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Tests treatment safety and results for Pelvic Pain Associated With Endometriosis or Adenomyosis
Official title Efficacy and Tolerability of TENS in Endometriosis-related Pain
ClinicalTrials.gov ID: NCT07393295
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women aged ≥ 18 years
- Endometriosis and/or adenomyosis diagnosed by imaging and/or histology
- Undergoing continuous, stable, and functional hormone treatment (with no menstruation) for at least 2 months
- No change in hormone treatment planned for the duration of the study
- Chronic pelvic pain for more than 6 months
You likely can't join if
- Pregnant or breastfeeding women
- Menopausal women
- Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days
- Patients with altered sensitivity in the area where the device is applied (hypoesthesia)
- Skin allergy to the gel or electrodes
- Dermatological problem in the stimulation area
See the full eligibility criteria
- Women aged ≥ 18 years
- Endometriosis and/or adenomyosis diagnosed by imaging and/or histology
- Undergoing continuous, stable, and functional hormone treatment (with no menstruation) for at least 2 months
- No change in hormone treatment planned for the duration of the study
- Chronic pelvic pain for more than 6 months
- Pelvic pain at least equal to 2 out of 3 (on the intensity scale: "0 - None," "1 - Mild," "2 - Moderate," "3 - Severe")
- Agreeing to participate in the study
- Agrees to limit pain relief treatment during the study to level I painkillers paracetamol and Acupan® (nefopam), and the NSAID Antadys® (flurbiprofen)
- Has a computer, tablet, or cell phone with an internet connection
- Is affiliated with a social security system or is a beneficiary of such a system
- Pregnant or breastfeeding women
- Menopausal women
- Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days
- Patients with altered sensitivity in the area where the device is applied (hypoesthesia)
- Skin allergy to the gel or electrodes
- Dermatological problem in the stimulation area
- Patients with an implanted pacemaker or active implanted medical device.
- Epilepsy
- Current thrombophlebitis or arterial thrombosis
- Cancer or malignant disease with an expected survival of \< 12 months
- Alcoholism or drug addiction
- Fibromyalgia
- Women who have already tried TENS
- Patients unable to understand and use the English language to communicate fluently
- Patients with cognitive impairments
- Untreated severe psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
- Participation in another intervention study that may impact the results of the current study
- Patient using \> 90 morphine equivalents/day (at least once in the last 28 days)
- Gynecological and/or endometriosis surgery planned within the next 3 months
- History of endometriosis surgery within the last 6 months
- Patient who has undergone a hysterectomy or bilateral oophorectomy
- Patient under legal protection (guardianship or conservatorship) or patient deprived of liberty
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.