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CTRI Number  CTRI/2024/08/072948 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 22/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of non-specific low back pain on foot position, Arch Shape, Disability, and Quality of Life in School Teachers of Delhi NCR. 
Scientific Title of Study   Relationship Of Non-specific Low back Pain On Calcaneal Frontal Plane Position, Congruence Of Medial Longitudinal Arch, Disability, And Quality of life Among School teachers of Delhi NCR 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anvita 
Designation  MPT Musculoskeletal student  
Affiliation  Banarsidas Chandiwala Institute of physiotherapy 
Address  Musculoskeletal department of Physiotherapy, Chandiwala estate maa Anandmai Marg Kalkaji South West DELHI 110019 India

South West
DELHI
110019
India 
Phone  9873344670  
Fax    
Email  Anvita00721@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti kataria 
Designation  Senior Assistant professor 
Affiliation  Banarsidas Chandiwala Institute of physiotherapy 
Address  Musculoskeletal department of Physiotherapy, Chandiwala estate maa Anandmai Marg Kalkaji South West DELHI 110019 India

South West
DELHI
110019
India 
Phone  9654441104  
Fax    
Email  jyoti.kataria@bcip.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Jyoti kataria 
Designation  Senior Assistant professor 
Affiliation  Banarsidas Chandiwala Institute of physiotherapy 
Address  Musculoskeletal department of Physiotherapy, Chandiwala estate maa Anandmai Marg Kalkaji South West DELHI 110019 India

South West
DELHI
110019
India 
Phone  9654441104  
Fax    
Email  jyoti.kataria@bcip.ac.in  
 
Source of Monetary or Material Support  
Musculoskeletal department of Physiotherapy, Chandiwala estate maa Anandmai Marg Kalkaji South West DELHI 110019 India 
 
Primary Sponsor  
Name  Anvita 
Address  Chandiwala Estate ,Maa Anandmai Marg Kalkaji 110019 
Type of Sponsor  Other [Self] 
 
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 Jyoti Kataria  Chandiwala estate maa Anandmai Marg Kalkaji South West DELHI 110019 India  Musculoskeletal department of Physiotherapy, Chandiwala estate maa Anandmai Marg Kalkaji South West DELHI 110019 India
South West
DELHI 		 9654441104

jyoti.kataria@bcip.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Banarsidas Chandiwala Institute of Physiotherapy Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Non specific Low back pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.School teachers of govt. and private schools.
2.Gender- Male and female both.
3.Age – 25 to 45 years
4.Work experience of more than 3 years.
 
 
ExclusionCriteria 
Details  1.School teachers who are pregnant or had delivered a year ago.
2.School teachers with immediate postoperative status (abdominal or low back surgery)
3.Having any neurological disorder and teachers undergoing psychological counselling therapy.
4.Had any history of malignancy or under any treatment for malignancy.
5.Any recent low back injury or trauma (last 6 months).
6.Teachers involved in any physical recreational activity (gym, yoga, aerobics).
7.Having low back tumor and infection, diseases associated with a neurological deficit, such as disc herniation, spinal stenosis, and radiating pain on the basis of clinical examination.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Numeric Pain Rating Scale (NPRS) – To assess low back pain.
2.Foot Posture Index (FPI-6) – To check the Calcaneal frontal plane position and congruence of medial longitudinal arch.
3.Modified Oswestry Low Back Pain Disability Questionnaire- To assess functional limitation due to low back pain.
4.12-Item Short Form Survey (SF-12) - To check the quality of life.
 		 1 DAY 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="178"
Sample Size from India="178" 
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)   03/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary   Non specific low back pain is very common among school teacher as they keep standing for long hours and this may affect their foot posture and quality of life in teachers due to excessive long hour standing
AIM of the study is to access the relationship of of non- specific low back pain on calcaneal frontal plane position, congruence of medial longitudinal arch, disability, and quality of life in school teachers.
SAMPLE SIZE is 178
Sample will taken from schools of Delhi-NCR

 
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