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The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Not Applicable
Completed
Conditions
Vestibulodynia
Interventions
Procedure: Acupuncture
Registration Number
NCT02362763
Lead Sponsor
Hadassah Medical Organization
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
42
Inclusion Criteria
  • Confirmed diagnosis of vestibulodynia
Exclusion Criteria
  • Pregnancy
  • Patient who received other treatment for vestibulodynia in the month preceding.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlsAcupunctureControls received five acupuncture sessions designed for sedation
Study groupAcupunctureSubjects received five acupuncture sessions designed to treat pain in the vulvar area
Primary Outcome Measures
NameTimeMethod
Female Sexual Function Index (FSFI) questionnaire1 month after completion of the assigned treatment
Secondary Outcome Measures
NameTimeMethod
Clinical examination1 month after completion of the assigned treatment

Visual presence or absence of vestibular erythema

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