Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon College of Oriental Medicine
• Collaborators: Council of Colleges of Acupuncture and Oriental Medicine; National Vulvodynia Association; Oregon Health and Science University
• Treatments: Lidocaine

Criteria

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.