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CTRI Number  CTRI/2024/08/072813 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 20/08/2024
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   Effect Of Matrix Rhythm Therapy On Hamstring Extensibility In Individuals With Chronic Low Back Pain: A Randomised Control Trial  
Scientific Title of Study   Effect Of Matrix Rhythm Therapy On Hamstring Extensibility, Pain And Function In Individuals With Chronic Nonspecific Low Back Pain: A Randomised Control Trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Varma 
Designation  PG Student  
Affiliation  DY Patil Deemed to be University, School of Physiotherapy  
Address  DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai School of physiotherapy, Msk lab 6th floor

Mumbai
MAHARASHTRA
400706
India 
Phone  9810301828  
Fax    
Email  varmaaditi14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shellette D Almeida 
Designation  Associate Professor  
Affiliation  DY Patil Deemed to be University, School of Physiotherapy  
Address  DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai School of Physiotherapy

Mumbai
MAHARASHTRA
400706
India 
Phone  8073899826  
Fax    
Email  shellette.almeida@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Aditi Varma 
Designation  PG Student  
Affiliation  DY Patil Deemed to be University, School of Physiotherapy  
Address  DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai School of Physiotherapy, 6th floor

Mumbai
MAHARASHTRA
400706
India 
Phone  9810301828  
Fax    
Email  varmaaditi14@gmail.com  
 
Source of Monetary or Material Support  
School of Pysiotherapy, D Y Patil University Navi Mumbai,400706, India 
 
Primary Sponsor  
Name  school of physiotherapy  
Address  DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai School of physiotherapy, Msk lab 6th floor,400706, India 
Type of Sponsor  Private medical college 
 
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 Aditi Varma   School of physiotherapy   Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Mumbai
MAHARASHTRA 		 9810301828

varmaaditi14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) For Biomedical and Health Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A- Matrix rhythm therapy with evidence-based exercise   3 sessions per week for 4 weeks Matrix Rhythm Therapy Application method: patient in prone lying position with hamstring muscle will be exposed and talcum powder will be administered to the treatment region. The apparatus is rod-shaped with a spiral-shaped vibration head that vibrates at 8-12 Hz. Matrix Mobil® will be used in a longitudinal stroking manner, with the probe of the device being pushed into the muscles of the hamstring. The session will be delivered for 60 minutes, with 30 minutes on each of the hamstring muscles segment Evidence-based exercise: week 1- Abdominal bracing, abdominal bracing with heel slides, balancing on swiss ball, trunk curls, hamstring stretch week 2- Abdominal bracing with bridging, Alternate arm raises on swiss ball, Arm raises on swiss ball, Abdominal bracing with alternate leg lifts, Hamstring stretch week3- Quadruped position with alternate leg and arm lift, bridging with alternate leg lifts, alternate leg and arm lift on swiss ball, same side arm and leg raises on a swiss ball, hamstring stretch week 4- quadruped alternate arm and leg lifts, side plank, balancing(side to side) on swiss ball, balancing (front to back) on swiss ball, hamstring stretch.  
Comparator Agent  Group B- Evidence-based exercises   3 sessions per week for 4 weeks Evidence-based exercise: week 1- Abdominal bracing, abdominal bracing with heel slides, balancing on swiss ball, trunk curls, hamstring stretch week 2- Abdominal bracing with bridging, Alternate arm raises on swiss ball, Arm raises on swiss ball, Abdominal bracing with alternate leg lifts, Hamstring stretch week3- Quadruped position with alternate leg and arm lift, bridging with alternate leg lifts, alternate leg and arm lift on swiss ball, same side arm and leg raises on a swiss ball, hamstring stretch week 4- quadruped alternate arm and leg lifts, side plank, balancing(side to side) on swiss ball, balancing (front to back) on swiss ball, hamstring stretch.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Individuals diagnosed with nonspecific LBP referred by a physician or
orthopedic surgeons for physiotherapy were approached.
2. individuals with back pain not attributed to known specific pathology and
test for Straight Leg Raise test (SLR) negative.
3. Individuals with hamstring tightness of more than 20 degrees on the Active Knee Extension test
4. Both males and females will be included

5. Age between 18-50 years.

6. Individuals diagnosed with non-specific low back pain.
7. Individuals who are willing to participate with informed consent voluntarily.
8. Individuals who can participate for 12 sessions for 4 weeks. 
 
ExclusionCriteria 
Details  1. individuals who recently underwent any medical treatment for lumbar region and lower limbs including corticosteroids injections
2. patients with any systemic disease
3. presence of malformation or open wounds on the region to be treated
4. patients with radiating pain, SI joint dysfunction, stress fractures f lumbar region
5. individuals with pain on VAS more than 7 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Active knee extension test
 		 Active knee extension test
baseline, 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Numerical pain rating scale
Roland morris disability questionnaire  		 baseline and after 4 weeks  
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/08/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 16/01/2025 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   This study aims to compare the effect of Matrix rhythm therapy along with evidence-based exercise and with only evidence-based exercise on hamstring extensibility, pain, and functional disability in individuals with nonspecific chronic low back pain with hamstring tightness. a sample size of 52 will be taken, in each group 26 individuals will be randomly allotted. Group A (n=26) will receive Matrix rhythm therapy (30 mins each leg) with evidence-based exercise and Group B (n=26) will receive evidence-based exercise only, both groups will receive treatment three times a week for 4 weeks. Outcomes will be measured at the beginning and end of the study. Active knee extension test will be used for hamstring extensibility, a Numerical Pain rating Scale will be used for pain and the Roland Morris disability questionnaire will be used for functional disability as outcome measures.  
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