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SPINE An International Journal for the study of the spine, Publish Ahead of Print

DOI: 10.1097/BRS.0000000000002874

Changes in the Sagittal Cranio-Cervical Posture Following a 12-Week Intervention Using a

Simple Spinal Traction Device

David Shahar1 DC and Mark G.L. Sayers1 PhD


1
School of Health and Sport Sciences, University of the Sunshine Coast, Maroochydore DC,
Queensland, Australia 4558

Corresponding Author:

David Shahar
c/o School of Health and Sport Sciences
University of the Sunshine Coast, Maroochydore DC, Queensland, Australia 4558
Telephone number: +61754569111
Fax number: +61731125972
Email: david.shahar@research.usc.edu.au
Address for reprints: David Shahar 2/1 Scholars Dr, Sippy Downs, QLD 5449 Australia.

The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for


this indication.
Standard university funds were received in support of this work.
Relevant financial activities outside the submitted work: DS is the developer of the Thoracic
Pillow®.

Copyright © 2018 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Abstract

Study Design: Non-controlled clinical trial

Objective: To assess the efficacy of a simple home spinal traction device on sagittal cranio-
cervical posture and related symptoms.

Summary of Background Data: Forward head protraction (FHP) and cranio-cervical


malalignment were shown to be consequential in the development adverse musculoskeletal
radiographic findings and symptoms in that region.

Methods: Participants (n = 13, 18 – 36-year-old) were drawn from a mildly symptomatic


population, all presented with cranio-cervical malalignment and considerable FHP. Participants
used a simple home spinal traction device for 12 weeks, 10 minutes/day. Sagittal cervical
radiographs and the SF36 health survey were obtained pre/post intervention and guideline
compliance was recorded. Radiographic evaluation included typical measurements of sagittal
cranio-cervical alignment and FHP (e.g. atlas plane line, vertical axis line, sagittal cranial angle,
absolute rotation angle). Standard paired samples t-tests, CHI Squared and Effect Size analyses
were used to assess pre- and post-intervention changes.

Results: Each of the key radiographic variables recorded significant moderate to very large
positive changes as a result of the intervention. Similarly, CHI squared analyses indicated that
saggital cervical spine configuration tended to become more lordotic (P=0.007), with four
participants shifting from a kyphotic to a lordotic presentation. SF36 health survey data
demonstrated mostly significant positive changes throughout all tested domains, and moderate
positive changes were recorded across all radiographic cranio-cervical mesured paramenters (e.g.
decreased FHP, increased cervical lordosis and cranial extention). Participants indicated high
level of protocol compliance.

Conclusions: This study has demonstrated that the unsupervised daily use of a simple home
spinal traction device (Thoracic Pillow®) proved effective in bringing positive plastic changes to
the sagittal cranio-cervical alignment and reduction in symptoms in the tested population during
a short intervention period.

Key Words: spine; spinal traction; cervical traction; neck; musculoskeletal; alignment; treatment
outcome; correction; pain, intervention; posture; prevention

Level of Evidence: 3

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Introduction

Neutral spine and neutral zone concepts were shown to offer protective mechanisms to the
musculoskeletal tissues by distributing load effectively on the involved weight bearing
structures.1 The normal sagittal cervical spine configuration is lordotic.2,3 Reduction in cervical
lordosis, cervical kyphosis and forward head protraction (FHP) were identified as the most
pervasive cranio-cervical malalignments.4-6 Cervical spine sagittal malalignment may result in
increased aberrant load on its functional units and increased intervertebral disc pressure leading
to posterior disc protrusion,7,8 and to the acceleration of degenerative processes in adjacent
segments.7,9,10 Accordingly, cervical spine malalignments may result in neurological pathologies
which are often debilitating to a point where surgical intervention is warranted.5,11

Cervical kyphosis often develops in response to advanced spinal degenerative disease, systemic
arthritis, trauma, neoplastic etiologist or multilevel laminectomies.5 This aberrant spinal
configuration is responsible for distortion of the acceptable load distribution ratio between the
anterior and posterior structures of the spine,12 and associated deformities.11 Similarly, both
cervical spine flexion and extension generate a significant disparity in load distribution and the
magnitude of the moment arm and load experienced by the cervical functional units and
masculature.13,14 Furthermore, weight bearing tasks are primaraly assigned to bone tissue, while
muscle tissue is predominantly involved in movement and balance maintenance. In the case of
increased FHP, load is partially transferred from the cervical spine to the posterior cranio-
cervical musculature.14 Therefore, it is not surprising that FHP is responsible for a decrease in
cervical ROM and an increase in cervical impairment, earning this condition clinical attention in
its own right.15

