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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05834153
Other study ID # REC/RCR & AHS/23/0523
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date August 1, 2023

Study information

Verified date March 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the effects of kinesiotaping and electrical muscle stimulation on low back pain and disability associated with diastasis recti.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Diastasis recti more than 2 or 2.5cm - 6 weeks' postpartum cesarean section females - Primigravida females - Low back pain due to DR Exclusion Criteria: - Normal vaginal delivery - Episiotomy - Multigravida women's - History of abdominal hernia - History of any abdominal surgery

Study Design


Related Conditions & MeSH terms


Intervention

Device:
kinesiotaping
This group underwent a KT application on rectus abdominis muscle (RAM), oblique abdominal muscles (OAM) and cesarean incision twice a week for a period of 4 weeks. First, the scar technique will apply using I band with a tension of 50 % on cesarean incision when the patient will be in supine position. Then, tape will apply on RAM using muscle technique from origin to insertion of the muscle with a tension between 15 and 25 %. Band will start on symphysis pubis with no tension, and then the patient was asked to stretch the abdominal region by deep abdominal respiration, and it will ended on xiphoid process. Finally, it will perform on the right and left external oblique muscles. The procedure will start with no tension from the bottom end of the 6-12th ribs and then the hip will placed in flexion and rotation to the opposite direction and the band will taped on pubic bone with a tension between 15 and 25 %
electrical muscle stimulation
It consists of 24 patients who will receive NMES and core stabilization exercises. The subjects will explain to relax their abdominal muscles while application Stimulation will apply by four large rectangular electrodes placed over the origin (pubic crest) and insertion (xiphoid process) of the rectus abdominis muscles bilaterally. Straps will used to fix the electrodes in place. A frequency of 80 pulses/min and with a pulse width of 0.1-0.5ms, will the parameter settings apply in this study. The total time for the application of stimulation will 30mins and until a good enough observable muscle contraction will achieve a gradual increase in intensity will perform

Locations

Country Name City State
Pakistan DHQ hospital Gujranwala Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale Numeric pain rating scale (an outcome measure) is a pain screening tool commonly used to assess pain severity using a 0 to 10 scale, with 0 measuring no pain and 10 meaning worst pain 4th week
Primary Manual muscle testing MMT The strength of rectus abdominis muscle will recorded on a 0 to 5-point scale using manual muscle test suggested by Dr. Lovett. The patients will positioned in a supine, crook lying attitude with the arms straight by the side. The subjects will directed to lift and reach upwards till the scapular lower end level and if the subject will able to achieve and hold this position successfully then will ask to perform the next position by crossing the hands over the chest and then leaning forward and lifting the scapula off the table. After the patient achieved this position successfully forward reaching with hands crossed and supporting at the back of the head will perform. The scores will recorded based on the position that the patient could achieve and sustain successfully i.e. scores 3, 4 and 5 respectively for the above mentioned positions 4th week
Primary Roland Morris Disability Questionnaire (RMDQ) for disability The questionnaire was used to measure the level and severity of disability occurring due to low back pain reflected by higher numbers on a 24-point scale. The questionnaire was taken at the beginning and after completion of the protocol and the clinical improvement was calculated based on the score 4th week
Primary Caliper method Inter Recti Distance (IRD): The inter recti distance measurement was done by the use of a skin tone caliper. The IRD was measured at three levels both pre and post protocol, that is 2 or more than 2.5 cm above and below the umbilicus and at the umbilicus 4th week
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