Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis
15 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Marwa Elsayed Mohamed Lecturer, Ph.D
- Número de teléfono: 01141825442
- Correo electrónico: Marwa.elsayed@pt.bsu.edu.eg
Ubicaciones de estudio
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Banī Suwayf, Egipto
- Reclutamiento
- Outpatient clinic, faculty of Physical Therapy, Beni Suef University
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Contacto:
- Marwa Elsayed Mohamed Lecturer, Ph.D
- Número de teléfono: 01141825442
- Correo electrónico: Marwa.elsayed@pt.bsu.edu.eg
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador falso: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Endometriosis Health Profile-30 (EHP-30) questionnaire
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Trans-perineal Ultrasound Assessment
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de mayo de 2026
Finalización primaria (Estimado)
20 de enero de 2027
Finalización del estudio (Estimado)
30 de enero de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de mayo de 2026
Publicado por primera vez (Actual)
18 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PEMF IN ENDOMETRIOSIS 2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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