ActiTENS Mini (Transcutaneous Electrical Stimulation) in Women With Chronic Pain From Pelvic Endometriosis
ENDOTENS
3 other identifiers
interventional
208
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2025
CompletedFirst Posted
Study publicly available on registry
January 5, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
January 7, 2026
December 1, 2025
1.8 years
December 19, 2025
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
NRS score: 0 is equivalent to no pain and 10 indicates the worst pain.
From the end of the first cross over period (3 months) to the end of the second cross over period (7 months)
Secondary Outcomes (12)
Efficacy of actiTENS mini on the quality of life
0 month (baseline for the first crossover period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months
Efficacy of actiTENS mini on the function of patients (EHP-30 and SFSI)
0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months
Efficacy of actiTENS mini on the quality of life and function of patients (PGIC)
0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months
Number of discharges for ineffectiveness in each group during the 3 months cross-over period
0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months
Better define the analgesic effect of actiTENS mini on endometriosis-related pain by measuring pain using different measures (NRS scale)
0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months
- +7 more secondary outcomes
Study Arms (2)
actiTENS mini - weak stimulation
OTHERAdult women suffering from pain related to confirmed pelvic endometriosis, visiting reference and pain centers will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the DM stimulation mode be assigned by randomization. Patients randomized into this arm will start the study in "actiTENS mini" then "weak stimulation" followed by an open phase where patients can use the DM as they wish.
weak stimulation - actiTENS mini
OTHERAdult women suffering from pain related to confirmed pelvic endometriosis, visiting reference and pain centers will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the DM stimulation mode be assigned by randomization. Patients randomized into this arm will start the study in "weak stimulation" then "actiTENS mini" followed by an open phase where patients can use the DM as they wish.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Chu Amiens Sud
Amiens, 80000, France
Clinique Tivoli-Ducos
Bordeaux, 33000, France
Chu Cote de Nacre - Caen
Caen, 14033, France
Aphp - Antoine Beclere
Clamart, 92140, France
Aphp - Louis Mourier
Colombes, 92700, France
Chi de Creteil
Créteil, 94000, France
Grenoble
Grenoble, 38700, France
Aphp - Kremlin Bicetre
Le Kremlin-Bicêtre, 94275, France
Hop Jeanne de Flandre Chu Lille
Lille, 59000, France
Hopital Croix-Rousse - Hcl
Lyon, 69317, France
Hopital Lyon Sud - Hcl
Lyon, 69495, France
Aphm - Hopital de La Conception
Marseille, 13005, France
Aphm - Hopital Nord
Marseille, 13005, France
Chru Nancy - Maternite
Nancy, 54042, France
Chu de Nantes Site Hotel Dieu Hme
Nantes, 44093, France
Aphp - Pitie Salpetriere
Paris, 75013, France
APHP - COCHIN - gynécologie
Paris, 75014, France
APHP - COCHIN -centre douleur
Paris, 75014, France
GH PARIS SITE SAINT JOSEPH - douleur chronique
Paris, 75014, France
Gh Paris Site Saint Joseph
Paris, 75014, France
Aphp - Hegp
Paris, 75015, France
APHP - Bichat
Paris, 75018, France
Chu La Miletrie
Poitiers, 86021, France
Ch Rene Dubos - Hopital Novo
Pontoise, 95300, France
Hopital Maison Blanche Chu Reims
Reims, 51092, France
Chru Rennes Site Hopital Sud
Rennes, 35200, France
Chu de Saint-Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PERROT Serge
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2025
First Posted
January 5, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
August 1, 2028
Last Updated
January 7, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Two years after the last publication
- Access Criteria
- Data sharing requires approval from both the sponsor and the Principal Investigator (PI), contingent upon a scientific project and the PI team's scientific contribution. The founder may also participate in the decision-making process. Teams seeking to acquire IPD must engage with the sponsor and the IP team to discuss the scientific (and commercial) objectives, the specific IPD required, the preferred data transmission format, and the proposed timeline. The necessity to inform patients about data sharing or the obligation to undertake procedures with data protection authorities will be evaluated. The provision of data through the secure institutional tools of the sponsor AP-HP will be prioritized. Technical feasibility and financial support considerations will precede the obligatory formalization of a contract, including detailed description of data processing and general and specific security measures. The processing must adhere to the European General Data Protection Regulation.
The deidentified individual participant data (IPD) that support the results reported in publications may be shared. Additionally, the IPD outlined in the protocol for a planned meta-analysis may also be made available. A data dictionary defining each field will be made available concurrently with the data transmission.