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CTRI Number  CTRI/2026/01/100913 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 21/12/2025
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   to check which of the two treatment technique is beneficial to manage lower back pain  
Scientific Title of Study   THE EFFECTIVENESS OF SELF MYOFASCIAL RELEASE VERSUS MAITLAND MOBILIZATION TECHNIQUE ALONG WITH MC GILLS BIG 3 EXERCISES AMONG NON SPECIFIC LOW BACK PAIN A RANDOMIZED CLINICAL 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  Nishka S Bolar 
Designation  Post Graduate Student  
Affiliation  Tejasvini Physiotherapy College 
Address  Tejasvini Physiotherapy College (A unit of Amar shanth charitable Trust) Opposite Anantha Padmanbha temple, Kudupu, Mangalore 575028

Dakshina Kannada
KARNATAKA
575028
India 
Phone  9591379450  
Fax    
Email  nishkabolar20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nishka S Bolar 
Designation  Post Graduate Student  
Affiliation  Tejasvini Physiotherapy College 
Address  Physiothereapy OPD Tejasvini Physiotherapy College (A unit of Amar shanth charitable Trust) Opposite Anantha Padmanbha temple, Kudupu, Mangalore 575028

Dakshina Kannada
KARNATAKA
575028
India 
Phone  9591379450  
Fax    
Email  nishkabolar20@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nishka S Bolar 
Designation  Post Graduate Student  
Affiliation  Tejasvini Physiotherapy College 
Address  Physiotherapy OPD Tejasvini Physiotherapy College (A unit of Amar shanth charitable Trust) Opposite Anantha Padmanbha temple, Kudupu, Mangalore 575028

Dakshina Kannada
KARNATAKA
575028
India 
Phone  9591379450  
Fax    
Email  nishkabolar20@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Nishka S Bolar 
Address  Post Graduate Student, Tejasvini Physiotherapy College, Kudupu, Mangalore 
Type of Sponsor  Other [Self Funded Study ] 
 
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 Subhashchandra Rai  Tejasvini Physiotherapy College  OPD Room, Tejasvini Physiotherapy College Opp Anantha Padmanbha Temple, Kudupu, Mangalore
Dakshina Kannada
KARNATAKA 
9448158751

physio.subhashrai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Maitland Mobilization Techniques  To perform the mobilization, the patient lies prone with abdominal support for comfort. The therapist stands close, following assessment of each lumbar vertebra, the most painful segment is targeted with it being hyper mobile. Gentle, small amplitude, Posterior Anterior Pressure is applied centrally to the spinous process of each lumbar vertebra. This involves six sets of 30 second Oscillations, with the amplitude adjusted to the patients tolerance. Six repetitions will be performed on each of the three spinous processes once daily. The patients pain in reassessed before treating another vertebral segment. The entire PA mobilization session typically will last about 10 minutes. 
Intervention  Self Myofascal release   The Self Myofascial Release procedure in this study involves as follows A standard 6 X 36 inch foam roller and Tennis ball. The foam roller is selected as the primary tool for applying sustained pressure and Participants are instructed to use specific SMFR techniques on several key muscle group: the Quadratus Lumborum with three into 30 seconds hold, each followed by one minute rest; the Thoracolumbar fascia and Para vertebral muscles in the T12 to L1 region, three into 40 seconds applications, also separated by one minute rests; the Psoas muscle with three into 30 seconds hold and one minute intervals; and finally, the Piriformis and gluteal muscles, with three into 30 seconds holds, each followed by a minute rest period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Subjects with Nonspecific low back pain
Sub acute or Chronic
without referred leg pain
VAS greater than or equal to 4
studnets with age group between 18 to 30 years  
 
ExclusionCriteria 
Details  Difficulty with isometric contractions or moderate physical exertion due to internal health issue (eg: Cardiovascular, pulmonary, systemic)
specific cause identified
known or suspected serious pathology
non mechanical low back pain
nerve root compromise
neurological signs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale   Pre(Day 0) to Post(Day 6) 
 
Secondary Outcome  
Outcome  TimePoints 
Schobers Method  Pre(Day 0) to Post(Day 6) 
Modified Oswestry Disability Index  Pre(Day 0) to Post(Day 6) 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   01/02/2026 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nishkabolar20@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

To Evaluate the effectiveness of Self Myofascial Release versus Maitland Mobilization Technique along with Mc Gill’s Big 3 Exercises among Non-Specific Low Back Pain. Low Back Pain, the most common cause of pain and disability worldwide, with approximately 90% cases affecting a substantial portion of the global population, this being classified as Non-Specific Low Back Pain (NSLBP). In 2025 the prevalence of low back pain is predictably going to reach up to 84% and the prevalence of chronic low back pain is 23%, the recurrent episode of pain and work disability in LBP is 44-78% and 26-37%.

Commonly used therapeutic technique is Manual therapy which is used by therapist in treating Low Back pain, having techniques like Mobilization and Manipulations, Manual therapy can be done by using Myofascial Release and Mulligan Mobilization, Maitland Mobilization technique in management for NSLBP.

Myofascial release (MFR) is a hands-on technique using pressure and stretching to ease tight tissues (fascia), reduce pain, and improve movement, which involves gentle, lasting pressure on sore spots, helping the fascia lengthen and relax. According to a systematic review, roller massage appears to be a method for increasing joint range of motion without a downside for muscle function. SMFR technique remarkably improves both pain and disability. 

Maitland mobilization, uses gentle, controlled movements of spinal joints within a patient’s pain-free limits, aiming to increase joint movement, decrease muscle tension, and relieve pain. Additionally, studies have investigated the effectiveness of Maitland mobilizations, in the management of NSLBP, highlighting the importance of a comprehensive assessment and treatment approach. 

Mc Gill’s Big 3 exercises are a widely utilized intervention in the management of NSLBP, targeting the trunk muscles to enhance spinal stability and pain which aim to activate and strengthen the muscles, improving their ability to stabilize the spine during movement and activities of daily living. 

It is important to note that optimal out comes are often achieved when core stability exercises are integrated into a comprehensive rehabilitation program that includes patient education, manual therapy, and other forms of exercise. 

Data will be collected from the students of Tejasvini Hospital Group of Institutions, Kudupu, Mangalore, Karnataka.

Sample size was determined using the standard deviation of VAS, The estimated sample size is 34 in each group. Participants will be divide into two groups for the study , group A with SMFR along Mc Gill big 3 exercise and group B Maitland mobilization techniques along Mc Gill Big 3 exercise. This interventional study will be conducted in the Hospital setting to compare the effects of Self Myofascial Release versus Maitland Mobilization Technique with Mc Gill’s Big 3 exercise among Non-specific low back pain. Participants will be recruited through the selection criteria. Data collection will involve three components. To measure pain, Visual analog scale. To check ROM, Schober Method. Modified Oswestry Disability Index  (MODI) questionnaire, evaluated the impact of LBP on the individual’s performance of daily activities. The Intervention will be conducted for one week with all the techniques and exercise given to patients. 









 
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