| CTRI Number |
CTRI/2020/10/028574 [Registered on: 22/10/2020] Trial Registered Prospectively |
| Last Modified On: |
06/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of left right discrimination task with neck joint position sense and pain in patients with long standing neck pain. |
|
Scientific Title of Study
|
Correlation of Laterality discrimination task with cervical joint position sense and pain in patients with Chronic non specific 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 |
Dipti Geete |
| Designation |
Assistant Professor |
| Affiliation |
P.T. School and Centre, Seth G.S. Medical College and KEM Hospital |
| Address |
P.T. School and Centre, Seth G.S. Medical College and KEM Hospital, Parel(E), Mumbai- 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869701464 |
| Fax |
|
| Email |
dipti_geete@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dipti Geete |
| Designation |
Assistant Professor |
| Affiliation |
P.T. School and Centre, Seth G.S. Medical College and KEM Hospital |
| Address |
P.T. School and Centre, Seth G.S. Medical College and KEM Hospital, Parel(E), Mumbai- 400012
MAHARASHTRA
400012
India |
| Phone |
9869701464 |
| Fax |
|
| Email |
dipti_geete@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shrutika Shelar |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
P.T. School and Centre, Seth G.S. Medical College and KEM Hospital |
| Address |
P.T. School and Centre, Seth G.S. Medical College and KEM Hospital, Parel(E), Mumbai- 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920598438 |
| Fax |
|
| Email |
shrutikashelar@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T. School and Centre, Seth G.S. Medical College and KEM Hospital |
|
|
Primary Sponsor
|
| Name |
Dipti Geete |
| Address |
P.T. School and Centre, Seth G.S. Medical College,
Acharya Dhonde Marg,
Parel(E) Mumbai- 400012
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dipti Geete |
P.T. School and Centre, Seth G.S. Medical College and KEM Hospital |
401, Physiotherapy OPD, Ground Floor, KEM Orthopedic Center,
Acharya Dhonde Marg,
Parel (E), Mumbai- 400012
Mumbai
MAHARASHTRA |
9869701464
dipti_geete@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Seth G.S. Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Chronic non- specific neck pain i.e pain experienced for more than 3 months |
|
| ExclusionCriteria |
| Details |
1. History of cervical trauma
2. Cervical myelopathy/ radiculopathy
3. History of cervical spine surgery
4. Infections or inflammatory pathologies involving cervical spine.
5. Systemic conditions like uncontrolled diabetes mellitus and fibromyalgia
6. Signs of central nervous system affection
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Response time (msec)
Accuracy (%) |
one time assessment in which outcome measures will be assessed only once on the day of data collection for each subject. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cervical joint position sense error
Pain |
The outcome measures will be assessed only once on the day of data collection for each subject |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/11/2020 |
| 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="6"
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 musculoskeletal disorder with a high prevalence in the population and is the fourth leading condition that generates greater disability. Chronic neck pain is associated with impairment in proprioception due to its peripheral effects along with altered body schema which refers to the internal representation of the body in the peri personal space. Laterality discrimination task measures the ability of a person to identify if the part is rotated to the left side or the right side and is dependent on the intact body representation or body schema. Cervical joint position sense is quantified by joint position error (JPE) measured in degrees and is a measure of cervical proprioception. Both sensory as well as proprioceptive information is utilized for the internal representation of the body i.e. body schema. Thus the aim of our study is to correlate laterality discrimination task performance through response time and accuracy with cervical joint position sense and pain.
This study will be conducted by recruiting 100 participants consisting of both males and females in the age group of 18-45 years in two groups. First group will consist of 50 patients with chronic non-specific neck pain and second group will consist of 50 age-gender matched asymptomatic controls. One time assessment of laterality discrimination task through response time and accuracy, cervical joint position sense through joint position sense error and pain through NRS will be done.
With the help of this study we will be able to understand if there is any correlation of laterality discrimination task with cervical joint position sense and pain. |