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CTRI Number  CTRI/2025/03/081506 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Back care education module for children with low back pain due to heavy backpack 
Scientific Title of Study   DEVELOPMENT AND VALIDATION OF LOW BACK EXERCISE MODULE AND ITS EFFECTIVENESS ON TRUNK MOBILITY AND POSTURE AMONG SCHOOL CHILDREN-A MIXED METHOD STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Leelasri M 
Designation  Master of physiotherapy 
Affiliation  Sri Devaraj Urs Academy Of Higher Education  
Address  R L Jalappa college of physiotherapy Sri Devaraj Urs Academy Of Higher Education and Research Kolar Karnataka
R L Jalappa college of physiotherapy Sri Devaraj Urs Academy Of Higher Education and Research Kolar Karnataka
Kolar
KARNATAKA
563103
India 
Phone  8523903926  
Fax    
Email  leelasrimanigandan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjali Suresh 
Designation  Professor and Guide 
Affiliation  Sri Devaraj Urs Academy Of Higher Education and Research Institute 
Address  R.L.Jalappa college of physiotherapy Sri Devaraj Urs Academy Of Higher Education and Research Institute Kolar Karnataka

Kolar
KARNATAKA
563103
India 
Phone  9448388427  
Fax    
Email  dranjali@sduaher.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Anjali Suresh 
Designation  Professor and Guide 
Affiliation  Sri Devaraj Urs Academy Of Higher Education and Research Institute 
Address  R.L.Jalappa college of physiotherapy Sri Devaraj Urs Academy Of Higher Education and Research Institute Kolar Karnataka

Kolar
KARNATAKA
563103
India 
Phone  9448388427  
Fax    
Email  dranjali@sduaher.ac.in  
 
Source of Monetary or Material Support  
R.L.Jalappa college of physiotherapy Sri Devaraj Urs Academy Of Higher Education and Research Institute Kolar Karnataka 563103 
 
Primary Sponsor  
Name  SDUAHER 
Address  R.L.Jalappa college of physiotherapy Sri Devaraj Urs Academy Of Higher Education and Research Institute Kolar Karnataka 563103  
Type of Sponsor  Other [Demeed university] 
 
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 Anjali Suresh  R L Jalappa central school  Mittakallahalli room number 101 Tamaka Kolar Karnataka 563103
Kolar
KARNATAKA 		 8523903926

leelasrimanigandan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, 563103  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  single arm trial  back education module develop and validate, questionnaire will be provided to know the low back pain of the participants, pre-test NPRS, lumbar ROM and posture assessment, 4 week intervention, post test as same as pre test 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Age between 12 to 18 years
Both male and females
School children who complain of back pain
NPRS numerical pain rating scale more than 3
School children who are carrying backpacks to school.
School children who carrying backpacks which is more than 10 percent of their body weight
 
 
ExclusionCriteria 
Details  School Children with any spinal deformity
School Children with psychological illness
School Children with neurological disorders
School Children who are not using backpacks regularly
Congenital or inherited musculoskeletal disorders
School Children carrying backpack less than 10 percent of their body weight.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NPRS
lumbar ROM
postural assessment using postural grid and GAITON software 		 1st week pre test and end of 4 week post test 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/03/2025 
Date of Study Completion (India) 30/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 developing and validating the back care education module by the 5 pediatric physiotherapist whose having 5 years of experience. questionnaire will be provided to the school children. according to inclusion and exclusion criteria will recruting the  participants. pre test will check the lumbar ROM, NPRS nd posture through postural grid and using GAITON software. validated module will be provided to the school children. 4 weeks of intervention will be given.after 4 weeks of intervention will do the post test. in post test will check the lumbar ROM, NPRS nd posture through postural grid and using GAITON software. 
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