Howard Schubiner.&#xD;
&#xD;
      Functional MRI brain imaging, self-reported clinical outcomes, and behavioral measures will&#xD;
      be collected pre- and post-treatment. A brief follow-up survey will be sent at months 1, 2,&#xD;
      3, 6, and 12 after the final assessment session. These will provide longer term data about&#xD;
      the trajectory and durability of patient improvement.&#xD;
&#xD;
      Additionally, a group of healthy controls, with no history of back pain, will complete the&#xD;
      baseline assessment. They will serve as a comparison group to probe whether the patterns of&#xD;
      observed brain activity is specific to CBP patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">November 26, 2019</completion_date>
  <primary_completion_date type="Actual">November 25, 2018</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>Participants will be randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid use. After an eligibility session, eligible participants will be randomized to the treatment group or the waitlist group (with a ratio of 2:1 treatment:waitlist), using a computer-generated random sequence. This scheme will result in three equally sized groups-placebo, psychotherapy, and waitlist-as the investigators will collapse data from the waitlist arms in the two studies for analyses. The investigators do not use a standard three-way randomization because the investigators do not want placebo participants to think they are in a control condition. Thus, the investigators constrain participant's expectations to either injection vs. waitlist or to psychotherapy vs. waitlist.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Researchers will not know which treatment the participants will be receiving (placebo or psychotherapy).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Pain Inventory-Short Form (BPI-SF)</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive Affect Scale Short Form (PANAS-SF)</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS- Depression</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa Scale of Kinesiophobia (TSK)</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. Scores range from 11-44 with higher scores indicating greater fear of pain, movement, and injury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Questionnaire (PCS)</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire used to help quantify an individual's pain experience. Measured 0-52. A higher score means a higher level of catastrophizing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timeline Follow-Back Measure for Alcohol (TLFB)</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Post-treatment-only outcome measure depicting a patient's subjective rating of overall improvement. Score ranges from 1-7 with a higher score indicating a higher level of change and improvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Satisfaction Questionnaire</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Post-treatment-only outcome measure depicting the patient's satisfaction with the treatment. Measured 0 - 100. A higher score means higher satisfaction with treatment/</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Affect Scale Short Form (PANAS-SF)</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire to rate negative affect, scores range from 5 - 25, with a higher score meaning a stronger negative affect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Anger</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Sleep</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Anxiety</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire measuring anxiety (8 items). Scores range from 8-40 with a higher score meaning more severe levels of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timeline Follow-Back Measure for Opioid Use (TLFB)</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timeline Follow-Back Measure for Cannabis (TLFB)</measure>
    <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
    <description>Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Back Pain Lower Back Chronic</condition>
  <condition>Back Pain, Low</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The open-label placebo treatment the investigators will use is based on past open-label placebo trials (Kam-Hansen et al., 2014; Kaptchuk et al., 2010; Kelley et al., 2012). Prior to treatment administration, patients will view a brief (~3 min) video summarizing scientific findings regarding the therapeutic power of placebo treatments. The video will describe established findings regarding placebo and suggest that placebos may still work even when patients know the treatment is a placebo. The video will state that believing in the placebo is not necessary, and the investigators ask only that patients keep an open mind. Patients will then receive a subcutaneous injection of 1ml medical grade saline into the lower back. The injection will be administered near the location of the pain, as specified by the participant. The investigators will use a standard needle used in subcutaneous injections of 27 gauge with a length from 1in to 1.5in.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psychotherapy will consist of one initial medical history session with Co-I Schubiner, followed by twice weekly 50 minute psychotherapy sessions for 4 weeks with a therapist, for a total of 9 sessions maximum. The purpose of the initial medical history session is to help evaluate the likelihood that the patient's back pain is caused by structural conditions in the back. Dr. Schubiner will then speak with patients for a 1 hour session in which he collects their medical history and discusses different possible causes of their back pain with them. This session will be conducted by phone, by HIPAA-compliant Zoom, or by another HIPAA-compliant videoconferencing technology in consultation with the OIT team at Dr. Schubiner's hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait-listed patients will be asked not to change their treatment regime for the 4 weeks in between their two fMRI sessions. Wait-listed patients in the placebo injection arm will be offered the opportunity to receive the placebo treatment (optional). Waitlisted participants in the psychotherapy arm will be given a copy of Dr. Schubiner's book and free access to his online self-help program (optional to accept these).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Open-Label Placebo Treatment for Chronic Back Pain</intervention_name>
    <description>Subcutaneous injection of 1ml medical grade saline into the lower back.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychotherapy Treatment for Chronic Back Pain</intervention_name>
    <description>Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session</description>
    <arm_group_label>Psychotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 21 to 70 with CBP will be enrolled.&#xD;
&#xD;
          -  CBP will be defined according to the criteria established by a recent NIH task force&#xD;
             (Deyo et al., 2014). Pain duration must be at least 3 months, with back pain being an&#xD;
             ongoing problem for at least half the days of the last 6 months. That is, patients can&#xD;
             meet criteria by either reporting pain every day for the past 3 months, or by&#xD;
             reporting pain on half or more of the days for the past 6+ months. This will be&#xD;
             determined by asking patients: (1) How long has back pain has been an ongoing problem&#xD;
             for you? (2) How often has low back pain been an ongoing problem for you over the past&#xD;
             6 months? A response of greater than 3 months to question 1 and a response of ''at&#xD;
             least half the days in the past 6 months'' to question 2 would define CBP.&#xD;
&#xD;
          -  Patients must rate pain intensity at 40/100 or greater on the Brief Pain&#xD;
             Inventory-Short Form (BPI-SF), in keeping with inclusion criteria from previous CBP&#xD;
             trials (Baliki et al., 2012; Cherkin et al., 2016; Hashmi et al., 2013; Seminowicz et&#xD;
             al., 2011).&#xD;
&#xD;
          -  Back pain must be elicited by our back pain device (see below).&#xD;
&#xD;
          -  Participants must also be comfortable and able to communicate via email or text&#xD;
             message, as several study measures are collected in this manner (see below).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Back pain associated with compensation or litigation issues as determined by&#xD;
             self-report within the past year.&#xD;
&#xD;
          -  Leg pain is greater than back pain. This suggests neuropathic pain, which may be less&#xD;
             responsive to placebo or psychotherapy.&#xD;
&#xD;
          -  Difficulty participating for technical/logistical issues (e.g., unable to get to&#xD;
             assessment sessions).&#xD;
&#xD;
          -  Self-reported diagnoses of schizophrenia, multiple personality disorder, or&#xD;
             dissociative identity disorder.&#xD;
&#xD;
          -  Self-reported use of intravenous drugs, due to concerns about infections and subject&#xD;
             compliance with experimental protocols.&#xD;
&#xD;
          -  Inability to undergo MRI as determined by MRI safety screen (e.g., pregnancy, metal in&#xD;
             body, claustrophobia, using the standard screen conducted by the MRI imaging&#xD;
             facility).&#xD;
&#xD;
          -  Hypersensitive or hyposensitive to pressure pain: unable to tolerate 7kg/cm2&#xD;
             stimulation or reporting no pain for 4kg/cm2 stimulation; see further details below.&#xD;
&#xD;
          -  Current regular use of an immunosuppressant drug, such as steroids. Such drugs&#xD;
             interfere with immunoassay results.&#xD;
&#xD;
          -  Self-reported history of metastasizing cancers-cancer of the breast, thyroid, lung,&#xD;
             kidney, prostate or blood cancers.&#xD;
&#xD;
          -  Self-reported history of stroke, brain surgery, or brain tumor.&#xD;
&#xD;
          -  Self-reported diagnosis of a specific inflammatory disorder: rheumatoid arthritis,&#xD;
             polymyalgia rheumatica, scleroderma, Lupus, or polymyositis.&#xD;
&#xD;
          -  Unexplained, unintended weight loss of 20 lbs. or more in the past year.&#xD;
&#xD;
          -  Cauda Equina syndrome, as screened for by self-reported inability to control bowel or&#xD;
             bladder function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tor Wager</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Boulder</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <results_first_submitted>October 27, 2021</results_first_submitted>
  <results_first_submitted_qc>February 24, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2023</results_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Colorado, Boulder</investigator_affiliation>
    <investigator_full_name>Jonathan Ashar</investigator_full_name>
    <investigator_title>Graduate student under the supervision of PI Wager</investigator_title>
  </responsible_party>
  <keyword>Placebo</keyword>
