Vulvodynia Pain Thresholds

Objective Assessment of Pain Thresholds in Women With Vulvodynia

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.

Study Overview

• Status: Terminated
• Conditions: Vulvodynia
• Intervention / Treatment: Diagnostic test: Thermographic Imaging and Mechanical Pain Assessment

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • UBMD Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vulvodynia; Women with localized, provoked vulvodynia	Diagnostic test: Thermographic Imaging and Mechanical Pain Assessment; Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera
Health Controls; Women without vulvar pain or other vulvar disorders.	Diagnostic test: Thermographic Imaging and Mechanical Pain Assessment; Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermographic Imaging of the Vulva.	Images of the vulva taken (prior to any provocation) with specialized temperature-sensitive camera. These images will then be overlaid on the annotated pain map.	Duration of study visit, approximately 1 hour
Thermographic Imaging of the Vulva	Images of the vulva taken with specialized heat-sensitive camera.	Duration of study visit, about 1 hour

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Vanessa M Barnabei, MD, PhD, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): January 6, 2024
• Study Completion (Actual): January 6, 2024

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 5, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Vulvar Diseases; Vulvodynia
• Other Study ID Numbers: 00004558; UL1TR001412 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No