TENS for endometriosis-related pelvic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pelvic Floor Function and Endometriosis-Related Pelvic Pain in Women

  This study will look at whether endometriosis-related pelvic pain is linked to pelvic floor muscle strength and related factors in women aged 18–50, comparing them with healthy controls.

  Recruiting University of Pecs · Pécs, Baranya · NCT07713108

• Comparing different techniques to treat endometriosis

  This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.

  Recruiting TriHealth Inc. · Cincinnati, Ohio · NCT06414083

• Postoperative Pain Trajectories After Endometriosis Surgery

  This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07882498

• Imaging endometriosis with a special PET tracer in adult women

  This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07876648

• Fiber supplement for digestive symptoms in endometriosis

  A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.

  Recruiting LOAM Science · San Francisco, California · NCT07875062

• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

  The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.

  Recruiting The Second People's Hospital of Huai'an · Huai'an, Jiangsu · NCT07860203

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.