the effectiveness of mechanical cervical traction combined with conventional therapy on patients...
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THE EFFECTIVENESS OF MECHANICAL CERVICAL TRACTION COMBINED WITH
CONVENTIONAL THERAPY ON PATIENTS WITH UNILATERAL MECHANICAL NECK PAIN
A research project submitted by
Bhatt Jahnvi Ashokkumar
Rathod Prerna Naranbhai
Tandel Krupali Vinodbhai
Tandel Soniya Sumanbhai
Under the Guidance of
Dr. DIBYENDUNARAYAN BID [PT]
MPT (Ortho), PGDSPT
SENIOR LECTURER
The Sarvajanik College of Physiotherapy,
Rampura, Surat.
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Declaration
This is to certify that Project entitled ‘THE EFFECTIVENESS OF MECHANICAL
CERVICAL TRACTION COMBINED WITH CONVENTIONAL THERAPY ON PATIENTS
WITH UNILATERAL MECHANICAL NECK PAIN’ is submitted by us in Bachelor of
Physiotherapy to ‘The Sarvajanik College of Physiotherapy, Surat’ comprises
only our original work and due acknowledgement has been made in the text to all
other material used.
Date: 18th June, 2013 Bhatt Jahnvi Ashokkumar
Rathod Prerna Naranbhai
Tandel Krupali Vinodbhai
Tandel Soniya Sumanbhai
Approved by: Dr. Dibyendunarayan Bid [PT]
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CERTIFICATE
This is to certify that Project entitled ‘THE EFFECTIVENESS OF MECHANICAL
CERVICAL TRACTION COMBINED WITH CONVENTIONAL THERAPY ON PATIENTS
WITH UNILATERAL MECHANICAL NECK PAIN’ which is submitted by Bhatt Jahnvi
Ashokkumar, Rathod Prerna Naranbhai, Tandel Krupali Vinodbhai and Tandel
Soniya Sumanbhai, is a record of the candidates’ work carried out by them under
my guidance and supervision.
The concept, design and review for this project were provided by the guide.
The data analysis and interpretation were provided by Dr. Thangamani
Ramalingam A.
The matter embodied in this project work is original.
Date: 18th June, 2013 Dr. Dibyendunarayan Bid [PT]
Guide’s signature
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ACKNOWLEDGEMENT
We owe our sincere thanks to Dr. Dibyendunarayan Bid [PT] for his constant guidance
and suggestions.
We sincerely thank to Dr. Thangamani Ramalingam A. [PT] for helping us in data
analyses and interpretation.
We sincerely thank all our teachers who taught us the finesse of physiotherapy.
It is indeed a matter of deep satisfaction to acknowledge our gratitude towards
Almighty.
We want to thank our respective dear parents who always held us high throughout
our study.
Bhatt Jahnvi Ashokkumar
Rathod Prerna Naranbhai
Tandel Krupali Vinodbhai
Tandel Soniya Sumanbhai
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Contents CHAPTER 1 - INTRODUCTION ........................................................................................................................ 9
1.1 The Problem and its Setting .................................................................................................................. 9
1.2 Aim of the Study ................................................................................................................................. 11
1.3 Hypothesis ........................................................................................................................................... 11
1.3.1 Null Hypothesis .......................................................................................................................... 11
1.3.2 Alternate Hypothesis ................................................................................................................. 11
1.4 Benefits of the Study .......................................................................................................................... 12
CHAPTER 2 – REVIEW OF THE RELATED LITERATURE ................................................................................. 13
2.1 Incidence and Prevalence of Neck Pain .............................................................................................. 13
2.2 Mechanical Neck Pain ........................................................................................................................ 14
2.2.1 Definition, etiology, risk factors and diagnosis of mechanical neck pain .................................. 14
2.2.2 Clinical Presentation .................................................................................................................. 16
2.3 Basic Normal Anatomy of Cervical spine ............................................................................................ 16
2.4 Functional Biomechanics of Cervical Spine (Levangie & Norkin, 2005) ............................................ 18
2.4.1 Kinematics .................................................................................................................................. 18
2.4.2 Kinetics ....................................................................................................................................... 23
2.5 Cervical Spine Traction ...................................................................................................................... 25
2.5.1 Introduction ............................................................................................................................... 25
2.5.2 Indication for Cervical Spine Traction ........................................................................................ 26
2.5.3 Types of Cervical spine Traction ................................................................................................ 26
2.5.4 Most effective positions for applying cervical traction ............................................................. 27
2.5.5 Force to be used in cervical spine traction ................................................................................ 27
2.5.6 Optimum angle for cervical spine traction ................................................................................ 27
2.5.7 Effects of Cervical spine Traction ............................................................................................... 28
CHAPTER 3 – METHODOLOGY .................................................................................................................... 29
3.1 Introduction ......................................................................................................................................... 29
3.2 Aim of Study ...................................................................................................................................... 29
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3.3 STUDY DESIGN ................................................................................................................................ 29
3.4 SUBJECT RECRUITMENT ................................................................................................................. 29
3.4.1 Sample and Selection Criteria .................................................................................................... 30
3.5 INCLUSION AND EXCLUSION CRITERIA ......................................................................................... 30
3.5.1 Inclusion criteria ......................................................................................................................... 30
3.5.2 Exclusion criteria ........................................................................................................................ 32
3.6 RESEARCH METHODOLOGY/PROCEDURE .................................................................................... 32
3.6.1 Treatment Group A – Mechanical cervical traction with conventional therapy. ...................... 33
3.6.2 Treatment Group B – Conventional therapy alone. .................................................................. 33
3.7 MEASUREMENTS .............................................................................................................................. 34
3.7.1 Objective measurements ........................................................................................................... 34
3.7.1.1 Universal Goniometer ............................................................................................................. 34
3.7.2 Subjective measurements .......................................................................................................... 35
3.7.2.1 Neck Disability Index (NDI) ...................................................................................................... 35
3.7.2.2 Numerical Pain Rating Scale .................................................................................................... 35
CHAPTER 4 – DATA ANALYSES AND INTERPRETATION ............................................................................... 36
4.1 Statistical analyses ............................................................................................................................. 36
4.2 Results ............................................................................................................................................... 36
4.2.1 One way repeated measure ANOVA for within group difference ............................................. 37
4.2.2 Independent t-test for between groups difference ................................................................... 46
4.2.3 NDI within Groups ...................................................................................................................... 48
4.2.4 NDI between Groups .................................................................................................................. 48
4.2.5 Correlation analysis for both the groups at week 2 ................................................................... 50
4.3 Limitations of Study ............................................................................................................................ 51
4.4 Discussion .......................................................................................................................................... 51
4.5 Conclusion ......................................................................................................................................... 52
CHAPTER 5 – RECOMMENDATIONS ............................................................................................................ 54
5.1 Recommendations............................................................................................................................... 54
Bibliography ................................................................................................................................................ 56
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Appendices .................................................................................................................................................. 60
Appendix-I: Neck Disability Index - Gujarati Version ................................................................................. 60
Appendix-II: Numerical Pain Rating Scale (NPRS). .................................................................................. 62
Appendix –III: Consent Letter ................................................................................................................... 63
Appendix-IV: Raw Data ............................................................................................................................ 64
List of Tables
Table 1 : Demographical characteristics ..................................................................................................... 36
Table 2 : Demographic & clinical characteristics ........................................................................................ 37
Table 3 : Measure- Flexion- Traction Group ............................................................................................... 38
Table 4 : Measure- Flexion- Conventional Group ....................................................................................... 39
Table 5 : Measure- Extension – Traction Group ......................................................................................... 40
Table 6 : Measure- Extension – Conventional Group ................................................................................. 40
Table 7 : Measure- Side Flexion – Traction Group ...................................................................................... 41
Table 8 : Measure- Side Flexion – Conventional Group .............................................................................. 42
Table 9 : Measure- Rotation – Traction Group ........................................................................................... 43
Table 10 : Measure- Rotation – Conventional Group ................................................................................. 43
Table 11 : Measure- NPRS- Traction Group ................................................................................................ 44
Table 12 : Measure- NPRS – Conventional Group ...................................................................................... 45
Table 13 : Between Groups differences independent t-test ...................................................................... 46
Table 14 : Paired Sample t-test ................................................................................................................... 48
Table 15 : Independent Sample t-Test ........................................................................................................ 49
Table 16 : Correlations (N=40) .................................................................................................................... 50
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List of Figures
Figure 1 Nodding motions of the atlanto-occipital joints. A. Flexion. B. Extension.................................... 20
Figure 2 Superior view of rotation at the atlantoaxial joints: The occiput and atlas pivot as one unit
around the dens of the axis. ....................................................................................................................... 21
Figure 3 A. Flexion of the lower cervical spinecombines anterior translation and sagittal plane rotation
of the superior vertebra. B. Extension combines posterior translation with sagittal plane rotation. ...... 22
Figure 4 Motion at the lower cervical interbody joints occurs in the plane of the zygapophyseal joints
about an axis perpendicular to the plane. .................................................................................................. 23
List of Graphs
Graph 1: Comparison of NPRS between groups ......................................................................................... 45
Graph 2: Comparison of NDI between groups ............................................................................................ 49
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CHAPTER 1 - INTRODUCTION
1.1 The Problem and its Setting
The average amount of productive time lost due to individuals suffering from
neck pain ranges from 2.8-11.3%, with the annual incidence of neck pain among
the working population ranging from 6-23 per 10,000 people (Côté et al., 2008). It
is found that 34% of the population suffers from neck pain, and 26-65% of those
suffer from mechanical neck pain.
