Impact of TECAR in Treatment of Rectus Diastasis

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

Study Overview

• Status: Completed
• Conditions: Rectus Diastasis
• Intervention / Treatment: Other: TECAR application

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Kafrelshiesk university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

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 surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TECAR application	Other: TECAR application; 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
Active Comparator: selected abdominal exercises program	Other: TECAR application; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rectus abdominis cross section area	1 cycle (42 days)
fat thickness	1 cycle (42 days)
intra-recti distance	1 cycle (42 days)

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Eman A Elhosary, Professor, Assistant professor of physical therapy, Physical therapy faculty, Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Diastasis, Muscle
• Other Study ID Numbers: PT/WH

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