Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
kinesiotaping
electrical muscle stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring kinesiotaping, electrical muscle stimulation, low back pain, diastasis recti, exercises
Eligibility Criteria
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
Sites / Locations
- DHQ hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
kinesiotaping
electrical muscle stimulation
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05834153
First Posted
April 18, 2023
Last Updated
July 31, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05834153
Brief Title
Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability
Official Title
Comparative Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability Associated With Diastasis Recti
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the effects of kinesiotaping and electrical muscle stimulation on low back pain and disability associated with diastasis recti.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
kinesiotaping, electrical muscle stimulation, low back pain, diastasis recti, exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
kinesiotaping
Arm Type
Experimental
Arm Title
electrical muscle stimulation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
kinesiotaping
Intervention Description
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 %
Intervention Type
Device
Intervention Name(s)
electrical muscle stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
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
Time Frame
4th week
Title
Manual muscle testing MMT
Description
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
Time Frame
4th week
Title
Roland Morris Disability Questionnaire (RMDQ) for disability
Description
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
Time Frame
4th week
Title
Caliper method
Description
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
Time Frame
4th week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
diastasis recti
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
imran amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hina gul, MSOMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ hospital
City
Gujranwala
State/Province
Punjab
ZIP/Postal Code
05499
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hina gul
Phone
03214979172
Email
hina.gul@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
aiza komal, DPT
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability
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