Mechanical neck pain (MNP) is the most common type of cervical spine pain
encountered. It is also referred to as simple or non-specific neck pain, and is
common in all groups of people. Often the exact cause of pain is unknown. It may
include discogenic pain, myofascial trigger points, ligaments in the cervical spine;
cervical facet syndrome or poor posture may also contribute to this pain.
The etiology of neck pain multifactorial and poorly understood (Binder, 2007)
(Bergman & Peterson, 2002). The common factors include poor posture,
depression, anxiety, aging, acute injury and occupational or sporting activities.
This leads to altered joint mechanics, muscle structure or function and can result
in mechanical neck pain. Gatterman; and Peterson & Bergman stated that the
most common cause of MNP is zygapophyseal joint locking and muscle strain
(Gatterman, 1998) (Bergman & Peterson, 2002).
According to Peloza, neck pain can be either intrinsic or extrinsic in nature.
Intrinsic pain is broken down into mechanical neck pain, this type of neck pain is
any neck pain which originates from the joints or intervertebral discs, whereas
extrinsic conditions are conditions which cause pain in the cervical spine; they
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include nerve root irritation, compression neuropathies, shoulder pathologies and
cardiovascular condition (Peloza, May 02, 2007).
An inflammatory reaction is initiated by musculoskeletal dysfunction; this is
identical to that for an infection. Pain accompanying inflammation may initiate a
local reflex muscle contraction, which over time may lead to ischemia and
therefore more pain (Bergman & Peterson, 2002).
Cervical traction consists of administering a distracting force to the neck in order
to separate the cervical segments and relieve compression of nerve root by
intervertebral discs. Several techniques and different durations have been
recommended in the literature (Colachis & Strohm, 1965). However, due to poor
methodological quality of the available data, there is currently little evidence to
suggest that individuals with MNP may benefit from physiotherapy combined
with traction aimed at improving hand strength, neck discomfort and to
decompress nerve impingement (Joghataei et al., 2004) (Jellad et al., 2009)
(Young et al., 2009).
In a similar type of study Joghataei et al. randomly assigned 30 patients with C7
radiculopathy due to disc herniation and/or cervical spondylosis to take part in a
treatment programme consisting of regular physiotherapy and exercises either
with or without intermittent cervical traction for 10 sessions. The group who
received intermittent cervical traction exhibited better improvements in grip
strength after 5 sessions, but not statistically significant differences were
observed between the two groups after 10 treatment sessions. Since, the authors
did not interpret the patients according to their etiology; the real benefits of the
cervical traction could not be ascertained (Joghataei et al., 2004).
With the above consideration, the present study was performed to compare the
clinical parameters of cervical traction with conventional physiotherapy and
conventional physiotherapy alone in the treatment of MNP.
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1.2 Aim of the Study
The aim of the study is to compare the efficacy of ‘mechanical cervical traction
with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in
mechanical neck pain. Here efficacy is measured on the basis of following
outcome measures: Neck Disability Index (NDI), Numerical Pain Rating Scale
(NPRS), and Goniometry for cervical range of motion.
1.3 Hypothesis
1.3.1 Null Hypothesis
H1: There will be no difference in pain relief due to ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.
H2: There will be no difference in improvement of ROM of cervical spine i.e. flexion, extension, side flexion (affected side), rotation (affected side) due to the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.
H3: There will be no difference in Neck Disability Index outcome measure of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.
H4: There will be no difference in Grip Strength improvement of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.
1.3.2 Alternate Hypothesis
A1: There will be difference in pain relief of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.
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A2: There will be difference in improvement of ROM of cervical spine i.e. flexion, extension, side flexion (affected side), rotation (affected side) due to the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.
A3: There will be difference in Neck Disability Index outcome measure of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.
A4: There will be difference in Grip Strength improvement of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.
1.4 Benefits of the Study
This study will add to the growing body of knowledge regarding the benefit of
combining the cervical traction with conventional physiotherapy in the treatment
of MNP.
The expected outcome of this study was to show if these two therapy techniques
yield comparable outcomes and if one technique is superior to the next which
should be the alternate choice of therapy.
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CHAPTER 2 – REVIEW OF THE RELATED LITERATURE
2.1 Incidence and Prevalence of Neck Pain
The prevalence of neck pain in musculoskeletal practice is second only to that of
low back pain (Vernon et al., 2007). In a cross-sectional survey on neck pain
within the general Norwegian population, Bovim et al. found that 34.4% of the
9918 responders had experienced neck pain within the last year and 13.8%
reported neck pain lasting more than six months (Bovim et al., 1994). In a
Canadian epidemiological neck pain study (n = 1133), Côte et al. found that
the six month prevalence of neck pain was 54.2% (Côte et al., 2003).
Guez et al. did a population-based study on the prevalence of neck pain in
northern Sweden (n = 6000) and found that 43% of the population reported
neck pain (48% woman and 38% men) and 18% of the population (19%
woman and 13% men) had chronic neck pain (lasting longer than six months).
Thirteen percent of these cases were of a non-traumatic origin and only 5% were
traumatic (Guez et al., 2002).
In South Africa, Ndlovu did a survey (n = 1000) of the indigenous African
population within the greater Durban area and found that individuals between
the ages of 21 – 30 years of age had a 50% incidence of neck pain and individuals
between the ages of 31 – 60 years of age had a 46.7% - 54.5% incidence of neck
pain (Ndlovu, 2006).
Due to the high incidence and prevalence of neck pain, internationally it is very
important to further evaluate efficacy of treatment techniques in the form of
clinical trials to improve the prognosis of mechanical neck pain.
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2.2 Mechanical Neck Pain
There has been a slow but constant increase in the amount of attention
paid to neck pain due to its escalating costs and burden on society (Côte et
al., 2003). Twenty-six to 71% of the adult population can recall experiencing an
episode of neck pain or stiffness in their life time. Neck pain is more common in
females than in males, with rates reported as high as 77.8% (Graham et al., 2008).
The natural history is unclear. Neck pain has a costly impact on society because of
visits to health care providers, sick leave, disability and loss of productivity. There
are a number of treatments available for neck pain, one of which is mechanical
traction.
2.2.1 Definition, etiology, risk factors and diagnosis of mechanical neck
pain
The term mechanical neck pain (MNP) can be explained as the physical forces
acting upon the cervical spine.
Pain can be caused by abnormal stress and strain on the vertebral column
and surrounding structures through poor posture, lifting and sitting habits.
Gatterman; and Bergman et al. stated that the most common cause of mechanical
neck pain is zygapophyseal joint locking and muscle strain (Gatterman, 1998)
(Bergman et al., 1993).
According to Haldeman, the Bone and Joint Decade 2000-2010 Task Force on
Neck Pain and Associated Disorders suggested the following classification system
for neck pain (Haldeman et al., 2008):
Grade I: Neck pain with no or minor interference with daily activities
Grade II: Neck pain with major interference on activities of daily living
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Grade III: Neck pain with neurological signs and symptoms
Grade IV: Neck pain due to structural pathology
According to Binder, most patients present with “non-specific (simple) neck
pain” where the signs and symptoms have a postural or mechanical basis.
Therefore, for the purpose of this study mechanical neck pain will be
classified as either Grade I or Grade II according to the above classification
system (Binder, 2007).
Peterson and Bergman stated that any event or condition (e.g. incorrect
posture, ageing, acute injury, congenital or developmental defects) which
leads to altered joint mechanics or muscle structure or function, can result
in mechanical neck pain (Bergman & Peterson, 2002).
Risk factors for mechanical neck pain include work that is physically
demanding or of a repetitive static nature, those of lower socioeconomic
standing, individuals with a history of previous neck trauma and those with co-
morbid pathologies. It has also been shown that the incidence of neck pain
increases with age and is more common among woman (Côte et al., 2003).
The diagnosis of mechanical neck pain can be made according to the
following criteria (Grieve, 1988):
a) Local chronic cervical pain with or without arm pain
b) Juxtaposition of hypo- and hypermobile segments of the cervical
spine due to spondylitic changes
c) Asymmetrical neck pain that gets worse as the day progresses and is
aggravated by driving, reading etc.
d) Unilateral occipital pain and neck pain
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e) Restricted and painful movements, especially rotation and lateral
flexion to the painful side
f) Prominent Levator Scapulae and upper and middle Trapezeus muscle
2.2.2 Clinical Presentation
Patients complaining of MNP may experience symptoms such as a dull aching pain
which may be sharp in character during inflammatory periods. There may be
associated symptoms of decreased cervical spine range of motion, muscle
hypertonicity, pain and /or headaches. MNP may be defined as pain which is
aggravated by movement, relieved by rest and that is not associated with serious
underlying pathology (Hubka & Hall, 1994). The pain is predominantly localized to
the cervical spine. The pain may radiate into the head, shoulder or between the
scapulae, this is predominantly due to myofascial involvement (Travell et al.,
1999).
During the physical examination postural changes may be evident such as an
antalgic position of the head compared to the shoulder position, wry neck,
decreased cervical lordosis, and/or anterior head carriage (Vizniak & Carnes,
2008). Active, passive and/or resisted isometric movements may be limited
and/or painful (Vizniak & Carnes, 2008).
