Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study
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
- 否
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
Judith Schlaeger
Assistant Professor
University of Illinois at Chicago
