Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
RecruitingNot applicableNCT04177511
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
- Conditions
- Interventions
- Device: Transcutaneous Auricular Vagus Nerve Stimulation
- Sponsor
- Hopital Foch
- Start date
- 2021-12-13
- Primary completion
- 2027-03-28
- Sex
- Female
- Age range
- from 15 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04177511