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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous auricular vagus nerve stimulation | Experimental | 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. |
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| Standard treatment | No Intervention | Patients of this arm will continue their standard treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mireille MICHEL-CHERQUI, MD | Contact | 0033 1 46 25 29 85 | drci.promotion@hopital-foch.com |
| Name | Affiliation | Role |
|---|---|---|
| Mireille MICHEL-CHERQUI, MD | Hopital Foch, Suresnes | Principal Investigator |
| Marc FISCHLER, MD PhD | Hopital Foch, Suresnes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Recruiting | Suresnes | Île-de-France Region | 92150 | France |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 |
| D000091662 | Genital Diseases |