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

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

Overview

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.

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.

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
• 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

Primary outcome measures

• 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)]

Secondary outcome measures (12)

• Efficacy of actiTENS mini on the quality of life [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: 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 (BPI score) [Time frame: 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 [Time frame: 0 month (baseline for the first cross over period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months]
• Define the pain profile of responders patients at baseline for actiTENS mini in endometriosis-related pain [Time frame: 0 month (baseline of the first cross over period), 4 months (baseline of the second period), 8 months (baseline of the third period)]
• Description of the optimal use of actiTENS mini in endometriosis-related pain in routine utilization [Time frame: 11 months]
• Comparison of care consumption over the cross-over study periods (Analgesic treatments consumed ) [Time frame: 0 month (baseline for the first period), 1 month, 3 months, 4 months (baseline for the second period), 5 months, 7 months]
• Comparison of care consumption over the cross-over study periods (Visits, hospitalizations, emergencies) [Time frame: 3 months and 7 months]
• Device utilization and tolerability of actiTENS mini in the treatment of chronic pain of moderate to severe intensity from endometriosis [Time frame: 1, 2, 3, 5, 6, 7, 9, 10, 11 months]

Eligibility criteria

Inclusion criteria

• 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.
• 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

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

France · 27 centers

• Chu Amiens Sud — Amiens
• Clinique Tivoli-Ducos — Bordeaux
• Chu Cote de Nacre - Caen — Caen
• Aphp - Antoine Beclere — Clamart
• Aphp - Louis Mourier — Colombes
• Chi de Creteil — Créteil
• Grenoble — Grenoble
• Aphp - Kremlin Bicetre — Le Kremlin-Bicêtre
• … and 19 more centers

Identifiers

NCT: NCT07317037 · APHP240907 · PHRC-23-0046 · 2025-A00238-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