Diastasis Recti Abdominis (DRA)NCT06909448
Effect of Capacitive and Resistive Radiofrequency on Postpartum Diastasis Recti
A study testing abdominal belt and TECAR therapy in people with Diastasis Recti Abdominis (DRA) and Radiofrequency, run by Cairo University.
Trial summary
To evaluate the effect of capacitive and resistive radiofrequency on postpartum rectus abdominis diastasis. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Diastasis Recti Abdominis (DRA), Radiofrequency
- What is being tested?
- abdominal belt and TECAR therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 6 Apr 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the effect of capacitive and resistive radiofrequency on postpartum rectus abdominis diastasis.
Read the 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.
- Conditions
- Diastasis Recti Abdominis (DRA), Radiofrequency
- Being tested
- abdominal belt, TECAR therapy
- Keywords
- Diastasis recti, radiofrequency therapy, physical exercises, postpartum
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal beltDevice
40 postpartum women will only wear abdominal belt for 14 weeks.
TECAR therapyDevice
will wear the same abdominal belt for 6 weeks then participating in TECAR therapy 3 sessions /week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | It will be consisted of 40 postpartum women who will only wear abdominal belt for 14 weeks. Receives: Device: abdominal belt |
| study group | Active comparator | will wear the same abdominal belt for 6 weeks then participating in TECAR therapy 3 sessions /week for 8 weeks. Receives: Device: abdominal belt; Device: TECAR therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 14 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start6 Apr 2025 (estimated)
- Primary completion7 Jul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis Recti Abdominis (DRA)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamil Omar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909448
- Sponsor's protocol ID
- radiofrequency on diastasis
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Capacitive and Resistive Radiofrequency on Postpartum Diastasis Recti
- ClinicalTrials.gov ID
- NCT06909448
- Acronym / sponsor ID
- radiofrequency on diastasis
- Conditions
- Diastasis Recti Abdominis (DRA), Radiofrequency
- Keywords
- Diastasis recti, radiofrequency therapy, physical exercises, postpartum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Apr 2025 (estimated)
- Primary completion
- 7 Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of capacitive and resistive radiofrequency on postpartum rectus abdominis diastasis.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Device: abdominal beltIt will be consisted of 40 postpartum women who will only wear abdominal belt for 14 weeks. |
| study group | Active comparator | Device: abdominal belt, Device: TECAR therapywill wear the same abdominal belt for 6 weeks then participating in TECAR therapy 3 sessions /week for 8 weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Any participant will be excluded if she meets one or more of the following criteria:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal belt40 postpartum women will only wear abdominal belt for 14 weeks. | Device | control group, study group |
| TECAR therapywill wear the same abdominal belt for 6 weeks then participating in TECAR therapy 3 sessions /week for 8 weeks. | Device | study group |
Primary outcome
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).
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal belt and TECAR therapy in people with Diastasis Recti Abdominis (DRA) and Radiofrequency, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Gamil Omar, PhD (00201003313126, mohamed.gamil2810@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound (time frame: 14 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.