ActiTENS Mini (Transcutaneous Electrical Stimulation) in Women With Chronic Pain From Pelvic Endometriosis
NCT ID: NCT07317037
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
208 participants
INTERVENTIONAL
2026-03-01
2028-08-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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actiTENS mini - weak stimulation
Adult 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.
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
Adult 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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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SUBLIMED (Donation of DMs and application development)
UNKNOWN
Ministry of Health, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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PERROT Serge
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PHRC-23-0046
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2025-A00238-41
Identifier Type: OTHER
Identifier Source: secondary_id
APHP240907
Identifier Type: -
Identifier Source: org_study_id
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