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NOT YET RECRUITING
NCT07317037
NA

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

DEVICE

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).

DEVICE

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