Vulvodynia Pain Thresholds

NCT04461210 | Terminated Results

• 2 other identifiers: 00004558UL1TR001412
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vulvodynia

Outcome Measures

Primary Outcomes (2)

• Annotated Pain Mapping

  Develop annotated pain maps showing region and size of area sensitive to mechanical stimulus. A cotton swab is used to lightly touch the vulva in 18 different locations and participant's assessment of pain on a scale of 0-10 is recorded.

  Duration of study visit, approximately 1 hour

• Quantitative Pain Description of the Vulva With Touch.

  The vulva is lightly touched with a cotton swab at 18 locations of the vulva. Participants rate pain at each location on a scale of 0-10, with 0 being no pain and 10 being worst. Only the pain scores from the 7 points of the inner vulva are presented here, since that is the primary site of pain in women with provoked vulvodynia.

  Immediate

Secondary Outcomes (2)

• Thermographic Imaging of the Vulva.

  Duration of study visit, approximately 1 hour

• Thermographic Imaging of the Vulva

  Duration of study visit, about 1 hour

Study Arms (2)

Vulvodynia

Women with localized, provoked vulvodynia

Diagnostic Test: Thermographic Imaging and Mechanical Pain Assessment

Health Controls

Women without vulvar pain or other vulvar disorders.

Diagnostic Test: Thermographic Imaging and Mechanical Pain Assessment

Interventions

Thermographic Imaging and Mechanical Pain Assessment DIAGNOSTIC_TEST

Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera

Health Controls; Vulvodynia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Vulvodynia is a sex-specific disorder. Only women will be enrolled.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women with localized, provoked vulvodynia and healthy controls without vulvar pain or other vulvar disorders.

You may qualify if:

• women meeting criteria for vulvodynia women seeking care for routine gynecologic exam

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UBMD Obstetrics and Gynecology

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Director of the Clinical and Translational Science Institute
• Organization: University at Buffalo

vmbarnab@buffalo.edu

7168884850

Study Officials

• Vanessa M Barnabei, MD, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: February 28, 2022
• Primary Completion: January 6, 2024
• Study Completion: January 6, 2024
• Last Updated: July 8, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)