跳至主要内容
临床试验/NCT02704234
NCT02704234已完成不适用

Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Change in Dyspareunia Questionnaire

研究概览

简要总结

Vulvodynia is a women's pain condition. Women have pain in their vulva, the area in their genitals between the vagina and labia (lips of the vagina). They also have pain when they have sexual intercourse or insert anything in the vagina. Sometimes they have so much pain, that they cannot have sex.

This research is being done for two reasons. The first reason is to test a set of special needles called double-blinded acupuncture needles to give acupuncture treatments (one is a real needle and the other is a fake needle). The second reason is to develop a protocol (checklist) that will be used in this and future studies, and to identify and resolve any procedural problems. The protocol will be first tested by the principal investigator who is also an acupuncturist. The investigator will perform acupuncture using the protocol, if necessary change the protocol, and then teach a second acupuncturist using the modified protocol how to use the double-blinded acupuncture needles.

The real needle called the penetrating needle penetrates the skin. The fake needle called the non-penetrating placebo touch needle does not penetrate the skin but it touches the skin so it feels like a needle is being inserted. It has a blunt tip.

Participants can't see which needle they are getting acupuncture with because the needles are housed in a double-blinded needle device which has two tubes (an inner and an outer) that neither the acupuncturists nor the participants can see through.

If a fake acupuncture needle can be used in acupuncture research like a sugar pill is used for drug studies to see how well the real medicine works, the investigators can see how effective acupuncture is. The investigators will be testing these needles to treat participants with vulvodynia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women previously diagnosed with generalized vulvodynia
  • women previously diagnosed with localized vestibulodynia,

排除标准

  • pregnancy
  • menopause
  • interstitial cystitis
  • irritable bowel syndrome
  • untreated vaginitis
  • cervicitis
  • pelvic inflammatory disease
  • any other pelvic pathology causing pain
  • concomitant physical therapy
  • concomitant biofeedback
  • concomitant massage
  • additional acupuncture

结局指标

主要结局

Change in Dyspareunia Questionnaire

时间窗: baseline and once per week for 5 weeks

Female Sexual Function Index

Change in Vulvar Pain Scale

时间窗: baseline and twice weekly for 5 weeks

PainReportIt, the computerized McGill Pain Questionnaire

次要结局

  • Vulvar Function Status Questionnaire(at baseline and 5 weeks)

研究者

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

Judith Schlaeger

Assistant Professor

University of Illinois at Chicago

研究点 (2)

Loading locations...

相似试验