Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-Pilot Study

Principal Investigators

Dates: 10/6/2015 - 4/30/2017

Co-Investigators:  Judith Schlaeger, Alana Steffen

Abstract: Our long-term goal is to demonstrate the effectiveness of acupuncture for the treatment of vulvodynia, a debilitating pain syndrome characterized by pain in the vulva and dyspareunia.  No therapies have been proven efficacious. These desperate women often turn to acupuncture. However, there have been no sham control studies of vulvodynia, a high priority population for several NIH institutes. Our recent randomized wait-list controlled pilot study of 36 women with vulvodynia, found a statistically significant  reduction in vulvar pain (p< .01) and dyspareunia (p< .003) and an increase in overall sexual function (p < .04) after a 13-needle, 10-session acupuncture protocol. Our results provided sufficient evidence that warranted further investigation of our protocol’s efficacy since the effect size observed in our wait-list control trial may not be replicated in a sham controlled trial. We just submitted an R21 application for a randomized controlled, double-blinded study to determine trends toward efficacy and feasibility of our acupuncture treatment protocol. Since we have not used these double-blinded acupuncture needles, we need to develop a protocol with IRSP funds to determine the procedures and steps of implementing the double-blinded acupuncture  needle protocol for this eventual R21 study. The PI will be trained by the inventor, become proficient, and will develop a Double-blinded Needle Implementation Protocol Checklist (Checklist). This will enable us to determine the feasibility of the PI being able to implement all procedures and steps so problems may manifest and be rectified, the need for modification of the Double-blinded Needle Implementation Protocol and that this protocol is ready to be successfully implemented in our forthcoming R21. We will use a sample of six women with vulvodynia, 18 years old to menopause. They will be randomized 1:1 either to the penetrating needle group or the non-penetrating touch placebo needle group. Treatments will be twice weekly for 5 weeks for 45 minutes. At the end of the study, the acupuncturist and subjects will complete a measure to assess whether or not they remained blind to needle type. Subjects will also complete a measure of study acceptability, the Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture. The specific aims are to: 1) describe the procedures and potential challenges to implementing a double-blinded needle acupuncture protocol (Checklist); 2) determine the feasibility of enrolling and retaining subjects in the Double-blinded Needle Implementation Protocol; and, 3) determine the range of scores in the subjects’ Acceptability Scale scores. We expect to produce the checklist that will be used in this and future studies, identify and rectify procedural problems, that all six subjects will report the 10-sessions study protocol as acceptable (scores ranging > 10 [80%], indicating high acceptability), and that 80% of the six subjects will complete the 10-session study protocol. Eventually, we will advance this work to a double-blinded randomized controlled trial design and obtain sufficient evidence to power a future R01 application in which we will establish the efficacy of acupuncture to treat the pain-related symptoms of vulvodynia.

Internal Research Support Program (IRSP)