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NCT Number: NCT06909448

Effect of Capacitive and Resistive Radiofrequency on Postpartum Diastasis Recti

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

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Key information

Conditions

Diastasis Recti Abdominis (DRA) Behavior Motor Activity Radiofrequency

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 muscle strains, severe knee osteoarthritis which may affect their physical activity.

Treatment and study plan

abdominal belt

Device

40 postpartum women will only wear abdominal belt for 14 weeks.

TECAR Therapy

Device

will wear the same abdominal belt for 6 weeks then participating in TECAR therapy 3 sessions /week for 8 weeks.

Primary outcomes

  1. Ultrasound

    Time frame: 14 week

    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).

  2. trunk flexors strength and endurance

    Time frame: 14 week

    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

  3. Assessment of functional status

    Time frame: 14 week

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Gamil Omar, PhD

CONTACT

[email protected]

00201003313126

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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