The Use of Acupuncture for the Treatment of Vulvar Vestibulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Female Sexual Function Index (FSFI) questionnaire
研究概览
简要总结
Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of vestibulodynia
排除标准
- •Pregnancy
- •Patient who received other treatment for vestibulodynia in the month preceding.
结局指标
主要结局
Female Sexual Function Index (FSFI) questionnaire
时间窗: 1 month after completion of the assigned treatment
次要结局
- Clinical examination(1 month after completion of the assigned treatment)
研究者
hamaniHMO
Dr. Yaron Hamani
Hadassah Medical Organization