Ireland
--:--IST
Starting soon Not applicable

ActiTENS Mini (Transcutaneous Electrical Stimulation) in Women With Chronic Pain From Pelvic Endometriosis

NCT07317037 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-03-01
Last updated
2026-01-07

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

actiTENS mini - weak stimulationweak stimulation - actiTENS mini

actiTENS mini - weak stimulation: Patients will wear the DM in "actiTENS mini" mode for 3 months then 1 washout period will be carried out before continuing the study with the DM in mode "weak stimulation" for 3 months. Finally, the last 3-month period will be carried out after 1 month of washout where patients will use the DM as they wish. The "weak stimulation" is the control group. The TENS will deliver current for 1 minute every 10 minutes, ramping down to 0 in the last 15 seconds. In the experimental group, patients will use the actiTENS mini, which will deliver electrical stimulation: Program P2 (Gate control 80 Hz).

weak stimulation - actiTENS mini: Patients will wear the DM in "weak stimulation" mode for 3 months then 1 washout period will be carried out before continuing the study with the DM in mode "actiTENS mini" for 3 months. Finally, the last 3-month period will be carried out after 1 month of washout where patients will use the DM as they wish. The "weak stimulation" is the control group. The TENS will deliver current for 1 minute every 10 minutes, ramping down to 0 in the last 15 seconds. In the experimental group, patients will use the actiTENS mini, which will deliver electrical stimulation: Program P2 (Gate control 80 Hz).

Study summary

Endometriosis is a condition that often causes pelvic pain, particularly during menstruation but also continuously and over long periods. Pharmacological treatments are only moderately effective or are associated with adverse effects. In this context, the search for non-pharmacological approaches to endometriosis pain is essential. Transcutaneous electrical nerve stimulation (TENS) is a portable pain relief technique that is rapidly developing for the treatment of endometriosis pain. The protocol presented aims to confirm the analgesic efficacy of this treatment for endometriosis pain. It will involve 27 gynecology and pain departments in mainland France. It will offer 30-minute sessions of daily stimulation, either suprapubic or lumbar. Several types of stimulation will be compared, with three 3-month phases, two blind phases, and a 3-month phase in which the system used will be fixed. The aim will be to reduce pain intensity as well as other parameters relating to quality of life and the impact of pain. If the effectiveness of this device is confirmed, it could lead to TENS being made available for endometriosis pain and potentially prescribed by gynecologists and midwives.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Women over 18 years old * Followed-up in gynecology consultation for endometriosis confirmed by specific imaging (MRI or ultrasound) * Referred to a gynecological or a pain center * With chronic pelvic pain (for at least 3 months) related to endometriosis, pelvic pain being the predominant symptom of endometriosis: pelvic pain present at least 15 days per month in the previous 3 months * Stable and optimal analgesic and hormonal treatments during the last 3 months: any modification of pharmacological treatment in the last 3 months * Pelvic pain of moderate to severe intensity or greater than or equal to 4 on an NRS of 0-10 on average during the 8 days preceding the inclusion visit and during the inclusion visit. * Informed about the concept and accepting the use of TENS as a device, a non-drug analgesic treatment. * Able to understand the use of TENS * Having a personal smartphone enabling the EndoTENS application to be downloaded * All women of childbearing potential (WOCBP) must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomized partner, spermicide-coated condoms * Willingness and ability to attend the scheduled study visits and comply with study procedures * Affiliated to Social Security. Exclusion Criteria: * Symptoms of endometriosis other than pelvic pain, predominant over pelvic pain (pelvic pain is not the main symptom): digestive disorders, unstable bladder, dyspareunia, infertility, fibromyalgia, sciatica, low back pain… * Present or past allergy to actiTENS mini pads. * Pelvic surgery planned within the next 11 months. * Drug or non-pharmacological treatments not stabilized, which could influence the pathology studied during the last 3 months * Changed of treatments for endometriosis planned in the next 10 months. * Patient presenting an absolute contraindication to TENS: patient with epilepsy, patient with a defibrillator, a pacemaker, a cochlear implant or other implanted electronic devices, patient with cardiac disorders, patient with decreased or altered sensation or sensitivity in the area to be treated, for example patients with allodynia (pain triggered by a stimulus that is normally painless) in the area to be treated. * Patient unable to express his consent or patient in deprivation of liberty. * Patient that already used or know the functioning principles of a TENS device previously to the clinical study * Contraindications to actiTENS mini * Pregnancy and breastfeeding * Patients under guardianship or curatorship and protected adults * Patients on AME (Aide Médicale de l'Etat = State Medical Assistance) * Current participation in another research study involving a therapeutic intervention. Participation to an observational research, or a non-interventional research is allowed

Primary outcome measure(s)

  • Change in the average pain measured with a NRS score of the last 28 days of each 3-month period of treatment, compared to baseline of each period — From the end of the first cross over period (3 months) to the end of the second cross over period (7 months)
    NRS score: 0 is equivalent to no pain and 10 indicates the worst pain.

Trial sites (27)

FacilityCityRegionStatus
Chu Amiens Sud Amiens France
Clinique Tivoli-Ducos Bordeaux France
Chu Cote de Nacre - Caen Caen France
Aphp - Antoine Beclere Clamart France
Aphp - Louis Mourier Colombes France
Chi de Creteil Créteil France
Grenoble Grenoble France
Aphp - Kremlin Bicetre Le Kremlin-Bicêtre France
Hop Jeanne de Flandre Chu Lille Lille France
Hopital Croix-Rousse - Hcl Lyon France
Hopital Lyon Sud - Hcl Lyon France
Aphm - Hopital de La Conception Marseille France
Aphm - Hopital Nord Marseille France
Chru Nancy - Maternite Nancy France
Chu de Nantes Site Hotel Dieu Hme Nantes France
Aphp - Pitie Salpetriere Paris France
APHP - COCHIN - gynécologie Paris France
APHP - COCHIN -centre douleur Paris France
GH PARIS SITE SAINT JOSEPH - douleur chronique Paris France
Gh Paris Site Saint Joseph Paris France
Aphp - Hegp Paris France
APHP - Bichat Paris France
Chu La Miletrie Poitiers France
Ch Rene Dubos - Hopital Novo Pontoise France
Hopital Maison Blanche Chu Reims Reims France
Chru Rennes Site Hopital Sud Rennes France
Chu de Saint-Etienne Saint-Etienne France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07317037 on ClinicalTrials.gov ↗ ← All trials in France