The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Completed

CT.gov ID

NCT02362763

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.

Condition or Disease	Intervention/Treatment	Phase
Vestibulodynia	Procedure: Acupuncture	N/A

Detailed Description

Patients were randomized to five acupuncture sessions designed to treat pain in the vulvar area (study group), or five acupuncture sessions designed for tranquility (controls). Participants and evaluating gynecologists were blinded to randomization. Participants were examined clinically before treatment and one month after completion of assigned treatment; at both visits they completed the Female Sexual Function Index (FSFI) questionnaire.

FSFI scores for pain during intercourse and total score were used to evaluate change. The examining gynecologist evaluated the degree of sensitivity to touch and the degree of local erythema. Response to treatment was evaluated for each group before and after treatment, and for study group compared to the control group.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group Subjects received five acupuncture sessions designed to treat pain in the vulvar area	Procedure: Acupuncture Patients randomized to the study group received five sessions of acupuncture in a series of points in the lower abdomen, lower back, hands, and feet. This combination of acupoints is believed to impact on the genital area, raise the pain threshold, and counteract inflammation. Control group patients received five sessions of acupuncture at acupoints that are believed to have no influence on the genital area, but are believed to have a general sedative effect.
Active Comparator: Controls Controls received five acupuncture sessions designed for sedation	Procedure: Acupuncture Patients randomized to the study group received five sessions of acupuncture in a series of points in the lower abdomen, lower back, hands, and feet. This combination of acupoints is believed to impact on the genital area, raise the pain threshold, and counteract inflammation. Control group patients received five sessions of acupuncture at acupoints that are believed to have no influence on the genital area, but are believed to have a general sedative effect.

Arm

Intervention/Treatment

Experimental: Study group

Subjects received five acupuncture sessions designed to treat pain in the vulvar area

Procedure: Acupuncture

Patients randomized to the study group received five sessions of acupuncture in a series of points in the lower abdomen, lower back, hands, and feet. This combination of acupoints is believed to impact on the genital area, raise the pain threshold, and counteract inflammation. Control group patients received five sessions of acupuncture at acupoints that are believed to have no influence on the genital area, but are believed to have a general sedative effect.

Active Comparator: Controls

Controls received five acupuncture sessions designed for sedation

Procedure: Acupuncture

Outcome Measures

Primary Outcome Measures

Female Sexual Function Index (FSFI) questionnaire [1 month after completion of the assigned treatment]

Secondary Outcome Measures

Clinical examination [1 month after completion of the assigned treatment]
Visual presence or absence of vestibular erythema

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed diagnosis of vestibulodynia

Exclusion Criteria:

Pregnancy
Patient who received other treatment for vestibulodynia in the month preceding.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator: Yaron Hamani, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

hamaniHMO, Dr. Yaron Hamani, Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT02362763

Other Study ID Numbers:

VESTIB-HMO-CTIL

First Posted:

Feb 13, 2015

Last Update Posted:

Feb 13, 2015

Last Verified:

Feb 1, 2015

Additional relevant MeSH terms:

Vulvodynia

Vulvar Vestibulitis

Study Results

No Results Posted as of Feb 13, 2015