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NCT Number: NCT04177511

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

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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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, Île-de-France Region, 92150, France

Location status: Recruiting

Location contact

Mireille Michel-cherqui, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change of symptoms related to the pelvic pain

    Time frame: 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 outcomes

  1. Efficacy on pain

    Time frame: 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"

  2. Efficacy on severity of patient's symptoms

    Time frame: 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"

  3. Efficacy on quality of life

    Time frame: Day 1 and 3 months after enrolment

    Self assessement of quality of life using Endometriosis Health Profile-5

  4. Efficacy on quality of life

    Time frame: Day 1 and 3 months after enrolment

    Self assessement of quality of life using EQ-5D scale

  5. Efficacy on Anxiety

    Time frame: Day 1 and 3 months after enrolment

    Self assessement of anxiety using the Hospital Anxiety and Depression scale

  6. Efficacy on gynecological and pelvic pain symptoms

    Time frame: Day 1 and 3 months after enrolment

    Self assessement of gynecological and pelvic pain symptoms using ENDOL-4D questionnaire

  7. Efficacy on gynecological and pelvic pain symptoms

    Time frame: D1 and 3 months after enrolment

    Self assessement of gynecological and pelvic pain symptoms using KESS questionnaire

  8. General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus

    Time frame: 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

  9. Collection of possible side effects

    Time frame: 3 months after Enrolement

    collection of vagal malaise, nausea and vomiting

Study contacts

Contact information is provided by the study sponsor or research team.

Mireille MICHEL-CHERQUI, MD

CONTACT

[email protected]

0033 1 46 25 29 85

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: Stim-Endom

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2019
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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