Acupuncture for Vulvodynia: A Pre-pilot Study

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.