  <keyword>Back</keyword>
  <keyword>Pain</keyword>
  <keyword>Chronic</keyword>
  <keyword>Mind-Body</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03294148/Prot_SAP_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Placebo</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>July 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03294148/ICF_005.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Control</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>July 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03294148/ICF_006.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Psychotherapy</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>July 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03294148/ICF_007.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pain Reprocessing Therapy (PRT)</title>
          <description>Received psychological treatment</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Open-label placebo</description>
        </group>
        <group group_id="P3">
          <title>Usual Care</title>
          <description>Continue usual care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pain Reprocessing Therapy (PRT)</title>
          <description>Received psychological treatment</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Open-label placebo</description>
        </group>
        <group group_id="B3">
          <title>Usual Care</title>
          <description>Continue usual care</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="50"/>
            <count group_id="B4" value="151"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.6" spread="16.2"/>
                    <measurement group_id="B2" value="39.4" spread="14.9"/>
                    <measurement group_id="B3" value="41.3" spread="15.9"/>
                    <measurement group_id="B4" value="41.1" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Brief Pain Inventory-Short Form (BPI-SF)</title>
        <description>1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory-Short Form (BPI-SF)</title>
          <description>1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.</description>
          <population>all available participants analyzed</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="1.24"/>
                    <measurement group_id="O2" value="2.84" spread="1.64"/>
                    <measurement group_id="O3" value="3.13" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Affect Scale Short Form (PANAS-SF)</title>
        <description>Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Affect Scale Short Form (PANAS-SF)</title>
          <description>Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.89" spread="3.38"/>
                    <measurement group_id="O2" value="15.20" spread="5.60"/>
                    <measurement group_id="O3" value="14.98" spread="3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS- Depression</title>
        <description>Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS- Depression</title>
          <description>Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.23" spread="4.94"/>
                    <measurement group_id="O2" value="11.75" spread="4.05"/>
                    <measurement group_id="O3" value="11.81" spread="4.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tampa Scale of Kinesiophobia (TSK)</title>
        <description>Questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. Scores range from 11-44 with higher scores indicating greater fear of pain, movement, and injury.</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Tampa Scale of Kinesiophobia (TSK)</title>
          <description>Questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. Scores range from 11-44 with higher scores indicating greater fear of pain, movement, and injury.</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.41" spread="5.37"/>
                    <measurement group_id="O2" value="22.16" spread="4.94"/>
                    <measurement group_id="O3" value="22.51" spread="6.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Catastrophizing Questionnaire (PCS)</title>
        <description>Questionnaire used to help quantify an individual's pain experience. Measured 0-52. A higher score means a higher level of catastrophizing.</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Catastrophizing Questionnaire (PCS)</title>
          <description>Questionnaire used to help quantify an individual's pain experience. Measured 0-52. A higher score means a higher level of catastrophizing.</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.30" spread="3.04"/>
                    <measurement group_id="O2" value="7.70" spread="2.44"/>
                    <measurement group_id="O3" value="8.19" spread="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Timeline Follow-Back Measure for Alcohol (TLFB)</title>
        <description>Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks)</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Timeline Follow-Back Measure for Alcohol (TLFB)</title>
          <description>Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks)</description>
          <population>all available participants analyzed</population>
          <units>Drinks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.63" spread="10.83"/>
                    <measurement group_id="O2" value="12.88" spread="14.30"/>
                    <measurement group_id="O3" value="8.02" spread="10.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change (PGIC)</title>
