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NCT Number: NCT07592403

Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pulsed Electromagnetic Therapy Trans Perineal Ultrasound Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic, faculty of Physical Therapy, Beni Suef University

Banī Suwayf, Egypt

Location status: Recruiting

Location contact

Marwa Elsayed Mohamed Lecturer, Ph.D

CONTACT

[email protected]

01141825442

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed Electromagnetic Field Therapy

Device

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 Pulsed Electromagnetic Field Therapy

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa Elsayed Mohamed Lecturer, Ph.D

CONTACT

[email protected]

01141825442

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis, A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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