| CTRI Number |
CTRI/2025/05/086160 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of cervical proprioception training on pain, proprioception and function in individuals with chronic non specific neck pain |
|
Scientific Title of Study
|
Effect of cervical proprioception training on pain, proprioception and function in individuals with chornic non specific neck pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patel Vishwa Narendrabhai |
| Designation |
Post Graduate |
| Affiliation |
Ahmedabad Insitute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Insitute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060
Ahmadabad
GUJARAT
380060
India |
| Phone |
8511014146 |
| Fax |
|
| Email |
vishwapatel1414@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alpa Purohit |
| Designation |
Vice Principle, PhD, PG Guide |
| Affiliation |
Ahmedabad Insitute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Insitute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060
Ahmadabad
GUJARAT
380060
India |
| Phone |
9313966648 |
| Fax |
|
| Email |
dralpaphysio@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alpa Purohit |
| Designation |
Vice Principle, PhD, PG Guide |
| Affiliation |
Ahmedabad Insitute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Insitute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060
Ahmadabad
GUJARAT
380060
India |
| Phone |
9313966648 |
| Fax |
|
| Email |
dralpaphysio@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Institute Of Medical Sciences Nr.S.P. Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060 |
|
|
Primary Sponsor
|
| Name |
Ahmedabad Insitute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj
Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
380060
Ahmadabad
GUJARAT
380060
India |
| Type of Sponsor |
Private medical college |
|
|
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 Alpa Purohit |
Ahmedabad Insitute of Medical Sciences |
Room no 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Insitute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060
Ahmadabad
GUJARAT
380060
India
Ahmadabad
GUJARAT |
09313966648
dralpaphysio@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Research And Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Non-Specific Neck Pain |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical Proprioception Training |
(3 Set X 20 Repetition) All These 3 Exercise
1) Head Relocation Exercise
2) Gaze Stability Exercise
3) Eye Control Movement
|
| Comparator Agent |
Conventional Therapy |
1) Hot Pack (15-20 Minutes)
(3 Times/Day 10 Rep. for 4 Weeks) For All These Exercise
2)Isometric Neck Muscle Exercise
3)Active Neck Range Of Motion
4)Shoulder Shrugging Exercise
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Both |
| Details |
Visual Analogue Scale:3-7
Modified Neck Disability Index;20%-70%
Neck Pain Duration More Than 3 Months |
|
| ExclusionCriteria |
| Details |
Recent Injury Or Surgery To Cervical Spine
Spondylolisthesis, Spondylolysis, Spondylosis
Spinal Infection Or Malignancy
Severe Musculoskeletal Disorders
Severe Neurological Disorders
Severe Cardiovascular Disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Joint Position Sense For Proprioception |
Pre And Post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
Pre And Post Intervention |
| Modified Neck Disability Index |
Pre And Post Intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2025 |
| 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="0"
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 THE STUDY •Cervical
proprioception plays a crucial role in maintaining the stability and function
of neck and head.
•Cervical
proprioception provide vital sensory information to the brain, which help to
control posture, balance and movement.
•If neck
proprioception is impaired
then it may influence postural control & balance,
as the posture appears to greatly affect the sensorimotor capacity of the cervical spine.
•Cervical
sensorimotor control involves central integration and processing of all the
afferent information (i.e. visual, vestibular and cervical proprioception).
•This
cervical sensorimotor control disturbances due to neck pain are considered as a
protective response to limit further stimulation of the painful tissue. •Such
disturbances may further cause tissue damage, which aggravates pain through
peripheral and central nervous system sensitization and promote dysfunction motion patterns.
•So
proper execution of the motor program through the cervical muscles for
maintenance of head posture and balance as well as stability of the cervical
joints.
•The
proprioception training may improve both pain and function of the patients
having affected sensorimotor control.
•As
very less evidence in India yet shows the effect of cervical proprioception
during rehabilitation of chronic non specific neck pain.
•So
the need arises to examine the effect of cervical proprioception training on
individuals with chronic non specific neck pain.
AIM
OF THE STUDY •To
evaluate the effect of cervical proprioception training on pain, proprioception
and function in individuals with chronic non specific neck pain.
OBJECTIVES
OF THE STUDY •To
evaluate the effect of cervical proprioception training on neck pain in
individuals with Chronic non specific neck pain by using Visual Analogue Scale.
•To
evaluate the effect of cervical proprioception training on neck proprioception
in individuals with chronic non specific neck pain by using Joint Position
Error.
•To
evaluate the effect of cervical proprioception training on neck function in
individuals with chronic non specific neck pain by using Modified Neck
Disability Index. •To
evaluate the effect of conventional therapy on neck pain in individuals with
Chronic non specific neck pain using Visual Analogue Scale. •To
evaluate the effect of conventional therapy on neck proprioception in
individuals with chronic non specific neck pain using Joint Position Error. •To
evaluate the effect of conventional therapy on neck function in individuals
with chronic non specific neck pain using Modified Neck Disability Index. •To
compare the effect of cervical proprioception training versus conventional
therapy on neck pain in individuals with chronic non specific neck pain by
using Visual Analogue Scale. •To
compare the effect of cervical proprioception training versus conventional
therapy on neck proprioception in individuals with chronic non specific neck
pain by using Joint Position Error. •To
compare the effect of cervical proprioception training versus conventional
therapy on neck function in individuals with chronic non specific neck pain by
using Modified Neck Disability Index.
PROCEDURE
The subject will be divided into two groups Group A: Cervical Proprioception Training Group B: Conventional Therapy
|