        <description>Post-treatment-only outcome measure depicting a patient's subjective rating of overall improvement. Score ranges from 1-7 with a higher score indicating a higher level of change and improvement</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change (PGIC)</title>
          <description>Post-treatment-only outcome measure depicting a patient's subjective rating of overall improvement. Score ranges from 1-7 with a higher score indicating a higher level of change and improvement</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.14" spread="0.88"/>
                    <measurement group_id="O2" value="3.61" spread="1.62"/>
                    <measurement group_id="O3" value="2.06" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Satisfaction Questionnaire</title>
        <description>Post-treatment-only outcome measure depicting the patient's satisfaction with the treatment. Measured 0 - 100. A higher score means higher satisfaction with treatment/</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Satisfaction Questionnaire</title>
          <description>Post-treatment-only outcome measure depicting the patient's satisfaction with the treatment. Measured 0 - 100. A higher score means higher satisfaction with treatment/</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.40" spread="8.01"/>
                    <measurement group_id="O2" value="57.61" spread="23.05"/>
                    <measurement group_id="O3" value="36.86" spread="23.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oswestry Disability Index</title>
        <description>Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability.</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Oswestry Disability Index</title>
          <description>Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability.</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.14" spread="10.63"/>
                    <measurement group_id="O2" value="19.00" spread="11.07"/>
                    <measurement group_id="O3" value="20.68" spread="10.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Negative Affect Scale Short Form (PANAS-SF)</title>
        <description>Questionnaire to rate negative affect, scores range from 5 - 25, with a higher score meaning a stronger negative affect</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Affect Scale Short Form (PANAS-SF)</title>
          <description>Questionnaire to rate negative affect, scores range from 5 - 25, with a higher score meaning a stronger negative affect</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.30" spread="3.04"/>
                    <measurement group_id="O2" value="7.70" spread="2.44"/>
                    <measurement group_id="O3" value="8.19" spread="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS Anger</title>
        <description>Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger.</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Anger</title>
          <description>Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger.</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.52" spread="3.91"/>
                    <measurement group_id="O2" value="9.89" spread="3.81"/>
                    <measurement group_id="O3" value="10.45" spread="3.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS Sleep</title>
        <description>Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Sleep</title>
          <description>Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.73" spread="6.75"/>
                    <measurement group_id="O2" value="20.50" spread="6.17"/>
                    <measurement group_id="O3" value="20.89" spread="6.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS Anxiety</title>
        <description>Questionnaire measuring anxiety (8 items). Scores range from 8-40 with a higher score meaning more severe levels of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal.</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Anxiety</title>
          <description>Questionnaire measuring anxiety (8 items). Scores range from 8-40 with a higher score meaning more severe levels of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal.</description>
          <population>all available participants analyzed</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.02" spread="6.16"/>
                    <measurement group_id="O2" value="13.89" spread="5.78"/>
                    <measurement group_id="O3" value="14.11" spread="6.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Timeline Follow-Back Measure for Opioid Use (TLFB)</title>
        <description>Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks)</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Timeline Follow-Back Measure for Opioid Use (TLFB)</title>
          <description>Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks)</description>
          <population>all available participants analyzed</population>
          <units>Opioid pills</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="4.50"/>
                    <measurement group_id="O2" value="0.36" spread="2.11"/>
                    <measurement group_id="O3" value="1.77" spread="8.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Timeline Follow-Back Measure for Cannabis (TLFB)</title>
        <description>Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks)</description>
        <time_frame>At post-treatment fMRI session, approximately 1 month after randomization</time_frame>
        <population>all available participants analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Reprocessing Therapy (PRT)</title>
