Trial Outcomes & Findings for Vulvodynia Pain Thresholds (NCT NCT04461210)
NCT ID: NCT04461210
Last Updated: 2025-07-08
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
18 participants
Primary outcome timeframe
Duration of study visit, approximately 1 hour
Results posted on
2025-07-08
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
14
|
|
Overall Study
COMPLETED
|
4
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vulvodynia Pain Thresholds
Baseline characteristics by cohort
| Measure |
Vulvodynia
n=4 Participants
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
|
Healthy Controls
n=14 Participants
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
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 10 • n=5 Participants
|
30 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
30.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of study visit, approximately 1 hourPopulation: Outcome measure is the average of the pain scores (scale 0-10 with 10 being worst) at 7 points of the inner vulva.
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.
Outcome measures
| Measure |
Vulvodynia
n=4 Participants
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
|
Healthy Controls
n=14 Participants
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
|
|---|---|---|
|
Annotated Pain Mapping
|
4.7 score on a scale
Interval 0.0 to 10.0
|
1.9 score on a scale
Interval 0.0 to 10.0
|
PRIMARY outcome
Timeframe: ImmediatePopulation: number of participants assessed
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.
Outcome measures
| Measure |
Vulvodynia
n=4 Participants
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
|
Healthy Controls
n=14 Participants
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
|
|---|---|---|
|
Quantitative Pain Description of the Vulva With Touch.
|
3.5 score on a scale
Standard Deviation 4.7
|
1.1 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Duration of study visit, approximately 1 hourPopulation: Maximum and minimum temperature assessment from images of the outer vulva at 12 touch points; Mean +/- SD.
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.
Outcome measures
| Measure |
Vulvodynia
n=4 Participants
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
|
Healthy Controls
n=13 Participants
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
|
|---|---|---|
|
Thermographic Imaging of the Vulva.
maximum temperature
|
36.4 temperature in Fahrenheit
Standard Deviation 0.21
|
36.8 temperature in Fahrenheit
Standard Deviation 0.58
|
|
Thermographic Imaging of the Vulva.
minimum temperature
|
32.2 temperature in Fahrenheit
Standard Deviation 1.8
|
31.9 temperature in Fahrenheit
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Duration of study visit, about 1 hourPopulation: Maximum and minimum temperature assessment from images of the inner vulva; Mean +/- SD.
Images of the vulva taken with specialized heat-sensitive camera.
Outcome measures
| Measure |
Vulvodynia
n=4 Participants
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
|
Healthy Controls
n=13 Participants
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
|
|---|---|---|
|
Thermographic Imaging of the Vulva
minimum temperature
|
33.2 temperature in Fahrenheit
Standard Deviation 1.8
|
34.3 temperature in Fahrenheit
Standard Deviation 2.1
|
|
Thermographic Imaging of the Vulva
maximum temperature
|
36.9 temperature in Fahrenheit
Standard Deviation 0.47
|
37.4 temperature in Fahrenheit
Standard Deviation 0.47
|
Adverse Events
Vulvodynia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of the Clinical and Translational Science Institute
University at Buffalo
Phone: 7168884850
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place