The Use of Acupuncture for the Treatment of Vulvar Vestibulitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Primary Endpoint
- Female Sexual Function Index (FSFI) questionnaire
Study Overview
Brief Summary
Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of vestibulodynia
Exclusion Criteria
- •Pregnancy
- •Patient who received other treatment for vestibulodynia in the month preceding.
Arms & Interventions
Study group
Subjects received five acupuncture sessions designed to treat pain in the vulvar area
Intervention: Acupuncture (Procedure)
Controls
Controls received five acupuncture sessions designed for sedation
Intervention: Acupuncture (Procedure)
Outcomes
Primary Outcomes
Female Sexual Function Index (FSFI) questionnaire
Time Frame: 1 month after completion of the assigned treatment
Secondary Outcomes
- Clinical examination(1 month after completion of the assigned treatment)
Investigators
hamaniHMO
Dr. Yaron Hamani
Hadassah Medical Organization