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| ID | Type | Description | Link |
|---|---|---|---|
| AU 2080 | Other Identifier | CPP (Comité de protection des personnes Sud-Est VI) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional TENS Group | Experimental | Conventional TENS for 4 weeks |
|
| Microstimulation TENS | Active Comparator | Microstimulation TENS for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional TENS | Device | Every TENS treatment lasts for 45 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean value of average pain | Change in the mean value of average pain over the previous 24 hours, measured daily during the P1 investigation phase (between D1 and D28±2), compared with the run-in period (between D-35 and D-8). Participants will assess their average pain over the past 24 hours on a 100 mm visual analog scale (VAS) every day. The average of these daily values will be calculated over the run-in period (between D-35 and D-8), during the P1 investigation phase (between D1 and D28±2), and during the P2 extension phase (between D29±2 and D56±2). The visual analog scale will be available on the data collection tool/website provided and accessible throu PC, tablet or smartphone. The VAS is presented as a 100 mm horizontal line with no boundaries, marked at the left end with "no pain" and at the other end with "worst pain imaginable." Repeated pain measurements during the run-in period will provide a reliable baseline value that takes into account daily variations. | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas LOBSTEIN | Contact | +33-389497361 | thomas.lobstein@monath-electronic.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bejamin MERLOT | IFEM Endo, Clinique Tivoli-Ducos, 5 rue Auguste Poirson, 33000 Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IFEM Endo, Clinique Tivoli-Ducos | Recruiting | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Microstimulation TENS |
| Device |
Every TENS treatment lasts for 45 minutes |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |