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

Recruiting now · Not applicable

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID: NCT04177511
Run by: Hopital Foch
People needed: 72
Starts: 2021-12-13
Expected to finish: 2027-03-28
Last updated by the study team: 2025-11-21

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: not accepted.

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 with atria trans vagal neurostimulation in the 12 months prior to inclusion
patient deprived of liberty or under guardianship

Where it is running

Hopital Foch — Suresnes, Île-de-France Region, France (enrolling)

Full record on ClinicalTrials.gov

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