            <description>Received psychological treatment</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Open-label placebo</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>Continue usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Timeline Follow-Back Measure for Cannabis (TLFB)</title>
          <description>Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks)</description>
          <population>all available participants analyzed</population>
          <units>Grams of cannabis</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.76" spread="25.32"/>
                    <measurement group_id="O2" value="3.31" spread="6.72"/>
                    <measurement group_id="O3" value="1.49" spread="3.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from enrollment through completion of the post-treatment fMRI session, an average of 1.5 months after enrollment.</time_frame>
      <desc>Adverse events were recorded when participants spontaneously reported them to study personnel.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pain Reprocessing Therapy (PRT)</title>
          <description>Psychological treatment</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Open-label placebo</description>
        </group>
        <group group_id="E3">
          <title>Usual Care</title>
          <description>Continue usual care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Yoni Ashar</name_or_title>
      <organization>Weill Cornell Medicine</organization>
      <phone>(646) 962-2820</phone>
      <email>joa9188@med.cornell.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03294148
org study id: 16-0544
nct id: NCT03294148
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Participants with chronic back pain will complete an online prescreen. They will then be
      randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy
      vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid
      use. Participants will then complete an in-person eligibility session, and eligible
      participants will be scheduled for the baseline assessment session. Following the baseline
      assessment session, participants will then be randomized to the treatment group or the
      waitlist group (with a ratio of 2:1 treatment:waitlist), using a computer-generated random
      sequence.

      This scheme will result in three equally sized groups-placebo, psychotherapy, and waitlist-as
      the investigators will collapse data from the waitlist arms in the two studies for analyses.
      The investigators do not use a standard three-way randomization because the investigators do
      not want placebo participants to think they are in a control condition. Thus, the
      investigators constrain participant's expectations to either injection vs. waitlist or to
      psychotherapy vs. waitlist.

      The placebo treatment is a subcutaneous injection of saline into the back. Participants will
      know that the treatment is a placebo, i.e., it is an "open label" placebo. Psychotherapy (8
      sessions) will be supervised by Alan Gordon and Howard Schubiner.

      Functional MRI brain imaging, self-reported clinical outcomes, and behavioral measures will
      be collected pre- and post-treatment. A brief follow-up survey will be sent at months 1, 2,
      3, 6, and 12 after the final assessment session. These will provide longer term data about
      the trajectory and durability of patient improvement.

      Additionally, a group of healthy controls, with no history of back pain, will complete the
      baseline assessment. They will serve as a comparison group to probe whether the patterns of
      observed brain activity is specific to CBP patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid use. After an eligibility session, eligible participants will be randomized to the treatment group or the waitlist group (with a ratio of 2:1 treatment:waitlist), using a computer-generated random sequence. This scheme will result in three equally sized groups-placebo, psychotherapy, and waitlist-as the investigators will collapse data from the waitlist arms in the two studies for analyses. The investigators do not use a standard three-way randomization because the investigators do not want placebo participants to think they are in a control condition. Thus, the investigators constrain participant's expectations to either injection vs. waitlist or to psychotherapy vs. waitlist.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Researchers will not know which treatment the participants will be receiving (placebo or psychotherapy).
measure: Brief Pain Inventory-Short Form (BPI-SF)
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: 1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.
measure: Positive Affect Scale Short Form (PANAS-SF)
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire to rate positive affect, scores range from 5 - 25, a higher score means stronger affect
measure: PROMIS- Depression
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire measuring depression (8 items). Scores range from 8-32. A higher score indicates higher levels of depressive symptoms
measure: Tampa Scale of Kinesiophobia (TSK)
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. Scores range from 11-44 with higher scores indicating greater fear of pain, movement, and injury.
measure: Pain Catastrophizing Questionnaire (PCS)
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire used to help quantify an individual's pain experience. Measured 0-52. A higher score means a higher level of catastrophizing.
