Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hopital Foch
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change of symptoms related to the pelvic pain
研究概览
简要总结
6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Several treatment strategies, including surgical ones, are proposed but they are sometimes insufficient because endometriosis-related pain is frequently accompanied by sensitization. Endometriosis surgery, when indicated, is therefore changeably effective, even though the lesions have been completely resected. Patients therefore consult Pain Units seeking for the effective treatment as the pain persist even after surgical management of endometriosis.
Vagus nerve stimulation is a non-invasive technique that includes an anti-inflammatory effect and a modulation of neurotransmitter production (adrenaline, norepinephrine; serotonin, acetylcholine). Yuan and Silberstein published a general review on the technique. Migraine and depression are one of the selected indications. In addition, Napadow et al. published favourable results in a short series of patients with chronic pelvic pain. The Investigators of this study have treated some patients with this technique with a result deemed satisfactory which leads to propose a randomized study to confirm this impression.
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged >= 15 years
- •With chronic pelvic pain and/ or dysmenorrhoea and/ or dyspareunia
- •Who has been cared for by a gynecologist in one of the institutions participating in the study
- •Diagnosed with endometriosis
- •Having signed an informed written consent
- •Affiliated to a health insurance scheme
排除标准
- •contraindication to the use of transcutaneous auricular vagus nerve stimulation (cardiac pathology, asthmatic patient)
- •pregnant or breastfeeding women
- •patient undergoing in vitro fertilization
- •associated pathology requiring long-term analgesic treatment
- •patient with atria trans vagal neurostimulation in the 12 months prior to inclusion
- •patient deprived of liberty or under guardianship
结局指标
主要结局
Change of symptoms related to the pelvic pain
时间窗: 3 months after enrolment
Self assessement of change using Patient's Global Impression of Change (PGIC) scale in which patients rate the improvement of their symptoms related to their pelvic pain from "No change or it get worse" to "A great deal better, and a considerable improvement that has made all the difference" . A favorable result will be "Better, and a definite improvement that has made a real and worthwhile difference" or "A great deal better, and a considerable improvement that has made all the difference"
次要结局
- Efficacy on Anxiety(Day 1 and 3 months after enrolment)
- Efficacy on gynecological and pelvic pain symptoms(D1 and 3 months after enrolment)
- Efficacy on pain(Day 1 and 3 months after enrolment)
- Efficacy on severity of patient's symptoms(Day 1 and 3 months after enrolment)
- General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus(3 months after enrolment)
- Collection of possible side effects(3 months after Enrolement)
- Efficacy on quality of life(Day 1 and 3 months after enrolment)