Protocol for double-blind RCT of acupuncture for vulvodynia

Judith M Schlaeger, Marie L Suarez, Jennifer E Glayzer, William H Kobak, Monya Meinel, Alana D Steffen, Larisa A Burke, Heather A Pauls, Yingwei Yao, Miho Takayama, Hiroyoshi Yajima, Ted J Kaptchuk, Nobuari Takakura, David Foster, Diana J Wilkie, Judith M Schlaeger, Marie L Suarez, Jennifer E Glayzer, William H Kobak, Monya Meinel, Alana D Steffen, Larisa A Burke, Heather A Pauls, Yingwei Yao, Miho Takayama, Hiroyoshi Yajima, Ted J Kaptchuk, Nobuari Takakura, David Foster, Diana J Wilkie

Abstract

Background: Vulvodynia, vulvar pain of unknown origin lasting at least 3 months, affects 7% of American women. Dyspareunia, its frequent companion, renders sexual intercourse virtually impossible. Although few therapies are efficacious and rapid pain relief is rarely possible, there have been no sham/placebo-controlled studies of acupuncture for vulvodynia. Aims are to: 1) determine efficacy of acupuncture for vulvodynia, 2) explore duration of the acupuncture effect.

Methods: In a pretest/posttest randomized controlled, double-blind (practitioner-patient) efficacy trial of a standardized acupuncture protocol, we will randomize 80 participants 1:1 to either penetrating needle or skin-touch placebo needle groups. Both types of needles are designed to blind both the acupuncturist and participant. Participants with vulvodynia will insert and remove a tampon as a standardized stimulus and complete primary measures of vulvar pain (pain intensity) and secondary measures of dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score) and sexual function (FSFI total score) pretreatment, after the 10th acupuncture session, and pain measures weekly until return to pretest levels. Upon study completion control group participants will be offered 10 free real acupuncture sessions.

Discussion: This is the first multi-needle multi-session RCT using double-blind acupuncture needles as a reliable sham. We hypothesize that controlling for baseline, at posttest there will be statistically significant less vulvar pain and dyspareunia and more sexual function over five weeks in the penetrating needle group compared to the skin touch placebo group.

Conclusion: This study is responsive to the need for efficacious pain management for women with vulvodynia.ClinicalTrials.gov Identifier: NCT03364127.

Keywords: Acupuncture; Double-blind acupuncture needles; Placebo; Provoked vestibulodynia; Tampon test; Vulvodynia.

Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Nobuari Takakura and the Educational Foundation of Hanada Gakuen possess a US patent 6575992B1, a Canadian patent CA 2339223, a Korean patent 0478177, a Taiwan patent 150135, a Chinese patent ZL00800894.9 (Title: Safe needle, placebo needle and needle set for double blind), and two Japanese patents 4061397 (Title: Placebo needle, and needle set for double-blinding) and 4315353 (Title: Safe needle) on the needles described in this abstract. Dr. Takakura is a salaried employee of the Educational Foundation of Hanada Gakuen. Dr. Diana J. Wilkie is the founder and chairman of eNURSING LLC, a company without current ownership of the PAINReportIt software. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

© 2022 The Authors.

Figures

Fig. 1
Fig. 1
A set of Double-Blind Needles.
Fig. 2
Fig. 2
Standardized treatment protocol for vulvodynia.
Fig. 3
Fig. 3
Flow chart of the study protocol.

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Source: PubMed

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