An observational study in Vulvodynia, sponsored by State University of New York at Buffalo. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by State University of New York at Buffalo · Observational
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.
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.
106 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's enrollment of 18 is below the median of 167 across 24 observational studies indexed under Vulvodynia.
Browse Vulvodynia studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women with localized, provoked vulvodynia and healthy controls without vulvar pain or other vulvar disorders.
Exclusion Criteria:
Women with localized, provoked vulvodynia
Diagnostic Test: Thermographic Imaging and Mechanical Pain Assessment
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
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.
Time frame: 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.
Time frame: Immediate
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.
Time frame: Duration of study visit, approximately 1 hour
Thermographic Imaging of the Vulva
Images of the vulva taken with specialized heat-sensitive camera.
Time frame: Duration of study visit, about 1 hour
| Milestone | Vulvodynia | Healthy Controls |
|---|---|---|
| Started | 4 | 14 |
| Completed | 4 | 14 |
| Not completed | 0 | 0 |
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.
| score on a scale | Vulvodynia | Healthy Controls |
|---|---|---|
| Annotated Pain Mapping | 4.7 (0 to 10) | 1.9 (0 to 10) |
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.
| score on a scale | Vulvodynia | Health Controls |
|---|---|---|
| Quantitative Pain Description of the Vulva With Touch. | 3.5 ± 4.7 | 1.1 ± 1.9 |
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.
| temperature in Fahrenheit | Vulvodynia | Health Controls |
|---|---|---|
| maximum temperature | 36.4 ± 0.21 | 36.8 ± 0.58 |
| minimum temperature | 32.2 ± 1.8 | 31.9 ± 1.65 |
Images of the vulva taken with specialized heat-sensitive camera.
| temperature in Fahrenheit | Vulvodynia | Health Controls |
|---|---|---|
| maximum temperature | 36.9 ± 0.47 | 37.4 ± 0.47 |
| minimum temperature | 33.2 ± 1.8 | 34.3 ± 2.1 |
Collected over Event reporting occurred for the duration of the participant's time in the study, generally about 1 hour.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vulvodynia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Healthy Controls | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Vulvodynia | Healthy Controls | Total |
|---|---|---|---|
| Mean | 32 ± 10 | 30 ± 9.3 | 30.6 ± 9.5 |
| Sex: Female, Male(Participants) | Vulvodynia | Healthy Controls | Total |
|---|---|---|---|
| Female | 4 | 14 | 18 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Vulvodynia | Healthy Controls | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 14 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Vulvodynia | Healthy Controls | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 4 | 11 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vulvodynia | Healthy Controls | Total |
|---|---|---|---|
| United States | 4 | 14 | 18 |
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Plan to share: No
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo