# Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes

> **NIH NIH R01** · UNIVERSITY OF ILLINOIS AT CHICAGO · 2021 · $387,284

## Abstract

Abstract
Our long-term 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 vulvar pain and
dyspareunia that renders sexual intercourse virtually impossible. Although no therapies have been proven
efficacious and rapid pain relief is unpredictable and rarely possible, there have been no sham control
studies of acupuncture as a treatment for vulvodynia, a high priority population for several NIH
institutes. In our recently published randomized wait-list controlled pilot study of 36 women with vulvodynia,
we found a statistically and clinically significant reduction in vulvar pain and dyspareunia and an increase in
overall sexual function after a 13-needle, 10-session acupuncture protocol. We have also demonstrated in a
small pilot study that it is feasible to use double-blind needles in the same 13-needle, 10- session acupuncture
protocol for the treatment of vulvodynia. We now propose a pretest/posttest randomized controlled, double-
blind design to determine efficacy of this acupuncture treatment protocol. Subjects will be randomized 1:1 to
either a penetrating needle group or a skin touch placebo needle group. The acupuncturist will be observed for
fidelity in use of both types of needles, which are designed to blind both the acupuncturist and subject to the
type of needle. Eighty subjects with vulvodynia will insert and remove a tampon as a standardized stimulus and
complete measures of vulvar pain (average pain intensity from pain now, least and worst pain in the past 24
hours [PAINReportIt®]); and dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score)
and sexual function (FSFI total score) at pretest (pretreatment baseline) and at posttest after the 10th
acupuncture session. 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 of vulvar pain (PAINReportIt® average pain
intensity), and (b) secondary outcomes of dyspareunia (FSFI dyspareunia) and sexual function (FSFI total).
Hypothesis: Controlling for baseline values, at posttest there will be statistically significant less vulvar pain
and dyspareunia and more sexual function over the five weeks in the penetrating needle group compared to
the skin touch placebo group. Aim 2. In subjects 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. We 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 (age, race, occupation).
These findings will provide important insights to guide future resea...

## Key facts

- **NIH application ID:** 10172941
- **Project number:** 5R01HD091210-05
- **Recipient organization:** UNIVERSITY OF ILLINOIS AT CHICAGO
- **Principal Investigator:** Judith Michelle Schlaeger
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $387,284
- **Award type:** 5
- **Project period:** 2017-09-01 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10172941

## Citation

> US National Institutes of Health, RePORTER application 10172941, Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes (5R01HD091210-05). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10172941. Licensed CC0.

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