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CTRI Number  CTRI/2026/02/104734 [Registered on: 25/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study comparing the effectiveness of myofascial release technique and instrument-assisted soft tissue mobilization on pain, lumbar mobility and functional disability among subjects with mechanical low back pain 
Scientific Title of Study   A study comparing the effectiveness of myofascial release technique and instrument-assisted soft tissue mobilization on pain, lumbar mobility and functional disability among subjects with mechanical low back pain 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
harleenkaur13.hb@gmail.com  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivangi 
Designation  Student 
Affiliation  DAV Institute of Physiotherapy and Rehabilitation 
Address  DAV Institute of Physiotherapy and Rehabilitation, Mahatma Raj, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008
DAV Institute of Physiotherapy and Rehabilitation, Mahatma Raj ,Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008
Jalandhar
PUNJAB
144008
India 
Phone  9878548696  
Fax    
Email  shivangi.sharma.0003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shivangi 
Designation  Student 
Affiliation  DAV Institute of Physiotherapy and Rehabilitation 
Address  DAV Institute of Physiotherapy and Rehabilitation, Mahatma Raj, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008

Jalandhar
PUNJAB
144008
India 
Phone  9878548696  
Fax    
Email  shivangi.sharma.0003@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shivangi 
Designation  Student 
Affiliation  DAV Institute of Physiotherapy and Rehabilitation 
Address  DAV Institute of Physiotherapy and Rehabilitation, Mahatma Raj, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008
DAV Institute of Physiotherapy and Rehabilitation, Mahatma Raj ,Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008
Jalandhar
PUNJAB
144008
India 
Phone  9878548696  
Fax    
Email  shivangi.sharma.0003@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Nil  
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Harleen Kaur PT  DAV institute of physiotherapy and rehabilitation  DAV institute of physiotherapy and rehabilitation Mahatma Hans Raj Marg, Opposite Burlton Park, Gurudev Nagar, Ram Nagar, Jalandhar, Punjab Mahatma Hans Raj Marg, Opposite Burlton Park, Gurudev Nagar, Ram Nagar, Jalandhar, Punjab
Jalandhar
PUNJAB 		 6239756870

harleenkaur13.hb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethics Committee (ICE)  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  Myofascial Release Technique group  Hydrocollator Pack (20 mins) +Interferential Therapy (4kHz carrier, 80Hz AMF, 20 mins) +Lumbar Stabilization Exercises + Core Stabilization Exercises + Myofascial Release Technique (90 seconds, 5 times/session) for (2 sessions/week) for 2 weeks.  
Comparator Agent  Instrument-Assisted Soft Tissue Mobilization group  Hydrocollator Pack (20 mins) +Interferential Therapy (4kHz carrier, 80Hz AMF, 20 mins) +Lumbar Stabilization Exercises + Core Stabilization Exercises + Instrument-Assisted Soft Tissue Mobilization (2 times/week) for 2 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Subjects with age group 18-45 years.
Subjects with both genders, male and female.
Subjects who are willing to participate in the study.
Subjects with mechanical low back pain and stiffness on low back
Subjects with mild to moderate pain (NPRS 4-6)
 
 
ExclusionCriteria 
Details  Subjects with a recent lower extremity fracture
Subjects with inflammatory joint diseases (Rheumatoid arthritis, Ankylosing spondylitis)
Subjects with pre-diagnosed soft tissue injuries
Subjects with pre-diagnosed lumbar disc herniation
Subjects with pre-diagnosed lumbar spondylosis
•Subjects with pre-diagnosed severe psychiatric disorders
•Subjects with neurological impairment and radiating pain in lower limb
•Subjects with any spinal and lower limb metal implants
•Pregnancy
•Malignancy
•Subjects with any open wound injury and skin infection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of Myofascial Release Technique and Instrument-Assisted Soft Tissue Mobilization on pain, lumbar mobility and functional disability among subjects with mechanical low back pain.
 		 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Lumbar Muscle Flexibility
Muscle Tenderness
Quality of life
Trunk Muscle Endurance 		 2 weeks 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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   N/A 
Date of First Enrollment (India)   01/05/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

A minimum of 45 subjects will be selected for the study as per inclusion and exclusion criteria between age group of 18-45 years. Participants will be randomly divided into 3 groups of 15 subjects each: Group A (Control group), Group B (Experimental group-1) and Group C (Experimental group-2). Group A will receive Hydrocollator Pack (20 mins) + Interferential Therapy (4kHz carrier, 80Hz AMF ,20 mins) + Lumbar Stabilization Exercises (12 reps, 5 sets) + Core Stabilization Exercises (5 reps, 1 set, 20 secs hold time) for (2 sessions/week) for 4 weeks. Group B will receive Hydrocollator Pack (20 mins) +Interferential Therapy (20mins) +Lumbar Stabilization Exercises + Core Stabilization Exercises + Myofascial Release Technique (90 seconds,5 times/session) for (2 sessions/week) for 4 weeks and Group C will receive Hydrocollator Pack (20 mins) +Interferential Therapy (20 mins) +Lumbar Stabilization Exercises + Core Stabilization Exercises + Instrument-Assisted Soft Tissue Mobilization (2 times/week) for 2 weeks. The baseline data will be recorded on 1st day (pre-intervention) and on 8th day (post-intervention). Total 8 sessions per subject will be given over 2 weeks i.e.,4 sessions per week. Outcome measures included in the study will be Numerical Pain Rating Scale for pain, Oswestry disability index (ODI) scale for functional disability, modified Schober’s test for lumbar range of motion.

 
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