Clinical trial NCT04177511: Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
Official title: Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Chronic pelvic pain
Transcutaneous Auricular Vagus Nerve Stimulation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 72
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of symptoms related to the pelvic pain
timeFrame: 3 months after enrolment
Secondary outcomes:
measure: Efficacy on pain
timeFrame: Day 1 and 3 months after enrolment
measure: Efficacy on severity of patient's symptoms
timeFrame: Day 1 and 3 months after enrolment
measure: Efficacy on quality of life
timeFrame: Day 1 and 3 months after enrolment
measure: Efficacy on quality of life
timeFrame: Day 1 and 3 months after enrolment
measure: Efficacy on Anxiety
timeFrame: Day 1 and 3 months after enrolment
measure: Efficacy on gynecological and pelvic pain symptoms
timeFrame: Day 1 and 3 months after enrolment
measure: Efficacy on gynecological and pelvic pain symptoms
timeFrame: D1 and 3 months after enrolment
measure: General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus
timeFrame: 3 months after enrolment
measure: Collection of possible side effects
timeFrame: 3 months after Enrolement
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile De France
Study officials:
affiliation: Hopital Foch, Suresnes
name: Marie-christine DJIAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Foch, Suresnes
name: Marc FISCHLER, MD PhD
role: STUDY_CHAIR
References: