Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation

Обзор

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.

Вмешательства

• Устройство Transcutaneous Auricular Vagus Nerve Stimulation
  Transcutaneous Auricular Vagus Nerve Stimulation has an eartip connected to an external stimulator. The device used in this study is the TENS Eco Plus commercialized by Schwa Medico and European Compliance (CE) marked. The electrode is positioned in the cymba concha of the left ear.

Первичные конечные точки

• Change of symptoms related to the pelvic pain [Срок оценки: 3 months after enrolment]

Вторичные конечные точки (9)

• Efficacy on pain [Срок оценки: Day 1 and 3 months after enrolment]
• Efficacy on severity of patient's symptoms [Срок оценки: Day 1 and 3 months after enrolment]
• Efficacy on quality of life [Срок оценки: Day 1 and 3 months after enrolment]
• Efficacy on quality of life [Срок оценки: Day 1 and 3 months after enrolment]
• Efficacy on Anxiety [Срок оценки: Day 1 and 3 months after enrolment]
• Efficacy on gynecological and pelvic pain symptoms [Срок оценки: Day 1 and 3 months after enrolment]
• Efficacy on gynecological and pelvic pain symptoms [Срок оценки: D1 and 3 months after enrolment]
• General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus [Срок оценки: 3 months after enrolment]
• Collection of possible side effects [Срок оценки: 3 months after Enrolement]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hopital Foch — Suresnes

Идентификаторы

NCT: NCT04177511 · 2019-0057

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