FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094498 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Validation 
Study Design  Other 
Public Title of Study   Predicting the Risk of Chronic Back Pain: Development and Testing of the LumbaRisk Model 
Scientific Title of Study   Development and validation of lumbar risk prediction model and its reliability testing for chronic non specific low back pain 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nityal Kumar ALagingi 
Designation  Assistant Professor 
Affiliation  Assistant Professor 
Address  Nityal Kumar Alagingi, Nitte Institute of Physiotherapy, Nitte(Deemed to be University),Mangalore
Nityal Kumar Alagingi, Nitte Institute of Physiotherapy, Nitte(Deemed to be University),Mangalore
Dakshina Kannada
KARNATAKA
575018
India 
Phone  7760547669  
Fax    
Email  nityalkumar2020@nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Dhanesh Kumar K U  
Designation  Principal  
Affiliation  Nitte Institute of Physiotherapy 
Address  Nitte Institute of Physiotherapy, Nitte(Deemed to be University),Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9019431417  
Fax    
Email  principal.nipt@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Dhanesh Kumar K U  
Designation  Principal  
Affiliation  Nitte Institute of Physiotherapy 
Address  Nitte Institute of Physiotherapy, Nitte(Deemed to be University),Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9019431417  
Fax    
Email  principal.nipt@nitte.edu.in  
 
Source of Monetary or Material Support  
Nityal Kumar, Assistant Professor, Nitte Institute of Physiotherapy, Mangalore, India, 575018 
 
Primary Sponsor  
Name  Nityal Kumar Alagingi 
Address  Nitte Institute of Physiotherapy, Nitte(Deemed to be University),Mangalore, Karnataka, 575018 
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 
Nityal Kumar   K S Hegde Charitable Hospital  Room no 60, Department of Physiotherapy,K S Hegde Charitable Hospital , Deralakatte
Dakshina Kannada
KARNATAKA 		 7760547669

nityalkumar2020@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Age between 19 to 45
Non specific low back pain
 
 
ExclusionCriteria 
Details  Any surgery
Specific low back pain
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development of a lumbar risk prediction model for chronic non-specific low back pain  Development of a lumbar risk prediction model for chronic non-specific low back pain 
 
Secondary Outcome  
Outcome  TimePoints 
Model validity (predictive accuracy)
Reliability of predictor variables and scoring system 		 Time frame: During validation phase and after final model validation  
 
Target Sample Size   Total Sample Size="623"
Sample Size from India="623" 
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)   22/09/2025 
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="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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

  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 (Others) - 

  6. For how long will this data be available start date provided 25-12-2027 and end date provided 05-05-2028?
    Response (Others) - 

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

Public Title:

Development and Validation of Lumbar Risk Prediction Model for Chronic Non-Specific Low Back Pain

Brief Summary for CTRI Registration:

This prospective cohort study aims to develop, validate, and assess the reliability of the Lumbar Risk prediction model, which estimates the risk of chronic non-specific low back pain (CNSLBP) among young adults aged 19–45 years. NSLBP is a multifactorial condition with no specific pathology, and early identification of high-risk individuals can significantly reduce chronicity and associated disability.

The study involves three phases:

  1. Phase 1 – Risk Factor Identification: A comprehensive literature review and expert survey will identify key risk factors using the biopsychosocial model.

  2. Phase 2 – Model Development & Validation: A prediction model will be developed using regression techniques and internally validated with 495 participants categorized into three groups—no pain, acute LBP, and chronic LBP. The model’s performance will be evaluated using AUC, sensitivity, specificity, and calibration plots.

  3. Phase 3 – Reliability Testing: Inter-rater and test-retest reliability will be assessed in a clinical setting using Intraclass Correlation Coefficient (ICC) on a sample of 60 participants.

Primary Objectives:

  • To develop and validate a predictive model to identify individuals at high risk of developing chronic NSLBP.

  • To assess the reliability (inter-rater and test-retest) of the developed model in a clinical setting.

Outcome:

A validated, reliable, and clinically applicable Lumbar Risk model that can aid physiotherapists and clinicians in predicting and managing the risk of chronic NSLBP effectively.

 
Close