Clinical trial NCT05900856: Effect of Ultrasound Cavitation on Static and Dynamic Balance in Obese Postnatal Women With Diastasis Recti
Official title: Effect of Ultrasound Cavitation on Static and Dynamic Balance in Obese Postnatal Women With Diastasis Recti
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectus Diastasis
Keywords: Ultrasound Cavitation, Static Balance, Dynamic Balance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ultrasound cavitation and low caloric diet regimen
Primary purpose: TREATMENT

Brief summary: the aim of this study is to investigate the efficacy of ultrasound cavitation on static and dynamic balance in obese postnatal women with diastasis recti

Detailed description: Rectus diastasis defined as the widening of the linea alba by more than 2 cm at the midline. A great proportion of pregnant women are complaining from rectus diastasis during pregnancy reaching 100% of all women that may continue for years after delivery in 66% of women, and do not return to the first state automatically. This occurs due to a combination of physiologic, hormonal and mechanical factors, leading to reduction of abdominal muscle functional strength, increased low back pain out of increased lumbar hyperlordosis and postural instability, which may seriously disable woman from taking care of her baby, perform her daily activities. Weight gain is one of the predisposing factors that increases the possibility of developing rectus diastasis postpartum. Being obese increases liability to have rectus diastasis as carrying excess abdominal fats puts greater pressure against linea alba and can develop or aggravate symptoms for both men and women. This massively displaces the center of gravity anteriorly, disturbs body balance, increases joint loads and influences negatively pelvis posture leading to increased anterior pelvic tilt with subsequent exaggerated lumbar hyperlordosis. Ultrasound cavitation is the most revolutionary method that destroys excess body fat through creating microbubbles and releasing energy that breaks down fat cells. This trial has two groups: one will be treated by low caloric diet regimen only and the second one will be treated by ultrasound cavitation in addition to low caloric diet regimen for eight weeks

Eligibility criteria: Inclusion Criteria:

1. All women had a diastasis recti more than 2.5 cm and less than 4 cm in supra umbilical region.
2. Their ages were ranged from 25: 35 years.
3. Their BMI was more than 30 Kg/ m2.
4. All women were with lumbar hyperlordosis.
5. All women were multipara.
6. Their mode of delivery was normal vaginal delivery.
7. They were selected from 2: 5 months postnatal.

Exclusion Criteria:

1. Previous cesarean section.
2. Previous abdominal and/ or back operation.
3. Spinal disorders.
4. Abdominal skin diseases.
5. Serious diseases such as heart disease, pace maker, uncontrolled diabetes or hypertension, autoimmune disease, malignancy, gastric ulcer, liver or renal failure and any other contraindication for body sculpting-weight loss.

Primary outcomes:
measure: Static postural balance
timeFrame: up to eight weeks
measure: Dynamic postural balance
timeFrame: up to eight weeks
Secondary outcomes:
measure: Abdominal subcutaneous fat thickness
timeFrame: up to eight weeks
measure: Inter recti distance
timeFrame: up to eight weeks
measure: Lumbar lordotic angle
timeFrame: up to eight weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Asmaa Maher Ahmed Zahran
Study officials:
References: