The Use of Acupuncture for the Treatmen… | Clinical Trial

Key information

Conditions

Vestibulodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases Vulvodynia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Confirmed diagnosis of vestibulodynia

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

Female Sexual Function Index (FSFI) questionnaire

Time frame: 1 month after completion of the assigned treatment

Secondary outcomes

Clinical examination

Time frame: 1 month after completion of the assigned treatment

Visual presence or absence of vestibular erythema

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Feb 13, 2015
Registry last updated: Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed