Actively Recruiting
Efficacy and Tolerability of TENS in Endometriosis-related Pain
Led by Monath Electronic · Updated on 2026-03-31
92
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Tolerability of TENS in Endometriosis-related Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 65 18 years
- Diagnosis of endometriosis and/or adenomyosis confirmed by imaging or histology
- On continuous, stable, and functional hormone treatment with no menstruation for at least 2 months
- No planned changes in hormone treatment during the study
- Chronic pelvic pain lasting more than 6 months
- Pelvic pain intensity of at least 2 out of 3 on the pain scale
- Willingness to participate in the study
- Agreement to limit pain relief medications during the study to paracetamol, nefopam, and flurbiprofen
- Access to a computer, tablet, or cell phone with internet connection
- Affiliated with or beneficiary of a social security system
You will not qualify if you...
- Pregnant or breastfeeding women
- Menopausal women
- Acute worsening of endometriosis symptoms in the last 28 days as judged by the investigator
- Altered skin sensitivity where the device is applied
- Allergy to gel or electrodes used with the device
- Skin problems in the stimulation area
- Presence of implanted pacemaker or active implanted medical device
- Epilepsy
- Current thrombophlebitis or arterial thrombosis
- Cancer or malignant disease with less than 12 months expected survival
- Alcoholism or drug addiction
- Fibromyalgia
- Previous use of TENS
- Inability to understand and communicate fluently in English
- Cognitive impairments
- Untreated severe psychiatric or psychological illness primarily affecting condition
- Participation in another intervention study that could affect results
- Use of more than 90 morphine equivalents per day at least once in last 28 days
- Planned gynecological or endometriosis surgery within next 3 months
- History of endometriosis surgery within last 6 months
- Previous hysterectomy or bilateral oophorectomy
- Under legal protection or deprived of liberty
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IFEM Endo, Clinique Tivoli-Ducos
Bordeaux, France, 33000
Actively Recruiting
Research Team
T
Thomas LOBSTEIN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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