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A randomized controlled trial comparing McKenzie therapy

and motor control exercises on the recruitment of trunk
muscles in people with chronic low back pain: a trial
protocol夽
Mark H. Halliday a,∗ , Paulo H. Ferreira b , Mark J. Hancock c , Helen A. Clare d
a Physiotherapy Department, Concord Repatriation General Hospital, Hospital Rd., Concord, NSW 2139, Australia
b Faculty of Health Sciences, The University of Sydney, 75 East St., Lidcombe, NSW 1825, Australia
c Faculty of Human Sciences, Macquarie University, Balaclava Rd., North Ryde, NSW 2113, Australia
d Physiotherapy Private Practice, 24/272 Pacific Highway, Crows Nest 2065, Australia

Abstract
Objective To investigate if McKenzie exercises when applied to a cohort of patients with chronic LBP who have a directional preference
demonstrate improved recruitment of the transversus abdominis compared to motor control exercises when measurements were assessed from
ultrasound images.
Design A randomized blinded trial with a 12-month follow-up.
Setting The Physiotherapy department of Concord Hospital a primary health care environment.
Participants 70-adults with greater than three-month history of LBP who have a directional preference.
Interventions McKenzie techniques or motor control exercises for 12-sessions over eight weeks.
Main outcome measures Transversus abdominus thickness measured from real time ultrasound images, pain, global perceived effect and
capacity to self-manage.
Discussion This study will be the first to investigate the possible mechanism of action that McKenzie therapy and motor control exercises
have on the recruitment of the transversus abdominus in a cohort of low back pain patients sub-classified with a directional preference. Patients
receiving matched exercises according to their directional preference are believed to have better outcomes than those receiving unmatched
exercises. A better understanding of the mechanism of action that specific treatments such as motor control exercises or McKenzie exercises
have on patients classified with a directional preference will allow therapist to make a more informed choice about treatment options.
© 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Keywords: McKenzie; Muscle; Recruitment; Ultrasound; Protocol; Low back pain

Introduction estimated to be £1632 million while indirect societal costs

Low back pain (LBP) is a common complaint with 70%
to 85% life time prevalence and an average point prevalence
of 30% [1,2]. Recurrence of LBP is also high; 50% within
one year, 60% within two years and 70% within five years
[3]. Direct health care costs of LBP in the UK in 1998 were
夽 Clinical Trial Registration: CTRN12611000971932.
∗ Correspondence: Tel.: +61 297677042; fax: +61 297678448.
E-mail address: mark.halliday@sswahs.nsw.gov.au (M.H. Halliday).
were estimated to be £10 668 million [4]. It has been esti-
mated that between 17% and 37% total medical costs for
LBP are attributable to allied health [5,6]. Therefore it is
appropriate that health professionals provide treatments that
promote independence from therapist reliance.
Treatment guidelines consistently recommend exercise
in the management of chronic LBP. However, while some
guidelines do not comment on the efficacy of different
exercise approaches [7–9] others recommend specific exer-
cises [10]. The American Physical Therapy Association

