Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Provoked, Localized VulvodyniaProvoked VestibulodyniaVulvar VestibulitisVulvodynia
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.

Trial Locations (1)

97239

Women's Health Research Unit; Oregon Health & Science University, Portland

All Listed Sponsors
collaborator

National Vulvodynia Association

OTHER

collaborator

Council of Colleges of Acupuncture and Oriental Medicine

UNKNOWN

collaborator

Oregon Health and Science University

OTHER

lead

Oregon College of Oriental Medicine

OTHER

NCT01996384 - Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study | Biotech Hunter | Biotech Hunter