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CTRI Number  CTRI/2024/07/069988 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Is the alignment of the spine related to chronic low backache?: An observational study 
Scientific Title of Study   Assessment of spinopelvic parameters in the normal Indian population and comparison with patients of chronic backache An observational 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  Tushar Lalchandani 
Designation  PG Resident 
Affiliation  AIIMS Bathinda 
Address  Orthopaedics Dept, Ground floor, OPD Block, AIIMS Bathinda

Bathinda
PUNJAB
151005
India 
Phone  09650338260  
Fax    
Email  tlchandani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj K Sharma 
Designation  Associate Professor 
Affiliation  AIIMS Bathinda 
Address  Orthopaedics Department, AIIMS Bathinda, Dabwali Road, Bathinda, Punjab

Bathinda
PUNJAB
151005
India 
Phone    
Fax    
Email  dr.pankajkristwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tushar Lalchandani 
Designation  PG Resident 
Affiliation  AIIMS Bathinda 
Address  Orthopaedics Department, Ground floor, OPD Building, AIIMS Bathinda

Bathinda
PUNJAB
151005
India 
Phone  09650338260  
Fax    
Email  tlchandani@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bathinda, Dabwali Road, Bathinda, Punjab, 151005 
 
Primary Sponsor  
Name  AIIMS Bathinda 
Address  Mandi Dabwali Rd, Bathinda, Punjab 151001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
AIIMS BATHINDA  Mandi Dabwali Rd, Bathinda, Punjab 151001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tushar Lalchandani  AIIMS Bathinda, Orthopaedics Department  Room 2015, Orthopaedics Department, All India Institute of Medical Sciences, Bathinda, Mandi Dabwali Road
Bathinda
PUNJAB 		 9650338260

tlchandani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bathinda Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Inclusion criteria
Consenting adults between 18-50 years age
Complaint of chronic low backache (>12 weeks)
Clinically diagnosed as a case of degenerative
spine disease by an experienced spine surgeon 
 
ExclusionCriteria 
Details  Exclusion criteria
Not consenting
<18 years or > 50 years of age
Systemic and metabolic disease affecting bone
(like RA)
Evidence of foot, ankle, knee or hip pathology
Evidence of spine pathology
Evidence of acute or chronic trauma
History of spine surgery
Evidence of malignancy or spinal metastasis
Females with positive urine pregnancy test
Females taking treatment to conceive, or planning
conception during or before recruitment
Females with history of multiple miscarriages/
birth defects 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
- To compare the sagittal spinopelvic parameters in asymptomatic v/s diseased population
(degenerative spine disease) with respect to the following parameters: TK, LL,SLA, LSA, C7SVA, PI, SS, PT 		 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
- To assess normal radiolographical parameters in Indian population & compare with
patients with chronic low backache. - To assess variability among asymptomatic controls with respect to age, sex, BMI, type of
work (hard labor v/s sedentary). - To look for markers predicting the onset or prognosticating the course of degenerative
spine disease. 		 1 month 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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)   15/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - 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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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 - Proposals should be directed to [tlchandani@gmail.com].

  6. For how long will this data be available start date provided 14-12-2023 and end date provided 14-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Aim
Assessment of spinopelvic parameters in the normal Indian population and comparison with
patients of chronic low backache : An observational study
Objectives
Primary Objectives
- To compare the sagittal spinopelvic parameters in asymptomatic v/s diseased population
(degenerative spine disease) with respect to the following parameters: TK, LL,SLA, LSA,
C7SVA, PI, SS, PT
Secondary Objectives
- To assess normal radiolographical parameters in Indian population and compare with
patients with chronic low backache.
- To assess variability among asymptomatic controls with respect to age, sex, BMI, type of
work (hard labor v/s sedentary).
- To look for markers predicting the onset or prognosticating the course of degenerative
spine disease.
Materials and Methods
1) Study Design:
Observational, case control study
2) Study Population:
Adult patients of age 18-60 years presenting to the Orthopaedics OPD of All India
Institute of Medical Sciences, Bathinda asymptomatic with respect to disorders of
spine (refer exclusion criteria) and patients presenting with complain of low
backache diagnosed as case of degenerative spine disease by a senior, experienced
orthopaedic spine surgeon.3) 
Study Area: Department of Orthopaedics, All India Institute of Medical Sciences, Bathinda
4) Study Duration: 2 years
 
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