http://dx.doi.org/10.1016/j.physio.2014.07.001
0031-9406/© 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Halliday MH, et al. A randomized controlled trial comparing McKenzie therapy and motor con-
trol exercises on the recruitment of trunk muscles in people with chronic low back pain: a trial protocol. Physiotherapy (2014),
http://dx.doi.org/10.1016/j.physio.2014.07.001
PHYST-772; No. of Pages 7
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(APTA) produced clinical practice guidelines that recom-
mend trunk stabilization or endurance exercises for sub-acute
and chronic LBP in patients that demonstrate impaired move-
ment coordination [11]. Directional preference (based on the
McKenzie approach) exercises utilizing repeated end range
movements in a specific direction are also recommended in
the APTA and Danish guidelines [10,11]. Efficacy for MDT
and motor control exercises for treatment of chronic LBP
has been demonstrated in systematic reviews of the literature
[12–14].
Two specific types of exercises utilized by therapists for
managing chronic LBP are Mechanical Diagnosis and Ther-
apy (MDT) commonly known as the McKenzie method
and motor control exercises. The commonality between
these treatment strategies is that they are patient-centered
approaches and emphasize patients’ self-efficacy by requir-
ing active patient participation. However, these interventions
are based upon completely different rationale for achieving
long term symptom relief.
The principle that underpins MDT is to identify the
non-specific mechanical syndromes that spinal pain can be
classified into from a thorough examination of the patient.
Each of the three syndromes: derangement, dysfunction
and posture syndrome have typical and distinctive mechan-
ical presentations. Derangement syndrome is characterized
by a varied clinical presentation and typical responses
to loading strategies, which may consist of changes in
pain location centrally or peripherally and in intensity.
These findings guide the therapist to implement the most
appropriate mechanical therapy according to the patient’s
classification [15].
Motor control exercises aim to restore optimum control
of the spine to meet the functional demands of the trunk
[16]. One of the strategies used to achieve spinal control is
the retraining of the coordination of the trunk muscles such
as transversus abdominus (TrA), obliquus internus (OI) and
obliquus externus (OE). During the implementation of motor
control exercises the therapist aims to integrate appropriate
recruitment patterns of the trunk muscles with normal func-
tion of other systems such as respiration and pelvic floor
control [16].
Despite the difference in theoretical rationale for how
motor control exercises and MDT might help people with
chronic LBP there is limited evidence that the mechanisms
are specific to the approach and different to each other. The
importance of TrA thickness is further underscored by find-
ings that showed it to be reduced in patients with LBP while
promising research showed that it can be increased after
motor control training [17–19]. However, it is unclear if these
changes are specific to motor control exercises. Studies using
ultrasound measurements of TrA thickness as a prime out-
come measurement have had varying results. One published
case series found changes in TrA muscle thickness imme-
diately after applying spinal manipulation therapy to LBP
patients which suggests that TrA activation may be improved
as pain and disability resolve with treatments that do not
Please cite this article in press as: Halliday MH, et al. A randomized controlled trial comparing McKenzie therapy and motor con-
trol exercises on the recruitment of trunk muscles in people with chronic low back pain: a trial protocol. Physiotherapy (2014),
http://dx.doi.org/10.1016/j.physio.2014.07.001
specifically aim to improve TrA thickness [20]. Conversely,
Ferreira et al. found that patients who received general exer-
cises or spinal mobilizations had a negative change in TrA
thickness, while those who received motor control exercises
had a 7% improvement in muscle thickness [19]. One study
comparing MDT and motor control exercises in a hetero-
geneous cohort of patients with chronic LBP who received
non-standard treatment found a greater increase in TrA thick-
ness in patients receiving motor control exercises compared
to McKenzie exercises [21]. The primary aim is to investigate
if MDT results in similar changes to TrA thickness as motor
control exercises in a cohort of patients with chronic LBP
and a directional preference.
A secondary aim of this study is to compare the effective-
ness of MDT to motor control exercises on short and long
term disability in patients with chronic LBP and a directional
preference. To do this we will recruit only people who demon-
strate a directional preference. While previous studies have
demonstrated centralization to be associated with a favorable
prognosis [22,23], there is no strong evidence the presence of
a directional preference identifies people who respond bet-
ter to MDT than other exercise approaches including motor
control exercises.
A tertiary aim of this trial is to compare the effectiveness
of MDT to motor control on the number of flare-ups after
discharge. This will provide a measure of the impact of these
intervention on the ability of participants to self-manage their
symptoms. A recent systematic review found moderate evi-
dence to support self-management of LBP [24]. One study
found patients with LBP treated with MDT sort less care than
those managed by a general practitioner [25]. We are inter-
ested to explore if patients were able to use the skills provided
to them to manage any exacerbation without the need to seek
care from a health professional. Self-management is a core
principle of MDT, while motor control exercise principles
do not specifically address self-management as a formal part
of the intervention. Therefore we will investigate if a greater
proportion of people having an exacerbation, who were in the
MDT group were able to manage a flare-up without seeking
additional care (Fig. 1).
Methods
Design
This study will be a randomized blinded clinical trial.
Power analysis
A sample size of 70 will provide 80% power for detec-
ting differences between groups of 7% in the recruitment of
trunk muscles assessed with ultrasonography and based on
the percentage of increase in muscle thickness as a function
of resting thickness levels. The 7% effect size is based on our
previous studies of ultrasonography for deep trunk muscles
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Potential participants
approached (n=140)

Enrollment Subjects excluded because did not

meet inclusion criteria (n=70)

Participants randomized (n=70)

Participants allocated to MDT (n=35) Participants allocated to motor control

exercises (n=35)

Follow-up
2 months

Estimated lost to follow-up (n=1) Estimated lost to follow-up (n=1)

Follow-up
12 months

Estimated lost to follow-up (n=2) Estimated lost to follow-up (n=2)

Fig. 1. Flow of participants through the trial.

and shown to be a clinical important difference between treat-
ment groups [19]. These calculations assume a worst-case
loss to follow-up of 10% in sample size calculation.
Inclusion and exclusion criteria
Seventy-adult patients will be recruited from the physio-
therapy musculoskeletal waiting list for treatment of LBP.
To be included patients must have had LBP for more than
three months. The location of the pain must be between
the twelfth rib and the buttock crease; it may refer to the
lower limbs extending to the foot and can be accompanied
by paraesthesia, anesthesia or myotomal weakness. Patients
must demonstrate a directional preference immediately fol-
lowing lumbar spine mechanical assessment. We will record
centralization by asking the patient to shade in a body chart
while standing, indicating all of the pain they are experienc-
ing immediately prior to and after the mechanical assessment.
A standardized grid numbered 1 to 6 will be then placed
across the body charts and if the location of the pain has
shifted proximally by one point when comparing the post-
assessment grid to the pre-assessment grid then centralizing
can be considered as having occurred. Inter-rater reliability
for this procedure is high (ICC = 0.96) [26]. If the pain has not
changed location but the most distal pain has reduced in inten-
sity by at least two points on an 11 point visual analog scale
immediately following mechanical assessment then a direc-
tional preference can be considered to have occurred even if
centralization was not demonstrated. Patients who have no
pain immediately prior to the mechanical assessment must
produce pain on the first movement and then abolish this
pain immediately following mechanical loading in the oppo-
site direction from the provocative movement. Patients will
be excluded if they: do not demonstrate a directional prefer-
ence, are under eighteen or over seventy years of age, cannot
follow simple verbal instructions or read trial information in
English, have an intellectual impairment, known metastatic
disease, history of spinal fracture, previous spinal surgery or

Please cite this article in press as: Halliday MH, et al. A randomized controlled trial comparing McKenzie therapy and motor con-
trol exercises on the recruitment of trunk muscles in people with chronic low back pain: a trial protocol. Physiotherapy (2014),
http://dx.doi.org/10.1016/j.physio.2014.07.001
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known osteoporosis. Pregnancy is also an exclusion criteria
and if a woman should become pregnant during the treatment
phase of the study they will be withdrawn.
Therapists, centers, ethics
Therapists who are classifying patients prior to admission
or applying MDT have obtained a certificate of Creden-
tialed Therapist from the McKenzie Institute International.
Therapists conducting motor control exercise have previous
training and are experienced in applying the protocol for
these techniques. The operator of the real time ultrasound
will receive training from an experienced operator who will
then assess the quality of the images obtained from a reli-
ability study of ten healthy individuals. The research assistant
responsible for ultrasound image analysis has conducted pre-
vious research in this area and is familiar with the protocol
[27].
This study will be conducted in the Physiotherapy
Department of Concord Hospital which is a major metropoli-
tan public hospital in Sydney, Australia. Ethical approval
was granted by the Sydney Local Health District Human
Ethics Committee. The study was registered with the Aus-
tralian New Zealand Clinical Trials Registry, trial number
CTRN12611000971932.
Interventions
Following randomization patients will be given an
appointment with a Physiotherapist to commence treatment.
The exact number of treatments will be up to the clinical judg-
ment of the treating Physiotherapist. Patients will be expected
to receive twelve sessions of treatment over an eight-week
period with no minimum amount of sessions required for an
intention to treat analysis. The specific application of tech-
niques will be delivered according to the patients’ needs based
on the principles of treatment to which the patient has been
randomized to receive.
MDT
MDT treatment will be prescribed according to the
principles outlined by McKenzie [15]. Treatment involves
mechanical therapy of both patient and therapist generated
forces utilizing sustained or repeated end range movements in
either loaded or unloaded postures according to the patients’
directional preference. The amount of force required and the
loading strategy to apply the force will be guided by symp-
tom response. The aim of treatment is to use forces such that
peripheral symptoms will be reduced, centralized, and abol-
ished; patients with central symptoms only will be reduced
and abolished with repeated end range movements or sus-
tained end range loading strategies. Once symptoms have
been stabilized any loss of range will be addressed by the
application of repeated end range movements in the direction
of movement loss. Postural education will be continuously
Please cite this article in press as: Halliday MH, et al. A randomized controlled trial comparing McKenzie therapy and motor con-
trol exercises on the recruitment of trunk muscles in people with chronic low back pain: a trial protocol. Physiotherapy (2014),
http://dx.doi.org/10.1016/j.physio.2014.07.001
reinforced including provision of a standard McKenzie lum-
bar roll when an extension preference is identified. Patients
will also be given instructions on how to self-manage future
exacerbations of their LBP including a copy of Treat Your
Own Back by Robyn McKenzie for reference [28].
Motor control exercises
The protocol for motor control exercises being used in
this study is based on principles published by Hodges and
Ferreira [16]. There are progressive phases to this proto-
col and patients can only progress when specific criteria
are met for each phase. Initially promotion of independent
contraction of the deep stabilizing muscles such as TrA and
multifidus being facilitated by pelvic floor contraction lead-
ing to their co-contraction is encouraged. Patients will also
be given instructions to control breathing with resting tidal
volumes throughout deep trunk activation maneuvers. Pro-
gression is achieved by precision of contraction in static
tasks and the implementation of deep muscle contraction into
dynamic tasks. Therapists will provide feedback on the per-
formance of exercises while less prompting is provided as
the patient masters the skill. Patients will be instructed to
practice exercises daily at home for 30-minutes. Patients will
be encouraged to attend twice a week for the first four weeks
and once per week for the second four weeks even if their
symptoms should resolve during the treatment episode.
Data collection procedures
Once the patient has accepted an invitation to participate
they will be asked to read the patient information booklet
and give written consent before being assessed for inclu-
sion. Included participants will then proceed to ultrasound
examination. Ultrasound images will be collected using a
5 cm T5 MHz linear array ultrasound transducer using sett-
ings for musculoskeletal exam, depth 6 focus 2.8. Measures
will be taken during resting and while patients perform iso-
metric contractions of the lower limbs against a 7.5% body
weight target. Body weight will be self-reported. Investiga-
tions of self-reporting of body weight have shown less than a
2 kg error which for this protocol will have a minimal effect
[29–31]. Patient will be asked to lie supine with arms crossed
on a plinth with their knees suspended in a harness from a
supporting frame. The hips are positioned at 50◦ flexion while
the knees are at 70◦ flexion with the feet supported on a bar
connected to a spring balance. The operator then positions
the real time ultrasound transducer laterally on the abdominal
wall and instructs the patient to perform low load isometric
knee flexion and knee extension movements in a random fash-
ion. When the desired amount of force is reached then a row
of lights are illuminated and the operator obtains the image.
A buzzer will sound if excessive force is used, the operator
may also give verbal feedback to help achieve the desired
maneuver. Twelve images are taken; four at rest, four during
knee flexion and four during knee extension. The ultrasound
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transducer is placed transversely across the left abdominal
wall along a line mid-way between the inferior angle of the
costal margin and the iliac crest. The medial edge of the trans-
ducer is positioned so that the medial edge of TrA is aligned
in the left-hand one-third of the ultrasound image when the
subject is relaxed. The images are then stored for analysis.
This process is described in detail elsewhere by Ferreira et al.
[17].
A research assistant then randomizes the images prior to
assessment by a blinded researcher who has had previous
experience in ultrasound analysis of trunk muscle thickness.
Customized software will be used to analyze the images.
Measurements are taken of muscle thickness in the center and
1 cm to the left and right of the muscle center from both res-
ting and contracted images. The sum of all 12-measurements
