<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/NCT03836586</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201802819 -N</org_study_id>
    <secondary_id>P30AG059297</secondary_id>
    <secondary_id>K22NS102334</secondary_id>
    <nct_id>NCT03836586</nct_id>
  </id_info>
  <brief_title>Study of Pain Catastrophizing</brief_title>
  <acronym>SPAC</acronym>
  <official_title>Contribution of Pain Catastrophizing to Race Group Differences in Pain and Pain-Related Brain Responses in Older Adults With Knee Osteoarthritis (OA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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>
      This study proposes to experimentally manipulate pain catastrophizing in order to investigate&#xD;
      the neural mechanisms by which pain catastrophizing influences the experience of pain among&#xD;
      non-Hispanic Blacks (NHBs) and non- Hispanic Whites (NHWs) with knee osteoarthritis (OA).&#xD;
      Therefore, participants will be randomized to either a single session cognitive-behavioral&#xD;
      intervention to reduce pain catastrophizing or a pain education control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 23, 2019</start_date>
  <completion_date type="Actual">June 7, 2021</completion_date>
  <primary_completion_date type="Actual">June 7, 2021</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 either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Catastrophizing Scale (PCS) at Day 2</measure>
    <time_frame>Day 2</time_frame>
    <description>13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing (&quot;Thinking back to your experience during the laboratory pain testing&quot;). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>Pain Catastrophizing Reduction Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain Education Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive general information about the neurobiology of pain and knee OA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-Behavioral Intervention</intervention_name>
    <description>This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.</description>
    <arm_group_label>Pain Catastrophizing Reduction Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain Education</intervention_name>
    <description>General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.</description>
    <arm_group_label>Pain Education Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  symptomatic knee OA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 45 years of age or older than 85 years of age&#xD;
&#xD;
          -  Prosthetic knee replacement or other clinically significant surgery to the arthritic&#xD;
             knee&#xD;
&#xD;
          -  uncontrolled hypertension (&gt;150/95)&#xD;
&#xD;
          -  Heart disease including heart failure&#xD;
&#xD;
          -  Peripheral neuropathy in which pain testing was contraindicated&#xD;
&#xD;
          -  Systemic rheumatic disorders including rheumatoid arthritis, systemic lupus&#xD;
             erythematosus, gout, and fibromyalgia&#xD;
&#xD;
          -  Neurological diseases such as Parkinson's, multiple sclerosis, stroke with loss of&#xD;
             sensory or motor function, or uncontrolled seizures&#xD;
&#xD;
          -  Significantly greater pain in body sites other than in the knee&#xD;
&#xD;
          -  Daily opioid use&#xD;
&#xD;
          -  Hospitalization within the preceding year for psychiatric illness&#xD;
&#xD;
          -  Currently pregnant or nursing/breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Terry, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health at the University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <results_first_submitted>August 22, 2022</results_first_submitted>
  <results_first_submitted_qc>November 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 22, 2022</results_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>catastrophizing</keyword>
  <keyword>cognitive-behavior therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>March 30, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03836586/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pain Catastrophizing Reduction Group</title>
          <description>This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.&#xD;
Cognitive-Behavioral Intervention: This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.</description>
        </group>
        <group group_id="P2">
          <title>Pain Education Group</title>
          <description>This group will receive general information about the neurobiology of pain and knee OA.&#xD;
Pain Education: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pain Catastrophizing Reduction Group</title>
          <description>This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.&#xD;
Cognitive-Behavioral Intervention: This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.</description>
        </group>
        <group group_id="B2">
          <title>Pain Education Group</title>
          <description>This group will receive general information about the neurobiology of pain and knee OA.&#xD;
Pain Education: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.</description>
        </group>
        <group group_id="B3">
          <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="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="10"/>
          </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="56.80" spread="6.83"/>
                    <measurement group_id="B2" value="64.20" spread="6.14"/>
                    <measurement group_id="B3" value="60.50" spread="7.26"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>non-Hispanic Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>non-Hispanic White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Catastrophizing Scale (PCS) at Day 2</title>
        <description>13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing (&quot;Thinking back to your experience during the laboratory pain testing&quot;). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome.</description>
        <time_frame>Day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pain Catastrophizing Reduction Group</title>
            <description>This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.&#xD;
Cognitive-Behavioral Intervention: This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.</description>
          </group>
          <group group_id="O2">
            <title>Pain Education Group</title>
            <description>This group will receive general information about the neurobiology of pain and knee OA.&#xD;
Pain Education: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Catastrophizing Scale (PCS) at Day 2</title>
          <description>13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing (&quot;Thinking back to your experience during the laboratory pain testing&quot;). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome.</description>
          <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="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.40" spread="25.38"/>
                    <measurement group_id="O2" value="15.25" spread="16.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected an average of 2 weeks.</time_frame>
      <desc>The cognitive-behavioral intervention posed minimal risk to participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pain Catastrophizing Reduction Group</title>
          <description>This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.&#xD;
Cognitive-Behavioral Intervention: This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.</description>
        </group>
        <group group_id="E2">
          <title>Pain Education Group</title>
          <description>This group will receive general information about the neurobiology of pain and knee OA.&#xD;
Pain Education: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.</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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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. Ellen Terry</name_or_title>
      <organization>University of Florida</organization>
      <phone>352-273-6441</phone>
      <email>elterry@ufl.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/NCT03836586
org study id: IRB201802819 -N
secondary id: P30AG059297
secondary id: K22NS102334
nct id: NCT03836586
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study proposes to experimentally manipulate pain catastrophizing in order to investigate
      the neural mechanisms by which pain catastrophizing influences the experience of pain among
      non-Hispanic Blacks (NHBs) and non- Hispanic Whites (NHWs) with knee osteoarthritis (OA).
      Therefore, participants will be randomized to either a single session cognitive-behavioral
      intervention to reduce pain catastrophizing or a pain education control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group
primary purpose: Supportive Care
masking: Single (Participant)
measure: Pain Catastrophizing Scale (PCS) at Day 2
time frame: Day 2
description: 13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing ("Thinking back to your experience during the laboratory pain testing"). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome.
arm group label: Pain Catastrophizing Reduction Group
arm group type: Experimental
description: This group will be assigned to a 30-minute, single-session cognitive-behavioral intervention designed to reduce pain catastrophizing.
arm group label: Pain Education Group
arm group type: Active Comparator
description: This group will receive general information about the neurobiology of pain and knee OA.
intervention type: Behavioral
intervention name: Cognitive-Behavioral Intervention
description: This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.
arm group label: Pain Catastrophizing Reduction Group
intervention type: Behavioral
intervention name: Pain Education
description: General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.
arm group label: Pain Education Group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ellen Terry, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 