Effect of High Intensity Focused Electromagnetic Field on Postnatal Diastasis Recti
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 42
- Primary Endpoint
- Inter-recti distance (IRD) 3 cm above the umbilicus
Overview
Brief Summary
This study will be conducted to investigate the effect of high-intensity focused electromagnetic field on postnatal diastasis recti.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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/cm
- •All women will be of sedentary lifestyle.
- •They will be clinically and medically stable when attending the study.
Exclusion Criteria
- •Cardiac disorders.
- •Active cancer.
- •Medical condition contraindicating the application of an electromagnetic field as epilepsy or having metal implants
- •Abdominal or back surgery.
- •Abdominal hernia.
- •History of abnormal pregnancy, uterine fibroid or polyhydramnios during pregnancy.
- •Neurological disorders as multiple sclerosis, stroke and spinal lesion.
- •Musculoskeletal diseases such as fractures and muscle strains which may affect their physical activity.
Arms & Interventions
High-intensity focused electromagnetic field + A program of abdominal exercises
It will consist of 21 postpartum women who will receive high-intensity focused electromagnetic field for 30 minutes, 2 times /week for 8 weeks, in addition to a program of abdominal exercises for 20 minutes, 3 times /week for 8 weeks.
Intervention: A program of abdominal exercises (Other)
A program of abdominal exercises
It will consist of 21 postpartum women who will only participate into a program of abdominal exercises, 20 minutes, 3 times /week for 8 weeks.
Intervention: A program of abdominal exercises (Other)
High-intensity focused electromagnetic field + A program of abdominal exercises
It will consist of 21 postpartum women who will receive high-intensity focused electromagnetic field for 30 minutes, 2 times /week for 8 weeks, in addition to a program of abdominal exercises for 20 minutes, 3 times /week for 8 weeks.
Intervention: High-intensity focused electromagnetic field (Device)
Outcomes
Primary Outcomes
Inter-recti distance (IRD) 3 cm above the umbilicus
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.
Inter-recti distance at the level of the umbilicus
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.
Inter-recti distance 3 cm below the umbilicus
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.
Right rectus abdominis muscle thickness
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.
Left rectus abdominis muscle thickness
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.
Right external oblique muscle thickness
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.
Left external oblique muscle thickness
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.
Secondary Outcomes
- one-minute sit-up test(8 weeks)
- Inventory of Functional Status After Childbirth (IFSAC) questionnaire(8 weeks)
Investigators
Salsabil Ahmed Hassan
Principal Investigator
Cairo University