Probable causes of MNP may include cervical disc injuries/prolapse, whiplash,
myofascial strains, ligamentous sprains, arthritis of the cervical spine, cervical
spine injury and occupational habits such as, poor posture (Vizniak & Carnes,
2008), all pathologies that may have lead to instability and would be contra-
indicated to cervical traction were ruled out by way of an extensive history and
cervical spine regional examination.
2.3 Basic Normal Anatomy of Cervical spine
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The cervical spine consists of seven vertebrae, which are divided into typical
(C3-C6) and atypical (C1, C2 and C7) vertebrae (Gatterman, 1990). The vertebral
artery passes through the oval transverse foramina of C1 to C6 (Moore & Dalley,
1999). The vertebral body of typical cervical vertebrae is small and longer
from side to side than anteroposteriorly. The superior surface is concave
(which forms the uncinate joints laterally) and convex inferiorly. The uncinate
joints are also known as the joints of Luschka. Some consider these joints to be
degenerative spaces in the discs that are filled with extracellular fluid, while
others classify them as synovial type joints (Moore & Dalley, 1999) because they
have articular cartilage, a joint space, a synovial membrane, subchondral bone
and a joint capsule. These joints form a barrier to posterolateral disc
protrusion, thereby protecting the spinal cord. However, if they hypertrophy
narrowing of the intervertebral canal may occur which can lead to nerve root
entrapment (Porterfield & DeRosa, 1995).
On the posterior aspect of the vertebrae, the two pedicles and two laminae form
the neural arch (Panjabi & White, 1990) which forms the boundaries of the
triangular vertebral foramen (Haldeman, 1992). The spinous process, as well as
the two transverse processes, arise from the laminae (Panjabi & White, 1990).
The joints on the superior and inferior surfaces of the transverse processes are
known as zygapophyseal or facet joints. The facet joints are orientated
approximately 45° to the horizontal and 90° to the sagittal plane
(Haldeman, 1992). The superior facet of the facet joint is directed supero-
posteriorly and the inferior facet is directed in an infero-posterior direction
(Moore & Dalley, 1999). The joint capsules are richly innervated by the
sinuvertebral or recurrent meningeal nerve and nociceptive fibers. Therefore,
injury to this capsule will result in pain.
Each of the atypical vertebrae is unique in their own way. The atlas is the
first cervical vertebrae; it has no body or spinous process but instead two
lateral masses connected by anterior and posterior arches. The superior
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articular facets are concave to receive the occipital condyles of the skull.
The C2 vertebrae, known as the axis, has a odontoid peg which projects
superiorly from the body. The last cervical vertebrae (C7), also known as
vertebra prominence due to its long spinous process, which is not bifid like
the rest of the cervical spine. The transverse processes of C7 are large but the
transverse foramina are too small for the vertebral artery to pass through (Moore
& Dalley, 1999).
There are intervertebral discs in between all cervical vertebrae except C1
and C2. These discs make up one fourth of the length of the cervical spine.
They are thicker anteriorly, thereby contributing to the cervical lordosis (Moore
& Dalley, 1999).
2.4 Functional Biomechanics of Cervical Spine (Levangie & Norkin, 2005)
Although the cervical region demonstrates the most flexibility of any of the
regions of the vertebral column, stability of the cervical region, especially of the
atlanto-occipital and atlantoaxial joints, is essential for support of the head and
protection of the spinal cord and vertebral arteries. The design of the atlas is such
that it provides more free space for the spinal cord than does any other vertebra.
The extra space helps to ensure that the spinal cord is not impinged on during the
large amount of motion that occurs here. The bony configuration of the atlanto-
occipital articulation confers some stability, but the application of small loads
produces large rotations across the occipito-atlanto-axial complex and also across
the lower cervical spine.
2.4.1 Kinematics
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The cervical spine is designed for a relatively large amount of mobility. Normally,
the neck moves 600 times every hour whether we are awake or asleep. The
motions of flexion and extension, lateral flexion, and rotation are permitted in the
cervical region. These motions are accompanied by translations that increase in
magnitude from C2 to C7. However, the predominant translation occurs in the
sagittal plane during flexion and extension. Excessive anteroposterior translation
is associated with damage to the spinal cord.
The atlanto-occipital joints allow for only nodding movements between the head
and the atlas (Fig. 1). In all other respects, the head and atlas move together and
function as one unit. The deep walls of the atlantal sockets prevent translations,
but the concave shape does allow rotation to occur. In flexion, the occipital
condyles roll forward and slide backward. In extension, the occipital condyles roll
backward and slide forward. Axial rotation and lateral flexion are not physiological
motions at these joints, inasmuch as they cannot be produced by muscle action.
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Figure 1 Nodding motions of the atlanto-occipital joints. A. Flexion. B. Extension
There is little agreement about the extent of the range of motion (ROM) available
at the atlanto-occipital joints. The combined ROM for flexion-extension
reportedly ranges from 10° to 30°. The total ROM available in both axial rotation
and lateral flexion is extremely limited by tension in the joint capsules that occurs
as the occipital condyles rise up the walls of the atlantal sockets on the
contralateral side of either the rotation or lateral flexion.
Motions at the atlantoaxial joint include rotation, lateral flexion, flexion, and
extension. Approximately 55% to 58% of the total rotation of the cervical region
occurs at the atlantoaxial joints (Fig. 2). The atlas pivots about 45° to either side,
or a total of about 90°. The alar ligaments limit rotation at the atlantoaxial joints.
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The remaining 40% of total rotation available to the cervical spine is distributed
evenly in the lower joints.
The shape of the zygapophyseal joints and the interbody joints dictates the
motion at the lower cervical segments. Pure anterior translation does not occur,
because it would cause the zygapophyseal joints to abut one another. Flexion of
these segments must include anterior tilt of the cranial vertebral body coupled
with anterior translation. Given the 45° slope, tilt of the vertebral body, in
addition to anterior translation, is necessary to get full motion from these joints
(Fig. 3). Extension includes posterior tilt of the cranial vertebral body, coupled
with posterior translation. Lateral flexion and rotation are also coupled motions,
because movement of either alone would cause the zygapophyseal joints to abut
one another and prevent motion. Lateral flexion is coupled with ipsilateral
rotation, and rotation is coupled with ipsilateral lateral flexion. These motions are
also a combination of vertebral tilt to the ipsilateral side and translations at the
zygapophyseal joints.
Figure 2 Superior view of rotation at the atlantoaxial joints: The occiput and atlas pivot as one unit around the dens of the axis.
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Figure 3 A. Flexion of the lower cervical spinecombines anterior translation and sagittal plane rotation of the superior vertebra. B. Extension combines posterior translation with sagittal plane rotation.
Mercer and Bogduk suggested that the notion of lateral flexion and horizontal
rotation are an artificial construct (Mercer & Bogduk, 2001). In their view,
movement should be viewed as gliding that occurs in the plane of the
zygapophyseal joints (Fig. 4). In this plane, the coupled motions are evident.
Lower cervical segments generally favor flexion and extension ROM; however,
there is great variability in reported ranges of motion in the individual cervical
segments. In general, the range for flexion and extension increases from the
C2/C3 segment to the C5/C6 segment, and decreases again at the C6/C7 segment.
The zygapophyseal joint capsules and the ligaments, in addition to the shape of
the joints, dictate motions at all of the cervical segments. The zygapophyseal joint
capsules are generally lax in the cervical region, which contributes to the large
amount of motion available here. The height in relation to the diameter of the
disks also plays an important role in determining the amount of motion available
in the cervical spine. The height is large in comparison with the anteroposterior
and transverse diameters of the cervical disks. Therefore, a large amount of
flexion, extension, and lateral flexion may occur at each segment, especially in
young persons, when there is a large amount of water in the disks.
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Figure 4 Motion at the lower cervical interbody joints occurs in the plane of the zygapophyseal joints about an axis perpendicular to the plane.
The disk at C5/C6 is subject to a greater amount of stress than other disks
because C5/C6 has the greatest range of flexion-extension and is the area where
the mechanical strain is greatest.
2.4.2 Kinetics
Although the cervical region is subjected to axial compression, tension, bending,
torsion, and shear stresses as in the remainder of the spinal column, there are
some regional differences. The cervical region differs from the thoracic and
lumbar regions in that the cervical region bears less weight and is generally more
mobile.
No disks are present at either the atlanto-occipital or atlantoaxial articulations;
therefore, the weight of the head (compressive load) must be transferred directly
through the atlanto-occipital joint to the articular facets of the axis. These forces
are then transferred through the pedicles and laminae of the axis to the inferior
surface of the body and to the two inferior zygapophyseal articular processes.
Subsequently, the forces are transferred to the adjacent inferior disk. The laminae
24
of the axis are large, which reflects the adaptation in structure that is necessary to
transmit these compressive loads. The trabeculae show that the laminae of both
the axis and C7 are heavily loaded, whereas the intervening ones are not. Loads
diffuse into the lamina as they are transferred from superior to inferior articular
facets.
The loads imposed on the cervical region vary with the position of the head and
body and are minimal in a well-supported reclining body posture. In the cervical
region from C3 to C7 compressive forces are transmitted by three parallel
columns: a single antero-central column formed by the vertebral bodies and disks
and two rod-like posterolateral columns composed of the left and right
zygapophyseal joints. The compressive forces are transmitted mainly by the
bodies and disks, with a little over one third transmitted by the two posterolateral
columns. Compressive loads are relatively low during erect stance and sitting
postures and high during the end ranges of flexion and extension. Cervical motion
segments tested in bending and axial torsion exhibit less stiffness than do lumbar
motion segments but exhibit similar stiffness in compression. In an experiment
with cadaver specimens, combinations of sagittal loads in vitro demonstrated that
the midcervical region from C2 to C5 is significantly stiffer in compression and
extension from C5 to T1. Specimens that were axially rotated before being tested
in flexion and compression failed at a lower flexion angle (17°) than at the mean
angle (25°) of nonaxially rotated specimens. The implication is that the head
should be held in a nonrotated position during flexion/extension activities to
reduce the risk of injury.
25
2.5 Cervical Spine Traction
2.5.1 Introduction
Gatterman (1990) defines spinal traction as the application of a drawing or a
pulling force along the long axis of the spine in order to stretch the soft tissues,
separate joint surfaces, and to separate bony fragments (Gatterman, 1990).
Traction is a method in which a distracting force is applied in order to stretch soft
tissues and separate articulating surfaces. Traction is often used as preparation
for other mobilization or manipulation procedures, since it is believed that
stretching of the muscles will lead to relaxation, thus improving local circulation
and diminishing pain.
Traction’s main effects on the vertebral structures are mechanical, consisting of
stretching of muscles and ligaments, distraction of vertebral bodies, separation of
facet joints, and enlargement of the intervertebral foramina. Although the
etiology of long standing pain is often difficult to be established, traction as a
therapeutic modality is frequently used with success (Tollison, 1989).
The term traction refers to the process of pulling one body in relationship to
another, which results in separation of two bodies. Traction is passive
translational movement of a joint, which occurs at right angles to the plane of the
joint between two bones, resulting in separation of joint surfaces (Bergman &
Davis, 1998). If a traction force is applied to a non-uniform structure, the greatest
stretch will be found at the weakest link, which will be the cervical spine in a
human body (Kekosz et al., 1986) .
In the treatment of the cervical spine, traction may be applied either manually or
by a mechanical apparatus. With mechanical traction the head is harnessed in a
halter that is attached to a crossbar that is either weighted or connected to a
mechanical device. Traction may be applied either in an upright sitting position or
with the patient in a supine lying position. In this position, the body and the
surface on which it lies provide the necessary counterforce. The angle of pull is
26
usually maintained at 20-25° of forward flexion, in an attempt to open the
intervertebral foramina (Tollison, 1989).
2.5.2 Indication for Cervical Spine Traction
General clinical indications for traction are degenerative disc disease, with or
without nerve root irritation, herniated intervertebral disc (except central disc
herniation which may induce cord compression), and facet joint osteoarthritis and
capsulitis (Kekosz et al., 1986). Gatterman (1990) states that intervertebral disc
protrusion, facet syndrome, nerve root compression, spondylolisthesis,
retrolisthesis, discogenic spondyloarthrosis and muscle spasm are indications for
traction (Gatterman, 1990).
2.5.3 Types of Cervical spine Traction
Types of spinal traction include continuous traction, sustained mechanical
traction, intermittent mechanical traction, manual traction and gravitational
traction. Continuous spinal traction can be applied for as long as several hours at
a time, with this extended time of traction, small amount of traction should be
used. Sustained mechanical traction involves traction that varies from a few
minutes to half an hour of traction, the shorter duration is accompanied with
heavier weights. Intermittent mechanical traction utilizes a mechanical device
that alternately applies and releases traction every few seconds. Manual traction
is applied for few seconds through the therapist grasping the patient.
Gravitational traction utilizes the patient’s own weight or a percentage thereof to
traction the segment, in need of traction (Saunders, 1985). Especially when
treating herniated disc or irritable conditions, static mode of traction is preferred
(Saunders & Saunders, 1993). Sustained (static) mechanical traction involves
application of a constant amount of traction for periods varying from a few
minutes to half an hour (Saunders, 1985).
27
2.5.4 Most effective positions for applying cervical traction
A comparative study was conducted between sitting and supine position for
cervical traction. Eight female students, ranging in age from 21-27 years, weighing
from 40-65 Kg, and with no history of cervical spine pathology were evaluated for
traction. The students were fitted with a 45° flexion halter designed to achieve
maximum pull force when placed on the occiput. X-rays were taken at 0 Kg, 14 Kg
and 18 Kg of traction force, and then measurement from C4-C7 vertebrae were
taken which determined the amount of separation. The result supported the use
of the supine position when administering cervical traction. The advantages were
greater posterior vertebral separation, increased relaxation, decreased muscle
guarding, increased stability, less force required to overcome head weight, and
diminished anterior anatomical curve of the cervical spine (Deets et al., 1977).
2.5.5 Force to be used in cervical spine traction
With regard to the increase in traction force, one study looked at the effects, that
traction produces. They state that with the initial traction force applied there is
no appreciable joint separation because the force applied needs to nullify the
compressive forces that are the result of muscle tension and cohesive forces
between articular surfaces. Then, as the traction force increases, it produces
tightening in the tissues surrounding the joint, which is described as “taking up
slack”. Also, with the traction force increased further, it produces a stretching
effect into the tissues crossing the joint (Bergman & Davis, 1998).
2.5.6 Optimum angle for cervical spine traction
Traditionally cervical traction is done with the neck in some degree of flexion.
Some clinicians believe that the greater the angle of flexion, the greater the
intervertebral separation in the lower cervical spine. With flexion at 20° and 24°
28
compression of the anterior structures actually occurs. The recommended
optimum angle for cervical traction is 15° flexion of pull for nearly every clinical
condition (Saunders & Saunders, 1993).
2.5.7 Effects of Cervical spine Traction
Saunders (1985) stated that spinal traction correctly performed can produce
many positive effects. Among these are distractions or separations of vertebral
bodies, a combination of distraction and gliding of facet joints, tensing of
ligamentous structures of the spinal segment, widening of the intervertebral
foramen, straightening of spinal curves, and stretching of spinal musculatures.
Medical treatment of musculoskeletal neck pain involves either conservative or
surgical treatment. For conservative treatment, traction is thought to be effective,
particularly in the treatment of neck pain with associated radicular symptoms.
Seventy to eighty percent of patients with radicular symptoms can be treated
conservatively, which includes oral medication, soft collars, cervical traction, and
other physiotherapy modalities (Alcantara et al., 2001).
The human body is provided with certain inherent qualities that provide for the
protection, maintenance, and restoration of health, of which the normal function
of the nervous system is major integrating force. In view of this literature review it
is clear to see that cervical spine traction have the potential to assist the body in
maintaining and restoring good health.
29
CHAPTER 3 – METHODOLOGY
3.1 Introduction
The purpose of this chapter is to describe the research, the participant
recruitment process and the treatment protocol followed as well as the
assessments and the type of measurements recorded.
3.2 Aim of Study
The aim of the study is to compare the efficacy of ‘mechanical cervical traction
with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in
mechanical neck pain. Here efficacy is measured on the basis of following
outcome measures: Neck Disability Index (NDI), Numerical Pain Rating Scale
(NPRS), and Goniometry for cervical range of motion.
3.3 STUDY DESIGN
This was a randomized two group parallel controlled clinical trial, utilizing
convenience sampling. A sample group of 40 symptomatic participants was used.
3.4 SUBJECT RECRUITMENT
This study was conducted using symptomatic participants only and all volunteers
were screened prior to their acceptance into the study based on the inclusion and
exclusion criteria.
30
3.4.1 Sample and Selection Criteria
Non-probability convenience sampling was used to obtain 40 participants with
chronic mechanical neck pain. These participants were then randomly assigned
into one of the two treatment groups (20 per group) using a computer
generated random allocation randomized table.
3.5 INCLUSION AND EXCLUSION CRITERIA
The following criteria were used to include/exclude subjects in the research:
3.5.1 Inclusion criteria
(a) Participants/patients had to be between the ages of 18 and 45 years as this
would exclude those patients who are more likely to have osteoarthritis which
is most commonly seen in the fifth and sixth decade of life (Yochum &
Rowe, 2005).
(b) Neck pain of a minimum duration of six weeks. This classified the neck pain
as chronic (Grieve, 1988).
(c) Signed informed consent form.
(d) Numerical pain rating scale [0-10]: scores between 4-9 to ensure group
homogeneity.
(e) The diagnosis of mechanical neck pain was made using the following
criteria (Grieve, 1988):
o Local chronic cervical pain with or without arm pain
31
o Juxtaposition of hypo- and hypermobile segments of the cervical spine
due to spondylitic changes
o Asymmetrical neck pain that gets worse as the day progress and is
aggravated by driving, reading etc
o Unilateral occipital and neck pain
o Restricted and painful movements, especially rotation and lateral flexion
to the painful side.
(f) Special orthopedic tests: A positive test will indicate pain at the level
of dysfunction (Gatterman, 1998). Two of the following three tests had to
be present.
Kemp’s test: Performed with the patient in the seated position with the
researcher behind them. The cervical spine was placed into a combination
of rotation, lateral flexion and extension. Pain was felt at the level of
dysfunction.
Cervical compression test: performed by applying manual downward
pressure on top of the patient’s head.
Lateral compression test: Performed with cervical spine in lateral flexion
of the head toward the painful side and applying downward pressure.
All three of these tests cause stress on the facet joint and narrowing of the
intervertebral foramen. Pain radiating down the arm indicates a
radiculopathy and local pain suggests a facet joint dysfunction (Magee,
2006).
32
3.5.2 Exclusion criteria
(a) Neck pain that was not of mechanical origin (Doherty et al., 2002) e.g.:
Inflammatory – infections, rheumatoid arthritis, spondylitis,
polymyalgia rheumatica, juvenile idiopathic arthritis.
Metabolic – osteoporosis, Paget’s disease, osteomalacia.
Neoplasia – metastases, myeloma, intrathecal tumors.
Other – fibromyalgia.
Referred pain – pharynx, aortic aneurysm, Pancoast tumor,
diaphragm, angina pectoris, teeth, cervical lymph nodes.
Neurological – nerve root entrapment and disc herniations in
the cervical spine.
(b) Patients with recent major trauma or fracture of the cervical spine.
(c) Patients whose primary complaint is that of headaches or facial
pain associated with neck pain.
(d) Any patient taking anti-inflammatory or muscle relaxant medication
would need to have a three day “wash out” period before participating in
the study (Seth, 1999).
3.6 RESEARCH METHODOLOGY/PROCEDURE
Once the participant was diagnosed with chronic mechanical neck pain, they were
then given the opportunity to ask any further questions and were informed
that they may withdraw from the study should they wish to do so. The
participant was then randomly allocated via using a computer generated
33
random allocation randomized table into one of two groups; group A:
Mechanical cervical traction with conventional therapy, group B: Conventional
therapy alone.
3.6.1 Treatment Group A – Mechanical cervical traction with conventional
therapy.
Group A participants; intervention will be given in the form of conventional
therapy plus Mechanical cervical traction.
Mechanical cervical traction will be given with a motorized traction machine
in the form of intermittent traction for 20 minutes with hold time 40 seconds
and rest time 10 seconds in supine position with 15° of neck flexion.
For Ultrasound, position of the participant will be in sitting with head
support. Participants will be treated with Ultrasound 1.5 Watt/cm2 for 8
minutes and after proper positioning of participant and therapist, ultrasound
is administered with proper instruction.
For Isometric neck exercises, position of the participant will be in sitting and
therapist will stand behind the patient. Isometric neck exercises are applied
with 15 repetitions for each of flexion, extension, lateral flexion and cervical
rotation with 5 seconds of hold time.
Same isometric exercises will be repeated at home in the evening.
3.6.2 Treatment Group B – Conventional therapy alone.
Group B participants; intervention will be given in the form of conventional
therapy. Participants will be treated with Ultrasound 1.5 Watt/cm2 for 8
minutes and for Ultrasound, position of the participant will be in sitting with
34
head support. After proper positioning of participant and therapist,
ultrasound is administered with proper instruction.
For Isometric neck exercises, position of the participant will be in sitting and
therapist will stand behind the patient. Isometric neck exercises are applied
with 15 repetitions for each of flexion, extension, lateral flexion and cervical
rotation with 5 seconds of hold time.
Same isometric exercises will be repeated at home in the evening, that
means isometric exercise is done twice daily.
3.7 MEASUREMENTS
3.7.1 Objective measurements
To obtain objective measurements, the Universal Goniometer was used. This
instrument is discussed below:
3.7.1.1 Universal Goniometer
It was found that goniometric measurements of AROM of the cervical spine made
by the same physical therapist had ICCs greater than .80 when made with the
CROM device or the Universal Goniometer (UG). When different physical
therapists measured the same patient's cervical AROM, the CROM device had
ICCs greater than .80, whereas the UG and Visual Estimation generally had ICCs
less than .80 (Youdas et al., 1991). Though CROM device is better than universal
goniometer in measuring Cervical ROM but universal goniometer can be used as
second choice due to unavailability of CROM device.
35
3.7.2 Subjective measurements
To quantify subjective outcomes, the patients were asked to complete the
Neck Disability Index form and the Numerical Pain Rating Scale form. These
two measurement tools are described below:
3.7.2.1 Neck Disability Index (NDI)
The NDI is a 10-item questionnaire that measures a patient’s self-reported neck
pain related disability. Questions include activities of daily living, such as: personal
care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity,
concentration and headache. The questions are measured on a six-point scale
from 0 (no disability) to 5 (full disability). The numeric response for each item is
summed for a total score ranging from 0 to 50 (MacDermid et al., 2009). A higher
NDI score indicates a greater patient’s perceived disability. The reliability (intra-
class correlation co-efficient [ICC]: 0.73 to 0.98), construct validity, and
responsiveness to change have all been demonstrated in various populations
(MacDermid et al., 2009). For patients with cervical radiculopathy, the minimal
detectable change is 10 points, and the clinically important difference is 7 points
(Cleland et al., 2006).
3.7.2.2 Numerical Pain Rating Scale
The level of upper limb and neck pain will be captured with the NPRS. Using an
11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable),
participants will be asked to answer the following question: “On a scale of 0 to 10,
where 0 corresponds to no pain and 10 to the worst imaginable pain, evaluate t
he intensity of your neck pain at this moment”. The NPRS is frequently used in
clinical studies in association with the NDI (Young et al., 2009), (Cleland et al.,
2008), (Childs et al., 2005). The NPRS is moderately reliable (ICC = 0.76) (Cleland
et al., 2008), and has a clinically important difference of 20% (Childs et al., 2005).
36
CHAPTER 4 – DATA ANALYSES AND INTERPRETATION
4.1 Statistical analyses
Since the outcome measures were measured at multiple time intervals and
generated interval data, repeated measures of ANOVA was used as primary
statistical analysis for within-group comparisons. Between-group differences at
each follow-up period were investigated with unpaired t-tests and within group
with paired t-test. For the total group correlation analysis was done. Statistical
significance was set at p<0.05 for all statistical analyses. Shapiro-Wilk test was
used to check the normality and all the data analysis was done in IBM SPSS
version 20.0.
4.2 Results
Table 1 : Demographical characteristics
Group Frequency %
Mechanical traction and conventional therapy
20 50
Conventional Therapy 20 50
Sex - Traction Group
Male 11 55
Female 9 45
Sex - Conventional Group
Male 8 40
Female 12 60
37
Table 2 : Demographic & clinical characteristics
Characteristics of Treatment Groups
Mean Traction Group
SD-Traction Group
Mean Conventional
Group
SD-Conventional
Group
Age 37.9000 7.86665 47.0500 7.69467
Height 158.2750 10.06489 156.0500 9.78976
Weight 60.8500 6.59565 61.8500 8.47457
Flex_Cx_Base_Active 26.5000 3.50188 27.4500 6.12566
Ext_Cx_Base_Active 34.4500 4.52449 34.3500 4.63709
Sd_Flex_Affectd_Base_Active 26.7500 1.86025 26.6500 1.87153
Rot_Affectd_Base_Active 34.9500 5.07289 37.2500 7.72470
Flex_Cx_wk1_Active 31.7000 3.06251 30.7500 6.49595
Ext_Cx_wk1_Active 40.1000 3.66922 35.1500 4.02982
Sd_Flex_Affectd_wk1_Active 35.6000 1.72901 31.1000 1.71372
Rot_Affected_wk1_Active 44.7500 3.65449 39.1000 6.25679
Flex_Cx_wk2_Active 36.5000 3.48682 34.6500 6.15822
Ext_Cx_wk2_Active 46.1000 3.40124 39.4500 3.85903
Sd_Flex_Afftectd_wk2_Active 37.9500 2.25890 35.7500 2.98901
Rot_Affectd_wk2_Active 51.1500 2.79614 44.0000 7.25476
NPRS_Base 8.2500 .55012 8.1500 .58714
NPRS_wk1 5.1500 .93330 6.3500 .67082
NPRS_wk2 3.2500 1.11803 4.8000 .83351
NDI_Base 44.8870 7.58888 39.7725 11.45592
NDI_Wk2 17.9005 2.54663 27.3810 7.36998
4.2.1 One way repeated measure ANOVA for within group difference
Flexion
A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean flexion scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.584, 30.103) = 346.90, p < 0.0005. We can, therefore, conclude that the
38
traction invention program elicits a significant improvement of 10o through the baseline to week 2. In conventional group, the mean flexion scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.336, 25.388) = 151.727, p<0.0005. We can, therefore, conclude that the conventional program elicits a statistically significant improvement 7.2o through the baseline to week 2.
Pair-wise Comparisons of Flexion Table 3 : Measure- Flexion- Traction Group
(I) factor1 (J) factor1 Mean
Difference
(I-J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 -5.200* .304 .000 -5.999 -4.401
3 -10.000* .465 .000 -11.219 -8.781
2 1 5.200* .304 .000 4.401 5.999
3 -4.800* .352 .000 -5.725 -3.875
3 1 10.000* .465 .000 8.781 11.219
2 4.800* .352 .000 3.875 5.725
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
39
Table 4 : Measure- Flexion- Conventional Group
(I) factor1 (J) factor1 Mean
Difference
(I-J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 -3.300* .291 .000 -4.064 -2.536
3 -7.200* .536 .000 -8.607 -5.793
2 1 3.300* .291 .000 2.536 4.064
3 -3.900* .376 .000 -4.888 -2.912
3 1 7.200* .536 .000 5.793 8.607
2 3.900* .376 .000 2.912 4.888
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
Extension A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean extension scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.608, 30.550) = 152.603, P < 0.0005. We can, therefore, conclude that the traction group elicits a statistically significant improvement of 11.65o through the baseline to week 2. In conventional group, the mean extension scores differed statistically significantly between measured time points (F (1.411, 26.811) = 20.295. p<0.0005. We can, therefore, conclude that the conventional intervention program elicits a statistically significant improvement of 5.1o through the baseline to week 2.
