EndometriosisNCT07592403
Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis
A study testing Pulsed Electromagnetic Field Therapy in people with Endometriosis and Pulsed Electromagnetic Therapy, run by Beni-Suef University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Pulsed Electromagnetic Therapy, Trans Perineal Ultrasound
- What is being tested?
- Pulsed Electromagnetic Field Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 16 May 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic, faculty of Physical Therapy, Beni Suef University
Banī Suwayf
Marwa Elsayed Mohamed Lecturer, Ph.D, 01141825442, Marwa.elsayed@pt.bsu.edu.eg
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Pulsed Electromagnetic Field Therapy, Sham pulsed electromagnetic field therapy
- Keywords
- Endometriosis, Pulsed Electromagnetic Field Therapy, trans perineal ultrasound
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Field TherapyDevice
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 therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Electromagnetic Field Therapy Group | Experimental | Participants in this group will receive pulsed electromagnetic field therapy in addition to stable standard medical care. Receives: Device: Pulsed Electromagnetic Field Therapy |
| 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. Receives: Device: Sham pulsed electromagnetic field therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks and at 3-month follow-up.
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline, 8 weeks and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start16 May 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Elsayed Mohamed, PhD, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592403
- Sponsor's protocol ID
- PEMF IN ENDOMETRIOSIS 2026
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07592403
- Acronym / sponsor ID
- PEMF IN ENDOMETRIOSIS 2026
- Keywords
- Endometriosis, Pulsed Electromagnetic Field Therapy, trans perineal ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 16 May 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Electromagnetic Field Therapy Group | Experimental | Device: Pulsed Electromagnetic Field TherapyParticipants in this group will receive pulsed electromagnetic field therapy in addition to stable standard medical care. |
| Sham Pulsed Electromagnetic Field Therapy Group | Sham comparator | Device: Sham pulsed electromagnetic field therapyParticipants in this group will receive sham pulsed electromagnetic field therapy sessions in addition to stable standard medical care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electromagnetic Field TherapyPEMF 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. | Device | Pulsed Electromagnetic Field Therapy Group |
| Sham pulsed electromagnetic field therapyParticipants 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. | Device | Sham Pulsed Electromagnetic Field Therapy Group |
Primary outcome
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.
2 secondary outcomes
Trans-perineal Ultrasound Assessment
Time frame: Baseline, 8 weeks and 3-month follow-up.
Pain Intensity scale (VAS)
Time frame: Baseline, 8 weeks and 3-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Field Therapy in people with Endometriosis and Pulsed Electromagnetic Therapy, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Elsayed Mohamed Lecturer, Ph.D (01141825442, Marwa.elsayed@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis Health Profile-30 (EHP-30) questionnaire (time frame: Baseline, 8 weeks and at 3-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.