ActiTENS Mini (Transcutaneous Electrical Stimulation) in Women With Chronic Pain From Pelvic Endometriosis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
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