- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07592403
Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis
May 15, 2026 updated by: Marwa Elsayed Mohamed, PhD, Beni-Suef University
Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis, A Randomized Controlled 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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Endometriosis is a chronic inflammatory gynecological disorder characterized by ectopic endometrial tissue growth and commonly associated with chronic pelvic pain, dysmenorrhea, dyspareunia, and impaired quality of life.
Myofascial dysfunction and pelvic floor muscle hypertonia are increasingly recognized as contributing factors to persistent pain and pelvic floor dysfunction in women with endometriosis.
Pulsed electromagnetic field therapy (PEMF) is a non-invasive physical modality with reported analgesic, anti-inflammatory, and tissue-healing effects in musculoskeletal and chronic pain disorders.
However, evidence regarding its use in women with endometriosis remains limited.
Therefore, this study aims to evaluate the effectiveness of PEMF therapy on pain severity, disease-specific quality of life, and pelvic floor morphometric changes assessed using four-dimensional trans perineal ultrasound (4D TPUS).
The study will also investigate whether improvements in ultrasound-derived levator hiatal dimensions and pelvic floor relaxation are associated with clinically meaningful reductions in chronic pelvic pain.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marwa Elsayed Mohamed Lecturer, Ph.D
- Phone Number: 01141825442
- Email: Marwa.elsayed@pt.bsu.edu.eg
Study Locations
-
-
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Banī Suwayf, Egypt
- Recruiting
- Outpatient clinic, faculty of Physical Therapy, Beni Suef University
-
Contact:
- Marwa Elsayed Mohamed Lecturer, Ph.D
- Phone Number: 01141825442
- Email: Marwa.elsayed@pt.bsu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pulsed Electromagnetic Field Therapy Group
Participants in this group will receive pulsed electromagnetic field therapy in addition to stable standard medical care.
|
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.
|
|
Sham Comparator: Sham Pulsed Electromagnetic Field Therapy Group
Participants in this group will receive sham pulsed electromagnetic field therapy sessions in addition to stable standard medical care.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endometriosis Health Profile-30 (EHP-30) questionnaire
Time Frame: Baseline, 8 weeks and at 3-month follow-up.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trans-perineal Ultrasound Assessment
Time Frame: Baseline, 8 weeks and 3-month follow-up.
|
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).
|
Baseline, 8 weeks and 3-month follow-up.
|
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Pain Intensity scale (VAS)
Time Frame: Baseline, 8 weeks and 3-month follow-up.
|
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.
|
Baseline, 8 weeks and 3-month follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2026
Primary Completion (Estimated)
January 20, 2027
Study Completion (Estimated)
January 30, 2027
Study Registration Dates
First Submitted
May 11, 2026
First Submitted That Met QC Criteria
May 14, 2026
First Posted (Actual)
May 18, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEMF IN ENDOMETRIOSIS 2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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