- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834153
Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability
Comparative Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability Associated With Diastasis Recti
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Gujranwala, Punjab, Pakistan, 05499
- DHQ Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 % |
|
Active Comparator: 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale
Time Frame: 4th week
|
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
|
|
Manual muscle testing MMT
Time Frame: 4th week
|
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
|
|
Roland Morris Disability Questionnaire (RMDQ) for disability
Time Frame: 4th week
|
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
|
|
Caliper method
Time Frame: 4th week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: hina gul, MSOMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0523
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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