NCT07393295

Efficacy and Tolerability of TENS in Endometriosis-related Pain

Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Monath Electronic · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* Endometriosis is defined by the presence of endometrial tissue outside the uterine cavity. It affects 6% to 10% of women of childbearing age. Depending on its location, a distinction is made between superficial endometriosis, adenomyosis, and deep endometriosis. The potential mechanisms of endometriosis are still under discussion. * Endometriosis is accompanied by a painful triad combining dysmenorrhea, dyspareunia, and chronic pelvic pain. * Pain requires treatment due to its multiple impacts in terms of quality of life, anxiety, depression, loss of productivity at work, and absenteeism. * Approximately one-third of women with endometriosis continue to suffer despite medical treatment. * The pain of endometriosis is multifactorial, involving inflammatory, nociceptive, neuropathic, neurovascular, myofascial, and hormonal mechanisms. The recurrence of endometriosis-related pain means that it must be considered a chronic pain syndrome leading to peripheral and central neural sensitization. The intensity of the pain is not correlated with the severity of the disease. * Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, easy-to-use, well-tolerated, self-administered technique widely used for its analgesic effect in acute and chronic pain. Several studies have suggested the effectiveness of TENS in the management of pelvic pain related to endometriosis, but they are of uneven quality. * Evaluating the effectiveness of TENS in the management of endometriosis-related pain under the best methodological conditions remains essential.

Conditions

• Pelvic Pain Associated With Endometriosis or Adenomyosis
• Pelvic Pain Associated With Refractory Endometriosis
• Endometriosis

Interventions

Type	Name	Description
DEVICE	Conventional TENS	Every TENS treatment lasts for 45 minutes
DEVICE	Microstimulation TENS	Every TENS treatment lasts for 45 minutes

Timeline

• Start date: 2026-03-15
• Primary completion: 2027-06-15
• Completion: 2027-12-31
• First posted: 2026-02-06
• Last updated: 2026-03-31

Locations

1 site across 1 country: France