Effect of Acupuncture on Patient Vulvodynia Outcomes

The investigators' goal is to demonstrate the effects of acupuncture for the treatment of
vulvodynia. Up to 14 million American women have vulvodynia, a debilitating pain syndrome
characterized by pain (burning, irritation, stinging or rawness) in the vulva and dyspareunia
that renders sexual intercourse virtually impossible and leaves these women desperate for
relief. Not only are women in pain, but they often lose their partners or have relationship
difficulties due to their inability to have sexual intercourse. No therapies have been proven
efficacious and rapid pain relief is unpredictable and rarely possible. After exhausting
Western Medicine options, these women often turn to acupuncture. But in contrast to other
pain conditions, there have been no acupuncture sham control studies of vulvodynia.

Only four studies, including one of the investigators', provide some evidence of the effect
of acupuncture on vulvodynia. In three, single-group acupuncture studies, women had less
pain, better quality of life, improved sexual health, and improved mental health. The
investigators' randomized wait-list controlled pilot study of 36 women with vulvodynia showed
great promise. The investigators found a statistically significant and clinically meaningful
reduction in vulvar pain and dyspareunia, and an increase in overall sexual function after a
5-week, 13-needle, 10 session acupuncture protocol. This newly developed, standardized
acupuncture treatment protocol is the first breakthrough in the treatment of this puzzling
disorder. It includes acupuncture points that relieve pain in the genitals. The results of
the investigators' initial pilot study provided the first evidence from a two-group design
that the acupuncture protocol could reduce pain intensity, pain during intercourse, and
increase overall sexual function. These findings, however, warrant stronger evidence to
support the inference that the effect is indeed due to the acupuncture since ours or no other
study included a sham control or provided follow-up data beyond immediate posttest, which
means that the duration of the acupuncture effect is unknown. The investigators' recent
feasibility study paves the way to overcome this gap by use of double-blind acupuncture
needles. Findings from these two studies support the investigators' proposal for the world's
first double-blind randomized controlled trial (RCT) of acupuncture for vulvodynia while
exploring its duration of effect.

The investigators propose a phase 2 double-blind, pretest/posttest RCT to compare effects of
penetrating needles or the skin touch placebo needles on vulvar pain in our 13-needle,
10-session acupuncture treatment protocol. A sample of 130 women, with a diagnosis of
vulvodynia, either generalized or provoked vestibulodynia, 18 to 45 years of age will be
recruited from clinical and community settings and 80 subjects are expected to complete the
study. Stratified by type of vulvodynia, participants will be randomized 1:1 either to the
penetrating needle group or the skin touch placebo needle group. These double-blind needles
will provide a strong sham procedure to mask both the acupuncturist and subject to the type
of needle used for the 10-treatment protocol.

Specific aims are to:

Aim 1. Compare the penetrating needle group and the skin touch placebo needle group for
effects on the: (a) primary outcome: vulvar pain (PAINReportIt® average pain intensity,
0-10), and (b) secondary outcomes: dyspareunia (FSFI dyspareunia) and sexual function (FSFI
total). The investigators hypothesize that controlling for baseline values, at posttest there
will be statistically significant less vulvar pain (primary) and dyspareunia and better
sexual function in the penetrating needle group compared to the skin touch placebo group.

Aim 2. In participants with a clinically meaningful reduction in pain intensity (at least 1.5
points) at posttest compared to pretest, describe the duration of the acupuncture treatment
and placebo effects weekly until pain returns to pretest or up to 12 weeks after posttest.
The investigators will describe the variability over time in vulvar pain intensity (0-10)
after a tampon insertion-removal stimulus and thereby explore the duration of the effect by
intervention group, vulvodynia subgroups, and demographic subgroups (e.g., age, race,
occupation). These findings will provide insights to guide future research on initial and
maintenance acupuncture for vulvodynia.

Inclusion Criteria:

1. a previous diagnosis of generalized vulvodynia or provoked vestibulodynia

2. 18 to 45 years old

3. a pain now score 4 or higher with tampon insertion and removal performed at the
initial screening exam

4. speak and read English

Exclusionary Criteria:

1. infectious conditions of the vulva/vagina

2. inflammatory conditions of the vulva/vagina

3. neoplastic disorders of the vulva/vagina

4. neurologic disorders of the vulva/vagina

5. trauma to the genitals

6. iatrogenic conditions of the genitals

7. hormonal deficiencies

8. co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic
inflammatory disease and documented history of endometriosis

9. menopause

Patients may have a history of but not have active in the last 6 months migraine headaches,
temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial
cystitis, painful bladder syndrome, or fibromyalgia.