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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Electromagnetic Field Therapy Group | Experimental | Participants in this group will receive pulsed electromagnetic field therapy in addition to stable standard medical care. |
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| Sham Pulsed Electromagnetic Field Therapy Group | Sham Comparator | Participants in this group will receive sham pulsed electromagnetic field therapy sessions in addition to stable standard medical care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Endometriosis Health Profile-30 (EHP-30) questionnaire | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Trans-perineal Ultrasound Assessment | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwa Elsayed Mohamed Lecturer, Ph.D | Contact | 01141825442 | Marwa.elsayed@pt.bsu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic, faculty of Physical Therapy, Beni Suef University | Recruiting | Banī Suwayf | Egypt |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Participants and outcome assessors will be blinded to group allocation. The sham device will appear identical to the active device in shape, sound, and operating indicators without delivering therapeutic electromagnetic output. Treating therapists will not participate in outcome assessment or data analysis.
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| 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. |
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| Baseline, 8 weeks and 3-month follow-up. |
| Pain Intensity scale (VAS) | 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. |
| D000091662 | Genital Diseases |