Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• National Vulvodynia Association

  collaborator OTHER

• Council of Colleges of Acupuncture and Oriental Medicine

  collaborator UNKNOWN

• Oregon Health and Science University

  collaborator OTHER

• Oregon College of Oriental Medicine

  lead OTHER

Principal Investigators

• Lee E Hullender Rubin, DAOM · Oregon College of Oriental Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2016-03-31

Completion

2016-03-31

Countries

• United States

Study Locations