Rectus DiastasisNCT05287282
Impact of TECAR in Treatment of Rectus Diastasis
A study testing TECAR application in people with Rectus Diastasis, run by Cairo University at 1 site in Egypt.
Trial summary
The study aim to evaluate the impact of TECAR treatment on rectus diastasis in postnatal women Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Rectus Diastasis
- What is being tested?
- TECAR application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- postnatal females suffering from diastasis recti more than 2.5 cm with bulged abdomen,
- Their age ranged from 25 - 35 years.
- Their body mass index (BMI) ranged from 25-35 kg/m2.
- All women delivered normally
Who cannot join
- Any participant was excluded if she had any disease that interferes with exercises (asthma), any skin disease or sensitivity that interferes with the application, any chest disease or cardiac disease or women had abdominal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of TECAR Therapy in Treatment of Post-natal Rectus Diastasis
The study aim to evaluate the impact of TECAR treatment on rectus diastasis in postnatal women
Read the detailed description
Radiofrequency (RF) is the emission of high frequency waves via an applicator. The transfer of electromagnetic energy stimulates targeted tissues. RF can be used in two ways: capacitive or resistive ( Kumarane etal.,2015) This has been shown to increase vascularization and reduce inflammation and swelling and to accelerate the healing process and provide pain relief( Duñabeitia et al., 2018). It is used to provide rapid pain relief for sport injuries and allows quicker recovery [Duñabeitia etal, 2018\& Weber T, Kabelka2011). low back pain and traumatology and urology (Notarnicola etal, 2017). The capacitive mode (CET) concentrates the energy to target soft tissues containing electrolytes: muscles, vascular or lymphatic tissues. The resistive mode (RET) targets denser tissues containing more fat and fiber (such as bones, ligaments and tendons). High frequency waves penetrate deep into tissues and increase both exchanges and temperature and a recent study has demonstrated the effects of RF on the skin microcirculation and the intramuscular blood flow (Kumaraane et al., 2015). To date, no study has evaluated the impact of TECAR treatment on rectus diastasis in postnatal women This study will be carried out on 30 postnatal females suffering from diastasis recti more than 2.5 cm with bulged abdomen, they will be selected from out patient physical therapy clinic, kafr el sheikh university. Their age ranged from 25 - 35 years. Their body mass index (BMI) ranged from 25-35 kg/m2. All women delivered normally
Exclusion criteria:
Any participant was excluded if she had any disease that interferes with exercises (asthma), any skin disease or sensitivity that interferes with the application, any chest disease or cardiac disease or women had abdominal or surgery.
All participants will read an explanation of the experimental procedures and sign an informed consent that is approved by the Ethical committee Institutional Review Board, Faculty of Physical Therapy, kafr elsheikh University, Egypt This study will be a randomized, double-blind, pre test-post test crossover trial with control group. The randomization procedure will be performed by a simple drawing of lots (A or B) which determined whether participants would receive the TECAR therapy and abdominal exercises ( group A) and abdominal exercises only in (group B). The randomization procedure will be performed through a computer program (Microsoft Excel 2010) that created a random table of numbers in which each number corresponded to the group A or B. After that, participants will be allocated according to the corresponding number of their allocation code. A researcher will be conducted the drawing procedures without informing participants and evaluators, to determine which will be in group A or group B. Thus, both participants and evaluators will be blinded to the allocation of treatment.
Study group (Group A):
It was consisted of 15 post natal women who will performed weight reduction diet ( 1200 kcal/day) , TECAR application and selected abdominal exercises program that consists of static abdominal and posterior pelvic tilting
Control group(Group B):
It was consisted of 15 postnatal women who was performed weight reduction diet (1200 kcal/day) and selected abdominal exercises and posterior pelvic tilting exercises.
- Conditions
- Rectus Diastasis
- Being tested
- TECAR application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECAR applicationOther
Radiofrequency (RF) is the emission of high frequency waves via an applicator. The transfer of electromagnetic energy stimulates targeted tissues. RF can be used in two ways: capacitive or resistive The capacitive mode (CET) concentrates the energy to target soft tissues containing electrolytes: muscles, vascular or lymphatic tissues. The resistive mode (RET) targets denser tissues containing more fat and fiber (such as bones, ligaments and tendons). High frequency waves penetrate deep into tissues and increase both exchanges and temperature and a recent study has demonstrated the effects of RF on the skin microcirculation and the intramuscular blood flow
| Study group | Role | What they receive |
|---|---|---|
| TECAR application | Experimental | Not described Receives: Other: TECAR application |
| selected abdominal exercises program | Active comparator | Not described Receives: Other: TECAR application |
What is being measured
The primary outcome is the main question the study is designed to answer.
rectus abdominis cross section area
Measured: 1 cycle (42 days)
fat thickness
Measured: 1 cycle (42 days)
intra-recti distance
Measured: 1 cycle (42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Jun 2022
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectus DiastasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Rafat, Cairo University
- Investigators
- Eman A Elhosary, Professor, Principal investigator, Assistant professor of physical therapy, Physical therapy faculty, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287282
- Sponsor's protocol ID
- PT/WH
- Status last verified
- Jan 2023
- First submitted
- 10 Mar 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of TECAR Therapy in Treatment of Post-natal Rectus Diastasis
- ClinicalTrials.gov ID
- NCT05287282
- Acronym / sponsor ID
- PT/WH
- Conditions
- Rectus Diastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 18 Mar 2022 (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.
The study aim to evaluate the impact of TECAR treatment on rectus diastasis in postnatal women
Detailed description
Radiofrequency (RF) is the emission of high frequency waves via an applicator. The transfer of electromagnetic energy stimulates targeted tissues. RF can be used in two ways: capacitive or resistive ( Kumarane etal.,2015) This has been shown to increase vascularization and reduce inflammation and swelling and to accelerate the healing process and provide pain relief( Duñabeitia et al., 2018). It is used to provide rapid pain relief for sport injuries and allows quicker recovery [Duñabeitia etal, 2018\& Weber T, Kabelka2011). low back pain and traumatology and urology (Notarnicola etal, 2017). The capacitive mode (CET) concentrates the energy to target soft tissues containing electrolytes: muscles, vascular or lymphatic tissues. The resistive mode (RET) targets denser tissues containing more fat and fiber (such as bones, ligaments and tendons). High frequency waves penetrate deep into tissues and increase both exchanges and temperature and a recent study has demonstrated the effects of RF on the skin microcirculation and the intramuscular blood flow (Kumaraane et al., 2015). To date, no study has evaluated the impact of TECAR treatment on rectus diastasis in postnatal women This study will be carried out on 30 postnatal females suffering from diastasis recti more than 2.5 cm with bulged abdomen, they will be selected from out patient physical therapy clinic, kafr el sheikh university. Their age ranged from 25 - 35 years. Their body mass index (BMI) ranged from 25-35 kg/m2. All women delivered normally
Exclusion criteria:
Any participant was excluded if she had any disease that interferes with exercises (asthma), any skin disease or sensitivity that interferes with the application, any chest disease or cardiac disease or women had abdominal or surgery.
All participants will read an explanation of the experimental procedures and sign an informed consent that is approved by the Ethical committee Institutional Review Board, Faculty of Physical Therapy, kafr elsheikh University, Egypt This study will be a randomized, double-blind, pre test-post test crossover trial with control group. The randomization procedure will be performed by a simple drawing of lots (A or B) which determined whether participants would receive the TECAR therapy and abdominal exercises ( group A) and abdominal exercises only in (group B). The randomization procedure will be performed through a computer program (Microsoft Excel 2010) that created a random table of numbers in which each number corresponded to the group A or B. After that, participants will be allocated according to the corresponding number of their allocation code. A researcher will be conducted the drawing procedures without informing participants and evaluators, to determine which will be in group A or group B. Thus, both participants and evaluators will be blinded to the allocation of treatment.
Study group (Group A):
It was consisted of 15 post natal women who will performed weight reduction diet ( 1200 kcal/day) , TECAR application and selected abdominal exercises program that consists of static abdominal and posterior pelvic tilting
Control group(Group B):
It was consisted of 15 postnatal women who was performed weight reduction diet (1200 kcal/day) and selected abdominal exercises and posterior pelvic tilting exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECAR application | Experimental | Other: TECAR application |
| selected abdominal exercises program | Active comparator | Other: TECAR application |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- postnatal females suffering from diastasis recti more than 2.5 cm with bulged abdomen,
- Their age ranged from 25 - 35 years.
- Their body mass index (BMI) ranged from 25-35 kg/m2.
- All women delivered normally
Key exclusion criteria (1 listed)
- Any participant was excluded if she had any disease that interferes with exercises (asthma), any skin disease or sensitivity that interferes with the application, any chest disease or cardiac disease or women had abdominal surgery.
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 |
|---|---|---|
| TECAR applicationRadiofrequency (RF) is the emission of high frequency waves via an applicator. The transfer of electromagnetic energy stimulates targeted tissues. RF can be used in two ways: capacitive or resistive The capacitive mode (CET) concentrates the energy to target soft tissues containing electrolytes: muscles, vascular or lymphatic tissues. The resistive mode (RET) targets denser tissues containing more fat and fiber (such as bones, ligaments and tendons). High frequency waves penetrate deep into tissues and increase both exchanges and temperature and a recent study has demonstrated the effects of RF on the skin microcirculation and the intramuscular blood flow | Other | TECAR application, selected abdominal exercises program |
Primary outcome
rectus abdominis cross section area
Time frame: 1 cycle (42 days)
fat thickness
Time frame: 1 cycle (42 days)
intra-recti distance
Time frame: 1 cycle (42 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Rectus Diastasis
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Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
Diastasis Recti Abdominis, Abdominal Wall Laxity
Recruiting
Effects of Pilates and Progressive Prone Plank Exercises in Diastasis Recti
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Active, not recruiting
Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)
Abdominal Rectus Diastasis
Recruiting
Acute Effects of Radiofrequency Diathermy in Postpartum Women With Diastasis Abdominis
Postpartum, Rectus Muscle Diastasis
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. This study is not recruiting at the moment.
Eman A Elhosary, Professor principal investigator
Assistant professor of physical therapy, Physical therapy faculty, Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECAR application in people with Rectus Diastasis, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rectus abdominis cross section area (time frame: 1 cycle (42 days)). 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 12 Jan 2023.