NCT Number: NCT07442487
This study will be conducted to investigate the effect of high-intensity focused electromagnetic field on postnatal diastasis recti.
Trial opening soon.
Get Notified25 year–35 year
Female
Interventional
Not applicable
Rectus diastasis is a prevalent condition that can have adverse health implications for women during both the antenatal and postnatal periods of pregnancy. Diastasis rectus abdominis (DRA) has been found to affect between 30% and 70% of pregnant women, and the increased inter rectus diastasis (IRD) can persist separated in the immediate postpartum period in 35% to 60% of women.
The contraction of all abdominal muscles reduces the abdominal horizontal diameter in such a way that a horizontal force will be generated, producing the approximation of both rectus abdominis muscles, particularly at umbilical level. So, increasing the abdominal muscles strength have proven to bring the left and right sides of the rectus diastasis together, convert the abdomen into a rigid cylinder and minimize the additional stress on the trunk or back.
High-intensity focused electromagnetic technology induces a rapidly changing magnetic field that triggers supramaximal abdominal muscle contractions, not achievable voluntarily. In response, the abdominal muscles grow and strengthen, which lead to a tighter abdomen; thus, increasing the strength and the contour of the abdominal muscles.
To date, few investigations have been conducted to evaluate the effects of high-intensity focused electromagnetic field on changes in the abdominal subcutaneous fat, thickness and separation. But, till now there is no previous study investigated its effect on diastasis recti in postnatal women. Hence, the present study will be conducted to examine the effect of high-intensity focused electromagnetic field on diastasis recti in postnatal women which is anticipated to offer significant benefits to medical service organizations and contribute to the expanding knowledge base of physical therapists in the scientific domain.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: 8 weeks
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
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
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
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
Ultrasound will be used to assess left rectus abdominis thickness before and after the 8-week intervention in both groups. Measurements will be performed by the same radiologist with participants in a supported crook-lying position. The transducer will be positioned perpendicular at the standardized anatomical landmark, and images will be captured at end-expiration.
Time frame: 8 weeks
Right external oblique muscle thickness will be evaluated using diagnostic ultrasound at baseline and post-intervention. All measurements will be performed by the same radiologist with participants in a relaxed crook-lying position. The probe will be placed perpendicular at the designated site, and readings will be recorded at the end of normal expiration.
Time frame: 8 weeks
Thickness of the left external oblique muscle will be assessed by ultrasound at baseline and after 8 weeks. Examinations will be conducted by the same radiologist with participants in a supported crook-lying position. The transducer will be positioned perpendicularly at the standardized location, and measurements will be obtained at end-expiration.
Time frame: 8 weeks
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
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.
Contact information is provided by the study sponsor or research team.
Manal Ahmed El-Shafei Mohamed, PhD
CONTACT
Salsabil Ahmed Hassan, B.Sc
CONTACT
Cairo University
Other
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