MedPath

Vulvodynia Pain Thresholds

Terminated
Conditions
Vulvodynia
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.

Recruitment & Eligibility

Status
TERMINATED
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
Primary Outcome Measures
NameTimeMethod
Annotated Pain MappingDuration of study visit, approximately 1 hour

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.

Quantitative Pain Description of the Vulva With Touch.Immediate

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.

Secondary Outcome Measures
NameTimeMethod
Thermographic Imaging of the Vulva.Duration of study visit, approximately 1 hour

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.

Thermographic Imaging of the VulvaDuration of study visit, about 1 hour

Images of the vulva taken with specialized heat-sensitive camera.

Trial Locations

Locations (1)

UBMD Obstetrics and Gynecology

🇺🇸

Buffalo, New York, United States

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

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