IFEM Endo, Clinique Tivoli-Ducos
Bordeaux, 33000, France
Location status: Recruiting
NCT Number: NCT07393295
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Bordeaux, 33000, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Every TENS treatment lasts for 45 minutes
Every TENS treatment lasts for 45 minutes
Time frame: 56 days
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.
Contact information is provided by the study sponsor or research team.
Monath Electronic
Industry
Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain
Acronym: ELECTRE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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