Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes
Dates: 9/1/17 - 5/31/22
Co-Investigators: JJudith Schlaeger, William Kobak, Alana Steffen
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 research on initial and maintenance acupuncture treatment protocols for control of vulvodynia pain.