The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Study Overview
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Brief Summary
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Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.

Detailed Description
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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.

Official Title
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The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Conditions
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Vestibulodynia

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of vestibulodynia Exclusion Criteria: Pregnancy Patient who received other treatment for vestibulodynia in the month preceding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Subjects received five acupuncture sessions designed to treat pain in the vulvar area | Procedure: Acupuncture<br>* 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.<br>|
| Active Comparator: Controls<br>Controls received five acupuncture sessions designed for sedation | Procedure: Acupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Sexual Function Index (FSFI) questionnaire |  | 1 month after completion of the assigned treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical examination | Visual presence or absence of vestibular erythema | 1 month after completion of the assigned treatment |