Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:16 AM
Study NCT ID:
NCT07393295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of TENS in Endometriosis-related Pain
Sponsor:
Monath Electronic
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELECTRE
Brief 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AU 2080 | OTHER | CPP (Comité de protection des personnes Sud-Est VI) | View |