Efficacy and Tolerability of TENS in Endometriosis-related Pain

NCT07393295 | Recruiting

• 2 other identifiers: 2025-A02028-41AU 2080
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

ELECTRE is a single-center, randomized, prospective, longitudinal, controlled, two-arm, single-blind study lasting 4 weeks (P1 investigation phase) after a 4-week run-in period. The study is followed by a 4-week extension phase (P2) in which all participants will be treated with active TENS. Randomization will be balanced according to a 1:1 ratio.

Conditions

Pelvic Pain Associated With Endometriosis or Adenomyosis; Pelvic Pain Associated With Refractory Endometriosis; Endometriosis

Outcome Measures

Primary Outcomes (1)

• Change in the mean value of average pain

  Change in the mean value of average pain over the previous 24 hours, measured daily during the P1 investigation phase (between D1 and D28±2), compared with the run-in period (between D-35 and D-8). Participants will assess their average pain over the past 24 hours on a 100 mm visual analog scale (VAS) every day. The average of these daily values will be calculated over the run-in period (between D-35 and D-8), during the P1 investigation phase (between D1 and D28±2), and during the P2 extension phase (between D29±2 and D56±2). The visual analog scale will be available on the data collection tool/website provided and accessible throu PC, tablet or smartphone. The VAS is presented as a 100 mm horizontal line with no boundaries, marked at the left end with "no pain" and at the other end with "worst pain imaginable." Repeated pain measurements during the run-in period will provide a reliable baseline value that takes into account daily variations.

  56 days

Study Arms (2)

Conventional TENS Group

EXPERIMENTAL

Conventional TENS for 4 weeks

Device: Conventional TENS

Microstimulation TENS

ACTIVE COMPARATOR

Microstimulation TENS for 4 weeks

Device: Microstimulation TENS

Interventions

Conventional TENS DEVICE

Every TENS treatment lasts for 45 minutes

Conventional TENS Group

Microstimulation TENS DEVICE

Every TENS treatment lasts for 45 minutes

Microstimulation TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥ 18 years
• Endometriosis and/or adenomyosis diagnosed by imaging and/or histology
• Undergoing continuous, stable, and functional hormone treatment (with no menstruation) for at least 2 months
• No change in hormone treatment planned for the duration of the study
• Chronic pelvic pain for more than 6 months
• Pelvic pain at least equal to 2 out of 3 (on the intensity scale: "0 - None," "1 - Mild," "2 - Moderate," "3 - Severe")
• Agreeing to participate in the study
• Agrees to limit pain relief treatment during the study to level I painkillers paracetamol and Acupan® (nefopam), and the NSAID Antadys® (flurbiprofen)
• Has a computer, tablet, or cell phone with an internet connection
• Is affiliated with a social security system or is a beneficiary of such a system

You may not qualify if:

• Pregnant or breastfeeding women
• Menopausal women
• Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days
• Patients with altered sensitivity in the area where the device is applied (hypoesthesia)
• Skin allergy to the gel or electrodes
• Dermatological problem in the stimulation area
• Patients with an implanted pacemaker or active implanted medical device.
• Epilepsy
• Current thrombophlebitis or arterial thrombosis
• Cancer or malignant disease with an expected survival of \< 12 months
• Alcoholism or drug addiction
• Fibromyalgia
• Women who have already tried TENS
• Patients unable to understand and use the English language to communicate fluently
• Patients with cognitive impairments

Sponsors & Collaborators

• Monath Electronic: lead

Study Sites (1)

IFEM Endo, Clinique Tivoli-Ducos

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Adenomyosis; Endometriosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Bejamin MERLOT

  IFEM Endo, Clinique Tivoli-Ducos, 5 rue Auguste Poirson, 33000 Bordeaux, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas LOBSTEIN

CONTACT

+33-389497361; thomas.lobstein@monath-electronic.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 6, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-01

Locations

FR (1)