Vulvodynia Pain Thresholds

NCT ID: NCT04461210

Last Updated: 2025-07-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-28

Study Completion Date

2024-01-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vulvodynia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vulvodynia

Women with localized, provoked vulvodynia

Thermographic Imaging and Mechanical Pain Assessment

Intervention Type DIAGNOSTIC_TEST

Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera

Health Controls

Women without vulvar pain or other vulvar disorders.

Thermographic Imaging and Mechanical Pain Assessment

Intervention Type DIAGNOSTIC_TEST

Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera

Interventions

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Thermographic Imaging and Mechanical Pain Assessment

Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Barnabei

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanessa M Barnabei, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

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UBMD Obstetrics and Gynecology

Buffalo, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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UL1TR001412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00004558

Identifier Type: -

Identifier Source: org_study_id

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