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Идёт набор NCT07592403

Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis

Без фазы С лечением Endometriosis Pulsed Electromagnetic Therapy Trans Perineal Ultrasound

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pulsed Electromagnetic Field Therapy, Sham pulsed electromagnetic field therapy.
Кому может быть актуально
Состояния в реестре: Endometriosis, Pulsed Electromagnetic Therapy, Trans Perineal Ultrasound. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Pulsed Electromagnetic Field Therapy
    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 st
  • Устройство Sham pulsed electromagnetic field therapy
    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.

Первичные конечные точки

  • Endometriosis Health Profile-30 (EHP-30) questionnaire [Срок оценки: Baseline, 8 weeks and at 3-month follow-up.]
Вторичные конечные точки (2)
  • Trans-perineal Ultrasound Assessment [Срок оценки: Baseline, 8 weeks and 3-month follow-up.]
  • Pain Intensity scale (VAS) [Срок оценки: Baseline, 8 weeks and 3-month follow-up.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Outpatient clinic, faculty of Physical Therapy, Beni Suef University — Banī Suwayf

Идентификаторы

NCT: NCT07592403 · PEMF IN ENDOMETRIOSIS 2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