Efficacy and Tolerability of TENS in Endometriosis-related Pain
Recruiting · NCT07393295 · Interventional (participants receive a specific treatment) · Lead sponsor: Monath Electronic
View the official record on ClinicalTrials.gov →Interventions studied
Conventional TENSMicrostimulation TENS
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Pregnant or breastfeeding women
- Menopausal women
- Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days
- Patients with altered sensitivity in the area where the device is applied (hypoesthesia)
- Skin allergy to the gel or electrodes
- Dermatological problem in the stimulation area
- Patients with an implanted pacemaker or active implanted medical device.
- Epilepsy
- Current thrombophlebitis or arterial thrombosis
- Cancer or malignant disease with an expected survival of \< 12 months
- Alcoholism or drug addiction
- Fibromyalgia
- Women who have already tried TENS
- Patients unable to understand and use the English language to communicate fluently
- Patients with cognitive impairments
- Untreated severe psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
- Participation in another intervention study that may impact the results of the current study
- Patient using \> 90 morphine equivalents/day (at least once in the last 28 days)
- Gynecological and/or endometriosis surgery planned within the next 3 months
- History of endometriosis surgery within the last 6 months
- Patient who has undergone a hysterectomy or bilateral oophorectomy
- Patient under legal protection (guardianship or conservatorship) or patient deprived of liberty
Where it is running
1 location listed.
- IFEM Endo, Clinique Tivoli-Ducos - Bordeaux, France