Vulvodynia Pain Thresholds

Overview

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.

Full Title of Study: “Objective Assessment of Pain Thresholds in Women With Vulvodynia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 31, 2024

Detailed Description

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.

Interventions

  • Diagnostic Test: Thermographic Imaging and Mechanical Pain Assessment
    • Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera

Arms, Groups and Cohorts

  • Vulvodynia
    • Women with localized, provoked vulvodynia
  • Health Controls
    • Women without vulvar pain or other vulvar disorders.

Clinical Trial Outcome Measures

Primary Measures

  • Annotated Pain Mapping
    • Time Frame: 2 years
    • Develop annotated pain maps showing region and size of area sensitive to mechanical stimulus

Secondary Measures

  • Change in pain map after clinical intervention
    • Time Frame: 3 years
    • Determine changes in the location and size of sensitive regions following various conventional clinical interventions for vulvodynia.
  • Database Development
    • Time Frame: 3 years
    • Develop a large, information-rich database of annotated pain maps from patients, and use Artificial Intelligence to identify patterns and trends.

Participating in This Clinical Trial

Inclusion Criteria

  • women meeting criteria for vulvodynia women seeking care for routine gynecologic exam Exclusion Criteria:

  • women less than 18 years of age current pregnancy women with vulvar or vaginal disorder other than pain

Gender Eligibility: Female

Vulvodynia is a sex-specific disorder. Only women will be enrolled.

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • State University of New York at Buffalo
  • Collaborator
    • National Center for Advancing Translational Sciences (NCATS)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vanessa Barnabei, Professor – State University of New York at Buffalo

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