Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain
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
• Chronic pelvic pain for more than 6 months
• Pelvic pain at least equal to 2 out of 3 (on the intensity scale: 0 - None, 1 - Mild, 2 - Moderate, 3 - Severe)
• Agreeing to participate in the study
• Agrees to limit pain relief treatment during the study to level I painkillers paracetamol and Acupan® (nefopam), and the NSAID Antadys® (flurbiprofen)
• Has a computer, tablet, or cell phone with an internet connection
⁃ Is affiliated with a social security system or is a beneficiary of such a system