NCT05287282

Brief Summary

The study aim to evaluate the impact of TECAR treatment on rectus diastasis in postnatal women

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

March 10, 2022

Last Update Submit

January 11, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • rectus abdominis cross section area

    1 cycle (42 days)

  • fat thickness

    1 cycle (42 days)

  • intra-recti distance

    1 cycle (42 days)

Study Arms (2)

TECAR application

EXPERIMENTAL
Other: TECAR application

selected abdominal exercises program

ACTIVE COMPARATOR
Other: TECAR application

Interventions

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

TECAR applicationselected abdominal exercises program

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelshiesk university hospital

Tanta, Egypt

Location

Study Officials

  • Eman A Elhosary, Professor

    Assistant professor of physical therapy, Physical therapy faculty, Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy, Basic Sciences department, Physical therapy faculty, Cairo University

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 18, 2022

Study Start

June 1, 2022

Primary Completion

August 31, 2022

Study Completion

September 30, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations