ActiTENS Mini (Transcutaneous Electrical Stimulation) in Women With Chronic Pain From Pelvic Endometriosis

Endometriosis is a condition that often causes pelvic pain, particularly during menstruation but also continuously and over long periods. Pharmacological treatments are only moderately effective or are associated with adverse effects. In this context, the search for non-pharmacological approaches to endometriosis pain is essential. Transcutaneous electrical nerve stimulation (TENS) is a portable pain relief technique that is rapidly developing for the treatment of endometriosis pain. The protocol presented aims to confirm the analgesic efficacy of this treatment for endometriosis pain. It will involve 27 gynecology and pain departments in mainland France. It will offer 30-minute sessions of daily stimulation, either suprapubic or lumbar. Several types of stimulation will be compared, with three 3-month phases, two blind phases, and a 3-month phase in which the system used will be fixed. The aim will be to reduce pain intensity as well as other parameters relating to quality of life and the impact of pain. If the effectiveness of this device is confirmed, it could lead to TENS being made available for endometriosis pain and potentially prescribed by gynecologists and midwives.

NCT Number	NCT07317037
Lead Sponsor	Assistance Publique - Hôpitaux de Paris Collaborators: SUBLIMED (Donation of DMs and application development), Ministry of Health, France
Conditions	Endometriosis
Enrollment	208 participants
Start Date	2026-03-01
Primary Completion	2027-12-01 (estimated)
Study Completion	2028-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-07