| 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
|
|
|
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
|
|
|
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).
|