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

Study acronym: Stim-Endom
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Apr 2025 to Mar 28, 2027v14
  2. Minor Study sites: 3 to 1
    • Primary and study completion dates: Feb 2025 to Apr 2025
    v13
  3. Minor Re-verified, no change to tracked fieldsv12
  4. Minor Start date changed from estimate of Dec 2021 to Dec 13, 2021v11
  5. Notable Start date: Oct 2021 to Dec 2021
    • Primary and study completion dates: Dec 2024 to Feb 2025
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Start date: Jun 2021 to Oct 2021
    • Primary and study completion dates: Aug 2024 to Dec 2024
    v9
  2. Notable Start date: Feb 2021 to Jun 2021
    • Primary and study completion dates: Apr 2024 to Aug 2024
    v8
  3. Notable Start date: Oct 2020 to Feb 2021
    • Primary and study completion dates: Dec 2023 to Apr 2024
    v7
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Nov 2023 to Dec 2023
    • Start date: Sep 2020 to Oct 2020
    • Site details revised at 3 of 3 sites
    v6
  5. Notable Start date: Jul 2020 to Sep 2020
    • Primary and study completion dates: Sep 2023 to Nov 2023
    v5
  6. Notable Start date: May 2020 to Jul 2020
    • Primary and study completion dates: Aug 2023 to Sep 2023
    v4
  7. Notable Start date: Feb 2020 to May 2020
    • Primary and study completion dates: May 2023 to Aug 2023
    v3
  8. Notable Start date: Dec 2019 to Feb 2020
    • Primary and study completion dates: Mar 2023 to May 2023
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04177511
Lead Sponsor Hopital Foch
Conditions
(from sponsor)
Endometriosis
Related terms Endometriosis
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov