Professional Documents
Culture Documents
A
Protocol submitted to
HOSMAT HOSPITAL EDUCATIONAL INSTITUTE
Bangalore
By
HOMA KHANAM
M.P.T. 1st year
M.P.T (Musculoskeletal and sports)
Guide: Dr. R. Dev Anand (PT)
1
RESEARCH APPROVAL
CONTENTS
2
Page No.
1 INTRODUCTION 04
1.1 Background of the study 04
1.2 Statement of the problem 05
1.3 Objective of the study 05
1.4 Aim of the study 05
1.5 Hypothesis 05
1.6 Null Hypothesis 06
1.7 Operational Definition 06
1.8 Clinical significance 06
2 REVIEW OF LITERATURE 07
3 METHODOLOGY 09
3.1 Study Design 09
3.2 Study Setting 09
3.3 Inclusion Criteria 09
3.4 Exclusion Criteria 09
3.5 Materials 09
3.6 Sampling 10
3.7 Sample size 10
3.8 Procedure 10
3.9 Outcome measures 15
3.10 Data analysis 15
4 REFERENCES 16
5 APPENDIX
Appendix I 20
Appendix II 21
Appendix III 23
Appendix IV 24
3
INTRODUCTION
1.1 Background of the study
Neck pain is a common complaint in general population. Among diverse neck pain
,mechanical neck pain is the most common type with pain confined in the area on posterior
aspect of neck, that can be exacerbated by neck movement or sustained posture. 1Along with
considerable cost for individual and society neck pain is a frequent source of disability
causing human suffering and affecting well being of individual.2
Cervical muscle impairment has been found in up to 70 percent of subject with neck
pain. The cervical impairment which are commonly noted are cervical pain, loss of ROM,
decreased strength &endurance and forward head posture. 4.There is a growing evidence that
subjects with neck pain have weakness or motor difficulty in facilitating the deep neck flexor
(DNF).4The location of deep neck flexor (longus colli & longus capitis) suggest that they play
an important role in stabilising cervical spine (Mayoux &Benhamour) in all position without
being influenced by gravity.4
It is theorised that when muscle performance is impaired, the balance between the
stabilisers on the posterior aspect of neck and deep neck flexor is disrupted, resulting in loss
of proper alignment of head & neck posture. In the presence of neck pain, weakness has been
identified in deep neck flexor muscles and subjects shows increased activity in their
superficial flexor muscle, presumably as a compensation strategy. 5A poor forward head
posture may occur as a result of loss of endurance of deep neck flexors.5
Many conservative treatment options are available for subjects with mechanical neck
pain and they are widely accepted as a standard form of practice. Various treatment options
available are exercises, manipulation, mobilisation, heat & cold therapy, IFT, TENS, US,
pulsed electromagnetic therapy etc. 6
4
O’ Leary et al ,(2007) stated that, coordination between superficial and deep flexors
is considered safe progression of exercises in patient with mechanical neck pain. 8.It is well
known that sternocleidomastoid and anterior scalene together provide 83% of cervical
flexion capacity.8If coordination between superficial & deep flexor is not corrected in the first
instance, the overwork of superficial flexor might mask or substitute for any impaired
performance of deep neck flexor in any premature progression to higher load exercises.
Jull et al showed improved deep neck flexor muscle activation following cranio
cervical flexion. 9
The practice of achieving coordination between superficial & deep neck flexor
& extensors are usually overlooked.
Clinician considered that self resisted isometric exercises for subjects with
mechanical neck pain are worthwhile. But evidence for much standard
treatment approach to neck pain is lacking.10
The aim of this study is to compare the efficacy of craniocervical flexion exercises in
supine & sphinx position( prone on elbow) against self resisted isometric training to
neck musculature on pain, disability& forward head posture in subjects with non
specific mechanical neck pain.
1.5 Hypothesis
5
training on pain, disability & forward head posture in subjects with non
specific mechanical neck pain.
Mechanical neck pain is the general term that refers to any type of pain caused by
placing abnormal stress & strain on muscles of cervical spine, in which movement of
neck is restricted & moving the neck may make pain worse but taking rest will
alleviate the pain.
6
Review of Literatures
Ana Claudia et al, 2008, in their study reported, that mechanical neck pain has no
detectable aetiology; it may be reproduced by provocating stimuli (stress).11
Jull et al, 2002, in their study quoted that, in the presence of neck pain, weakness has
been identified in the deep neck flexor muscles & patient shows increased activity in the
superficial flexors as a compensatory strategy.9
Jull & Falla et al, 2002, concluded in their study that activation of deep neck flexor is
increased at each stage of cranio cervical flexion & activity of sternocliedomastoid
and anterior scalene reduced after training cranio cervical flexion.9
In a study by O’Leary et al, 2007,stated that, coordination between the deep &
superficial flexor is necessary for safe progression of exercises in subjects with neck
pain.8
Jull & Mehwa Kim et al 2007, in their study compared the cranio cervical flexion
exercise & conventional exercise of cervical flexion in patients with neck pain on
isometric neck muscle strength &found no differences between the two exercises.15
Barbara Cagnie et al, 2008, in their study quoted that; MRI has demonstrated the
CCF muscle contraction method elicits activation of deep cervical flexors longus colli
& longus capitis. 12
Jull G Trott et al 2008, in their study quoted that ,to train coordination of the deep &
superficial extensors , craniocervical flexion can be performed with the patient in 4
point kneeling. 14
7
A rezasolthani et al 2010 in their study proved that traditional isometric strength
training is found to be less effective than neuromuscular facilitation exercises.25
Dennis et al 2000, in his study had done analysis of head & neck posture using
camera & computer, measured normal head & neck angle as 43.7 degree, with a
standard starting reference point.16
-VernonH, Mior S et al, 1991, NDI was used to measure subjects perceived level of disability
due to their neck pain.27
-The Neck Disability: the reliability and validity is proved with test retest=0.89 & ICC
=0.68.26
8
METHODOLOGY
Intervention study
Age 20 to 50 years.
Spinal stenosis
Spasmodic torticollis
Frequent migraine
Fibromyalgia
9
Uncooperative patient
Carcinoma
Cervical radiculopathy
3.5 Materials:
Digital camera
Plumb line
3.7 Sample size: 60(group A 20, group B 20, and group C 20)
3.8 Procedure:
Interested subjects shall be informed about aims & procedure of the study. They shall
sign the written consent, to be considered a study subject. A general physiotherapy
assessment shall be taken and the base line data shall be collected on the reporting date.
The subject shall be assigned into three groups by concealed allocation. Subject number and
group name shall be typed on paper and a researcher (batch mate) who is not involved in the
study will randomise the slips and put them in sealed cover. The subject shall undergo
intervention in one of the three groups for 6 sessions within 1 week duration. After 6 th session
of intervention post treatment data will be collected.
10
Procedure to measure pain intensity (13)
Pain intensity will be evaluated by means of a visual analogue scale (VAS), ranging from 0
cm to 10 cm, wherein the subjects will mark a point according to their pain level, a higher
pain score correspond to more intense pain. Resting pain and pain level after aggravating
activity shall be taken for pre & post comparison.
NDI will be used to obtain the subject`s perceived level of disability due to their neck pain.
Subject will be instructed to mark their level of disability on NDI .Any queries shall be
answered to enable the subject to mark the components appropriately.
Subjects will be positioned in sitting with their knees in 90deg of flexion and their feet flat on
the ground. A plumb line will be positioned in the background. The starting position will be
standardised by placing the subject in an upright position that is a vertical pelvic position. A
digital camera will be mounted on a stand and placed laterally one meter away from the
subject. Bright colour markers will be placed on the C7 spinous process and over the tragus
of ear. The resting forward head posture will be the outcome measure. The subject may
change the resting forward head posture if he is conscious. To avoid this, the subject will be
instructed to perform flexion & extension of neck 10 times. After which a lateral photograph
will be taken, to avoid experimental bias. The same procedure shall be repeated for 5 trials
with rest intervals of 15 seconds between each trial. The average of forward head posture
will be considered for data analysis. The researcher shall analyse the lateral photograph,
using computer software MB Ruler27 (Fig. 1) will be used to measure the degree of forward
head posture.
11
Fig 1: analysis of forward head posture
The base of triangle of MB Ruler is adjusted on computer screen to overlap the plumb line.
The vertical line is adjusted horizontally at the level of C7 spine. And the mobile angle (red
line) is aligned to the line connecting C7 spinous process and tragus of ear. The angle shown
as α in the MB Ruler program shall be considered for data recording.
The Cranio Cervical Flexion (CCF) test consists of five incremental movement of cranio
cervical flexion,& the performance will be guided by visual feedback from an air filled
pressure sensor (Chattanooga Group Inc, MA 01760-2098).The subject shall be positioned in
supine crook lying with the neck in neutral position( no pillow).
The uninflated pressure sensor shall be placed behind the neck so that it abuts the occiput &
it will be inflated to a stable baseline pressure of 20mm of hg, a standard pressure sufficient
to fill the space between the testing surface & the neck but not put neck into lordosis. The
subject will be instructed to put the tip of tongue over upper palate & nod the head into
flexion (as in saying YES). The subject is instructed to raise the level of pressure in pressure
biofeedback (PBFB) device from 20 mm Hg to 22 mm Hg and hold for a minimum of 10
seconds. One familiarization phase will be included. The trail is considered positive only if
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the subject is able to hold the target pressure without activating superficial neck muscles and
able to sustain without fluctuations. If the subject is able to hold for 10 seconds, the subject
shall be instructed to perform the same procedure and hold at 24mmHg for 10 seconds. In
similar way increments of 2 mmHg will be added. If the subject meets the target pressure
level and holds for 10 seconds, a rest interval of 30 seconds is given before proceeding to
next level. The time of isometric hold on neck muscle will be calculated by summation of
time periods held at various levels.
Description of intervention:
Each of the three training group will have 20 subjects. In each group, treatment regimens
shall be for 6 sessions per week for 1 week duration, lasting approx 45 minute per session.
In this group, the subject shall be instructed to isometric contraction for neck flexors,
extensors, and side flexors. The subject will be instructed to use both hands to press the
forehead (backward force) and the subject should resist the force actively by not letting go
the flexor contraction. Similarly, hands are placed over back of head and over temples to
resist IM contractions of neck extensors and lateral flexors respectively. The instructions to
the subject would be “Attempt to push your head backward but do not let your head move”
and “Attempt to push your head sideways but do not let your head move” respectively.
Repetition: 10 times for flexion, extension, side flexion to left & right, rotations
to both the side.
Note:
subject will be instructed to inform any inconvenience felt during the exercise
Patient will be instructed to continue the same as home exercise thrice a day.
The DNF endurance training will be given by, subject in supine crook lying with neck in
neutral. The subject will be instructed to put the tip of tongue over the upper palate and nod
the head in to flexion ( as in saying yes).the performance will be guided by feedback from an
air filled pressure sensor placed behind the neck , to monitor subtle flattening of the cervical
lordosis, which occurs with the contraction of longus colli.. The subject is instructed to raise
the level of pressure in pressure biofeedback (PBFB) device from 20 mm Hg to 22 mm Hg
and hold for 5 seconds. The subject is facilitated to hold the target pressure without activating
superficial neck muscles and without fluctuations. IM hold is performed for 5 seconds x 10
13
repetitions, with rest intervals of 10 seconds between repetitions. Similarly 3 sets are given
with gradual progression. If the subject is able to hold for 10 seconds with each of 10
repetitions, the target pressure is incremented by 2 mmHg. Patients will attempt to target
progressive 2mm of Hg pressure increments from a base line of 20mm of Hg to the final
target of 30mm Hg.
3 sets.
3 sets
Note:
The therapist will provide feedback about superficial neck muscle usage and
correct the pattern of movement.
In the 3rd group, craniocervical flexion training will be given. The subject shall be trained to
perform ‘chin tucks’ in supine lying position as a part of familiarization of procedure. As the
experimental treatment, the subject shall be positioned in sphinx position (prone on elbow)
with shoulder protracted & neck in neutral. A command “Tuck in your chin and hold” will be
given to them by the researcher. This position shall be maintained for 10 seconds.
Note: subject will be instructed to report any inconvenience felt during exercise session.
14
Flow chart depicting procedure:
N=60
Baseline outcome
Collected
Concealed randomisation
15
Pain intensity using VAS
After the intervention, difference (difference between pre & post measurement of data)
in NDI, forward head posture, VAS, Time score in CCFT Test within the groups will be
compared using Wilcoxon Sign Rank Test and between the group will be compared using
Kruskal Wallis Test. And to find out the group having most significant improvement,
between the group Kruskal wallis Test will be used. The mean difference & their 95% CI will
be calculated.
REFERENCES
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1. Rotasalai Kanlaynaphotpornl, Adit Chiradenant, Roongtiwa Vachalathiti. The
immediate effects of mobilisation technique on pain and range of motion in patient
presenting with unilateral neck pain: A RCT.Arch Phys Med Rehabil 2009;90:187-92.
2. Petri K Salo, Arja H. Hakkinen, Hannu Kautiainen & Jari Ylinen. Effect of neck
strength training on health – related quality of life in females with chronic neck pain.a
RCT 1 year follow up, health & quality of life outcome 2010, 8:48.
4. Kevin a Harris, Darren M Heer, Tanja C Roy, Diane M Santos, Julie M Whitman.
Reliability of a measurement of neck flexor muscle endurance. physical therapy.
2005; 85(12):1349-55.
5. Deborah Falla, Gwendolyn Jull, Trevor Russel, Bill Vicenzino, Paul Hodges. Effect
of Neck Exercise on Sitting Posture in Patients with Chronic neck pain. Physical
therapy.2007; 87(4):408-17.
