Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

Acupuncture Augmentation of Lidocaine for the Treatment of Provoked, Localized vulvodynia-a Feasibility and Acceptability Pilot Study

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.

This is a randomized, controlled, single-blinded, pilot trial to study the feasibility and acceptability of acupuncture and 5% lidocaine. Patients will be recruited from the patient population of the Oregon Health & Science University Vulvar Health Clinic. Thirty (30) patients with PLV will be enrolled as study participants into the study. Fifteen (15) will be allocated in the treatment (classical) acupuncture + 5% lidocaine group and fifteen (15) will be allocated in the control (non-classical) acupuncture + 5% lidocaine group via a computer generated randomization program to balance allocation based on four variables: pain intensity, smoking status, body mass index, and pain duration.

The acupuncturist will interview each patient and perform an exam of the pulse and tongue. A standardized acupuncture treatment will be assigned, and both groups will receive 18 acupuncture treatments that follow a standardized protocol on classical or non-classical acupuncture points, with or without mild electrical stimulation. All study participants will self-apply lidocaine cream to their genital region four times daily during the study.

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 acupuncture within the last three months.