The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Vestibulodynia Clinical Trial

Official title:

The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362763
• Other study ID #: VESTIB-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: February 9, 2015
• Start date: June 2006
• Est. completion date: June 2007

Study information

• Verified date: February 2015
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of vestibulodynia

Exclusion Criteria:

• Pregnancy

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vestibulodynia
• Vulvar Vestibulitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female Sexual Function Index (FSFI) questionnaire		1 month after completion of the assigned treatment	No
Secondary	Clinical examination	Visual presence or absence of vestibular erythema	1 month after completion of the assigned treatment	No