Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change in Vulvar Pain Scale
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •women previously diagnosed with generalized vulvodynia
- •women previously diagnosed with localized vestibulodynia,
Exclusion Criteria
- •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
Arms & Interventions
Active Acupuncture
Active Acupuncture 2 times per week for 5 weeks
Intervention: Active Acupuncture (Other)
Placebo
Placebo Acupuncture 2 times per week for 5 weeks
Intervention: Placebo Acupuncture (Other)
Outcomes
Primary Outcomes
Change in Vulvar Pain Scale
Time Frame: baseline and twice weekly for 5 weeks
PainReportIt, the computerized McGill Pain Questionnaire
Change in Dyspareunia Questionnaire
Time Frame: baseline and once per week for 5 weeks
Female Sexual Function Index
Secondary Outcomes
- Vulvar Function Status Questionnaire(at baseline and 5 weeks)
Investigators
Judith Schlaeger
Assistant Professor
University of Illinois at Chicago