| CTRI Number |
CTRI/2019/02/017685 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
13/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
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Public Title of Study
|
A study to analyze the effectiveness of exercise program in improving the neck position sense among patients with long standing neck pain |
|
Scientific Title of Study
|
A study to analyze the effectiveness of exercise program in improving the proprioceptive acquity among patients with chronic neck pain |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Deepika Shristhudhi |
| Designation |
post graduate student |
| Affiliation |
Sri Ramachandra Instituite of Higher Education and Research |
| Address |
No: 2/42, Gandhi Nagar,Karampakkam, Porur, Chennai.
No:1,Sri Ramachandra Nagar,Porur,Chennai - 60116
Chennai
TAMIL NADU
600116
India |
| Phone |
9787469969 |
| Fax |
|
| Email |
shristhudhideepika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A D Gopalswami |
| Designation |
associate professor |
| Affiliation |
Sri Ramachandra Instituite of Higher Education and Research |
| Address |
No:1,sri ramachandra nagar, Porur, Chennai.
No:1,Sri Ramachandra Nagar,Porur,Chennai - 60116
Chennai
TAMIL NADU
600116
India |
| Phone |
8248514287 |
| Fax |
|
| Email |
adgopalswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Deepika Shristhudhi |
| Designation |
post graduate student |
| Affiliation |
Sri Ramachandra Instituite of Higher Education and Research |
| Address |
No: 2/42, Gandhi Nagar,Karampakkam, Porur, Chennai.
No:1,Sri Ramachandra Nagar,Porur,Chennai - 60116
Chennai
TAMIL NADU
600116
India |
| Phone |
9787469969 |
| Fax |
|
| Email |
shristhudhideepika@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funding,
no. 2/42,gandhi nagar,
karambakkam,
porur- 600116 |
|
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Primary Sponsor
|
| Name |
S Deepika Shristhudhi |
| Address |
Sri Ramachandra Instituite of Higher Education and Research |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| S Deepika Shristhudhi |
Sri Ramachandra hospital |
Sri Ramachandra Institute of Higher Education and Researcch(SRIHER), DU,No:1,Sri Ramachadra nagar,Porur.
Chennai
TAMIL NADU |
9787469969
shristhudhideepika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research - ETHICS COMMITTE FOR STUDENTS PROJECTS |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M990||Segmental and somatic dysfunction, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. chronic mechanical neck pain subjects
2.subjects with upper cervical involvement
3. subjects with cervical radiculopathies |
The extent of joint position error and the response to proprioception training will be evaluated in all the three groups. |
| Intervention |
1. Training cervical joint position sense.
2. Training cervical movement sense.
3. Re - education of deep cervical flexor movement patters.
4. Re- education of dorsal neck muscles |
All the interventions will be provided to all the three groups of patients with chronic neck pain |
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Neck pain with minimum duration of 8-12 weeks.
Unilateral or bilateral pain in the posterior neck or shoulder region when moving or palpating the cervical spine.
Upper cervical involvement with or without headache.
Patients with cervical radiculopathy |
|
| ExclusionCriteria |
| Details |
Previous cervical trauma.
Fracture or surgery in cervical spine.
Deformity of the spine (kyphosis, Scoliosis)
Inner ear infections.
Inflammatory Rheumatologic disease.
Vertebro - basilar artery insufficiency.
Malignancy.
Neurological evidence leading to balance disturbance (eg: sensory ataxia) |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Cervico-cephalic relocation test |
On the day of initial assessment and at the end of treatment session ie.,after 2 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Cranio cervical flexion test |
Cranio cervical flexion test using pressure biofeedback |
| Neck disability Index |
On the day of initial assessment and at the end of treatment session ie.,after 2 weeks |
|
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Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
10/03/2019 |
| 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="4"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The aim of the study is to evaluate the proprioceptive deficit in patients with 3 categories of neck pain - mechanical neck pain, upper cervical involvement, and cervical radiculopathies and to evaluate the improvement in proprioceptive acquity among 3 categories of neck pain patients following intervention. On the first visit, patients full filling the selection criteria and signing the informed consent form will be taken up for the study and will be categorized into 3 groups depending upon their presentations. Group A - subjects with mechanical neck pain,Group B - subjects with upper cervical involvement, Group c - cervical radiculopathies. The subjects then undergo a pre - test evaluation of cervicocephalic relocation, pressure biofeedback and NDI inorder to obtain a baseline measure, followed by intervention for a period of 2 weeks (3 days/ week). Following the intervention, the subjects undergo a post - test evaluation. The pre and post test measures will be obtained for data analysis
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