FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/08/009240 [Registered on: 03/08/2017] Trial Registered Prospectively
Last Modified On: 13/11/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Prevalence and service utilization regarding low back pain among health care workers 
Scientific Title of Study   To assess the prevalence, knowledge, disability and service utilization regarding low back pain among health care workers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NK/2039/Res/897 dated 01.04.15 version 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Babita Ghai  
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research  
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009533  
Fax  01722744401  
Email  ghaibabita1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Babita Ghai  
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research  
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12


CHANDIGARH
160012
India 
Phone  7087009533  
Fax  01722744401  
Email  ghaibabita1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Babita Ghai  
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research  
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12


CHANDIGARH
160012
India 
Phone  7087009533  
Fax  01722744401  
Email  ghaibabita1@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India  
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research  
Address  Department of Anaesthesia and Intensive Care, PGIMER, Sector-12, Chandigarh 160012 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 
Babita Ghai  Post Graduate Institute of Medical Education and Research   Department of Anaesthesia and Intensive Care, Fourth Floor, Nehru Building, PGIMER, Sector-12
Chandigarh
CHANDIGARH 		 7087009533
01722744401
ghaibabita1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, PGIMER   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult population more than 18years of age of either gender working in health centers in and around Chandigarh  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult population ≥18years of age of either gender working in health centers in and around Chandigarh and willing to participate in the study by providing written informed consent
2. Subject may or may not be suffering from LBP
 
 
ExclusionCriteria 
Details  Any adult person not willing to participate in the study 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the prevalence of low back pain (LBP) in a probability sample of adults health care workers.  Life time prevalence 
 
Secondary Outcome  
Outcome  TimePoints 
To describe the health service utilization pattern of LBP subjects in these health care workers
To analyze factors associated with LBP and health service utilization pattern of the LBP subjects
To assess the level of knowledge regarding prevention of low back pain among health care workers.
To evaluate the psychometric properties of the Indian adaptation of the Aberdeen LBP Disability Scale.
 		 current prevalence, three year and recurrent prevalence  
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 01/05/2015 
Date of Study Completion (India) Date Missing 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Subjects were required to complete a questionnaire to assess for low-back pain history. The questionnaire is designed to identify lifetime prevalence, current prevalence, three year and recurrent prevalence and duration of the LBP. Lifetime prevalence is defined as the proportion of the population that had experienced an episode at some point in their lifetime. Point (current) prevalence is defined as the proportion of the population that had been cases within the previous week. Recurrent LBP is identified by the question `do you get back pain regularly’; this question referred to the previous three years and is classified by repeated acute episodes. An anatomical drawing is used to identify the localization of the back pain. The consequences of LBP experience are also examined. Questions are asked relating to absence from work, medical treatment and limitation of activity.

 
Close