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Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain
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.
* 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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
IFEM Endo, Clinique Tivoli-Ducos
Bordeaux, France
Start Date
March 15, 2026
Primary Completion Date
June 15, 2027
Completion Date
December 31, 2027
Last Updated
February 6, 2026
92
ESTIMATED participants
Conventional TENS
DEVICE
Microstimulation TENS
DEVICE
Lead Sponsor
Monath Electronic
NCT05951452
NCT06611501
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05726786