Actively Recruiting

Phase Not Applicable
Age: 15Years +
FEMALE
NCT04177511

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

Led by Hopital Foch · Updated on 2025-11-21

72

Participants Needed

1

Research Sites

275 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 15Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 6 15 years
  • Experiencing chronic pelvic pain and/or painful periods and/or pain during intercourse
  • Receiving care from a gynecologist at a participating study center
  • Diagnosed with endometriosis
  • Provided signed informed consent
  • Covered by a health insurance plan
Not Eligible

You will not qualify if you...

  • Contraindications to transcutaneous auricular vagus nerve stimulation such as heart conditions or asthma
  • Pregnant or breastfeeding women
  • Patients undergoing in vitro fertilization
  • Having other conditions that require long-term pain medication
  • Received vagus nerve stimulation treatment within 12 months prior to joining
  • Individuals deprived of liberty or under guardianship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hopital Foch

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

Actively Recruiting

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Research Team

M

Mireille MICHEL-CHERQUI, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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