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CTRI Number  CTRI/2022/09/045656 [Registered on: 19/09/2022] Trial Registered Prospectively
Last Modified On: 16/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Factors influencing cervical proprioception among neck pain population  
Scientific Title of Study   Factors influencing cervical proprioception in individuals with neck pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Visali CEJ 
Designation  Student 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research Porur Chennai
Sri Ramachandra Institute of Higher Education and Research Porur Chennai
Chennai
TAMIL NADU
600116
India 
Phone  8939694107  
Fax    
Email  t0220010@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  MR K SUBBIAH 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research Porur Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9443033118  
Fax    
Email  subbiah@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  MR KSUBBIAH 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research Porur Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9443033118  
Fax    
Email  subbiah@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
sri ramachandra institute of higher education and research 
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Faculty of Physiotherapy Porur Chennai 
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 
Visali CEJ  Sri Ramachandra Hospital G-Block OPD  Sri Ramachandra Institute of Higher Education & Research Faculty of physiotherapy porur
Chennai
TAMIL NADU 
8939694107

t0220010@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M953||Acquired deformity of neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  observational  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  With the history of neck pain,
With or without radiation into dorsal or upper limb. 
 
ExclusionCriteria 
Details  Subjects with previous history of surgery in cervical spine, inflammatory disease, vertebro-basilar artery insufficiency, malignancy, neurological disease, whiplash injury, cervical myelopathy were excluded.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numerical pain rating scale (NPRS)
Cervical range of motion
Cranio cervical strength and endurance test
Cervical joint position error test (CJPE)
Neck disability index
 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="186"
Sample Size from India="186" 
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)   20/09/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  


  Neck  pain is a common condition and one of the leading causes of disability worldwide. Impairment of cervical proprioception was identified as the main problem in the neck pain group which occurs through a variety of mechanisms that subsequently lead to cervical sensorimotor control disturbances. Proprioception alance impairments were present in neck pain and healthy population. Conflicting evidence/association found between neck muscle endurance, pain intensity, and disorder type and duration with joint position error. Limited information is available regarding proprioceptive impairment among the acute neck pain population.

 

The Subjects who met the inclusion criteria would be recruited for the study, after obtaining written consent and the subjects will be undergoing a standardized musculoskeletal assessment. Evaluation of  pain, cervical range of motion, cervical muscle endurance ,regional function and cervicocephalic proprioception will be obtained from all enrolled subjects. Pain intensity will be measured using patient self-reported numeric pain rating scale, cervical range of motion will be  measured using single bubble inclinometer, cervical muscle endurance evaluated by - cranio cervical flexion test (using Chattanooga’s pressure biofeedback), neck flexor endurance test, neck extensor endurance test and regional function using Neck Disability Index (NDI) and cervicocephalic proprioception will be assessed using cervical joint position error test(CJPET).

 

 

 
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