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CTRI Number  CTRI/2024/11/076731 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 07/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study on Core exercises versus Kinesio Taping with Physiotherapy in Low Back Pain. 
Scientific Title of Study   To find the Effectiveness of Core Stabilization Exercises along with Conventional Physiotherapy versus Kinesio Taping along with Conventional Physiotherapy on Pain Function and Quality of Life in Patients with Non-Specific Low Back Pain: A Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raina Mishra  
Designation  MPT student 
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology  
Address  Ortho Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology,RIICO Institutional Area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7014443128  
Fax    
Email  raina2008@mgumst.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemendra Kumar Sharma  
Designation  Associate Professor  
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology  
Address  Room No 14, Physiotherapy OPD, Basement, Mahatma Gandhi Hospital, Mahatma Gandhi University of Medical Sciences and Technology,RIICO Institutional Area, Sitapura, Tonk Road, jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9460888177  
Fax    
Email  hemendra.physio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hemendra Kumar Sharma  
Designation  Associate Professor  
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology  
Address  Room No 14, Physiotherapy OPD, Basement, Mahatma Gandhi Hospital, Mahatma Gandhi University of Medical Sciences and Technology,RIICO Institutional Area, Sitapura, Tonk Road, jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9460888177  
Fax    
Email  hemendra.physio@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, sitapura, tonk road,Jaipur, Rajasthan (India), 302022 
 
Primary Sponsor  
Name  Raina Mishra 
Address  238-A taruchhaya nagar taron ki kunt, Tonk Road, Sanganer, SanganerBzar, Jaipur,Rajasthan, 302029 
Type of Sponsor  Other [(SELF)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemendra Kumar Sharma  Mahatma Gandhi Hospital,Jaipur   Room No. 14 Physiotherapy OPD, Basement
Jaipur
RAJASTHAN 
9460888177

hemendra.physio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Core Stabilization Exercises along with Conventional Physiotherapy   This 3-week orthopedic physiotherapy program includes five weekly sessions starting with a warm-up of dynamic stretching and light aerobics. Core activation (pelvic tilts, bridging), core strengthening (plank, dead bug), and flexibility exercises (cat-cow, child’s pose) support stability and mobility. Soft tissue mobilization involves foam rolling and trigger point release for the lower back, while ergonomic education promotes spine health. Interferential Current (IFT) electrotherapy is applied to painful areas five days a week for pain relief. Each exercise includes 10 reps with a 30-second rest. 
Comparator Agent  Kinesiology Taping along with conventional Physiotherapy  For lumbar support, kinesiology tape is applied with the patient in a comfortable position. After cleaning the skin, a Y-strip or I-strip is placed along the lumbar spine, with additional strips around painful areas as needed. The tape’s pull direction varies by therapeutic goal, and it can be worn for 3–5 days. Conventional physiotherapy may include exercises and Interferential Current (IFT) for pain relief. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Diagnosed with nonspecific low back pain based on clinical evaluation, and a history of LBP exceeding 12 weeks.
Able to understand and follow exercise or taping instructions.
Have a minimum pain level (at activity) of 2 or above on NPRS (Numeric Pain Rating Scale) and had LBP for at least 3 months
Willing to participate in a supervised rehabilitation program 
 
ExclusionCriteria 
Details  Individuals with specific pathologies causing low back pain (e.g., herniated disc, spinal stenosis).
History of spine surgery within the past year. Known allergy or skin sensitivity to taping materials.
Pregnancy, as core stabilization exercises, may need modification.
Cardiovascular or systemic diseases or any condition which contraindicated or made exercise training impossible.
Physiotherapy previously received for at least 12 months or any surgery affecting the lumbar region.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain by using the NPRS scale Roland Morris Questionnaire for Function
Quality of life by using SF-36 score Instrument
 
3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Pain by using the NPRS scale Roland Morris Questionnaire for Function
Quality of life by using SF-36 score Instrument
 
1st week and 2nd week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   23/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

40 participants will be randomly divided into two groups. In Group A: all 20 patients will be treated by Core Stabilization along with conventional physiotherapy treatment. Group B: all 20 patients will be treated with Kinesio taping along with conventional physiotherapy treatment. All participants will be assessed for back pain, function, and Quality of life. A Numeric Pain Rating Scale (NPRS) will be used to measure the intensity of pain, functional performance will be assessed using the Roland Morris Disability Questionnaire (RMDQ) scale, and Quality of life will be assessed by SF -36. 

All variables will be measured at baseline, at the end of the second week and third week of the study.

Group A (Core Stabilization exercises along with conventional physiotherapy)

Warm-up Includes a combination of dynamic stretching and light aerobic activities to increase blood flow and prepare the muscles for exercise.

Core Activation Exercises:

a. Pelvic Tilts: Lie on your back with knees bent. Gently tilt your pelvis upward, flattening your lower back against the floor. Hold for a few seconds and release. Repeat 10  times.

b. Bridging: Lie on your back with knees bent and feet hip-width apart. Lift your hips toward the ceiling, engaging your glutes. Hold for a few seconds and lower back down. Repeat 10 times.

Core Strengthening Exercises:

a. Plank: Start in a forearm plank position. Maintain a straight line from head to heels, engaging the core. Hold for 20-30 seconds, gradually increasing the duration.

b. Dead Bug: Lie on your back with arms extended toward the ceiling and legs lifted. Lower one arm and the opposite leg toward the ground without arching your back. Return to the starting position and repeat on the other side. Perform 10  reps.

Flexibility and Mobility Exercises:

a. Cat-Cow Stretch: Start on hands and knees. Arch your back up (cat) and then lower it down (cow) in a controlled manner. Repeat for 10 cycles.

b. Child’s Pose: Kneel on the floor, sit back on your heels, and reach your arms forward. Hold for 20-30 seconds, feeling a stretch in the lower back.

10 repetitions were given per session with 30 secs of rest will be given in between the session. Total 5 sessions in a week for 3 weeks

Conventional Physiotherapy

Soft Tissue Mobilization: Method: Hands-on techniques to address muscle tightness and trigger points.

Myofascial Release (Foam Rolling): Roll the foam roller along the muscles of the lower back, paying attention to areas of tightness. Focus on the paraspinal muscles, glutes, and hip rotators.

Trigger Point Release: Use a massage ball or your fingers to apply pressure to specific trigger points in the lower back and surrounding areas.29

Education and Ergonomics: Provide education on posture, body mechanics, and ergonomics to promote optimal spine health.

10 repetitions were given per session with 30 secs of rest will be given in between the session. Total 5 sessions in a week for 3 weeks

Modality: Electrotherapy Interferential Current (IFT): 

Interferential Current will be given on the painful area for 5 days a week for an initial 3 weeks according to the protocol mentioned below

Interferential current for pain relief. A patient will be advised to do the exercises in 5 sessions per week.

 

Group B (K-Taping along with conventional Physiotherapy)

Patient position: Usually in a comfortable, neutral position – either lying down or sitting. Skin Preparation: Ensure the skin is clean and dry before applying the tape. For Lumbar Spine Support: Apply a Y-strip or I-strip vertically along the spine, covering the lumbar region. The tape may provide support and proprioceptive feedback,  For Painful Areas: Apply additional strips or fan strips around the area of pain, extending from the spine to the sides. This may help in reducing local discomfort, Direction of Pull: The direction of the tape’s pull may vary based on the intended effect – it could be applied with stretch or without, depending on the therapeutic goal.  

Taping Technique: Y-Strip: This involves applying a single strip of tape with two tails extending from a common base. It is commonly used for spine support, I-Strip: A single strip without tails, often used for general support or to follow muscle fibers. The duration of the K-tape application can vary. Some practitioners recommend wearing the tape for 3-5 days, allowing for skin breathing periods.

In Conventional physiotherapy, subjects receive physiotherapy exercises and physical modalities such as Interferential Current (IFT).



10 patients from each group were seen, exercises were performed and ytaping were done according to the group. Post data has been saved.

 
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