Vulvodynia
Conditions
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.
Interventions
DIAGNOSTIC_TESTThermographic Imaging and Mechanical Pain Assessment
Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera
Sponsors
National Center for Advancing Translational Sciences (NCATS)
State University of New York at Buffalo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annotated Pain Mapping | Duration 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Vulva | Duration of study visit, about 1 hour | Images of the vulva taken with specialized heat-sensitive camera. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vulvodynia Women with localized, provoked vulvodynia
Thermographic Imaging and Mechanical Pain Assessment: Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera | 4 |
| Healthy Controls Women without vulvar pain or other vulvar disorders.
Thermographic Imaging and Mechanical Pain Assessment: Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera | 14 |
| Total | 18 |
Baseline characteristics
| Characteristic | Vulvodynia | Total | Healthy Controls |
|---|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 10 | 30.6 years STANDARD_DEVIATION 9.5 | 30 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 18 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 15 Participants | 11 Participants |
| Region of Enrollment United States | 4 participants | 18 participants | 14 participants |
| Sex: Female, Male Female | 4 Participants | 18 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 14 |
| other Total, other adverse events | 0 / 4 | 0 / 14 |
| serious Total, serious adverse events | 0 / 4 | 0 / 14 |
Outcome results
Primary
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
Population: Outcome measure is the average of the pain scores (scale 0-10 with 10 being worst) at 7 points of the inner vulva.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vulvodynia | Annotated Pain Mapping | 4.7 score on a scale |
| Healthy Controls | Annotated Pain Mapping | 1.9 score on a scale |
Primary
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
Population: number of participants assessed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vulvodynia | Quantitative Pain Description of the Vulva With Touch. | 3.5 score on a scale | Standard Deviation 4.7 |
| Healthy Controls | Quantitative Pain Description of the Vulva With Touch. | 1.1 score on a scale | Standard Deviation 1.9 |
Secondary
Thermographic Imaging of the Vulva
Images of the vulva taken with specialized heat-sensitive camera.
Time frame: Duration of study visit, about 1 hour
Population: Maximum and minimum temperature assessment from images of the inner vulva; Mean +/- SD.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vulvodynia | Thermographic Imaging of the Vulva | maximum temperature | 36.9 temperature in Fahrenheit | Standard Deviation 0.47 |
| Vulvodynia | Thermographic Imaging of the Vulva | minimum temperature | 33.2 temperature in Fahrenheit | Standard Deviation 1.8 |
| Healthy Controls | Thermographic Imaging of the Vulva | maximum temperature | 37.4 temperature in Fahrenheit | Standard Deviation 0.47 |
| Healthy Controls | Thermographic Imaging of the Vulva | minimum temperature | 34.3 temperature in Fahrenheit | Standard Deviation 2.1 |
Secondary
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
Population: Maximum and minimum temperature assessment from images of the outer vulva at 12 touch points; Mean +/- SD.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vulvodynia | Thermographic Imaging of the Vulva. | maximum temperature | 36.4 temperature in Fahrenheit | Standard Deviation 0.21 |
| Vulvodynia | Thermographic Imaging of the Vulva. | minimum temperature | 32.2 temperature in Fahrenheit | Standard Deviation 1.8 |
| Healthy Controls | Thermographic Imaging of the Vulva. | maximum temperature | 36.8 temperature in Fahrenheit | Standard Deviation 0.58 |
| Healthy Controls | Thermographic Imaging of the Vulva. | minimum temperature | 31.9 temperature in Fahrenheit | Standard Deviation 1.65 |