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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001412 | U.S. NIH Grant/Contract | View source |
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Investigator retired and no other investigator was able to resume the study.
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vulvodynia | Women with localized, provoked vulvodynia |
| |
| Health Controls | Women without vulvar pain or other vulvar disorders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermographic Imaging and Mechanical Pain Assessment | Diagnostic Test | Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Immediate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Duration of study visit, approximately 1 hour |
| Thermographic Imaging of the Vulva |
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Inclusion Criteria:
Exclusion Criteria:
Vulvodynia is a sex-specific disorder. Only women will be enrolled.
Women with localized, provoked vulvodynia and healthy controls without vulvar pain or other vulvar disorders.
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa M Barnabei, MD, PhD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UBMD Obstetrics and Gynecology | Buffalo | New York | 14203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Healthy Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | mean age of each group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Outcome measure is the average of the pain scores (scale 0-10 with 10 being worst) at 7 points of the inner vulva. | Posted | Mean | Full Range | score on a scale | Duration of study visit, approximately 1 hour |
|
Event reporting occurred for the duration of the participant's time in the study, generally about 1 hour.
This was an observational study with no intervention and essentially no risk for serious adverse events. Temporary discomfort with touch of the cotton swab during examination, especially in participants with known history of vulvar pain, was expected. No participant noted persistent or worsening pain following the examination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 No adverse events. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of the Clinical and Translational Science Institute | University at Buffalo | 7168884850 | vmbarnab@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2024 | May 31, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2024 | May 31, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Images of the vulva taken with specialized heat-sensitive camera. |
| Duration of study visit, about 1 hour |
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 |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | No exclusions based on ethnicity. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
|
| 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. | number of participants assessed | Posted | Mean | Standard Deviation | score on a scale | Immediate |
|
|
|
| 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. | Maximum and minimum temperature assessment from images of the outer vulva at 12 touch points; Mean +/- SD. | Posted | Mean | Standard Deviation | temperature in Fahrenheit | Duration of study visit, approximately 1 hour |
|
|
|
| Secondary | Thermographic Imaging of the Vulva | Images of the vulva taken with specialized heat-sensitive camera. | Maximum and minimum temperature assessment from images of the inner vulva; Mean +/- SD. | Posted | Mean | Standard Deviation | temperature in Fahrenheit | Duration of study visit, about 1 hour |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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 No adverse events. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |