FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078112 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 13/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the Effectiveness of Myofascial Release and Foam Rolling for Managing Specific and Non-Specific Low Back Pain 
Scientific Title of Study   Effectiveness Of Myofascial Release Technique Versus Foam Roller On Specific And Non Specific Low Back Pain And Function 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratima Sarwadikar  
Designation  Assistant Professor  
Affiliation  Dr. D.Y Patil College Of Physiotherapy 
Address  Dr. D.Y Patil College Of Physiotherapy, D.Y Patil Vidyapeeth, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7798260498  
Fax    
Email  pratima.sarwadikar@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratima Sarwadikar  
Designation  Assistant Professor  
Affiliation  Dr. D.Y Patil College Of Physiotherapy 
Address  Dr. D.Y Patil College Of Physiotherapy, D.Y Patil Vidyapeeth, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7798260498  
Fax    
Email  pratima.sarwadikar@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Pratima Sarwadikar  
Designation  Assistant Professor  
Affiliation  Dr. D.Y Patil College Of Physiotherapy 
Address  Dr. D.Y Patil College Of Physiotherapy, D.Y Patil Vidyapeeth, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7798260498  
Fax    
Email  pratima.sarwadikar@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr DY Patil College Of Physiotherapy, Pimpri, Pune, Maharashtra, India 411018 
 
Primary Sponsor  
Name  Dr DY Patil College of Physiotherapy 
Address  Dr. D.Y Patil College Of Physiotherapy, D.Y Patil Vidyapeeth, Pimpri, Pune 411018 
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 Pratima Sarwadikar  Dr DY Patil College of Physiotherapy   Out Patient Department Dr D Y Patil College Of Physiotherapy Dr D Y Patil Vidyapeeth Pune
Pune
MAHARASHTRA 		 7798260498

pratima.sarwadikar@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Sub-Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Foam Roller  Foam Roller on paraspinal muscles 60 seconds and 10 minutes cryotherapy 3 times a week for 2 weeks 
Intervention  Myofascial Release Technique   Myofascial release technique for 60 seconds on paraspinal muscles and cryotherapy for 10 minutes 3 times a week for 2 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  Individual with neck pain and back pain.
Individual having muscular tightness of back.
Limited functional mobility
 
 
ExclusionCriteria 
Details  Recent injury, fall.
Any severe cardiorespiratory, neurological disorder.
Recent surgeries of hip and knee, spine.
Psychologically ill individuals.
Individuals who is not willing to participation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale   Day 1 and Day 6 
 
Secondary Outcome  
Outcome  TimePoints 
Patient Specific Functional Scale  Day 1 and Day 6 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   24/12/2024 
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  

This study will aim to compare the effectiveness of myofascial release (MFR) and foam rolling in managing both specific and non-specific low back pain (LBP) and improving functional mobility in individuals aged 18-64 years, including both males and females. Participants will have back pain, muscular tightness in these areas, and limited functional mobility. Exclusion criteria will include recent injuries, falls, or surgeries (hip, knee, or spine), severe cardiorespiratory or neurological disorders, psychological illnesses, and individuals unwilling to participate. Both interventions will be administered three times a week for four weeks, focusing on pain reduction and functional improvement. Outcome measures will include the Visual Analog Scale (VAS) for pain and the Patient-Specific Functional Scale (PSFS) for assessing functional mobility and activity limitations. The study will assess the comparative effectiveness of MFR and foam rolling in improving pain and function in individuals with specific and non-specific LBP.

 
Close