Spinal traction is a modality that is used throughout several allied health professions for the
treatment of conditions associated with spinal malalignment such as FHP and cervical kyphosis,
and symptoms such as cephalgia, cervicalgia and cervical radiculopathy.16-21 Surprisingly,
despite its common use, questions remain as to both the effectiveness of cervical traction
modalities and quality of the associated research design and trial methodologies.16,20,22 Cervical
traction can be applied through several different modalities, using different vectors, force and
method of utilisation.19,20,22 Importantly, in most reported cases, cervical traction therapy was
provided to participants under supervision in a clinical setting, with these two conditions
potentially limiting treatment duration and patient compliance due to ongoing associated costs
and time considerations. Furthermore, in most cases, traction modalities were acting on the
cervical spine only, without consideration for the accommodations required by other regions of
the spine. And finally, in most reported cases, outcomes focused only on symptomatic changes
and not on structural augmentation.16-23 The aim of this investigation was to assesses the
symptomatic and structural changes in the cranio-cervical region following a 12-week
intervention through the daily use of a simple home spinal traction device.

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Methods

This project was provided full ethics approval by the Human Research Ethics Committee of the
University of the Sunshine Coast. Participant selection for this study was based on recent data
analysis for a different project.24 Prior to enrolling in to this project, informed consent was
obtained from all participants and participants rights were protected throughout this study.
Furthermore, it was made clear to all participants that data collected during this project will be
submitted for publication and that patient’s confidentiality will be protected. All participants
invited to take part in the current study previously displayed a considerable forward head
protraction (FHP) and abnormal cervical spine configuration.25 Participants’ symptomology were
extracted directly from pre-intervention SF36 health survey data (refer to pre intervention data in
Table 1), with all reporting mild, intermittent non-specific complaints (e.g. headache, neck pain,
neck stiffness). Of the 17 invited participants, 4 did not comply with the study protocol and were
consequently excluded. Accordingly, this project involved 13 (18 – 36-year-old) mildly
symptomatic volunteers (females=11, males=3, height 171 ±8 cm, mass 67 ±12 kg, BMI 23 ±4).
No congenital abnormalities were detected in this sample during radiographic analysis.

Upon enrollment into this project, participants were given an adjustable full spinal traction
device (Thoracic Pillow®, Figure 1A-C) and were instructed in its use. Participants were asked
to lie supine on the device (Figure 1c) for 10 mins per day over the course of the 12 week
intervention period, logging their frequency and duration of use.

Pre/post-testing were based on analyses of the lateral cervical radiographs and SF36 health
survey data. All radiographs were obtained by a qualified technician at the same facility, by the
same digital capturing techniques and equipment. During image acquisition, participants were
instructed to stand in their normal posture looking straight ahead, with their right shoulder in
contact with the wall mounted Bucky. The tube-to-Bucky distance was kept constant at 1.5 m. An
experienced clinician conducted all radiographic analyses using standard software (Genesis
OmniVue® Genesis Digital Imaging, Inc. Los Angeles, CA). During analysis, the clinician was
free to magnify the images to increase accuracy. Previously we have shown these data collection
methods to be both accurate and reliable.26

All variables assessed on pre and post radiographic studies were based on well established
measures (Figure 2) of spinal alignment and lateral cervical spine configuration classification.25
The sagittal cranial angle (SCA, Figure 2b) measure, although not typically used in the literature,
is easy to measure, based on clearly identifiable landmarks and provides an indication of sagittal
cranial attitude.

                                                            

 The Thoracic Pillow® was developed by D.S., first in 2007 with the version used in this project developed in 2015. 

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Description of Mesurments

Atlas plane angle (APA, Figure 2a): This angle is formed in the sagittal plane between a
horizontal line and a line connecting the inferior points of the anterior and posterior arches of C1.
Increased APA is suggestive of increased C1 and upper cervical spine extension (lordosis).6

Sagittal cranial angle (SCA, Figure 2b): This angle is formed in the sagittal plane between a
horizontal line and a line connecting the most caudal point of the occipital curve to the posterior
edge of the hard palate. Increased CA is suggestive of increased cranial extension.

