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ActiTENS Mini (Transcutaneous Electrical Stimulation) in Women With Chronic Pain From Pelvic Endometriosis
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Official title: ActiTENS Mini (Transcutaneous Electrical Stimulation) in Women With Chronic Pain From Pelvic Endometriosis : a Randomized, Controlled Multicenter Cross-over Study Compared to Weak TENS Treatment, Followed by an Open-label Extension Phase
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
208
Start Date
2026-03-01
Completion Date
2028-08-01
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (27)
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