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CTRI Number  CTRI/2023/03/050451 [Registered on: 07/03/2023] Trial Registered Prospectively
Last Modified On: 04/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Finding factors causing non-specific neck pain in working women 
Scientific Title of Study   Identification of factors associated with non- specific neck pain in working women. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Reetika Yadav 
Designation  student 
Affiliation  Amity University 
Address  Amity institute of physiotherapy, Amity University Noida Campus Sector-125, Noida, Uttar Pradesh 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9711408014  
Fax    
Email  reetika.yadav@s.amity.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Pragya Kumar 
Designation  Assistant professor 
Affiliation  Amity University 
Address  Amity institute of physiotherapy, Amity University Noida Campus Sector-125, Noida, Uttar Pradesh 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9878529787  
Fax    
Email  pkumar24@amity.edu  
 
Details of Contact Person
Public Query  
Name  Dr Pragya Kumar 
Designation  Assistant professor 
Affiliation  Amity University 
Address  Amity institute of physiotherapy, Amity University Noida Campus Sector-125, Noida, Uttar Pradesh 201301

Balrampur
UTTAR PRADESH
201301
India 
Phone  9878529787  
Fax    
Email  pkumar24@amity.edu  
 
Source of Monetary or Material Support  
Amity University, Amity institute of physiotherapy, F1 Block, lower ground floor. 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [No primary sponsor] 
 
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 Surendra Yadav   Triton hospital  Triton Hospital, Physiotherapy department, Samarpan physiotherapy and rehabilitation center. Basement area, CC - 30 & 31, Block C, Nehru Enclave, Kalkaji, New Delhi - 110019
South
DELHI 		 8826550288

info@sprc.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Amity institute of physiotherapy  Approved 
Triton hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  53.00 Year(s)
Gender  Female 
Details  participants with age group between 25-53 years.
Working women past 2 year
Participants can read and write English language and had cleared class tenth.
 
 
ExclusionCriteria 
Details  1.Cervical disc prolapse
2.Cervical spinal stenosis
3.Cervical post operative conditions
4.history of severe trauma
5.cervical instability
6.Pregnant women
7.Cervical radiculopathy
8.Medical history of cardiovascular or cerebrovascular accident or disease, hypertension.
9.History of smoking. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.NDI scale - Neck Disability Index
2.QERNP scale - Questionnaire for the evaluation of risk factors associated with non-specific neck pain
 		 30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1.Neck range of motion assessment with goniometer.
2.Forward head posture assessment is done by Tragus to wall test.
3.Rounded shoulder measurement -Acromion to table distance test.
4.Neck flexors endurance is measured by chin tuck test
 		 30 minutes 
 
Target Sample Size   Total Sample Size="196"
Sample Size from India="196" 
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)   16/03/2023 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
It is a cross- sectional study to determine the factors associated with non- specific neck pain in working women. 
The main objectives of the study is 
To determine the prevalence of non-specific neck pain in working women.

To evaluate association of factors (individual, physical, psychological, workplace and lifestyle) with occurrence of non-specific neck pain in working women.
The study is designed to determine factors categorized under domains such as individual, physical, psychological, workplace and social lifestyle factors resulting in neck pain among working women. So far there is no study that has evaluated combination of factors among working women at workplace and home in relation to occurrence of non-specific neck pain.
Working women are taken in the study based on inclusion and exclusion criteria and ask to fill questionnaires and assessment is done using certain physical test and then the analysis will be done which factors are associated with non-specific neck pain in working women.
 
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