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
|
|
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
|
|
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. |