<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/NCT03018782</url>
  </required_header>
  <id_info>
    <org_study_id>1608017472</org_study_id>
    <nct_id>NCT03018782</nct_id>
  </id_info>
  <brief_title>Pain Screening in Refugee Survivors of Torture</brief_title>
  <official_title>The Implementation of a Novel Pain-screening Tool in the Diagnoses of Pain Symptoms and Syndromes in Refugee Survivors of Torture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are evaluating refugee torture survivors who are receiving services at the&#xD;
      Weill Cornell Center for Human Rights. There are two research questions in this study: if the&#xD;
      current standard of care results in the under or missed diagnosis of pain and pain syndromes,&#xD;
      and if a validated pain screening tool can supplement the current standard protocol used in&#xD;
      the assessments of survivors of torture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research plan consists of three components:&#xD;
&#xD;
        1. The Weill Cornell Center for Human Rights will coordinate with the research team&#xD;
           regarding eligible subjects.&#xD;
&#xD;
        2. Researchers will contact potential subjects utilizing interpreter services.&#xD;
&#xD;
        3. Interested participants will be scheduled for an appointment for an examination by a&#xD;
           pain physician and to complete the Brief Pain Inventory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 21, 2019</completion_date>
  <primary_completion_date type="Actual">June 21, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with chronic pain or pain syndromes as assessed by a non-invasive pain evaluation conducted by a pain physician</measure>
    <time_frame>Day 1</time_frame>
    <description>Evaluate whether or not current standard protocols for the assessment of survivors of torture result in under or missed diagnosis of pain and pain syndromes that are identifiable by a pain specialist physician</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with chronic pain or pain syndromes as assessed by the Brief Pain Inventory (BPI) Short Form</measure>
    <time_frame>Day 1</time_frame>
    <description>Evaluate whether or not a validated pain screening tool can supplement the current standard protocols used in the assessment of survivors of torture.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>Brief Pain Inventory Short Form</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Completes the Brief Pain Inventory Short Form</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brief Pain Inventory Short Form</intervention_name>
    <description>Brief Pain Inventory Short Form</description>
    <arm_group_label>Brief Pain Inventory Short Form</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women from any country over the age of 18&#xD;
&#xD;
          -  refugees receiving services from the Weill Cornell Center for Human Rights&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have not experienced torture&#xD;
&#xD;
          -  Subjects whose representative does not believe that they are a good candidate for the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gunisha Kaur, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eliana Weinstein, BS</last_name>
    <role>Study Director</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>July 17, 2021</last_update_submitted>
  <last_update_submitted_qc>July 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018782
org study id: 1608017472
nct id: NCT03018782
lead sponsor: 
has dmc: No
The investigators are evaluating refugee torture survivors who are receiving services at the
      Weill Cornell Center for Human Rights. There are two research questions in this study: if the
      current standard of care results in the under or missed diagnosis of pain and pain syndromes,
      and if a validated pain screening tool can supplement the current standard protocol used in
      the assessments of survivors of torture.
The research plan consists of three components:

        1. The Weill Cornell Center for Human Rights will coordinate with the research team
           regarding eligible subjects.

        2. Researchers will contact potential subjects utilizing interpreter services.

        3. Interested participants will be scheduled for an appointment for an examination by a
           pain physician and to complete the Brief Pain Inventory.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of participants with chronic pain or pain syndromes as assessed by a non-invasive pain evaluation conducted by a pain physician
time frame: Day 1
description: Evaluate whether or not current standard protocols for the assessment of survivors of torture result in under or missed diagnosis of pain and pain syndromes that are identifiable by a pain specialist physician
measure: Number of participants with chronic pain or pain syndromes as assessed by the Brief Pain Inventory (BPI) Short Form
time frame: Day 1
description: Evaluate whether or not a validated pain screening tool can supplement the current standard protocols used in the assessment of survivors of torture.
arm group label: Brief Pain Inventory Short Form
arm group type: Other
description: Completes the Brief Pain Inventory Short Form
intervention type: Other
intervention name: Brief Pain Inventory Short Form
description: Brief Pain Inventory Short Form
arm group label: Brief Pain Inventory Short Form
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Gunisha Kaur, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Eliana Weinstein, BS
role: Study Director
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No
ipd description: There is no plan to make individual participant data available to other researchers