xml: <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/NCT05991440</url>
    </required_header>
    <id_info>
      <org_study_id>202306132</org_study_id>
      <secondary_id>R01MD017565</secondary_id>
      <nct_id>NCT05991440</nct_id>
    </id_info>
    <brief_title>Examining Racial and Socioeconomic Differences in Chronic Low Back Pain</brief_title>
    <acronym>ERASED</acronym>
    <official_title>Racial and Socioeconomic Differences in Chronic Low Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Washington University School of Medicine</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>
        The purpose of this research study is to gain a better understanding of how people's racial&#xD;
        background and socioeconomic status (e.g., income, education, and employment) impact their&#xD;
        experiences of chronic low back pain (cLBP).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To elucidate racial group disparities in clinical symptoms among NHBs and NHWs with cLBP.</measure>
      <time_frame>two years</time_frame>
      <description>Clinical pain severity will be observed through quantitative sensory testing and self-reported questionnaires and surveys.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To elucidate racial group disparities in experimental pain sensitivity among NHBs and NHWs with cLBP.</measure>
      <time_frame>two years</time_frame>
      <description>Quantitative sensory testing equipment and biological markers assayed via blood samples.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To elucidate racial group disparities in psychosocial risk factors, among NHBs and NHWs with cLBP.</measure>
      <time_frame>two years</time_frame>
      <description>Psychosocial risk factors that will be observed will be greater increases in depressive symptoms, anxiety, and perceived stress, as well as greater social isolation and loneliness through the use of self-reported questionnaires and surveys.</description>
    </primary_outcome>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Chronic Pain</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood will be collected for analysis&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          For this study we will incorporate a combination of clinic-based and community-based&#xD;
          participant recruitment. Participants will be recruited from the Pain Treatment Clinics at&#xD;
          the Wash U Pain Center and VUMC, as well as the surrounding communities in St. Louis and&#xD;
          Nashville, respectively.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion:&#xD;
  &#xD;
            -  Non-specific cLBP that has persisted for at least 3 months and has resulted in pain on&#xD;
               at least half the days in the past 6 months.&#xD;
  &#xD;
            -  Age 18 - 85; the lower end of this age range was chosen to capture the growing&#xD;
               prevalence of young adults with cLBP, and participants over 85 years are increasingly&#xD;
               likely to meet one or more exclusion criteria.&#xD;
  &#xD;
            -  Participants report ethnic group as non-Hispanic and racial group as either&#xD;
               Black/African American or White/Caucasian.&#xD;
  &#xD;
          Exclusion:&#xD;
  &#xD;
            -  Low back pain that is attributable to other factors such as ankylosing spondylitis,&#xD;
               infection, malignancy, compression fracture of other trauma.&#xD;
  &#xD;
            -  Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus&#xD;
               erythematosus, fibromyalgia).&#xD;
  &#xD;
            -  Any other chronic pain condition that the participant believes to be more prominent or&#xD;
               severe than the low back pain.&#xD;
  &#xD;
            -  A history of clinically significant surgery to the low back within the past year.&#xD;
  &#xD;
            -  Uncontrolled hypertension (i.e. SBP/DBP of &gt; 150/95), cardiovascular or peripheral&#xD;
               arterial disease.&#xD;
  &#xD;
            -  Poorly controlled diabetes (HbA1c &gt; 8%).&#xD;
  &#xD;
            -  Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy).&#xD;
  &#xD;
            -  Serious psychiatric disorder requiring hospitalization within the past 12 months or&#xD;
               characterized by active suicidal ideation.&#xD;
  &#xD;
            -  Diminished cognitive function that would interfere with understanding of study&#xD;
               procedures.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Burel Goodin, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Washington University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Burel R Goodin, PhD</last_name>
      <phone>314-273-6403</phone>
      <email>burel@wustl.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Washington University School of Medicine</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Burel R Goodin, PhD</last_name>
        <phone>314-273-6403</phone>
        <email>burel@wustl.edu</email>
      </contact>
      <investigator>
        <last_name>Burel R Goodin, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
      <investigator_full_name>Burel Goodin</investigator_full_name>
      <investigator_title>Prof of Anesthesiology</investigator_title>
    </responsible_party>
    <keyword>lower back pain</keyword>
    <keyword>Race</keyword>
    <keyword>Socioeconomic</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Back Pain</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991440
  org study id: 202306132
  secondary id: R01MD017565
  nct id: NCT05991440
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research study is to gain a better understanding of how people's racial
        background and socioeconomic status (e.g., income, education, and employment) impact their
        experiences of chronic low back pain (cLBP).
  observational model: Case-Control
  time perspective: Prospective
  measure: To elucidate racial group disparities in clinical symptoms among NHBs and NHWs with cLBP.
  time frame: two years
  description: Clinical pain severity will be observed through quantitative sensory testing and self-reported questionnaires and surveys.
  measure: To elucidate racial group disparities in experimental pain sensitivity among NHBs and NHWs with cLBP.
  time frame: two years
  description: Quantitative sensory testing equipment and biological markers assayed via blood samples.
  measure: To elucidate racial group disparities in psychosocial risk factors, among NHBs and NHWs with cLBP.
  time frame: two years
  description: Psychosocial risk factors that will be observed will be greater increases in depressive symptoms, anxiety, and perceived stress, as well as greater social isolation and loneliness through the use of self-reported questionnaires and surveys.
  Blood will be collected for analysis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Burel Goodin, PhD
  role: Principal Investigator
  affiliation: Washington University School of Medicine
  last name: Burel R Goodin, PhD
  phone: 314-273-6403
  email: burel@wustl.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Washington University School of Medicine
  investigator full name: Burel Goodin
  investigator title: Prof of Anesthesiology
  mesh term: Back Pain
  mesh term: Low Back Pain
  mesh term: Chronic Pain