Vulvodynia Pain Thresholds

Vulvodynia Clinical Trial

Official title:

Objective Assessment of Pain Thresholds in Women With Vulvodynia

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04461210
• Other study ID #: 00004558
• Secondary ID: UL1TR001412
• Status: Suspended
• Start date: February 28, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 18
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Vulvodynia

Intervention

Diagnostic Test:
• Thermographic Imaging and Mechanical Pain Assessment
Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera

Locations

Country	Name	City	State
United States	UBMD Obstetrics and Gynecology	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annotated Pain Mapping	Develop annotated pain maps showing region and size of area sensitive to mechanical stimulus	2 years
Secondary	Change in pain map after clinical intervention	Determine changes in the location and size of sensitive regions following various conventional clinical interventions for vulvodynia.	3 years
Secondary	Database Development	Develop a large, information-rich database of annotated pain maps from patients, and use Artificial Intelligence to identify patterns and trends.	3 years