Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis
15 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Marwa Elsayed Mohamed Lecturer, Ph.D
- Telefoonnummer: 01141825442
- E-mail: Marwa.elsayed@pt.bsu.edu.eg
Studie Locaties
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Banī Suwayf, Egypte
- Werving
- Outpatient clinic, faculty of Physical Therapy, Beni Suef University
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Contact:
- Marwa Elsayed Mohamed Lecturer, Ph.D
- Telefoonnummer: 01141825442
- E-mail: Marwa.elsayed@pt.bsu.edu.eg
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Pulsed Electromagnetic Field Therapy Group
Participants in this group will receive pulsed electromagnetic field therapy in addition to stable standard medical care.
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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.
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Sham-vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Endometriosis Health Profile-30 (EHP-30) questionnaire
Tijdsspanne: Baseline, 8 weeks and at 3-month follow-up.
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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.
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Baseline, 8 weeks and at 3-month follow-up.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Trans-perineal Ultrasound Assessment
Tijdsspanne: Baseline, 8 weeks and 3-month follow-up.
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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).
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Baseline, 8 weeks and 3-month follow-up.
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Pain Intensity scale (VAS)
Tijdsspanne: Baseline, 8 weeks and 3-month follow-up.
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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.
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Baseline, 8 weeks and 3-month follow-up.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
16 mei 2026
Primaire voltooiing (Geschat)
20 januari 2027
Studie voltooiing (Geschat)
30 januari 2027
Studieregistratiedata
Eerst ingediend
11 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
14 mei 2026
Eerst geplaatst (Werkelijk)
18 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
15 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PEMF IN ENDOMETRIOSIS 2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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