Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation (Stim-Endom)

Hopital Foch

Status: Enrolling

Conditions: Endometriosis

Treatments: Device: Transcutaneous Auricular Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04177511

2019-0057

Details and patient eligibility

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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Transcutaneous auricular vagus nerve stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Standard treatment

No Intervention group

Description:

Patients of this arm will continue their standard treatment.