Efficacy and Tolerability of TENS in Endometriosis-related Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMonath Electronic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Conventional TENS
  • Microstimulation TENS

Treatment groups

92 Participants
are divided into 2 treatment groups

Sponsors and collaborators