provoked, localized vulvodynia treatment with acupuncture and lidocaine pilot study

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

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.

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.

Eligibility 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.

Keywords: vulvodynia provoked, localized vulvodynia vulvar vestibulitis provoked vestibulodynia vulvovaginal pain vulvar pain vaginal pain chronic pain lidocaine numbing agent anesthetic cream acupuncture electroacupuncture electrical stimulated acupuncture manual acupuncture classical acupuncture non-classical acupuncture traditional chinese medicine tcm chinese medicine acupuncture and oriental medicine aom treatment feasibility pilot study patient reported outcomes measure information system tampon test cotton swab test pain diary research electronic data capture redcap