<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/NCT04461210</url>
  </required_header>
  <id_info>
    <org_study_id>00004558</org_study_id>
    <secondary_id>UL1TR001412</secondary_id>
    <nct_id>NCT04461210</nct_id>
  </id_info>
  <brief_title>Vulvodynia Pain Thresholds</brief_title>
  <official_title>Objective Assessment of Pain Thresholds in Women With Vulvodynia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>State University of New York at Buffalo</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>
      Annotated pain maps will be created showing region and size of areas sensitive to mechanical&#xD;
      stimulus in both women affected by vulvar pain and unaffected control patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will develop annotated pain maps showing region and size of areas sensitive&#xD;
      to mechanical stimulus. The pain maps will be created by combining IR images, photographs,&#xD;
      and clinical input, and will be correlated with patient co-morbidities. The IR images will&#xD;
      assess for areas of inflammation and increased skin temperature. Pain maps will be created&#xD;
      with patient response to mechanical stimulation with a cotton swab and will be overlaid on&#xD;
      the thermographic images. Through this combination of measurements, the investigators plan to&#xD;
      expand the diagnostic tools used in patient care as well as on the classification of this&#xD;
      heterogeneous disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Interim analysis&#xD;
  </why_stopped>
  <start_date type="Actual">February 28, 2022</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Annotated Pain Mapping</measure>
    <time_frame>2 years</time_frame>
    <description>Develop annotated pain maps showing region and size of area sensitive to mechanical stimulus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain map after clinical intervention</measure>
    <time_frame>3 years</time_frame>
    <description>Determine changes in the location and size of sensitive regions following various conventional clinical interventions for vulvodynia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Database Development</measure>
    <time_frame>3 years</time_frame>
    <description>Develop a large, information-rich database of annotated pain maps from patients, and use Artificial Intelligence to identify patterns and trends.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Vulvodynia</condition>
  <arm_group>
    <arm_group_label>Vulvodynia</arm_group_label>
    <description>Women with localized, provoked vulvodynia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Controls</arm_group_label>
    <description>Women without vulvar pain or other vulvar disorders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Thermographic Imaging and Mechanical Pain Assessment</intervention_name>
    <description>Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera</description>
    <arm_group_label>Health Controls</arm_group_label>
    <arm_group_label>Vulvodynia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with localized, provoked vulvodynia and healthy controls without vulvar pain or other&#xD;
        vulvar disorders.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women meeting criteria for vulvodynia women seeking care for routine gynecologic exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women less than 18 years of age current pregnancy women with vulvar or vaginal&#xD;
             disorder other than pain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Vulvodynia is a sex-specific disorder. Only women will be enrolled.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UBMD Obstetrics and Gynecology</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Vanessa Barnabei</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vulvodynia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04461210
org study id: 00004558
secondary id: UL1TR001412
nct id: NCT04461210
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Annotated pain maps will be created showing region and size of areas sensitive to mechanical
      stimulus in both women affected by vulvar pain and unaffected control patients.
The investigators will develop annotated pain maps showing region and size of areas sensitive
      to mechanical stimulus. The pain maps will be created by combining IR images, photographs,
      and clinical input, and will be correlated with patient co-morbidities. The IR images will
      assess for areas of inflammation and increased skin temperature. Pain maps will be created
      with patient response to mechanical stimulation with a cotton swab and will be overlaid on
      the thermographic images. Through this combination of measurements, the investigators plan to
      expand the diagnostic tools used in patient care as well as on the classification of this
      heterogeneous disorder.
observational model: Cohort
time perspective: Prospective
measure: Annotated Pain Mapping
time frame: 2 years
description: Develop annotated pain maps showing region and size of area sensitive to mechanical stimulus
measure: Change in pain map after clinical intervention
time frame: 3 years
description: Determine changes in the location and size of sensitive regions following various conventional clinical interventions for vulvodynia.
measure: Database Development
time frame: 3 years
description: Develop a large, information-rich database of annotated pain maps from patients, and use Artificial Intelligence to identify patterns and trends.
arm group label: Vulvodynia
description: Women with localized, provoked vulvodynia
arm group label: Health Controls
description: Women without vulvar pain or other vulvar disorders.
intervention type: Diagnostic Test
intervention name: Thermographic Imaging and Mechanical Pain Assessment
description: Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera
arm group label: Health Controls
arm group label: Vulvodynia
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Vulvodynia is a sex-specific disorder. Only women will be enrolled.
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Vanessa Barnabei
investigator title: Professor
mesh term: Vulvodynia
sharing ipd: No