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

NCT04177511 | Recruiting

• 1 other identifier: 2019-0057
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Chronic pelvic pain; Transcutaneous Auricular Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Efficacy on pain

  Day 1 and 3 months after enrolment

• Efficacy on severity of patient's symptoms

  Day 1 and 3 months after enrolment

• Efficacy on quality of life

  Day 1 and 3 months after enrolment

• Efficacy on quality of life

  Day 1 and 3 months after enrolment

• Efficacy on Anxiety

  Day 1 and 3 months after enrolment

Study Arms (2)

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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Standard treatment

NO INTERVENTION

Patients of this arm will continue their standard treatment.

Interventions

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.

Transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 deprived of liberty or under guardianship

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

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

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Mireille MICHEL-CHERQUI, MD

  Hopital Foch, Suresnes

  PRINCIPAL INVESTIGATOR

• Marc FISCHLER, MD PhD

  Hopital Foch, Suresnes

  STUDY CHAIR

Central Study Contacts

Mireille MICHEL-CHERQUI, MD

CONTACT

0033 1 46 25 29 85; drci.promotion@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 26, 2019
• Study Start: December 13, 2021
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)