NCT01996384

Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Oregon College of Oriental Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Classical Acupuncture	Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are 0.18x30-40mm, manufactured by Dong Bae Corporation (DBC), Korea. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
PROCEDURE	Non-classical acupuncture	Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in non-classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are DBC Brand, Korea, 0.18x30-40mm. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
DRUG	Lidocaine	Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-11-27
• Last updated: 2017-10-06

Locations

1 site across 1 country: United States