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EndometriosisENDOTENSNCT07317037

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

A study testing actiTENS mini - weak stimulation and weak stimulation - actiTENS mini in people with Endometriosis, run by Assistance Publique - Hôpitaux de Paris at 27 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometriosis
What is being tested?
actiTENS mini - weak stimulation and weak stimulation - actiTENS mini
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
27 sitesFrance
Study dates
1 Mar 2026to 1 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shohreh AZIMI contact

+33144841779

shohreh.azimi@aphp.fr

LE MAO Laura contact

+33156095497

laura.le-mao@aphp.fr

27 sites in 1 country

France27 sites

  • Chu Amiens Sud

    Amiens, 80000

    FOULON ARTHUR, Foulon.Arthur@chu-amiens.fr

  • Clinique Tivoli-Ducos

    Bordeaux, 33000

    ROMAN HORACE, 05 64 10 09 45, horace.roman@gmail.com

  • Chu Cote de Nacre - Caen

    Caen, 14033

    JAMARD ESTELLE, 02 31 06 31 06, jamard-e@chu-caen.fr

  • Aphp - Antoine Beclere

    Clamart, 92140

    DEFFIEUX XAVIER, 01 45 37 44 87, xavier.deffieux@aphp.fr

  • Aphp - Louis Mourier

    Colombes, 92700

    SIFFERT MARC, 01 47 60 63 39, marc.siffert@aphp.fr

  • Chi de Creteil

    Créteil, 94000

    SALHI YANN, 01 57 02 22 44, Yann.Salhi@chicreteil.fr

  • Grenoble

    Grenoble, 38700

    MICHY THIERRY, 04 76 76 75 75, tmichy@chu-grenoble.fr

  • Aphp - Kremlin Bicetre

    Le Kremlin-Bicêtre, 94275

    CAPMAS PERRINE, 01 45 21 77 14, perrine.capmas@aphp.fr

  • Hop Jeanne de Flandre Chu Lille

    Lille, 59000

    RUBOD DIT GUILLET CHRYSTELLE, 03 20 44 67 57, Chrystele.RUBODDITGUILLET@chu-lille.fr

  • Hopital Croix-Rousse - Hcl

    Lyon, 69317

    DUBERNARD GIL, 04 72 07 16 42, gil.dubernard@chu-lyon.fr

  • Hopital Lyon Sud - Hcl

    Lyon, 69495

    BOLZE PIERRE-ADRIEN, 04 78 86 65 96, pierre-adrien.bolze@chu-lyon.fr

  • Aphm - Hopital de La Conception

    Marseille, 13005

    PIVANO AUDREY, 04 91 38 37 02, audrey.pivano@ap-hm.fr

  • Aphm - Hopital Nord

    Marseille, 13005

    NETTER ANTOINE, 04 91 38 00 00, Antoine.NETTER@ap-hm.fr

  • Chru Nancy - Maternite

    Nancy, 54042

    MARTIN ELENA, 03 83 85 82 21, E.MARTIN@chru-nancy.fr

  • Chu de Nantes Site Hotel Dieu Hme

    Nantes, 44093

    CARDAILLAC Claire, Claire.CARDAILLAC@chu-nantes.fr

  • Aphp - Pitie Salpetriere

    Paris, 75013

    FAVIER AMELIA, 01 42 17 81 33, amelia.favier@aphp.fr

  • APHP - COCHIN - gynécologie

    Paris, 75014

    MARCELLIN Louis, 01 58 41 36 61, louis.marcellin@aphp.fr

  • APHP - COCHIN -centre douleur

    Paris, 75014

    PERROT Serge, +33 1 58 41 15 40, serge.perrot@aphp.fr

  • GH PARIS SITE SAINT JOSEPH - douleur chronique

    Paris, 75014

    FREMAUX MARGOT, 01 44 12 61 80, mfremaux@ghpsj.fr

  • Gh Paris Site Saint Joseph

    Paris, 75014

    ABO CAROLE, 01 44 12 84 84, cabo@ghpsj.fr

  • Aphp - Hegp

    Paris, 75015

    BATS ANNE-SOPHIE, 01 56 09 35 86, anne-sophie.bats@aphp.fr

  • APHP - Bichat

    Paris, 75018

    KOSKAS MARTIN, 01 40 25 76 10, martin.koskas@aphp.fr

  • Chu La Miletrie

    Poitiers, 86021

    RANNOU DELPHINE, 05 49 44 39 15, Delphine.RANNOU@chu-poitiers.fr

  • Ch Rene Dubos - Hopital Novo

    Pontoise, 95300

    PONCELET CHRISTOPHE, 01 30 75 40 75, christophe.poncelet@ght-novo.fr

  • Hopital Maison Blanche Chu Reims

    Reims, 51092

    GRAESSLIN OLIVIER, 03 26 78 35 17, ograesslin@chu-reims.fr

  • Chru Rennes Site Hopital Sud

    Rennes, 35200

    Nyangoh Timoh KRYSTEL, 02 99 26 71 20, Krystel.NYANGOH.TIMOH@chu-rennes.fr

  • Chu de Saint-Etienne

    Saint-Etienne, 42055

    CHAULEUR CELINE, 04 77 82 86 11, celine.chauleur@chu-st-etienne.fr

Other trials in France

About this study

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

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.

Read the detailed description

The study will be proposed to women of adult age during a routine consultation for endometriosis-related pain, in gynecology and pain centers, in France, if they meet the inclusion and exclusion criteria of the study.

Information will be given to them and a necessary period of reflection not exceeding one week will be granted to them.