Forward head protraction (FHP, Figure 2c): This is a sagittal plane measurement in millimetres
of a horizontal line drawn from the posterior inferior corner of C2 to a vertical line emanating
from the posterior inferior corner of C7. Increased measurement of the horizontal line is
suggestive of increased FHP.6

Absolute rotation angle (ARA, Figure2d): This angle is formed in the sagittal plane between a
line drawn along the posterior aspect of C2’s body and a line drawn along the posterior aspect of
C7’s body. Increased ARA is suggestive of increased global cervical lordosis.6

Relative rotation angle (RRA, Figure 2e): This angle is formed in the sagittal plane between two
lines drawn along the posterior aspect of the bodies of two adjacent vertebrae. Increased RRA is
suggestive of increased extension between the two bones.6

Statistical Analysis

Differences in pre- and post-intervention variables were assessed using Paired t-Tests. The need
to conduct multiple t-Tests meant that the alpha level was adjusted to the more conservative P <
0.01. The relative magnitude of differences were quantified using standard Cohen’s Effect Size
(ES) analyses with the following descriptors used to define the magnitude of the ES: <0.2 =
trivial, 0.2-0.6 = small, 0.6-1.2 = moderate, and 1.2-2.0 = large.27 All statistical analyses were
performed using the statistics package SPSS for Windows (version 20), with data presented as
means (±1 standard deviation [SD]) unless stated otherwise.

Results

Overall, each of the key radiographic variables recorded significant moderate to large positive
changes as a result of the intervention (Figure 3a to 3d). Similarly, CHI squared analyses
indicated that post-intervention cervical saggital spine configuration tended to become more
lordotic (P=0.007), with four of the participants shifting from a kyphotic to a lordotic
presentation.

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SF36 health survey results demonstrated positive changes throughout all tested domains,
although not all changes were significant (Table 1). Importantly, all but the Change in Health
and Role Limitation – Mental categories recorded large improvements (ES>0.8). Participant log
books indicated that 5 participants followed the intervention guidelines precisely, while 6
participants missed fewer than 5 days over the entire intervention period. Conversely, 2 of the
participants used the Thoracic Pillow®on alternating days. Importantly all participants,
irrespective of the level of compliance, recorded postive changes in the SF36 Health Survey data.
None of the participants indicated that they experienced any discomfort when using the Thoracic
Pillow®.

Discussion

This study aimed to assess whether a 12-week intervention using a home-based spinal traction
device (Thoracic Pillow®) can bring about plastic changes in cranio-cervical posture in a group
of mildly sympotmatic participants. Importantly, results show that within this relatively short
intervention period, not only was positive plastic deformation in the sagittal cranio-cervical
configuration achieved, but participants reported a reduction in sympotmology and increases in
quality of life.

The post-intervention decrease in FHP suggests that the cranial mass has shifted posteriorally.
Theoretically, this positive change would result in load being transfered from the cranio-cervical
extensors to the spine. With the exception of ARA, our pre-intervention radiographic analysis
data were more than 1 SD from the typical values set in landmark research by Harrison, et al. 6;
however, our post-intervention data improved to be within their values. Although our ARA
values improved significantly following our intervention, these data remained considerably
lower than those reported perviously.6 This discrepancy can be explained using the
inclusion/exclusion criteria from this earlier research,6 with participants presenting with non-
lordotic cervical spinal alignments being excluded from the study. Similarly, the relatively low
SCA, APA, and ARA pre-intervention values, together with non-lordotic sagittal cervical
configurations in 12 of 13 participants, suggest that our population’s neutral cranio-cervical
posture was significantly flexed. The post-intervention changes in these values suggest our
population’s neutral posture shifted towards a global cranio-cervical extension. Accordingly, all
above changes may have favorable implications on participants’ cervical and suboccipital
extensors’ rigidity and associated symptoms (e.g. cranio-cervical stiffness, cervicalgia and
cephalgia), as flexed cranio-cervical posture has been shown to increase mechanical load and
symptomology in that region.14,28,29

A clear strength of this project is the effectiveness of a non-supervised, home-based intervention


protocol, particularly given that protocols such as these typically result in poor compliance.30
Clearly, while 4 of the 17 participants failed to adhere to this regimen (and were subsequently
excluded), positive results appear to be achievable even amongst the participants who did not
adhere strictly to the guidelines. While further research is required in this domain, it is likely that

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protocols such as these, which require intrinsic levels of motivation (and ease of use), will result
in greater retention in the long-term. The exploratory nature of this research means that results
may not be transferrable to other populations, and so care should be taken to avoid
overinterpreting these data.

The use of a multiregional spinal traction device in this study seemed sensible, as cervical
sagittal cervical spine alignment is firmly linked to global spinal and pelvic alignment.5,31-33
There are clear linkages between all adjacent spinal segments, with thoracic hyper-kyphosis, for
example, being shown to limit cervical spine range of motion (ROM).15,34,35 Accordingly, a
multiregional spinal traction setting may also provide a more comfortable participant experience,
as all regions can accommodate changes respectively without excessive strain on any one
particular region. This may have also contributed to the relatively high levels of compliance
amongst our test population.

