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临床试验/NCT04461210
NCT04461210终止不适用

Objective Assessment of Pain Thresholds in Women With Vulvodynia

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
18
试验地点
1
主要终点
Annotated Pain Mapping

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Annotated Pain Mapping

时间窗: 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.

时间窗: 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.

次要结局

  • Thermographic Imaging of the Vulva.(Duration of study visit, approximately 1 hour)
  • Thermographic Imaging of the Vulva(Duration of study visit, about 1 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa Barnabei

Professor

State University of New York at Buffalo

研究点 (1)

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