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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometriosis

Intervention / Treatment
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* Device: Transcutaneous Auricular Vagus Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous auricular vagus nerve stimulation<br>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. | Device: Transcutaneous Auricular Vagus Nerve Stimulation<br>* 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.<br>|
| No Intervention: Standard treatment<br>Patients of this arm will continue their standard treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of symptoms related to the pelvic pain | 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 | 3 months after enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy on pain | 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 | Day 1 and 3 months after enrolment | 
| Efficacy on severity of patient's symptoms | 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 | Day 1 and 3 months after enrolment | 
| Efficacy on quality of life | Self assessement of quality of life using Endometriosis Health Profile-5 | Day 1 and 3 months after enrolment | 
| Efficacy on quality of life | Self assessement of quality of life using EQ-5D scale | Day 1 and 3 months after enrolment | 
| Efficacy on Anxiety | Self assessement of anxiety using the Hospital Anxiety and Depression scale | Day 1 and 3 months after enrolment | 
| Efficacy on gynecological and pelvic pain symptoms | Self assessement of gynecological and pelvic pain symptoms using ENDOL-4D questionnaire | Day 1 and 3 months after enrolment | 
| Efficacy on gynecological and pelvic pain symptoms | Self assessement of gynecological and pelvic pain symptoms using KESS questionnaire | D1 and 3 months after enrolment | 
| General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus | Self assessement of satisfaction using a satisfaction questionnaire involving satisfaction, adherence to treatment sessions and ease of use of the device | 3 months after enrolment | 
| Collection of possible side effects | collection of vagal malaise, nausea and vomiting | 3 months after Enrolement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pelvic pain, Transcutaneous Auricular Vagus Nerve Stimulation