TENS for endometriosis-related pelvic pain
Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain
NA · Monath Electronic · NCT07393295
This study tests whether two types of TENS (conventional and microstimulation) can reduce chronic pelvic pain in adults with endometriosis or adenomyosis who are on stable hormone therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Monath Electronic (industry) |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT07393295 on ClinicalTrials.gov |
What this trial studies
ELECTRE is a single-center, randomized, prospective, longitudinal, controlled, two-arm, single-blind trial with a 4-week run-in period followed by a 4-week randomized treatment phase and a 4-week extension in which all participants receive active TENS. Participants are randomized 1:1 to conventional TENS or microstimulation TENS and are asked to limit other pain medications to specified options. Eligible participants are adult women with imaging or histology-confirmed endometriosis or adenomyosis, chronic pelvic pain for more than six months, and stable hormone treatment. The trial measures tolerability and pain outcomes to compare the two TENS approaches.
Who should consider this trial
Good fit: Adult women (≥18 years) with imaging- or histology-confirmed endometriosis or adenomyosis, chronic pelvic pain >6 months, on continuous stable hormone therapy with no planned changes, able to limit other analgesics, and with internet access are ideal candidates.
Not a fit: People who are pregnant, breastfeeding, menopausal, experiencing an acute worsening of disease, not on stable hormone therapy, or who require stronger pain medications are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, this could provide a non-drug, self-administered option to lessen chronic pelvic pain for people with endometriosis or adenomyosis.
How similar studies have performed: Several small studies and reports have suggested TENS can help pelvic pain related to endometriosis, but prior evidence is limited and mixed in quality.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux
- IFEM Endo, Clinique Tivoli-Ducos — Bordeaux, France (RECRUITING)
Study contacts
- Principal investigator: Bejamin MERLOT — IFEM Endo, Clinique Tivoli-Ducos, 5 rue Auguste Poirson, 33000 Bordeaux, France
- Study coordinator: Thomas LOBSTEIN
- Email: thomas.lobstein@monath-electronic.fr
- Phone: +33-389497361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pelvic Pain Associated With Endometriosis or Adenomyosis, Pelvic Pain Associated With Refractory Endometriosis, Endometriosis