Musculoskeletal tissue degeneration resulting from conditions such as cranio-cervical flexion


and FHP often develops asymptomatically over time, and has been attributed to both the natural
ageing processes and environmental factors.36-43 Consequently, by the time of diagnosis, tissue
remodelling may be well established and irreversible.44-48 Morbidity and disability due to pain
arising from the cervical spine alone imposes an increasing social and financial burden on
individuals and societies.20,44,45,49-53 The complexity associated with diagnostic and therapeutic
interventions pertaining to the cervical spine is related directly to the region’s wide range of
motion, mass of the cranium and density of vital organs in the region.5 In recent years, flexed
cranio-cervical posture has been put in the spotlight when cranio-cervical symptoms across the
population have been linked increasingly with the emergence and reported exessive use of
handheld technologies.14,54,55 Recently, we have linked the extended use of handheld
technologies with a morphological adaptation in the form of excessive exosteosis, emanating
from the occipital squama in young adoults.24,26,56 Surely, the use of handheld technologies will
not diminish soon, and future posture-related demands will persist. Therefore, consideration must
be given to the modus operandi of these devices and countermeasures to the increased sustained
load at the cranio-cervical region should be implemented. Importantly, neck pain should be
viewed ideally as an incident reoccurring with different extent of recovery throughout life 53
Therefore, there is a need for the early implementation of effective, simple, and affordable
prevention intervention strategies.

The authors acknowledge that to improve data reliability and to draw a conclusion on the long-
term effect of this intervention, a cross-over design longitudinal study in a larger randomly
selected sample should be performed. However, study duration and sample selection bias, which
included participants with predetermined cranio-cervical structural abnormalities, are reflective
of normal practice. Furthermore, a potential conflict of interest exists as D.S. is the developer of
the Thoracic Pillow®. However, radiographic analysis reliability was tested against an
experienced observer external to this study, and statistical analysis was performed by non-
aligned member of the research team.

Copyright © 2018 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
This study aimed to assess whether a simple intervention using a home-based spinal traction
device (Thoracic Pillow®) can bring about plastic changes in cranio-cervical posture in a group
of mildly sympotmatic participants. The positive changes recorded in the sagittal cranio-cervical
postures (e.g. FHP reduction, and increased cervical lordosis) and reduction of symptomatology
in the tested population provide evidence for the efficacy of the device’s use. Results suggest the
device is easy to use, with relatively high levels of compliance, despite the unsupervised nature
of the intervention. This approach to addressing these common postural abnormalities may have
clinical merit for prevention intervention.

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Legandss

Figure 1. An adjustaable full spin


nal traction unit
u (Thoraciic Pillow®).

a. The Thhoracic Pillo


ow® in its cllosed positio
on to accomm
modate indivviduals of smmaller body ssize.
b. The Thhoracic Pillo
ow® in its exxtended formm to accommmodate tall inndividuals. cc. The cerviccal
spine is only
o partially
y supported and extendeed.

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Figure 21.
2 Radiograp
phic measurrements cond
ducted pre- aand post-inteervention.

a. Atlas plane
p angle. b. Sagittal cranial
c angle. c. Forwardd head protraaction. d. Abbsolute rotatiion
6
angle. e. Relative rottation angle.

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Figure 3. Graphical comparison of pre- and post-intervention
p data foor each of thhe key sagittaal
cranio-ceervical alignm
ment variablles.

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Table 1. Results from the SF36 Health Survey presented as the means (±1SD), with data

including both the level of significance and relative magnitude of any changes from pre- to post-

intervention.

Variable Pre Post P ES


Physical Function 62.3 (27.1) 81.9 (3.3) 0.017 0.92
Social Function 77.2 (17.7) 89.8 (9.5) 0.005 0.83
Mental Health 70.8 (15.1) 82.2 (10.5) 0.016 0.81
Pain 75.3 (22.3) 91.5 (12.0) 0.003 0.84
Change in Health 61.5 (16.5) 69.2 (25.3) 0.219 0.36
Role limitation - Physical 73.1 (34.6) 98.1 (6.9) 0.021 0.91
Role Limitation - Mental 82.2 (22.0) 92.4 (14.5) 0.040 0.54
Energy / Vitality 54.2 (21.0 71.5 (11.1) 0.013 0.93
Health Perceptions 65.4 (17.6) 80.0 (12.1) 0.001 0.88

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