NCT07592403

Brief Summary

This randomized, sham-controlled, double-blinded clinical trial aims to investigate the effects of pulsed electromagnetic field therapy (PEMF) on pain intensity, quality of life, and pelvic floor morphometric changes assessed by four-dimensional trans perineal ultrasound (4D TPUS) in women diagnosed with endometriosis. Participants will be randomly allocated into either a PEMF therapy group or a sham PEMF control group. Both groups will continue receiving stable standard medical care throughout the study period. Assessments will be conducted at baseline, after completion of the 8-week intervention period, and at 3-month follow-up.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Jan 2027

First Submitted

Initial submission to the registry

May 11, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

May 16, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2027

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 11, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

EndometriosisPulsed Electromagnetic Field Therapytrans perineal ultrasound

Outcome Measures

Primary Outcomes (1)

  • Endometriosis Health Profile-30 (EHP-30) questionnaire

    The Endometriosis Health Profile-30 questionnaire will be used to assess disease-specific quality of life. The EHP-30 evaluates pain, emotional well-being, control and powerlessness, social support, and self-image. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating poorer health-related quality of life.

    Baseline, 8 weeks and at 3-month follow-up.

Secondary Outcomes (2)

  • Trans-perineal Ultrasound Assessment

    Baseline, 8 weeks and 3-month follow-up.

  • Pain Intensity scale (VAS)

    Baseline, 8 weeks and 3-month follow-up.

Study Arms (2)

Pulsed Electromagnetic Field Therapy Group

EXPERIMENTAL

Participants in this group will receive pulsed electromagnetic field therapy in addition to stable standard medical care.

Device: Pulsed Electromagnetic Field Therapy

Sham Pulsed Electromagnetic Field Therapy Group

SHAM COMPARATOR

Participants in this group will receive sham pulsed electromagnetic field therapy sessions in addition to stable standard medical care.

Device: Sham pulsed electromagnetic field therapy

Interventions

PEMF will be applied using a low-frequency pulsed electromagnetic stimulation device with sinusoidal waveform output targeting the lower abdominal and pelvic regions. Treatment sessions will be administered three times weekly for 8 consecutive weeks, with each session lasting approximately 20 minutes. Treatment parameters will include pulsed frequency ranging from 10 Hz, magnetic field intensity ranging from 2 mT, and pulse duration ranging from 250 microseconds. Standard medical care include stable hormonal therapy and prescribed analgesic medications without modification during the study period.

Pulsed Electromagnetic Field Therapy Group

Participants in this group will receive sham pulsed electromagnetic field therapy sessions in addition to stable standard medical care. The sham device will appear identical to the active device in shape, sound, and operating indicators without delivering therapeutic electromagnetic output. Session duration, participant positioning, and treatment frequency will match those of the experimental group.

Sham Pulsed Electromagnetic Field Therapy Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18 to 45 years
  • Clinically, radiologically, or laparoscopically diagnosed endometriosis
  • Chronic pelvic pain persisting for at least 6 months
  • Stable pharmacological or hormonal treatment for at least 3 months before enrollment
  • Ability to understand study procedures and provide written informed consent

You may not qualify if:

  • Pregnancy or planned pregnancy during the study period
  • History of gynecological or pelvic malignancy
  • Active pelvic inflammatory disease or acute pelvic infection
  • Implanted electronic medical devices such as pacemakers or neurostimulators
  • Previous pelvic surgery within the past 6 months
  • Participation in another clinical trial during the previous 3 months
  • Neurological, rheumatological, or severe musculoskeletal disorders affecting assessment procedures
  • Contraindications to electromagnetic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic, faculty of Physical Therapy, Beni Suef University

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Marwa Elsayed Mohamed Lecturer, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors will be blinded to group allocation. The sham device will appear identical to the active device in shape, sound, and operating indicators without delivering therapeutic electromagnetic output. Treating therapists will not participate in outcome assessment or data analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physiotherapy for Women Health

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 18, 2026

Study Start

May 16, 2026

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations