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Effect of High Intensity Focused Electromagnetic Field on Postnatal Diastasis Recti

ConditionDiastasis Recti
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-35
SponsorCairo University

About this trial

This study will be conducted to investigate the effect of high-intensity focused electromagnetic field on postnatal diastasis recti.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postnatal women (6 months after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus) diagnosed and referred from the obstetrician.

Multiparous women (2-3) times delivered vaginally with or without episiotomy.

Their ages will range from 25 -35 years old.

Their BMI will be less than 30 kg/cm2.

Disqualifiers

Cardiac disorders.

Active cancer.

Medical condition contraindicating the application of an electromagnetic field as epilepsy or having metal implants

Abdominal or back surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • A program of abdominal exercises

    Other intervention

    All women in both groups will be adhered to a program of abdominal strengthening exercise that includes static abdominal, abdominal crunch, and external oblique exercises. Each exercise will be repeated 15 times and will be increased by five repetitions each week throughout the study period, with total time of 20 minutes/ session, 3 times weekly for 8 weeks.

  • High-intensity focused electromagnetic field

    Device

    High-intensity focused electromagnetic field will be administered only to the experimental group, targeting the abdominal region for 30 minutes per session, twice weekly for 8 weeks. Sessions will be performed in the supine position, with the applicator centered over the umbilicus and secured to prevent movement. Stimulation intensity will start at 0% and be gradually increased to achieve strong yet tolerable muscle contractions, guided by continuous visual monitoring and patient feedback to ensure comfort and uniform abdominal activation.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: A program of abdominal exercisesActive comparator 1 intervention
Group B: High-intensity focused electromagnetic field + A program of abdominal exercisesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Inter-recti distance (IRD) 3 cm above the umbilicus

IRD at 3 cm above the umbilicus will be measured using diagnostic ultrasound to assess upper abdominal rectus separation. Assessments will be performed at baseline and after 8 weeks for both groups by the same radiologist. Participants will be positioned in relaxed crook-lying, with the transducer placed perpendicular to the linea alba. Measurements will be taken at the end of normal expiration.

Time frame
8 weeks
2

Inter-recti distance at the level of the umbilicus

IRD at the umbilical level will be evaluated using real-time ultrasound at baseline and post-intervention for all participants. Examinations will be conducted by the same radiologist under standardized conditions. With participants in a relaxed crook-lying position, the transducer will be positioned over the umbilicus, and IRD will be measured between the medial borders of the rectus muscles at end-expiration.

Time frame
8 weeks
3

Inter-recti distance 3 cm below the umbilicus

IRD 3 cm below the umbilicus will be assessed by ultrasound to reflect lower abdominal rectus separation. Measurements will be obtained at baseline and after 8 weeks for both groups by the same radiologist. Participants will lie in a supported crook-lying position, with the transducer placed perpendicular to the linea alba, and readings taken at the end of normal expiration.

Time frame
8 weeks
4

Right rectus abdominis muscle thickness

Thickness of the right rectus abdominis will be measured using ultrasound at baseline and after 8 weeks for all participants. Assessments will be conducted by the same radiologist with participants in a relaxed crook-lying position. The probe will be placed perpendicular at the umbilical-midintercostal intersection, and measurements will be taken at the end of normal expiration.

Time frame
8 weeks

Secondary outcomes

1

one-minute sit-up test

Abdominal muscle strength and endurance will be evaluated before and after the intervention using the one-minute sit-up test. Participants will lie supine with knees flexed and feet stabilized, then perform as many sit-ups as possible within one minute. Each repetition involves touching the knees with the elbows and returning to the floor. The total number of repetitions will be recorded, with higher scores indicating greater abdominal strength and endurance.

Time frame
8 weeks
2

Inventory of Functional Status After Childbirth (IFSAC) questionnaire

Functional status will be assessed using the Inventory of Functional Status After Childbirth (IFSAC) questionnaire. All participants in Groups A and B will complete the questionnaire at baseline and after completion of the study program. The IFSAC is a validated and reliable instrument designed to evaluate postpartum functional performance across five domains: infant care, personal care, household activities, social and community participation, and occupational activities. The questionnaire consists of 36 items rated on a four-point scale, with higher mean scores indicating better functional status.

Time frame
8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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