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Efficacy and Tolerability of TENS in Endometriosis-related Pain

RecruitingNAAges 18 Years - anyFemaleMonath Electronic
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Women aged ≥ 18 years 2. Endometriosis and/or adenomyosis diagnosed by imaging and/or histology 3. Undergoing continuous, stable, and functional hormone treatment (with no menstruation) for at least 2 months 4. No change in hormone treatment planned for the duration of the study 5. Chronic pelvic pain for more than 6 months 6. Pelvic pain at least equal to 2 out of 3 (on the intensity scale: "0 - None," "1 - Mild," "2 - Moderate," "3 - Severe") 7. Agreeing to participate in the study 8. Agrees to limit pain relief treatment during the study to level I painkillers paracetamol and Acupan® (nefopam), and the NSAID Antadys® (flurbiprofen) 9. Has a computer, tablet, or cell phone with an internet connection 10. Is affiliated with a social security system or is a beneficiary of such a system Exclusion Criteria: 1. Pregnant or breastfeeding women 2. Menopausal women 3. Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days 4. Patients with altered sensitivity in the area where the device is applied (hypoesthesia) 5. Skin allergy to the gel or electrodes 6. Dermatological problem in the stimulation area 7. Patients with an implanted pacemaker or active implanted medical device. 8. Epilepsy 9. Current thrombophlebitis or arterial thrombosis 10. Cancer or malignant disease with an expected survival of \< 12 months 11. Alcoholism or drug addiction 12. Fibromyalgia 13. Women who have already tried TENS 14. Patients unable to understand and use the English language to communicate fluently 15. Patients with cognitive impairments 16. Untreated severe psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition 17. Participation in another intervention study that may impact the results of the current study 18. Patient using \> 90 morphine equivalents/day (at least once in the last 28 days) 19. Gynecological and/or endometriosis surgery planned within the next 3 months 20. History of endometriosis surgery within the last 6 months 21. Patient who has undergone a hysterectomy or bilateral oophorectomy 22. Patient under legal protection (guardianship or conservatorship) or patient deprived of liberty
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What it tests

  • Conventional TENS
  • Microstimulation TENS
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Where

1 site
IFEM Endo, Clinique Tivoli-Ducos
Bordeaux, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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