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

Not Applicable

Recruiting

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Transcutaneous auricular vagus nerve stimulation	Transcutaneous Auricular Vagus Nerve Stimulation	A 30-minute session twice a day during 3 months of transcutaneous auricular vagus nerve stimulation using the TENS Eco Plus. Standard treatment will be continued by the patients of this arm.

Primary Outcome Measures

Name	Time	Method
Change of symptoms related to the pelvic pain	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"

Secondary Outcome Measures

Name	Time	Method
Efficacy on Anxiety	Day 1 and 3 months after enrolment	Self assessement of anxiety using the Hospital Anxiety and Depression scale
Efficacy on gynecological and pelvic pain symptoms	D1 and 3 months after enrolment	Self assessement of gynecological and pelvic pain symptoms using KESS questionnaire
Efficacy on pain	Day 1 and 3 months after enrolment	Self assessement of pain using Endometriosis-associated pelvic pain scale on which patients rate their current pain intensity from 0 "No pain" to 10 "worst possible pain"
Efficacy on severity of patient's symptoms	Day 1 and 3 months after enrolment	Physician assessement of severity of patient's symptoms using Global Clinical Impressions-Severity scale on which physicians rate the severity of patient's symptoms from "not evaluated" to "Among the sickest patients"
Efficacy on quality of life	Day 1 and 3 months after enrolment	Self assessement of quality of life using EQ-5D scale
General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus	3 months after enrolment	Self assessement of satisfaction using a satisfaction questionnaire involving satisfaction, adherence to treatment sessions and ease of use of the device
Collection of possible side effects	3 months after Enrolement	collection of vagal malaise, nausea and vomiting