ELECTRE is a single-center, randomized, prospective, longitudinal, controlled, two-arm, single-blind study lasting 4 weeks (P1 investigation phase) after a 4-week run-in period.
The study is followed by a 4-week extension phase (P2) in which all participants will be treated with active TENS.
Randomization will be balanced according to a 1:1 ratio.
Women aged ≥ 18 years
Endometriosis and/or adenomyosis diagnosed by imaging and/or histology
Undergoing continuous, stable, and functional hormone treatment (with no menstruation) for at least 2 months
No change in hormone treatment planned for the duration of the study
Pregnant or breastfeeding women
Menopausal women
Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days
Patients with altered sensitivity in the area where the device is applied (hypoesthesia)
Parallel
Conventional TENS
DeviceEvery TENS treatment lasts for 45 minutes
Microstimulation TENS
DeviceEvery TENS treatment lasts for 45 minutes
Change in the mean value of average pain
Change in the mean value of average pain over the previous 24 hours, measured daily during the P1 investigation phase (between D1 and D28±2), compared with the run-in period (between D-35 and D-8). Participants will assess their average pain over the past 24 hours on a 100 mm visual analog scale (VAS) every day. The average of these daily values will be calculated over the run-in period (between D-35 and D-8), during the P1 investigation phase (between D1 and D28±2), and during the P2 extension phase (between D29±2 and D56±2). The visual analog scale will be available on the data collection tool/website provided and accessible throu PC, tablet or smartphone. The VAS is presented as a 100 mm horizontal line with no boundaries, marked at the left end with "no pain" and at the other end with "worst pain imaginable." Repeated pain measurements during the run-in period will provide a reliable baseline value that takes into account daily variations.
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