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

Endometriosis Clinical Trial

— Stim-Endom  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04177511
• Other study ID #: 2019-0057
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: February 2025

Study information

• Verified date: February 2023
• Source: Hopital Foch
• Contact: Marie-Christine DJIAN, MD
• Phone: 0033 1 46 25 19 22
• Email: mc.djian[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Hopital Saint Joseph	Paris
France	CHI Poissy-St-Germain	Poissy	Ile De France
France	Hopital Foch	Suresnes	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy on pain	Self assessement of pain using Endometriosis-associated pelvic pain scale on which patients rate their current pain intensity from 0 "No pain" to 10 "worst possible pain"	Day 1 and 3 months after enrolment
Secondary	Efficacy on severity of patient's symptoms	Physician assessement of severity of patient's symptoms using Global Clinical Impressions-Severity scale on which physicians rate the severity of patient's symptoms from "not evaluated" to "Among the sickest patients"	Day 1 and 3 months after enrolment
Secondary	Efficacy on quality of life	Self assessement of quality of life using Endometriosis Health Profile-5	Day 1 and 3 months after enrolment
Secondary	Efficacy on quality of life	Self assessement of quality of life using EQ-5D scale	Day 1 and 3 months after enrolment
Secondary	Efficacy on Anxiety	Self assessement of anxiety using the Hospital Anxiety and Depression scale	Day 1 and 3 months after enrolment
Secondary	Efficacy on gynecological and pelvic pain symptoms	Self assessement of gynecological and pelvic pain symptoms using ENDOL-4D questionnaire	Day 1 and 3 months after enrolment
Secondary	Efficacy on gynecological and pelvic pain symptoms	Self assessement of gynecological and pelvic pain symptoms using KESS questionnaire	D1 and 3 months after enrolment
Secondary	General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus	Self assessement of satisfaction using a satisfaction questionnaire involving satisfaction, adherence to treatment sessions and ease of use of the device	3 months after enrolment
Secondary	Collection of possible side effects	collection of vagal malaise, nausea and vomiting	3 months after Enrolement