Low Back PainNCT05834153
Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability
A study testing kinesiotaping and electrical muscle stimulation in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of kinesiotaping and electrical muscle stimulation on low back pain and disability associated with diastasis recti. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- kinesiotaping and electrical muscle stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diastasis recti more than 2 or 2.5cm
- 6 weeks' postpartum cesarean section females
- Primigravida females
- Low back pain due to DR
Who cannot join
- Normal vaginal delivery
- Episiotomy
- Multigravida women's
- History of abdominal hernia
- History of any abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability Associated With Diastasis Recti
To compare the effects of kinesiotaping and electrical muscle stimulation on low back pain and disability associated with diastasis recti.
- Conditions
- Low Back Pain
- Being tested
- kinesiotaping, electrical muscle stimulation
- Keywords
- kinesiotaping, electrical muscle stimulation, low back pain, diastasis recti, exercises
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotapingDevice
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 stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| kinesiotaping | Experimental | Not described Receives: Device: kinesiotaping |
| electrical muscle stimulation | Active comparator | Not described Receives: Device: electrical muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4th week
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
Measured: 4th week
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
Measured: 4th week
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
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Oct 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834153
- Sponsor's protocol ID
- REC/RCR & AHS/23/0523
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability Associated With Diastasis Recti
- ClinicalTrials.gov ID
- NCT05834153
- Acronym / sponsor ID
- REC/RCR & AHS/23/0523
- Conditions
- Low Back Pain
- Keywords
- kinesiotaping, electrical muscle stimulation, low back pain, diastasis recti, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effects of kinesiotaping and electrical muscle stimulation on low back pain and disability associated with diastasis recti.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kinesiotaping | Experimental | Device: kinesiotaping |
| electrical muscle stimulation | Active comparator | Device: electrical muscle stimulation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diastasis recti more than 2 or 2.5cm
- 6 weeks' postpartum cesarean section females
- Primigravida females
- Low back pain due to DR
Key exclusion criteria (5 listed)
- Normal vaginal delivery
- Episiotomy
- Multigravida women's
- History of abdominal hernia
- History of any abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kinesiotapingThis 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 % | Device | kinesiotaping |
| electrical muscle stimulationIt 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 | Device | electrical muscle stimulation |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hina gul, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesiotaping and electrical muscle stimulation in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 4th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.