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CTRI Number  CTRI/2025/06/088315 [Registered on: 05/06/2025] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study Comparing Neck Joint Sense in People with Long-standing Neck Pain and difficulty doing daily activities, with healthy people of the same age and gender. 
Scientific Title of Study   Comparison of Cervical Proprioception in Patients with Chronic Neck Pain and Functional Disability versus Age- and Gender- matched Asymptomatic Individuals. A Cross-Sectional 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  Dr Bharati Asgaonkar  
Designation  Associate Professor 
Affiliation  Topiwala National Medical College and Dr B.Y.L. Charitable Hospital 
Address  OPD 24, Physiotherapy department, PT School and Centre, Topiwala National Medical College and Dr. B.Y.L. Charitable Hospital, Dr. A.L, Dr. Anandrao Nair Marg, Mumbai Central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  9987103028  
Fax    
Email  bharatida1234@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharati Asgaonkar  
Designation  Associate Professor 
Affiliation  Topiwala National Medical College and Dr B.Y.L. Charitable Hospital 
Address  OPD 24, Physiotherapy department, PT School and Centre, Topiwala National Medical College and Dr. B.Y.L. Charitable Hospital, Dr. A.L, Dr. Anandrao Nair Marg, Mumbai Central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  9987103028  
Fax    
Email  bharatida1234@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Humera Nizamuddin Shaikh  
Designation  MPT 1 
Affiliation  Topiwala National Medical College and Dr B.Y.L. Charitable Hospital 
Address  OPD 24, Physiotherapy department, PT School and Centre, Topiwala National Medical College and Dr. B.Y.L. Charitable Hospital, Dr. A.L, Dr. Anandrao Nair Marg, Mumbai Central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  7738702980  
Fax    
Email  humerashaikh956@gmail.com  
 
Source of Monetary or Material Support  
P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai Central. Mumbai: 4000003 Maharashtra. India 
 
Primary Sponsor  
Name  NIL  
Address  NIL  
Type of Sponsor  Other [NIL ] 
 
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 Bharati Asgaonkar   P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai  OPD-24, Room no. 2 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai : 400008
Mumbai
MAHARASHTRA 
9987103028

bharatida1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M542||Cervicalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  For study group
Patients with neck pain more than 3 months
Neck Disability Index score between 5 to 34
Individuals able to read and write in English, Hindi or Marathi language

For control group
No neck pain.
Neck Disability Index score between 0 to 4.
Individuals willing to participate in study.
Individuals able to read and write in English, Hindi or Marathi language. 
 
ExclusionCriteria 
Details  For study group
Severe pain VAS score more than 7
Any sensory or motor impairments in the upper limb
Giddiness on head movements
Restricted Neck ROM due to severe muscle spasm.
Positive vertebral Artery test

For control group
Individuals with Neck pain
Individuals with any cervical related trauma and surgery in past 6 months
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cervical joint position error test.  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NIL  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   16/06/2025 
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="1"
Months="6"
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 - NO
Brief Summary   NEED OF STUDY
The Physiotherapy OPD receives many patients with chronic neck pain, it is most common condition affecting the activity of daily life. With the growing number of patients experiencing neck pain, it is essential to identify the underlying cause.
Previous studies have identified the impairment in cervical proprioception among individuals with chronic neck pain. These disturbances are believed to serve as a protective mechanism, aiming to minimize further stimulation of the affected and painful tissues.
Disruptions in cervical proprioception can compromise neck muscle coordination, alter head posture, and restrict the cervical functional range of motion. These changes in posture and movement can significantly affect daily activities.
It is important to understand the relationship between cervical proprioception and functional disability. However, limited research has compared proprioceptive impairments and it’s impact functional activities between individuals with chronic neck pain and healthy individuals in Indian population.
This study aims to evaluate the extent of proprioceptive dysfunction in patients with chronic neck pain who have functional limitations, compare it with healthy individuals.
Additionally, these connections may contribute for developing targeted interventions and including cervical proprioception exercises in physiotherapy treatment can help prevent future impairments and reduce their impact on functional limitations.

AIM
To compare the cervical proprioception in patients with chronic neck pain and functional disability versus age- and gender- matched Asymptomatic individuals

OBJECTIVES
1. To assess cervical proprioception using cervical joint position error test in patients with chronic neck pain and functional disability
2. To assess cervical proprioception using cervical joint position error test in Asymptomatic individuals.
3. To compare the cervical proprioception in patients with chronic neck and functionally disabled and Asymptomatic individuals.

PROCEDURE
Participants will be enrolled in the study depending on the selection criteria and willingness to participate in the study.

Informed consent and case record form will be filled.

Cervical joint position error test will be assessed 

Data will be analyzed

DATA MANAGEMENT AND ANALYSIS PROCEDURE
•Cervical proprioception will be evaluated using Joint Position Error Test.
• Data will be tested for Normality.
• If the data passes the normality test, Parametric unpaired t- test will be used.
• If the data does not pass normality test, Non-parametric- Mann-Whitney U test will be use.
 
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