Vulvodynia Clinical Trial
Official title:
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.
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