40
Pair-wise Comparisons of Extension Table 5 : Measure- Extension – Traction Group
(I) factor1 (J) factor1 Mean
Difference
(I-J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 -5.650* .670 .000 -7.409 -3.891
3 -11.650* .796 .000 -13.739 -9.561
2 1 5.650* .670 .000 3.891 7.409
3 -6.000* .503 .000 -7.319 -4.681
3 1 11.650* .796 .000 9.561 13.739
2 6.000* .503 .000 4.681 7.319
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
Table 6 : Measure- Extension – Conventional Group
(I) factor1 (J) factor1 Mean
Difference (I-
J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 -.800 1.033 1.000 -3.511 1.911
3 -5.100* .940 .000 -7.568 -2.632
2 1 .800 1.033 1.000 -1.911 3.511
3 -4.300* .524 .000 -5.675 -2.925
3 1 5.100* .940 .000 2.632 7.568
2 4.300* .524 .000 2.925 5.675
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
Side-Flexion
A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean side flexion scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.941, 36.874) = 270.229, p<0.0005. We can, therefore, conclude that the
41
traction group elicits a significant improvement of 11.2o through the baseline to week 2. In conventional group, the mean flexion scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.214, 23.074) = 134.385 p<0.0005. We can, therefore, conclude that the conventional invention program elicits a statistically significant improvement 9.1o through the baseline to week 2.
Pair-wise Comparisons of Side Flexion Table 7 : Measure- Side Flexion – Traction Group
(I) factor1 (J) factor1 Mean
Difference (I-
J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 -8.850* .488 .000 -10.131 -7.569
3 -11.200* .551 .000 -12.645 -9.755
2 1 8.850* .488 .000 7.569 10.131
3 -2.350* .483 .000 -3.617 -1.083
3 1 11.200* .551 .000 9.755 12.645
2 2.350* .483 .000 1.083 3.617
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
42
Table 8 : Measure- Side Flexion – Conventional Group
(I) factor1 (J) factor1 Mean
Difference
(I-J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 -4.450* .294 .000 -5.223 -3.677
3 -9.100* .718 .000 -10.984 -7.216
2 1 4.450* .294 .000 3.677 5.223
3 -4.650* .568 .000 -6.141 -3.159
3 1 9.100* .718 .000 7.216 10.984
2 4.650* .568 .000 3.159 6.141
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
Rotation
A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean rotation scores differed statistically significantly between baseline, week 1 and week 2; F (1.806, 34.375) = 254.165, p<0.0005. We can, therefore, conclude that the traction group elicits a statistically significant improvement of 16.2o through the through the baseline to week 2. In conventional group, the mean rotation scores differed statistically significantly between baseline, week 1 and week 2; F (1.862, 35.370) = 127.181, p<0.0005. We can, therefore, conclude that the conventional invention program elicits a statistically significant improvement 6.789o through the baseline to week 2.
43
Pair-wise Comparisons of Rotation Table 9 : Measure- Rotation – Traction Group
(I) factor1 (J) factor1 Mean
Difference
(I-J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 -9.800* .698 .000 -11.633 -7.967
3 -16.200* .829 .000 -18.376 -14.024
2 1 9.800* .698 .000 7.967 11.633
3 -6.400* .630 .000 -8.054 -4.746
3 1 16.200* .829 .000 14.024 18.376
2 6.400* .630 .000 4.746 8.054
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
Table 10 : Measure- Rotation – Conventional Group
(I) factor1 (J) factor1 Mean
Difference
(I-J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 -1.850* .393 .000 -2.880 -.820
3 -6.750* .422 .000 -7.858 -5.642
2 1 1.850* .393 .000 .820 2.880
3 -4.900* .492 .000 -6.190 -3.610
3 1 6.750* .422 .000 5.642 7.858
2 4.900* .492 .000 3.610 6.190
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
44
NPRS
A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean NPRS scores differed statistically significantly between baseline, week 1 and week 2; F (1.872, 35.568) = 261.216, p<0.0005. We can, therefore, conclude that the traction group elicits a significant improvement of pain reduction -5.000 through the baseline to week 2. In conventional group, the mean rotation scores differed statistically significantly between measured time points (F (1.737, 33.004) = 143.371, p<0.0005. We can, therefore, conclude that the conventional group treatment elicits a statistically significant improvement of pain reduction -3.330 through the baseline to week 2.
Pair-wise Comparisons of NPRS Table 11 : Measure- NPRS- Traction Group
(I) factor1 (J) factor1 Mean
Difference
(I-J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 3.100* .191 .000 2.600 3.600
3 5.000* .229 .000 4.398 5.602
2 1 -3.100* .191 .000 -3.600 -2.600
3 1.900* .240 .000 1.271 2.529
3 1 -5.000* .229 .000 -5.602 -4.398
2 -1.900* .240 .000 -2.529 -1.271
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
45
Table 12 : Measure- NPRS – Conventional Group
(I) factor1 (J) factor1 Mean
Difference
(I-J)
Std. Error Sig.b 95% Confidence Interval for
Differenceb
Lower Bound Upper Bound
1 2 1.800* .186 .000 1.311 2.289
3 3.350* .233 .000 2.740 3.960
2 1 -1.800* .186 .000 -2.289 -1.311
3 1.550* .170 .000 1.104 1.996
3 1 -3.350* .233 .000 -3.960 -2.740
2 -1.550* .170 .000 -1.996 -1.104
Based on estimated marginal means
*. The mean difference is significant at the .05 level.
b. Adjustment for multiple comparisons: Bonferroni.
Graph 1: Comparison of NPRS between groups
46
4.2.2 Independent t-test for between groups difference
The value of two tailed significance is more than .05 (p>.05) for all baseline
flexion, extension, side-flexion, rotation and NPRS. There is no significant
difference in between groups’ scores of week 1 and week 2 flexion scores. The
value of two tailed significance is less than .05 (p<.05) for extension week 1, side-
flexion week 1, rotation week 1, extension week 2, side-flexion week 2, rotation
week 2 and NPRS week 1 and week 2 scores between groups shows that there is
a significant difference in their scores.
Table 13 : Between Groups differences independent t-test
t df Sig. (2-tailed)
Flex_Cx_Base_Active
Equal variances assumed -.602 38 .551
Equal variances not
assumed -.602 30.220 .552
Ext_Cx_Base_Active
Equal variances assumed .069 38 .945
Equal variances not
assumed .069 37.977 .945
Sd_Flex_Affectd_Base_Act
ive
Equal variances assumed .169 38 .866
Equal variances not
assumed
.169 37.999 .866
Rot_Affectd_Base_Active
Equal variances assumed -1.113 38 .273
Equal variances not
assumed -1.113 32.818 .274
Flex_Cx_wk1_Active
Equal variances assumed .592 38 .558
Equal variances not
assumed
.592 27.048 .559
Ext_Cx_wk1_Active Equal variances assumed 4.062 38 .000
47
Equal variances not
assumed
4.062 37.671 .000
Sd_Flex_Affectd_wk1_Acti
ve
Equal variances assumed 8.267 38 .000
Equal variances not
assumed
8.267 37.997 .000
Rot_Affected_wk1_Active
Equal variances assumed 3.487 38 .001
Equal variances not
assumed
3.487 30.612 .002
Flex_Cx_wk2_Active
Equal variances assumed 1.169 38 .250
Equal variances not
assumed
1.169 30.047 .252
Ext_Cx_wk2_Active
Equal variances assumed 5.781 38 .000
Equal variances not
assumed
5.781 37.410 .000
Sd_Flex_Afftectd_wk2_Act
ive
Equal variances assumed 2.626 38 .012
Equal variances not
assumed 2.626 35.365 .013
Rot_Affectd_wk2_Active
Equal variances assumed 4.113 38 .000
Equal variances not
assumed 4.113 24.523 .000
NPRS_Base
Equal variances assumed .556 38 .582
Equal variances not
assumed .556 37.840 .582
NPRS_wk1
Equal variances assumed -4.669 38 .000
Equal variances not
assumed -4.669 34.496 .000
NPRS_wk2
Equal variances assumed -4.971 38 .000
Equal variances not
assumed -4.971 35.136 .000
48
4.2.3 NDI within Groups
The value of two tailed significance is less than .05 (p<.05) for traction group
shows that there is a significant difference in NDI score through the baseline and
week two with t (19) = 15.759. The mean difference was 26.98.
The value of two tailed significance is less than .05 (p<.05) for conventional group
shows that there is a significant difference in NDI score through the measure
times between baseline and week two with t (19)=6.541. The mean difference
was 14.03.
So it can be stated that the traction group benefited with more reduction of NDI
score.
Table 14 : Paired Sample t-test
Paired Differences t df Sig. (2-
tailed) Mean Std.