is then averaged to give a mean measurement of muscle thick-
ness. The baseline measurement is expressed as 100% muscle
thickness and is then compared to follow-up measurements
which will be expressed as a percentage change in muscle
thickness.
Secondary outcome questionnaires will be collected by
a blinded research assistant at baseline, following discharge
and at 12 months, while data regarding patients’ capacity
to self-manage exacerbations of LBP will be collected by a
blinded research assistant via email or telephone interview
every two months from discharge to 12-month follow-up.
Randomization
Following collection of baseline measurements patients
will then be randomized to treatment allocation by a
blinded investigator with sequentially numbered opaque
sealed envelopes. The randomization process was created
using computer generated numbers.
Outcome measures
The primary outcome measurement is recruitment of the
trunk muscles TrA, OI and OE expressed as percentage
changes in muscle thickness increases obtained from real
time ultrasound images. The reliability for this outcome mea-
sure was good to excellent for single measurements and
poor too good for changes in thickness from base line mea-
surements [32]. This outcome will be collected at baseline,
following treatment discharge and again at 12-month follow-
up.
Secondary outcomes will be patients’ perception of func-
tion measured by the Patient Specific Functional Scale [3 to
30 point scale) [33], global improvement measured by the
Global Perceived Effect questionnaire (rated from −5 to 5)
[34] and pain intensity using an eleven point Visual Analogue
Scale (VAS). Data will be collected at enrolment, following
treatment discharge and at 12 months. Data will also be col-
lected regarding patients who reported an exacerbation of
more than two points on an eleven point visual analog scale
over the preceding two months and whether they were able
Please cite this article in press as: Halliday MH, et al. A randomized controlled trial comparing McKenzie therapy and motor con-
trol exercises on the recruitment of trunk muscles in people with chronic low back pain: a trial protocol. Physiotherapy (2014),
http://dx.doi.org/10.1016/j.physio.2014.07.001
xxx.e5
to self-manage or required further intervention from a health
professional.
Data analysis
The software to be used for statistical analysis will be
SPSS 22.0 (IBM Corporation, NY, USA).
The primary measures of effect of treatment will be
recruitment of TrA at treatment discharge. The statistician
will be given grouped data, but data will be coded so that
the statistician will remain blinded to patients’ group alloca-
tion. Separate analyses will be conducted to determine the
effects of treatment at discharge and 12 months. Analysis
will be by intention-to-treat, with data being analyzed for
all randomized subjects for whom follow-up data are avail-
able. The emphasis in the analysis will be on estimation of
the effects of intervention rather than hypothesis testing. We
will use analysis of covariance with the baseline value of the
outcome being used as a covariate in each separate analysis.
Discussion
The main purpose of this study is to compare the effect
of MDT and motor control exercises on the thickness of the
TrA, OI and OE. The results will provide evidence on whether
changes in recruitment of trunk muscles occur only as a result
of exercises targeting motor control or if changes can also
occur as a result of a MDT exercise program aimed at reduc-
ing pain and increasing function in a cohort of people with
chronic LBP who have a directional preference. By estab-
lishing trunk muscle recruitment as our primary outcome
we will be able to investigate the mechanisms underlying
MDT and motor control exercises and further our under-
standing of the mechanisms responsible for TrA recruitment
work in people with chronic LBP who have a directional
preference.
Findings for the secondary outcomes of pain function and
global perceived effect will make an important contribution
to the knowledge regarding treatment subgroups for LBP.
Previous research suggests outcomes for patients with low
back pain can be improved by targeting different approaches,
including directional preference exercises and motor con-
trol exercises, to patients likely to respond best to a specific
approach [35]. Our results will test whether patients previ-
ously reported to be responders to McKenzie who have been
classified as presenting with a derangement syndrome do in
fact respond better to repeated end range or sustained loading
strategies including therapist generated forces and postural
education when compared to utilizing motor control exercises
for this sub-group of patients’ with mechanical LBP.
Finally the outcome pertaining to patients’ capacity to
self-manage exacerbations of their LBP following discharge
will shed some light on whether an approach such as
MDT that emphasizes prophylaxis, results in any difference
when compared to motor control exercises that does not
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emphasize self-management following discharge in a sub-
group of people who demonstrate a directional preference
who have chronic LBP.
Limitations
The authors acknowledge several limitations in this study.
As we will only include patients with directional preference
our results cannot be generalized to the entire population of
patients with LBP. As with all long-term follow-up studies the
dropout rate can be substantial although we have accounted
for that in our sample size calculations.
Acknowledgements
Steven May and Mark Werneke assisted with creation
of working definitions for the inclusion criteria related to
the mechanical assessment of patients. Gavin Robertson and
Rafael Pinto collected and analyzed the real time ultrasound
images. Yin Yee Lie collected data on patients’ ability to
self-manage. David Roberts and Tim Morcombe provided
treatment and Margareta Otero managed the randomization
process.
Ethical approval: This clinical trial received ethical approval
from the Sydney Local Health District Human Ethics Com-
mittee of Concord Repatriation General Hospital, approved
by the National Ethics Committee, Human research ethics
approval number: HREC/10/CRGH/153.
Funding: The trial received competitive funding from the
International MDT Research Foundation, funder approval
number: 2011-01346. We also received a donation of 35
copies of ‘Treat Your Own Back’ by Robyn McKenzie from
Spinal Publications New Zealand Ltd. Back Care Products
Australia supplied McKenzie lumbar rolls. The Interna-
tional MDT Research Foundation, Spinal Publications New
Zealand Ltd. and Back Care Products Australia took no part
in design of the trial or publication of this manuscript.
Conflict of interest: Helen Clare is currently a board mem-
ber of the McKenzie Institute International and head of the
teaching faculty of the McKenzie Institute International.
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Please cite this article in press as: Halliday MH, et al. A randomized controlled trial comparing McKenzie therapy and motor con-
trol exercises on the recruitment of trunk muscles in people with chronic low back pain: a trial protocol. Physiotherapy (2014),
http://dx.doi.org/10.1016/j.physio.2014.07.001