First phase: a cross-over trial After giving their informed consent, women will be included and randomized either to the actiTENS mini treatment arm or to the low activity treatment arm for 3 months, followed by a wash out period of 28 days. After this first cross-over period, women initially randomized to the actiTENS mini arm will be switched to the low activity arm for 3 months, inversely patients initially in the low activity treatment arm will be switched to the actiTENS mini treatment for the same duration of 3 months.

During the first cross-over study, women will be treated 60 minutes twice daily by a TENS device applied both on the pelvic anterior and sacral posterior region, with the P2 program.

Second phase: an open-label trial After a wash out period of 28 days, all patients will enter the 3-month open phase where only actiTENS mini treatment will be prescribed for 3 months, women choosing freely the region of stimulation (anterior, posterior or both), the program of stimulation and the duration of stimulation.

Conditions
Endometriosis
Being tested
actiTENS mini - weak stimulation, weak stimulation - actiTENS mini
Keywords
pain, endometriosis, trans-cutaneous electrical stimulation, medical device
Medical subject headings
Endometriosis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • actiTENS mini - weak stimulationDevice

    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 miniDevice

    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 groups in NCT07317037
Study groupRoleWhat they receive
actiTENS mini - weak stimulationOtherAdult 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.
Receives: Device: actiTENS mini - weak stimulation
weak stimulation - actiTENS miniOtherAdult 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.
Receives: Device: weak stimulation - actiTENS mini

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Efficacy of actiTENS mini on the quality of life

    Quality of life is measured by EuroQol-5D.

    Measured: 0 month (baseline for the first crossover period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months

  2. Efficacy of actiTENS mini on the function of patients (EHP-30 and SFSI)

    Specific functional scores of endometriosis: EHP-30 and SFSI. EHP30 questionnaire is comprised of two parts, the first being the core questionnaire, which consist of five scales (pain, control and powerlessness, emotional wellbeing, social support, and self-image) and contained a total of 30 items. The items within the scales are summed to create a raw score and then each scale was translated into a score ranging from 0 (best health status) to 100 (worst health status)

    Measured: 0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months

  3. Efficacy of actiTENS mini on the quality of life and function of patients (PGIC)

    Global impression of change (PGIC). With this scale, the patient reflects on their perception of the efficacy of the intervention on their limitations regarding activities, symptoms, emotions, and overall quality of life. It consists of a 7-point verbal scale, with the options "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", and "very much worse"

    Measured: 0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months

  4. Number of discharges for ineffectiveness in each group during the 3 months cross-over period

    Measured: 0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months

  5. Better define the analgesic effect of actiTENS mini on endometriosis-related pain by measuring pain using different measures (NRS scale)

    • Current pain intensity on a NRS from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
    • Background average pain (NRS) over the previous 28 days
    • Pain intensity during flares (NRS)
    • Number of patients with a reduction of 30 and 50% in current pain intensity (NRS)
    • Number of days with pain greater than or equal to 4/10 in the previous 28 days

    Measured: 0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months

  6. Better define the analgesic effect of actiTENS mini on endometriosis-related pain by measuring pain (BPI score)

    Generic functional pain score: BPI score.

    Measured: 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. Better define the analgesic effect of actiTENS mini on endometriosis-related pain by measuring pain

    Percentage of Pain Relief since the start of the treatment (% from 0 to 100% of pain relief)

    Measured: 0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months

  8. Define the pain profile of responders patients at baseline for actiTENS mini in endometriosis-related pain

    At the first visit of each phase, a precise evaluation of pelvic pain (location, flares, neuropathic (DN4 questionnaire) and nociplastic component (IASP algorithm for nociplastic pain)), body diagram of pain, and psychological symptoms (HADs questionnaire) of the patients will be carried out, to define the pain phenotypes of patients responding to the treatment (a responder patient is defined as a patient with an average reduction in NRS pain over the last 28 days of 30 to 50% compared to baseline).

    Measured: 0 month (baseline of the first cross over period), 4 months (baseline of the second period), 8 months (baseline of the third period)

  9. Description of the optimal use of actiTENS mini in endometriosis-related pain in routine utilization

    During the open-label third phase, at the end (11 months), we will describe the preferred modalities of actiTENS mini use in practice by the patients most of the time (>70%) during this 3-month open label period: TENS programs, TENS electrode location, duration and frequency of stimulation. Quality of life and function questionnaires and measures of pain will also be measured during this third phase.

    Measured: 11 months

  10. Comparison of care consumption over the cross-over study periods (Analgesic treatments consumed )

    Analgesic treatments consumed since the previous visit at 0, 1, 3, 4, 5, 7 months

    Measured: 0 month (baseline for the first period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months

  11. Comparison of care consumption over the cross-over study periods (Visits, hospitalizations, emergencies)

    Visits, hospitalizations, emergencies over the 3 previous months at 3 and 7 months

    Measured: 3 months and 7 months

  12. Device utilization and tolerability of actiTENS mini in the treatment of chronic pain of moderate to severe intensity from endometriosis

    Device utilization and tolerability every month through the application by the connected device (type of adverse events and date of occurrence, number of discharges for adverse effects in each group, terms of use of the TENS in case of adverse event).

    Measured: 1, 2, 3, 5, 6, 7, 9, 10, 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
A randomized, multicenter, prospective, controlled, cross-over study followed by an open-label study.
Masking
None (open label)
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07317037
Sponsor's protocol ID
APHP240907
Other IDs
PHRC-23-0046, 2025-A00238-41
Acronym
ENDOTENS
Status last verified
Dec 2025
First submitted
19 Dec 2025
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing actiTENS mini - weak stimulation and weak stimulation - actiTENS mini in people with Endometriosis, run by Assistance Publique - Hôpitaux de Paris at 27 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shohreh AZIMI (+33144841779, shohreh.azimi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From the end of the first cross over period (3 months) to the end of the second cross over period (7 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07317037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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