VulvodyniaNCT04461210

Vulvodynia Pain Thresholds

An observational study of Vulvodynia, run by State University of New York at Buffalo at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Vulvodynia
What is being tested?: Thermographic Imaging and Mechanical Pain Assessment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 28 Feb 2022to 6 Jan 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Study population: Women with localized, provoked vulvodynia and healthy controls without vulvar pain or other vulvar disorders.

Who may be able to join

women meeting criteria for vulvodynia women seeking care for routine gynecologic exam

Who cannot join

women less than 18 years of age current pregnancy women with vulvar or vaginal disorder other than pain

Trial locations and contacts

1 site in 1 country.

United States1 site

UBMD Obstetrics and Gynecology
Buffalo, New York, 14203

Other trials in United States

About this study

Official title: Objective Assessment of Pain Thresholds in Women With Vulvodynia

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.

Read the 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.

Conditions: Vulvodynia
Being tested: Thermographic Imaging and Mechanical Pain Assessment
Medical subject headings: Vulvodynia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thermographic Imaging and Mechanical Pain AssessmentDiagnostic test
Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera

Study groups in NCT04461210
Study group	Role	What they receive
Vulvodynia		Women with localized, provoked vulvodynia Receives: Diagnostic Test: Thermographic Imaging and Mechanical Pain Assessment
Health Controls		Women without vulvar pain or other vulvar disorders. Receives: Diagnostic Test: Thermographic Imaging and Mechanical Pain Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Immediate

Secondary outcomes (2)

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.
Measured: Duration of study visit, approximately 1 hour
Thermographic Imaging of the Vulva
Images of the vulva taken with specialized heat-sensitive camera.
Measured: Duration of study visit, about 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 20226 Jan 2024

First posted8 Jul 2020
Study start28 Feb 2022
Primary completion6 Jan 2024
Study completion6 Jan 2024

Why it stopped: Investigator retired and no other investigator was able to resume the study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for VulvodyniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04461210
Sponsor's protocol ID: 00004558
Other IDs: UL1TR001412
Status last verified: Jul 2025
First submitted: 2 Jul 2020
Last updated: 8 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Not yet recruiting
CPP Among Somali Women in Norway: SCED
Chronic Pelvic Pain
Active, not recruiting
Lasertherapy for Vulvodynia
Vulvodynia

All Vulvodynia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Objective Assessment of Pain Thresholds in Women With Vulvodynia
ClinicalTrials.gov ID: NCT04461210
Acronym / sponsor ID: 00004558
Conditions: Vulvodynia
Study type: Observational
Recruitment status: TerminatedReason stopped: Investigator retired and no other investigator was able to resume the study.
Enrolment: 18 participants (actual)
Lead sponsor: State University of New York at BuffaloUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 28 Feb 2022 (actual)
Primary completion: 6 Jan 2024 (actual)
Study completion: 6 Jan 2024 (actual)
First posted: 8 Jul 2020 (actual)
Results: Posted 8 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Vulvodynia	–	Diagnostic Test: Thermographic Imaging and Mechanical Pain AssessmentWomen with localized, provoked vulvodynia
Health Controls	–	Diagnostic Test: Thermographic Imaging and Mechanical Pain AssessmentWomen without vulvar pain or other vulvar disorders.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Women with localized, provoked vulvodynia and healthy controls without vulvar pain or other vulvar disorders.

Key inclusion criteria (1 listed)

women meeting criteria for vulvodynia women seeking care for routine gynecologic exam

Key exclusion criteria (1 listed)

women less than 18 years of age current pregnancy women with vulvar or vaginal disorder other than pain

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thermographic Imaging and Mechanical Pain AssessmentAssessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera	Diagnostic test	Health Controls, Vulvodynia

Primary outcome

Annotated Pain Mapping
Time frame: 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.
Time frame: 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.

2 secondary outcomes

Thermographic Imaging of the Vulva.
Time frame: Duration of study visit, approximately 1 hour
Thermographic Imaging of the Vulva
Time frame: Duration of study visit, about 1 hour

Results and safety

Results posted to the registry on 8 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vulvodynia	4	4
Healthy Controls	14	14

Primary outcome: Annotated Pain Mapping

Time frame: Duration of study visit, approximately 1 hour. Mean (Full Range). Unit: score on a scale

Measure	Vulvodynia n = 4	Healthy Controls n = 14
Value	4.7 (0 to 10)	1.9 (0 to 10)

Population analysed: Outcome measure is the average of the pain scores (scale 0-10 with 10 being worst) at 7 points of the inner vulva.

Primary outcome: Quantitative Pain Description of the Vulva With Touch.

Time frame: Immediate. Mean (Standard Deviation). Unit: score on a scale

Measure	Vulvodynia n = 4	Health Controls n = 14
Value	3.5 (4.7)	1.1 (1.9)

Population analysed: number of participants assessed

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Event reporting occurred for the duration of the participant's time in the study, generally about 1 hour.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vulvodynia	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Healthy Controls	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Vulvodynia

Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Not yet recruiting
CPP Among Somali Women in Norway: SCED
Chronic Pelvic Pain
Active, not recruiting
Lasertherapy for Vulvodynia
Vulvodynia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vanessa M Barnabei, MD, PhD principal investigator

University at Buffalo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Vulvodynia, run by State University of New York at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annotated Pain Mapping (time frame: Duration of study visit, approximately 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04461210.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.