measure: Timeline Follow-Back Measure for Alcohol (TLFB)
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire used to assess daily drinking (number of drinks consumed over past two weeks)
measure: Patient Global Impression of Change (PGIC)
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Post-treatment-only outcome measure depicting a patient's subjective rating of overall improvement. Score ranges from 1-7 with a higher score indicating a higher level of change and improvement
measure: Treatment Satisfaction Questionnaire
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Post-treatment-only outcome measure depicting the patient's satisfaction with the treatment. Measured 0 - 100. A higher score means higher satisfaction with treatment/
measure: Oswestry Disability Index
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Back pain disability questionnaire measured on a scale of 0-100. A higher score indicates a higher severity of disability.
measure: Negative Affect Scale Short Form (PANAS-SF)
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire to rate negative affect, scores range from 5 - 25, with a higher score meaning a stronger negative affect
measure: PROMIS Anger
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire measuring anger (5 items) with a score range of 5-25. Higher scores indicate a higher severity of anger.
measure: PROMIS Sleep
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire measuring sleep disturbance (8 items). Scores range from 8-40. Higher scores indicate higher levels of sleep disturbance
measure: PROMIS Anxiety
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire measuring anxiety (8 items). Scores range from 8-40 with a higher score meaning more severe levels of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal.
measure: Timeline Follow-Back Measure for Opioid Use (TLFB)
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire used to assess daily opioid use (number of pills consumed over past two weeks)
measure: Timeline Follow-Back Measure for Cannabis (TLFB)
time frame: At post-treatment fMRI session, approximately 1 month after randomization
description: Questionnaire used to assess daily cannabis use (number of grams consumed over past two weeks)
arm group label: Placebo
arm group type: Experimental
description: The open-label placebo treatment the investigators will use is based on past open-label placebo trials (Kam-Hansen et al., 2014; Kaptchuk et al., 2010; Kelley et al., 2012). Prior to treatment administration, patients will view a brief (~3 min) video summarizing scientific findings regarding the therapeutic power of placebo treatments. The video will describe established findings regarding placebo and suggest that placebos may still work even when patients know the treatment is a placebo. The video will state that believing in the placebo is not necessary, and the investigators ask only that patients keep an open mind. Patients will then receive a subcutaneous injection of 1ml medical grade saline into the lower back. The injection will be administered near the location of the pain, as specified by the participant. The investigators will use a standard needle used in subcutaneous injections of 27 gauge with a length from 1in to 1.5in.
arm group label: Psychotherapy
arm group type: Experimental
description: Psychotherapy will consist of one initial medical history session with Co-I Schubiner, followed by twice weekly 50 minute psychotherapy sessions for 4 weeks with a therapist, for a total of 9 sessions maximum. The purpose of the initial medical history session is to help evaluate the likelihood that the patient's back pain is caused by structural conditions in the back. Dr. Schubiner will then speak with patients for a 1 hour session in which he collects their medical history and discusses different possible causes of their back pain with them. This session will be conducted by phone, by HIPAA-compliant Zoom, or by another HIPAA-compliant videoconferencing technology in consultation with the OIT team at Dr. Schubiner's hospital.
arm group label: Waitlist
arm group type: No Intervention
description: Wait-listed patients will be asked not to change their treatment regime for the 4 weeks in between their two fMRI sessions. Wait-listed patients in the placebo injection arm will be offered the opportunity to receive the placebo treatment (optional). Waitlisted participants in the psychotherapy arm will be given a copy of Dr. Schubiner's book and free access to his online self-help program (optional to accept these).
intervention type: Other
intervention name: Open-Label Placebo Treatment for Chronic Back Pain
description: Subcutaneous injection of 1ml medical grade saline into the lower back.
arm group label: Placebo
intervention type: Behavioral
intervention name: Psychotherapy Treatment for Chronic Back Pain
description: Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session
arm group label: Psychotherapy
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tor Wager
role: Principal Investigator
affiliation: University of Colorado, Boulder
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: University of Colorado, Boulder
investigator full name: Jonathan Ashar
investigator title: Graduate student under the supervision of PI Wager
mesh term: Back Pain
mesh term: Chronic Pain
mesh term: Low Back Pain
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