Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07393295
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07393295
Study Brief:
Protocol Section:
NCT07393295