| CTRI Number |
CTRI/2024/04/065766 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
effect of strengthening and proprioceptive training along with stretching on pain, ROM, joint position
error and strength in chronic neck pain patients. |
|
Scientific Title of Study
|
Effect of proprioceptive training and motor control exercises along with conventional exercises on
pain ROM proprioception and strength in patients with chronic non-specific neck pain - A single
blinded Randomized Controlled Trial. |
| Trial Acronym |
Interventional |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal Ashokrao Palkar |
| Designation |
MPT second year Musculoskeletalsciences |
| Affiliation |
D V V P Fs College of Physiotherapy |
| Address |
Department of musculoskeletal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8329845959 |
| Fax |
|
| Email |
palkarsnehal121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deepak Anap |
| Designation |
professor and HOD of musculoskeletal physiotherapy |
| Affiliation |
D V V P Fs College of Physiotherapy |
| Address |
Department of musculoskeletal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890200972 |
| Fax |
|
| Email |
deepak.anap@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehal Ashokrao Palkar |
| Designation |
MPT second year Musculoskeletalsciences |
| Affiliation |
D V V P Fs College of Physiotherapy |
| Address |
Department of musculoskeletal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8329845959 |
| Fax |
|
| Email |
palkarsnehal121@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy |
| Address |
Department of musculoskeletal sciences Block 1 basement DVVPFs
college of physiotherapy Oppo Govt Milk Dairy MIDC 414111
Ahmadnagar MAHARASHTRA |
| 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 Snehal Palkar |
Vitthalrao Vikhe Patil memorial hospital Ahmednagar |
Department of Musculo
skeletalsciences Opp
Govt Milk Dairy M I D C
Ahmednagar 414111
MAHARASHTRA.
Ahmadnagar
MAHARASHTRA |
8329845959
palkarsnehal121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS College of Physiotherapy Institutional ethical Committe Ahmednagar |
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 |
conventional neck exercises |
1) Cervical active range of
motion exercises 2) Cervical
isometric strengthening
exercises3) Self stretching A)
Upper trapezius The participant
will be in supine position. The
ipsilateral hand behind the back
to stabilize the scapulae.
Participant will be instructed the
patient to rotate his neck
towards the tight side, then side
bends away from the tight side
and adds neck flexion. Hold for
30 seconds, performed 3
times/session[22]. B) Levator
scapulae The participant will be
in a sitting position, with the
head side, bend and rotated
away from the tight side. To
stabilize the scapula, the tight
side hand holds the chair. The
other hand will be placed on the
head to gently pull the head
forward and diagonal opposite
to the tight muscle. Hold for 30
seconds, performed 3
times/session. 22 4)
Strengthening exercises A)
Middle trapezius The participant
will be in prone lying on the
plinth, shoulder and elbow joints
at a 90- degree angle. The
participants will be instructed to
take the arm up, holds for 5
seconds, 10 repetitions 3
sets/session. B) Lower
trapezius The participants will
be in prone lying with the
shoulder joints at a 135-degree abduction elbow extended. Ask
the participants to take the arm
up, holds for 5 seconds, 10
repetitions 3 sets/session |
| Intervention |
motor control exercise training |
1) craniocervical flexor exercise:
The exercise will be required
subject to be lie on back with
knees bent. Start by looking up
at a point on the ceiling, then,
with your eyes, look at a spot on
the wall just above your knees.
Feel the back of your head slide
up the bed as you perform a
slow and gentle nod, as if
you’re indicating “yes.†Hold
the position for ten seconds
then relax. Look up to a point on
the ceiling to resume the
starting position. Repeat 10
times. 2) craniocervical extensor
exercise; For the cervical
extension exercise, the
participants will be maintained
craniocervical flexion and then
lifted and hold the head and
neck for 10 seconds then relax
in a prone position. 3)Strengthening neck retraction
(sitting) Participants will be tuck
in chin after slightly elevating
head toward the ceiling.
Completing this movement
should take two to three
seconds. Repeat 10 times. 4)
Strengthening neck retraction
(lying) Participant will be lying
comfortably on back without any
pillow. participants will be slide
his/her head upward while
keeping chin tucked in.
Participants feel a gentle stretch
behind your neck. Completing
this movement should take 2-3
seconds. Repeat 10 times.
Duration :Each of these four
exercises was performed for
three sets of 10-12 repetitions,
taking an approximate total
duration of 10 to 20 minutes. |
| Intervention |
proprioceptive training |
1) Eye-head-neck co-ordinationequired subjects to be seated
and to fix their eyes on a target
in front of them. Subject then
moved their head maximally, in
a slow and carefully controlled
movement, in one direction,
while keeping their eyes fixed
on the target straight ahead.
The sequential movements
included left and right axial
rotation, flexion and extension.
Repeat 10 times/session. 2)
Eye-head-neck-upper limb
co-ordination exercise The
exercise will be required seated
subjects to hold up both arms in
front of them with their thumb
extended upwards. Subjects
were asked to keep their eyes
fixed on one thumb as the
ipsilateral arm went through the
sequential movements of left
and right rotation, flexion and
extension, with the eyes and
head followed the movements in
a slow and coordinated fashion.
Repeat 10 times/session. 3)
Oculomotor exercises
Oculomotor exercise will be
progressed through several
stages, commencing with eye
movement with the head
stationary, progressing to
movements of the head with
visual fixation on a target.
Duration : Each of these four exercises was performed for three sets of 10-12 repetitions, taking an approximate total duration of 10 to 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
- |
|
| ExclusionCriteria |
| Details |
1.Signs of serious pathology (e.g., malignancy, inflammatory
disorders, Infections). 2. History of trauma or fracture in cervical
spine. 3.Signs of cervical radiculopathy or myelopathy. 4.Vascular
syndromes such as basilar insufficiency. 5. Alternative treatment for
neck pain or shoulder 6 month prior to the study. 6.Unwilling to do
the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain, ROM, proprioception and strength |
At baseline, at 2 weeks, and at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
26/04/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [palkarsnehal121@gmail.com].
- For how long will this data be available start date provided 15-08-2024 and end date provided 06-11-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is aim to find out the effectiveness of proprioceptive training and motor control exercises along with conventional neck exercises on pain, ROM, proprioception and strength in patients with chronic non-specific neck pain. RCT. 18
subjects 6 in each group will be recruited based on inclusion and exclusion criteria. There will be 3 groups proprioceptive group, motor control group and control group. conventional treatment will be given to all groups. outcome measures are pain,
ROM, proprioception and strength. Pre intervention outcome measure will be taken. Intervention will be given for 2 weeks and post treatment outcome measures will be taken. follow up will be taken after 4 weeks. analysis and result will be
calculated |