CompletedPhase 1

Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

United States19 participantsStarted 2013-11

Plain-language summary

The investigators research project is a randomized, controlled, single-blinded, feasibility pilot study. The investigators will study the feasibility of a novel treatment for women with Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine is a numbing agent and common first treatment for this disorder. Acupuncture is a treatment commonly used for other pain disorders. The investigators will compare two types of acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5% lidocaine cream. Researchers want to determine if acupuncture is acceptable and convenient to women with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine cream will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV pain.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Literate, English speaking, premenopausal, women meeting Friedrich's criteria for Provoked, localized vulvodynia * Reported introital dyspareunia longer than three months duration; * Average pain score greater than 4 on Visual Analog Scale (VAS) at enrollment with cotton swab test and Tampon Test; * Able to insert an Original Regular Tampax™ tampon. Exclusion Criteria: * Co-existing conditions leading to dyspareunia including generalized unprovoked vulvodynia, atrophic vaginitis, vulvovaginal dermatoses (e.g. lichen sclerosus), or genital infection (e.g. herpes simplex virus or yeast infection). * Pregnant or postpartum and breastfeeding; * Use of neuromodulator medications (e.g. Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), Tricyclic Antidepressants, or anti-seizure medications) started in the last six months. If taken for longer, must be on a stable dose for at least six months and still report moderate to severe pain. Selective Serotonin Reuptake Inhibitors (SSRIs) are allowed; * Postmenopausal as defined by surgical or natural menopause (no menses for 12 months); * Chronic pelvic pain defined as daily, non-menstrual pain in pelvis or lower abdomen for longer than three months duration; * Must be able to refrain from other treatments for PLV including non-traditional options (e.g. other medications, physical therapy, sex therapy, acupuncture, naturopathic remedies) during the course of the study (6 months). * Use of SNRIs, lidocaine, or acu…

What they're measuring

Tampon Test

Timeframe: Weeks 1 and 12 study period

Trial details

NCT IDNCT01996384

SponsorOregon College of Oriental Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03