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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2027-03-28

Brief Summary

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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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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcutaneous auricular vagus nerve stimulation

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.

Group Type EXPERIMENTAL

Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type 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.

Standard treatment

Patients of this arm will continue their standard treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transcutaneous Auricular Vagus Nerve Stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No