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CTRI Number  CTRI/2026/01/101812 [Registered on: 22/01/2026] Trial Registered Prospectively
Last Modified On: 21/01/2026
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   Exercise Programs For Reducing Back Pain: McGill Big Three Versus Core Strengthening 
Scientific Title of Study   Effect of McGill Big Three Versus Core Strengthening Exercises in Subjects with Non-Specific Low Back Pain – A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
mahimanyk11@gmail.com  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Apeksha Hungund 
Designation  Assistant Professor  
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center, room no, 39 department of orthopaedic manual therapy room no.13, sagar floor, Belgaum Karnataka 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  8310725829  
Fax    
Email  apeksha_hungund@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Apeksha Hungund 
Designation  Assistant Professor  
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center, room no, 39 department of orthopaedic manual therapy room no.13, sagar floor, Belgaum Karnataka 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  8310725829  
Fax    
Email  apeksha_hungund@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Shrushti Basagond Hebbi 
Designation  Intern 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center, room no, 39 department of orthopaedic manual therapy room no.13, sagar floor, Belgaum Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  8107724439  
Fax    
Email  srustihebbi2003@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr. Prabhakar Kore hospital and research center, Nehru Nagar, Belagavi -590010 India 
 
Primary Sponsor  
Name  KAHER Institute of Physiotherapy 
Address  KAHER institute of physiotherapy, JNMC campus, Nehru Nagar, Belagavi- 590010 India 
Type of Sponsor  Research institution and hospital 
 
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 
DrApeksha Hungund  KAHER Institute of Physiotherapy  Advanced Physiotherapy center, room no, 39 department of orthopaedic manual therapy room no.13, sagar floor, Belgaum Karnataka 590010 India
Belgaum
KARNATAKA 		 08310725829

apeksha_hungund@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee KAHER institute of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Non Specific Low Back Pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Core strengthening exercises   The subjects will be given core strengthening exercises for 6 week , 3 days per week , for 18 sessions. The exercises like single knee of chest, knee to chest , prone lying with pillow with one leg sliding , cycling in supine , briding will be given for 10 second hold with 10 repetitions and along with hot moist pack and interferential therapy for 20 minutes. 
Intervention  McGill Big Three Exercises   The subjects will be given McGill Big Three exercises for 6 week, 3 days per week, for 18 sessions. The exercises like bird dog , modified curl ups , side planks will be given for 10 second hold with 10 repetitions and along with hot moist pack and interferential therapy for 20 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Both male and female aged between 18-35 years willing to participate with non specific low back pain. Having non specific low back pain since two months or more. Pain intensity greater than or equal to three on Visual Analog Scale at baseline. 
 
ExclusionCriteria 
Details  Any co morbid factors like congenital, malignant, autoimmune and neurological conditions involving head, neck and spine. Any trauma to head, neck and spine region less than six months. Pregnancy or less than six months postpartum. Who are unable to comprehend to the commands. Undergoing any professional physical activity training. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain using visual analog scale, strength using pressure biofeedback, Range of Motion using Modified Modified Schober’s test, and quality of life using Oswestry Low back pain disability questionnaire.  Pre intervention and post 6 weeks of interventions 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   05/02/2026 
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="0"
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   EFFECT OF McGILL BIG THREE VERSUS CORE  STRENGTHENING EXERCISES IN SUBJECT WITH NON – SPECIFIC LOW BACK PAIN-RANDOMIZED CONTROLLED TRIAL 

AIM:

To evaluate the effect of McGill big three versus core strengthening exercises in subjects with non-specific low back pain on pain, strength, quality of life and range of motion.

OBJECTIVES:

To evaluate the effect of McGill big three versus core strengthening exercises in subjects with non-specific low back pain on pain using visual analog scale, strength  using pressure biofeedback, Range of Motion using Modified Modified Schober’s test, and quality of life using Oswestry Low back pain disability questionnaire. 

METHODOLOGY:

Study type: Randomized Controlled Trial 

Target population: Both Male and Female aged between 18-35 years with non-specific low back pain 

Sample size: 32 participants 

OUTCOME MEASURES: 

Pain using visual analog scale, strength  using pressure biofeedback, Range of Motion using Modified Modified Schober’s test, and quality of life using Oswestry Low back pain disability questionnaire. 

INCLUSION CRITERIA

1.     Both male and female aged between 18-35 years willing to participate with non-specific low back pain.(16)

2.     Having non – specific  low back pain since 2 months or more.(17)

3.     Pain intensity greater than equal to 3 on Visual Analog Scale at baseline.(18)

 

EXCLUSION CRITERIA

1.     Any co- morbid factors like congenital, malignant, autoimmune and neurological conditions involving head, neck and spine.

2.     Any trauma to head, neck and spine region less than 6 months.

3.     Pregnancy or less than 6 months postpartum.

4.     Who are unable to comprehend to the commands.

5.     Undergoing any professional physical activity training. 

PROCEDURE: 

Prior to the commencement of the study an ethical clearance will be obtained from KAHER Institute of Physiotherapy’s Institutional Ethical Committee. 

Following which we will register our study in CTRI. 

Participants will be screened according to the outcome measures. 

Participants will be briefed about the study. 

a written informed consent will be given to the participants and those consenting to participate will be recruited after screening. 

brief demographic data will be obtained from each participant prior to the assessment. 

Participants will be randomly allotted by envelop method into two groups; group A and group B. Group A will be given Mcgill Big Three Exercises and Group B will receive core Strengthening exercises. 


Goup A (McGill Big Three)

Each exercise will be given for 10 reps with a rest interval of 2 minutes. 

McGill Big Three exercises include: Modified curl up, side plank and bird dog. 

These will be given for 3 days/week for 6 weeks


Group B (Core strengthening Exercises)

Group B will receive conventional exercises which include single and double knee to chest, prone lying with pillow with one leg sliding, cycling in supine, bridgeing exercises for 3 days/week for 6 weeks.

Each exercise will be given for 10 reps with rest interval of 2 minutes between exercises. 

Both Group A and Group B will be treated with hot moist pack for 20 minutes and IFT on low back region for 20 minutes for 3 days/week for 6 weeks 

 
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