Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

Completed · Phase 1

Conditions studied: Provoked, Localized Vulvodynia, Provoked Vestibulodynia, Vulvar Vestibulitis, Vulvodynia

In brief

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.

Key facts

Study ID

NCT01996384

Run by

Oregon College of Oriental Medicine

People needed

19

Starts

2013-11-01

Expected to finish

2016-03-01

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Women's Health Research Unit; Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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