Deviation
Std. Error
Mean
95% Confidence Interval of
the Difference
Lower Upper
Pair
1
NDIbasetrac -
NDItracweek2 26.98650 7.65831 1.71245 23.40230 30.57070 15.759 19 .000
Pair
2
NDIbasecon -
NDIweek2con 12.94700 8.85256 1.97949 8.80387 17.09013 6.541 19 .000
4.2.4 NDI between Groups
The value of two tailed significance is more than .05 (p>.05) for NDI baseline
scores between groups shows that there is no significant difference in NDI score
t(38)=1.664. The value of two tail significance is less than .05 (p<.05) for week two
NDI scores between groups shows that there is a significant difference in NDI
score through the baseline and week 2 with t(38) = -5.437. The mean difference
was -9.480. So, the traction group benefited with more reduction of NDI score.
49
Graph 2: Comparison of NDI between groups
Table 15 : Independent Sample t-Test
Levene's Test for
Equality of
Variances
t-test for Equality of Means
F Sig. t df Sig. (2-
tailed)
Mean
Difference
Std. Error
Difference
95% Confidence Interval
of the Difference
Lower Upper
NDI_Base
Equal variances
assumed 5.902 .020 1.664 38 .104 5.11450 3.07270 -1.10585 11.33485
Equal variances
not assumed
1.664 32.983 .105 5.11450 3.07270 -1.13707 11.36607
NDI_Wk2
Equal variances
assumed 14.047 .001 -5.437 38 .000 -9.48050 1.74359 -13.01021 -5.95079
Equal variances
not assumed
-5.437 23.473 .000 -9.48050 1.74359 -13.08336 -5.87764
50
4.2.5 Correlation analysis for both the groups at week 2
The bivariate correlation analysis among the variables for both the two groups
showed flexion and extension at week two negatively influencing NDI score
(r= -.413, -.543). Flexion contributes to extension(r=.586) and extension and side
flexion contributes to rotation(r=.336, .443) positively. Extension negatively
influencing the NPRS scores(r=-.470) and NPRS score contributes positively to NDI
score at week two(r=.639).
Table 16 : Correlations (N=40)
Flex_Cx_wk2_A
ctive
Ext_Cx_wk2_Ac
tive
Sd_Flex_
Afftectd
_wk2_Ac
tive
Rot_Affectd
_wk2_Activ
e
NPRS_
wk2
NDI_W
k2
Flex_Cx_wk2_Active
1 .586**
.015 -.157 -.304 -.413**
.000 .926 .335 .056 .008
40 40 40 40 40
Ext_Cx_wk2_Active
1 .135 .336* -.470
** -.543
**
.406 .034 .002 .000
40 40 40 40
Sd_Flex_Afftectd_wk2_Act
ive
1 .433**
-.165 -.281
.005 .309 .079
40 40 40
Rot_Affectd_wk2_Active
1 -.024 -.111
.884 .497
40 40
NPRS_wk2
1 .639**
.000
40
NDI_Wk2
1
**. Correlation is significant at the 0.01 level (2-tailed).
*. Correlation is significant at the 0.05 level (2-tailed).
51
4.3 Limitations of Study
In this study data should have been collected by independent observer, which
was not feasible in this study.
Misunderstanding of NPRS and NDI questionnaire may have affected their
response, and therefore the outcome of results.
Regarding the objective measurements, the results from the study could have
been faulty due to both human errors when reading calibrations and the possible
risk of incorrect user methods.
The outcome of the study could have been more significant when looking at the
sample group; the small sample group may have failed to provide significant
information that could have been available from a large sample size.
4.4 Discussion
The effect of cervical traction for mechanical neck pain in short term is subject to
debate and controversies. The aim of the present study was to find out the reality
and the present study showed some positive results in the traction group patients
with conventional physiotherapy treatment; compared with conventional
physiotherapy alone. The difference of mean score of flexion, extension, side
flexion and rotation is 2.8o, 6.4o, 2.1o and 9.4o between the traction group and
conventional group at the end of two weeks treatment; which was gained by
adding traction as treatment along with conventional physiotherapy treatment.
The extension and rotation was also convincing in terms of improvement for
inclusion of traction as treatment.
Traction therapy for the cervical spine involves a tractive force applied to the neck
via a mechanical system which improves conduction disturbance primarily by
increasing the amount of blood flow from the nerve roots to the spinal
52
parenchyma. This can be applied intermittently or continuously. When we look at
the literature data, analysis reveals moderate evidence of benefit for intermittent
traction, but no benefit for continuous traction in mechanical neck disorders
(Hattori et al., 2002) (Graham et al., 2006).
Lecocq’s literature review (Lecocq et al., 2005) stated that cervical traction has
several different modes of action, with a very small increase in the intervertebral
space (a few tenths of a millimeter) and a reduction in intradiscal pressure, with a
possible Herniated Disc [HD] suction effect. The HD can also be pushed back by
tension in the posterior longitudinal ligament. In terms of the muscles, the effect
of cervical traction is characterized by stabilization of (or even an increase in)
activity of the trapezius muscle during the first 3 to 6 minutes. The inhibitory
‘‘gate control’’ effect on nociceptive influx transmission requires experimental
confirmation. Furthermore, placebo and psychological effects must be considered
when analyzing the effect of cervical traction.
The NPRS scale mean score difference at the end of two weeks for traction and
conventional treatment group was 1.7 on a scale of 0-10 for inclusion of traction
as treatment and between the group NDI score mean difference at the end of
two weeks also showed contribution of 9.5% more reduction on NDI for
disability.
The correlation analysis for the both groups showed significant relationship
between NPRS and NDI scores and flexion and extension contributes negatively to
NDI score. Moreover extension negatively influences the NPRS score.
4.5 Conclusion
The inclusion of cervical traction as a treatment tool along with the conventional
physiotherapy treatment for mechanical neck pain proved beneficial in terms of
improving cervical mobility, pain reduction and disability perception. Therefore
cervical traction can be recommended as complimentary modality in mechanical
neck pain.
53
The mechanism by which ICT reduces neck and arm pain is possibly by
unloading the components of the spine by stretching muscles, ligaments and
functional units, reducing adhesions within the dural sleeve, nerve root
decompression within the central foramina, and increasing joint mobility.
Traction also decreases intervertebral disc pressure as stated by Saunders
(Saunders & Saunders, 1993). Reduced tonic muscle contraction and improved
vascular status in the epidural space and perineural structures may also
reduce pain.
The study duration was short, only 2 weeks, and the results apply to short term
only, which might differ in the longer run. Sample size taken for the study is
small and bigger sample might have led to some differences in the results. All
the measurements were taken manually and this may introduce human error
which might affect the reliability.
However, in one study, no specific effect of traction over standard
physiotherapeutic interventions was observed in adults with chronic neck pain.
Hence, it is suggested that clinicians should consider this chronic neck condition
and to focus on exercise therapy in the management of patients suffering from
chronic neck pain (Pinar et al., October 2008). Every research study has its own
set of confounding factors that may affect the study’s clinical outcome.
Hence, we conclude that, intermittent cervical traction should have a place
in the management of MNP along with neck exercises in reducing neck and arm
pain, neck disability and in improving activities of daily living.
54
CHAPTER 5 – RECOMMENDATIONS
5.1 Recommendations
1. MNP is variable by nature; therefore, subsequent studies should consider
methods of producing a more uniform sample group, taking into account
the patient’s age, gender, chronicity of neck pain, socio-economic
background and emotional stress levels.
2. A more extensive study should be performed, with a larger sample group
to allow for the general population to be more accurately represented.
3. Have an equal ratio of males to females as participants and compare to the
results of the study.
4. Isolate gender to either males or females, this may produce a different
outcome or stronger statistical results; this may help determine whether
both sexes respond similarly to treatment.
5. Further objective measurements should be included with regards to
measuring changes in pain during study. This might take the form of an
Algometer.
6. The study could be performed isolating the level to be treated. This will
allow a more specific reading.
55
7. Objective and subjective reading should be taken before and immediately
after treatment sessions. This would allow for both the immediate and
prolonged effects of the treatment to be investigated.
8. A follow up, one month after the cessation of the treatment sessions to
determine the long term benefits of treatment with regards to pain,
disability and cervical ROM should be included.
9. This study can also include grip strength measurement using Jamar
Dynamometer to observe the improvement in grip strength of participants
during study at week 1 and week 2 etc.
