Efficacy and Tolerability of TENS in Endometriosis-related Pain

Sponsor
Monath Electronic
Study ID
NCT07393295
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional TENS — DEVICE
    Every TENS treatment lasts for 45 minutes
  • Microstimulation TENS — DEVICE
    Every TENS treatment lasts for 45 minutes

Study Details

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.

Key Dates

First listed
Feb 6, 2026
Start date
Mar 15, 2026
Status verified
Jan 2026
Primary completion
Jun 15, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Conventional TENS Group
    Conventional TENS for 4 weeks
  • Active Comparator: Microstimulation TENS
    Microstimulation TENS for 4 weeks

Primary Outcome Measure

Change in the mean value of average pain [ Time Frame: 56 days ]

Central Contacts

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