17
8. Jull, D.Falla, B. Vicenzino, P.W. Hodge. .Effect of therapeutic exercise on activation
of deep cervical flexor muscle in people with chronic neck pain. Manual therapy
2009; 14:696-01.
9. Jull G, Trott P, Potter H.A RCT of exercise & manipulative therapy for cervicogenic
headache. Spine 2002, 27; 1835-45.
10. Jari linen, Esa Pekka Takala, Matti Nykanen. Active neck muscle training in the
treatment of chronic neck pain in women. A RCT. JAMA, 2003, 289(19), 2509-16.
11. Ana Claudia, Violino Cunha, Thomaz Nogueira Burke, Fabio Jorge Renovato Franca,
Amelia Pasqual Marques. Effect of global posture re education & of static stretching
on pain, range of motion & quality of life in women with chronic neck pain.A RCT.
Clinics 2008; 63(6) 763-70.
12. Barbara Cagnie,Nele Dickx, Ian Peeters, Jan Tuytens,Eric Achten, Dirk Cambier&
Lieven Danneels. The use of functional MRI to evaluate cervical flexor activity
during different cervical flexion exercises. J Appl Physiol, 2008; 104:230-35.
13. Shaun O` Leary, Deborah Falla, Paul W. Hodge, Gwendolyn Jull, Bill Vicenzino. A
specific therapeutic exercise of the neck induces immediate local hypoalgesias. The
journal of pain.2007; 8(11):832-39.
14. G. Jull, Shaun P O`Leary, Deborah L. Falla. Clinical assessment of the deep cervical
flexor muscles: the cranio cervical flexion test. Journal of manipulative &
physiological therapeutics .2008;31(7):525-33
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15. Mehwa Kim, Shaun O`Leary, Gwendolyn Jull, Bill Vicenzino. Specificity in
retraining cranio cervical flexor muscle performance.JOSPT.2007; 37(1):3-9.
16. Dennis R Ankrums, Kristie J. Nemeth. Head and neck posture at computer
workstations- what`s neutral. 14th triennial congress of the international ergonomic
association.2000; 5:565-68.
17. Jennifer Lyn Keating, Peter Kent, Megan Davidson, Ross Duke. Predicting short term
response and non response to neck strengthening exercises for chronic neck pain.
Journals of whiplash & related disorder.2005; 4:44-55.
19. Shaun P O`Leary, Bill T Vicenzino, G.Jull. A new method of isometric dynamometry
for the craniocervical flexor muscles. Physical therapy.2005; 85(6):556-64.
20. Chantal HP de Koning,Sylvia P van den Heuvel, J Bart Stall .Clinometric evaluation
of methods to measure muscle functioning in patients with non – specific neck pain: a
system: a systematic review. BMC musculoskeletal.2008; 9:1471-2474.
21. Jari Y linen, Riku Nikander, Matti Nykanen, Hannu Kautiainen. Effect of neck
exercises on cervicogenic headache: A RCT. J rehab Med 2010; 42: 344-49.
22. Ian A. Young, Lori A. Michener, Joshua A Cleland, Arnold J. Aguilera. Manual
therapy, exercises, & traction for patient with cervical radiculopathy. Physical
therapy.2009; 89(7):632-42.
19
23. Nicole H. Raney, Evan J. Peterson, Tracy A Smith et al, development of a clinical
prediction rule to identify patient with neck pain likely to benefit from cervical
traction & exercises.Eur Spine J.2009;18:382-91.
26. , Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative
Physiol Ther.1991; 14(7):409-15.
APPENDIX – I
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HOSMAT College of Physiotherapy
Consent Form
I acknowledge that the research study has been explained to me and I understand that
agreeing to participate in the research means that I am willing to
I have been informed about the purpose; procedures, measurements and risks involved in
the research and my queries towards the research have been clarified.
I provide consent to the researcher to use the information, video or audio recordings, for
research and educational purpose only.
I understand that my participation is voluntary and can withdraw at any stage of the
research project.
I understand that no monitory benefit will be given for participation in this research study.
Signature Date
APPENDIX II
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Assessment Form:
Name: age/ sex:
Hospital number:
Group(A/B/C/):
Chief complaint:
History:
Severity of pain
Area of pain
Irritability
Aggravating factor
Relieving factor
Scanning examination:
Distraction test
Outcomes:
22
Outcomes & Pre intervention Post intervention Difference
Total score
VAS(10)
NDI(50)
FHP(in degree)
CCFT(in sec)
Appendix III
23
Appendix IV
24
25