56
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60
Appendices
Appendix-I: Neck Disability Index - Gujarati Version
UZNG V;DY"TF 5|`GFJ,L
VF 5|`GFJ,L TDFZL UZNGGL 5L0FG[ ;DHJF DF8[ AGFJJFDF\ VFJL K[ VG[ T[GF äFZF TDFZF ZMH AZMHGL lS|IFDF\ YTF O[ZOFZGL
DC[ZAFGL SZLG[ NZ[S lJEFUGL ;FY[ VF5[,L lJUT p5Z lGXFGL SZJL VG[ HF6LV[ KLV[ S[4 V[S H lJEFUGF A[ S[ +6 JFSIM ,FU] 50L
XS[ K[P5Z\T] H[ JFSI TDFZL 5L0FGL ;{FYL GHLS CMI4 T[GL ;FD[ lGXFGL SZJLP
lJEFU v! s5L0FGL lTJ|TFf
DG[ VF 1F6 SM. 5L0F GYLP
DG[ VF 1F6 36L VMKL 5L0F K[P
DG[ VF 1F6[ 5L0FGL lTJ|TFDF\ YM0M JWFZM K[P
DG[ VF 1F6[ UZNGGL 5L0FDF\ 36M H JWFZM K[P
DG[ VF 1F6[ UZNGGL 5L0FDF\ B]A H JWFZM K[P
DG[ VF 1F6[ B]A H JWFZ[ 5L0F K[ H[ V;CI K[P
lJEFUvZ s;FZ;\EF/f
C]\ JWFZFGL 5L0F l;JFI 5MTFGL ;FZ;\EF/ ZFBL XS] K]P
5MTFGL ;FZ;\EF/ ZFBL XS] K] 56 T[GF äFZF 5L0FDF\ JWFZM YFI K[P
5MTFGL ;FZ;\EF/DF\ N]BFJM YFI K[ VG[ C]\ WLZH VG[ SF/HL ZFB] K]P
5MTFGL ;FZ;\EF/ DF8[ VgIGF ;CFIGL H~Z 50[ K[P
5MTFGF ;FZ;\EF/ DF8[ VgIGF ;CFIGL H~Z 50[ K[P
C]\ S50F 5C[ZJFDF\ VG[ WMJFDF\ TS,LO VG]EJ] K]P VG[ 5YFZLJX K]P
lJEFUv# sp\RSJ]Pf
C]\ SM.56 N]BFJF JUZ EFZ[ ;FDFG p\RSL XS] K]P
C]\ EFZ[ ;FDFG N]BFJF ;FY[ p\RSL XS] K]P
DFZF UZNGGL 5L0F DG[ EFZ[ ;FDFG HDLG 5ZYL p\RSJF DF8[ ZMS[ K[ 5Z\T] C] C/JFYL YM0] JWFZ[ JHG p\RSL XS] K]\
HM V[ IMuI HuIFV[ ZFB[, CMIP
C]\ OST C/JM ;FDFG H p\RSL XS] K]P
C]\ S\.56 p\RSL XSTM GYLP
lJEFU v$ sJF\RGf
C]\ DFZL .rKF D]HA S\.56 N]BFJF JUZ JF\RL XS]\ K]P
C]\ YM0L 5L0F ;FY[ .rKF D]HA JF\RL XS] K]P
C]\ UZNGGL YM0L JWFZ[ 5L0FGL ;FY[ .rKF D]HA JF\RL XSTM GYLP
61
C]\ EFuI[H JF\RL XS]\ K]P SFZ6 S[ DFZL 5L0FDF\ B]A H JWFZM K[P
C]\ S\. 56 JF\RL XSTM GYLP
lJEFU v5 sDFYFGM N]BFJMf
DG[ DFYFGF N]BFJFGL ;D:IF GYLP
DG[ SIFZ[S YM0F DFYFGF N]BFJFGL ;D:IF ZC[ K[ H[ SIFZ[S VFJ[ K[P
DG[ YM0F JWFZ[ DFYFGF N]BFJFGL ;D:IF ZC[ K[ H[ SIFZ[S VFJ[ K[P
DG[ YM0F JWFZ[ DFYFGF N]BFJFGL ;D:IF ZC[ K[ H[ SFIDL ZC[ K[P
DG[ 5|tI[S 1F6 DFYFGF N]BFJFGL ;D:IF B]A JWFZ[ ZC[ K[P
DG[ 5|tI[S 1F6 DFYFGF N]BFJFGL ;D:IF ZC[ H K[P
lJEFU v& sV[SFU|TFf
C]\ SM.56 D]XS[,L JUZ V[SFZU| ZCL XS] K]P
C]\ YM0L D]XS[,L ;FY[ 5]ZTM V[SFU| ZCL XS] K]P
V[SU|TF HF/JJFDF\ DG[ YM0L H DF+FDF\ D]xS[,L 50[ K[P
DG[ V[SFU|TF HF/JJFDF\ B]A H D]xS[,L 50[ K[P
C]\ V[SFU|TF HF/JL XSTM H GYLP
lJEFU v * sSFI"f
C]\ DFZL .rKF D]HA DFZ]\ AW] ZMHAZMHG]\ SFI" SZL XS] K]P
C]\ DFZ]\ ;FDFgI ZMHAZMHG]\ SFI" SZL XS] K] 56 JWFZ[ GCLP
C]\ DFZ]\ DM8FEFUG]\ SFI" SZL XS] K] 56 JWFZ[ GCLP
C]\ DFZ]\ ZMHAZMHG]\ SFI" SZL XSTM GYLP
C]\ EFuI[H S\.S SFI" SZL XS] K]P
C]\ DFZ]\ S\.56 SFI" SZL XSTM GYLP
lJEFU v(s 0=F.\JLU qC\SFZJ]f
C]\ DFZL UF0L SM.56 N]BFJF JUZ R,FJL XS] K]P
C]\ DFZF UZNGGF\ YM0F N]BFJF ;FY[ DFZL .rKF D]HA UF0L R,FJL XS] K]P
C]\ DFZL .rKF D]HA UF0L R,FJL XS] K] 5Z\T] T[GF äFZF DFZF UZNGGL 5L0FGL TLJ|TFDF\ YM0M JWFZM YFI K[P
C]\ EFuI[H UF0L R,FJL XS] K]P SFZ6 S[ T[GF äFZF DFZL UZNGGL 5L0FGL TLJ|TFDF\ 36M JWFZM YFI K[P
C]\ DFZL UF0L R,FJL H XSTM GYLP
lJEFU v )slG\ãFf
DG[ lG\ãFDF\ SM. TS,LO GYLp
DG[ lG\ãFDF YM0L H B,[, 5CM\R[ K[ sV[S S,FS SZTF VMKLf
DG[ lG\ãFDF B,[, 5CM\R[ K[P s! YL Z S,FSf
62
DG[ lG\ãFDF YM0L JWFZ[ B,[, 5CM\R[ K[P sZ YL # S,FSf
DFZL lG\ãFDF B]A B,[, 5CM\R[ K[ s # YL 5 S,FSf
DFZL lG\ãFDF 5]Z[5]ZL B,[, 5CM\R[ K[P s5v* S,FSf
lJEFU v !_ sDGMZ\HGf
C]\ DFZL AWL DGMZ\HG 5|J'lTVM UZNGGF\ SM.56 N]BFJF JUZ SZL XS] K]P
C]\ DFZL AWL DGMZ\HG 5|J'lTVM UZNGGF\ YM0F N]BFJF ;FY[ SZL XS] K]P
C]\ AWL GCL 5Z\T] DM8FEFUGL DGMZ\HG 5|J'lTVM SZL XS] K]P
C]\ DFZL UZNGGL 5L0FG[ SFZ6[ YM0L 36L DGMZ\HG 5|J'lTVM SZL XS] K]P
C]\ DFZL UZNGGL 5L0FG[ SFZ6[ EFuI[ H DFZL DGMZ\HG 5|J'lTVM SZL XS] K]P
C]\ SM.56 DGMZ\HG 5|J'lTVM SZL XSTM GYLP
Appendix-II: Numerical Pain Rating Scale (NPRS).
63
Appendix –III: Consent Letter
સમંિત પ�ક
મ�, .................................................. આ ફોમ� મા ંમા�હતી વાચંી છે (અથવા ત ેમને અ�ય એ
વાચંી છે). �ુ ંકોઇ પણ ��ો �છૂવા માટ� ��ુત હતો અને તેઓ એ જવાબ આ�યો છે. માર� �મર
18 વષ�ની ઉપર છે અને, માર� પસદંગી શ��ત ઉપયોગ કર�ને, આથી આ અ�યાસ મા ંસહભાગી
તર�ક� સમાવેશ સમંિત �દાન ક�ંુ � ં…………………………………………………………
.………………………………………………………………………………………………………………………………
…………………………………………. (અ�યાસ શીષ�ક).
(1) મ� આ સમંિત ફોમ� વાચંી છે અને સમ� છે અને મા�હતી મને �દાન કરવામા ંઆવેલ છે.
(2) આ સમંિત દ�તાવેજ મને સમ�વામા આવી છે.
(3) મારા અિધકારો અન ેજવાબદાર�ઓ મને તપાસ કરનાર �ારા સમ�વામા આવી છે.
(4) મને આ અ�યાસ મા ંભાગ લેવા સાથે સકંળાયેલ જોખમો �ગે સલાહ આપેલ છે.
(5) �ુ ંએ હક�કત થી પ�ર�ચત � ંક� �ુ ંકોઈપણ સમયે કોઈપણ કારણો આ�યા િવના આ અ�યાસ
માથંી બહાર જઈ શ�ુ � ંઅને તે આ હો��પટલમા ંમાર� ભિવ�યમા ંસારવાર પર અસર કરશ ેનહ�.
(6) �ુ ંઅહ� તપાસકતા�ઓને પરવાનગી આ� ુ� ંક� તેઓ આ અ�યાસમા ંભાગ લેવા પ�રણામે �
�ણકાર� મેળવી છે ત ેિનયમનકાર� સ�ાવાળાઓ, સરકાર� એજ�સીઓ, અને નીિતશા� સિમિત.
સામે �કાિશત કર� શક� છે.
(7) જો માર� મા�હતી �હ�રમા ંર�ૂ કરવામા ંઆવે તો માર� ઓળખ ��ુત રાખવામા ંઆવશે.
આ સમંિત દ�તાવેજ સાઇન કર�ને, �ુ ં�મા�ણત ક� � ંક� આ દ�તાવેજ મા ંઆપેલ મા�હતી મન ે
�પ�ટ કરવામા ંઆવેલ છે અને મને સમજ પડ� છે.
દદૉ ની સહ� : Date:
64
Appendix-IV: Raw Data