Effect of Capacitive and Resistive Radiofrequency on Postpartum Diastasis Recti

To evaluate the effect of capacitive and resistive radiofrequency on postpartum rectus abdominis diastasis.

Study Overview

• Status: Not yet recruiting
• Conditions: Radiofrequency; Diastasis Recti Abdominis (DRA)
• Intervention / Treatment: Device: abdominal belt; Device: TECAR therapy

Detailed Description

Eighty females postpartum with rectus diastasis will be included in this study; they will be recruited the outpatient clinic at El Mahalla Al Kobra (The first author's pervious workplace) and will be referred by obstetric and genecology physicians. Patients will be assigned into two groups.

Group A: It will include 40 patients participating in abdominal belt. Group B: It will include 40 patients participating in abdominal belt plus TECAR therapy.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Gamil Omar, PhD; Phone Number: 00201003313126; Email: mohamed.gamil2810@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Postpartum women (7 days after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus).

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

  3. Their age will be ranged from 20 -35 years old. 4. Their BMI will be less than 30 kg/cm2.

Exclusion Criteria:

• Any participant will be excluded if she meets one or more of the following criteria:

Postpartum women will be excluded from the study if they have:

1. Abdominal or back surgery.
2. Abdominal hernia.
3. History of abnormal pregnancy, uterine fibroid or polyhydramnios during pregnancy.
4. Neurological disorders as multiple sclerosis, stroke and spinal lesion.
5. Musculoskeletal diseases such as fractures muscle strains, severe knee osteoarthritis which may affect their physical activity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; It will be consisted of 40 postpartum women who will only wear abdominal belt for 14 weeks.	Device: abdominal belt; 40 postpartum women will only wear abdominal belt for 14 weeks.
Active Comparator: study group; will wear the same abdominal belt for 6 weeks then participating in TECAR therapy 3 sessions /week for 8 weeks.	Device: abdominal belt; 40 postpartum women will only wear abdominal belt for 14 weeks.; Device: TECAR therapy; will wear the same abdominal belt for 6 weeks then participating in TECAR therapy 3 sessions /week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound	The distance between the recti muscles at 3 levels will be measured at the beginning and again at the end of the study duration, i.e., 8 weeks. The desired measurement locations will be marked with a water-soluble pen: 4.5 cm above the umbilicus, at the midpoint, and 4.5 cm below the umbilicus. The measurements will be performed at rest and during contraction. Each woman will be asked to lie in a crock lying position, crossing the arms over the chest and raising the head until the spine of the scapulae will be off the table surface. The women will maintain a partial curl-up while the examiner palpates the medial borders of the right and left rectus abdominis muscle bellies at the marked location. With the linear transducer, it will be positioned transversely along the linea alba in the direction of the muscles and adjusted to perceived inert recti distance width. Three trials will be taken for each assessment, and the mean will be recorded. (Khandale & Hande, 2016).	14 week
trunk flexors strength and endurance	Trunk flexion strength will be graded from zero to five using Daniels and Worthingham's procedure (Hislop et al., 2013) as follows: Grades: (Hislop et al., 2013). Grade 5 (Normal) Patient complete ROM until inferior angle of the scapulae are off table (weight of arms serves as resistance). Grade 4 (Good) Patient complete ROM until inferior angle of the scapulae are off table. Resistance of arms is reduced in the cross-chest position. Grade 3 (Fair) Patient complete ROM and lifts trunk until inferior angle of the scapulae are off table with arms at side. Grade 2 (Poor) Patient is unable to clear the inferior angle of the scapula from the table Grade 1 (Trace) No depression of the rib cage but visible or palpable contraction occurs. Grade 0 (Zero) No activity Patient Positioning: Grade 5 (Normal): Supine with fingertips lightly touching the back of the head. For grade 4: Supine with arms crossed over chest. For grade 3: Supine with arms at side. For grade 0 to 2: Supine with arms at	14 week
Assessment of functional status	All participating women with diastasis recti in both groups (A&B) will be asked to fill the Inventory of functional status after childbirth questionnaire before and after the end of the study program.	14 week

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 6, 2025
• Primary Completion (Estimated): July 7, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Diastasis recti, radiofrequency therapy, physical exercises, postpartum
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations; Diastasis, Muscle
• Other Study ID Numbers: radiofrequency on diastasis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No