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Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Subjects received five acupuncture sessions designed to treat pain in the vulvar area |
|
| Controls | Active Comparator | Controls received five acupuncture sessions designed for sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Female Sexual Function Index (FSFI) questionnaire | 1 month after completion of the assigned treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical examination | Visual presence or absence of vestibular erythema | 1 month after completion of the assigned treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaron Hamani, MD | Hadassah Medical Organization | Principal Investigator |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |