Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

Vulvodynia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Provoked Vestibulodynia
• Provoked, Localized Vulvodynia
• Vulvar Vestibulitis
• Vulvodynia

• NCT number: NCT01996384
• Study type: Interventional
• Source: Oregon College of Oriental Medicine
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Completion date: March 2016