Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBeni-Suef University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pulsed Electromagnetic Field Therapy
DevicePEMF 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.
Sham pulsed electromagnetic field therapy
DeviceParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Pulsed Electromagnetic Field Therapy GroupExperimental treatment 1 intervention
Group B: Sham Pulsed Electromagnetic Field Therapy GroupSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 8 weeks and at 3-month follow-up.Secondary outcomes
1
Trans-perineal Ultrasound Assessment
Four-dimensional transperineal ultrasound (4D TPUS) will be used to quantitatively assess levator hiatal area in women with endometriosis. Levator hiatal area is a sensitive and comprehensive indicator of pelvic floor function because it reflects overall levator hiatus dimensions and distensibility. In women with endometriosis, it may provide an objective marker of pelvic floor muscle dysfunction and treatment-related functional changes. Ultrasound examination will be performed by a blinded assessor with participants in the lithotomy position using a transperineal convex probe (3-8 MHz) following standardized bladder emptying procedures. Measurements will be obtained at rest, during maximal voluntary pelvic floor contraction, and during maximal Valsalva maneuver. Levator hiatal area will be recorded in square centimeters (cm²).
Time frame
Baseline, 8 weeks and 3-month follow-up.2
Pain Intensity scale (VAS)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain.
Time frame
Baseline, 8 weeks and 3-month follow-up.Sponsors and contacts
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Source ClinicalTrials.gov