Protocol for double-blind RCT of acupuncture for vulvodynia
Schlaeger JM, Suarez ML, Glayzer JE, Kobak WH, Meinel M, Steffen AD, Burke LA, Pauls HA, Yao Y, Takayama M, Yajima H, Kaptchuk TJ, Takakura N, Foster D, Wilkie DJ · Contemporary Clinical Trials Communications · 2022 December
DOI 10.1016/j.conctc.2022.101029
Objective
To determine the efficacy of acupuncture for vulvodynia, a condition characterized by vulvar pain lasting at least 3 months, often accompanied by dyspareunia.
Conclusions
In a randomized controlled, double-blind (practitioner-patient) efficacy trial, 80 participants will be randomly assigned to either a penetrating needle group or a skin-touch placebo needle group. Both types of needles are designed to blind both the acupuncturist and participant. The study will use a standardized acupuncture protocol, and participants will self-administer a standardized stimulus (tampon insertion and removal). Primary measures include vulvar pain intensity, and secondary measures include dyspareunia and sexual function. Measures will be taken pretreatment, after the 10th acupuncture session, and weekly until return to pretest levels. The study aims to address the lack of sham-controlled studies on acupuncture for vulvodynia and hypothesizes significant improvements in vulvar pain, dyspareunia, and sexual function in the penetrating needle group compared to the skin-touch placebo group.
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