Vulvodynia Pain Thresholds

Suspended

• Conditions: Vulvodynia
• Interventions: Diagnostic Test: Thermographic Imaging and Mechanical Pain Assessment

• Registration Number: NCT04461210
• Lead Sponsor: State University of New York at Buffalo

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.

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 Timeline

• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-08
• Study Start: 2022-02-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health Controls	Thermographic Imaging and Mechanical Pain Assessment	Women without vulvar pain or other vulvar disorders.
Vulvodynia	Thermographic Imaging and Mechanical Pain Assessment	Women with localized, provoked vulvodynia

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UBMD Obstetrics and Gynecology; 🇺🇸 Buffalo, New York, United States