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CTRI Number  CTRI/2024/06/068736 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Exploring Prevalence and Risk Factors of Persistent Low Back Pain Among Auto Rickshaw Drivers in Greater Noida 
Scientific Title of Study   Prevalence and associated risk factors among auto Rickshaw drivers with persistent Low Back Pain in Greater Noida- A cross sectional 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  Dr Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B319, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B319, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Usman Gani Faiyazi 
Designation  Student 
Affiliation  Galgotias University 
Address  Room No. E004, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9599796985  
Fax    
Email  usmangani500@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell, Galgotias University A315, Plot No 2, Sector 17 A, Opposite Buddha International circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India 203201 
 
Primary Sponsor  
Name  Galgotias University 
Address  Room No A315, Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International circuit, Greatwr Noida, Gautam Buddha Nagar, Uttar Pradesh, India 203201 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohammad Sidiq  Galgotias University  Room No. E003, Department of Physiotherapy, Galgotias University
Gautam Buddha Nagar
UTTAR PRADESH 		 6006204628

sidufatima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Commitee, Galgotias University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M679||Unspecified disorder of synovium and tendon,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  ProfessioNAL autorickshaw drivers
Per day driving more than equal to 8 hours 16 
Work experience greater than or equal to 5 years 
 
 
ExclusionCriteria 
Details  Those with recent injuries, trauma (slip/fall injuries sustained for any reason other than professional driving work)
Limb length discrepancy
Congenital musculoskeletal morbidities, and prior limb surgery were excluded from the study.
Diagnosed musculoskeletal, neurological and cardiopulmonary disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale
Rolland Morris Disability Questionnaire 		 Baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="376"
Sample Size from India="376" 
Final Enrollment numbers achieved (Total)= "353"
Final Enrollment numbers achieved (India)="353" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/07/2024 
Date of Study Completion (India) 29/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [usmangani500@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 30-07-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - na
Brief Summary   The study investigates the prevalence and associated risk factors among autorickshaw drivers experiencing persistent low back pain in Greater Noida. It likely explores the extent of low back pain within this occupational group and identifies potential factors contributing to its persistence. Factors such as prolonged sitting, poor ergonomics, vehicle vibrations, and lifting heavy loads may be among the risk factors considered. The study’s methodology likely involves surveying a sample of auto-rickshaw drivers, assessing the frequency and severity of their low back pain, and examining potential correlations with various occupational and personal variables. Findings could offer insights into the specific challenges faced by auto-rickshaw drivers in terms of musculoskeletal health and may inform interventions aimed at reducing the prevalence and impact of low back pain in this population, potentially leading to improved occupational health and well-being. 
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