Identifying Patients With Chronic Low Back Pain

Who Respond Best to Mechanical Diagnosis and

Therapy: Secondary Analysis of a Randomized
Controlled Trial
Alessandra Narciso Garcia, Luciola da Cunha Menezes
Costa, Mark Hancock and Leonardo Oliveira Pena Costa
PHYS THER. Published online October 22, 2015
Originally published online October 22, 2015
doi: 10.2522/ptj.20150295

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 Research Report
Identifying Patients With Chronic
Low Back Pain Who Respond Best to
Mechanical Diagnosis and Therapy:
Secondary Analysis of a Randomized
Controlled Trial
Alessandra Narciso Garcia, Luciola da Cunha Menezes Costa, Mark Hancock,
Leonardo Oliveira Pena Costa
A.N. Garcia, PT, Masters and Doc-
toral Programs in Physical Ther-
Background. “Mechanical Diagnosis and Therapy” (MDT) (also known as the McKenzie apy, Universidade Cidade de São
method), like other interventions for low back pain (LBP), has been found to have small effects Paulo, Rua Cesario Galeno 475,
for people with LBP. It is possible that a group of patients respond best to MDT and have larger São Paulo, Brazil, CEP 03071-000.
effects. Identification of patients who respond best to MDT compared with other interventions Address all correspondence to Ms
would be an important finding. Garcia at: alessandrag_narciso@
yahoo.com.br.
Objective. The purpose of the study was to investigate whether baseline characteristics of L.C.M. Costa, PT, PhD, Masters
patients with chronic LBP, already classified as derangement syndrome, can identify those who and Doctoral Programs in Physical
respond better to MDT compared with Back School. Therapy, Universidade Cidade de
São Paulo.
Methods. This study was a secondary analysis of data from a previous trial comparing MDT M. Hancock, PT, PhD, Discipline of
with Back School in 148 patients with chronic LBP. Only patients classified at baseline Physiotherapy, Macquarie Univer-
assessment as being in the directional preference group (n!140) were included. The effect sity, Sydney, New South Wales,
modifiers tested were: clear centralization versus directional preference only, baseline pain Australia.
location, baseline pain intensity, and age. The primary outcome measures for this study were L.O.P. Costa, PT, PhD, Masters
pain intensity and disability at the end of treatment (1 month). Treatment effect modification and Doctoral Programs in Physical
was evaluated by assessing the group versus predictor interaction terms from linear regression Therapy, Universidade Cidade de
models. Interactions !1.0 for pain and !3 for disability were considered clinically important. São Paulo.

[Garcia AN, Costa LCM, Hancock

Results. Being older met our criteria for being a potentially important effect modifier; M, Costa LOP. Identifying patients
however, the effect occurred in the opposite direction to our hypothesis. Older people had with chronic low back pain who
1.27 points more benefit in pain reduction from MDT (compared with Back School) than respond best to mechanical diag-
younger participants after 1 month of treatment. nosis and therapy: secondary anal-
ysis of a randomized controlled
trial. Phys Ther. 2016;96:xxx–xxx.]
Limitations. The sample (n!140) was powered to detect the main effects of treatment but
not to detect the interactions of the potential treatment effect modifiers. © 2016 American Physical Therapy
Association
Conclusions. The results of the study suggest older age may be an important factor that Published Ahead of Print:
can be considered as a treatment effect modifier for patients with chronic LBP receiving MDT. October 22, 2015
As the main trial was not powered for the investigation of subgroups, the results of this Accepted: October 4, 2015
secondary analysis have to be interpreted cautiously, and replication is needed. Submitted: May 25, 2015

Post a Rapid Response to

this article at:
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Chronic Low Back Pain and Mechanical Diagnosis and Therapy
T he cause of low back pain (LBP)
cannot be definitively identified in
the majority of cases, and as such
the label “nonspecific low back pain”
(NSLBP) is widely used.1–3 Although
approximately 85% of patients with LBP
in primary care are considered to have
NSLBP,2 most clinicians believe that
NSLBP includes several different sub-
groups and is not one condition.4 – 6
Several subgrouping systems have been
developed to attempt to improve
outcomes for patients with NSLBP
rather than using a “one-size-fits-all”
approach.5,7–10
“Mechanical Diagnosis and Therapy”
(MDT), also known as the McKenzie
method, is one such subgrouping
approach.11 This method, proposed
by Robin McKenzie in 1981,11 classifies
patients into 3 syndromes or
groups— derangement, dysfunction, and
postural— based on responses to
repeated end-range movements per-
formed by the patient and assessed by
the clinician. Classification is based
largely on a patient’s response to sus-
tained postures and repeated move-
ments.11,12 Based on the classification, an
intervention approach is selected.11,12
During the assessment, it is important to
identify the directional preference
response, which is characterized by a
reduction of pain intensity, centraliza-
tion (pain referred in a peripheral loca-
tion from the spine moves to the central
lower back and is progressively abol-
ished),11 or abolished pain. The MDT
method emphasizes the use of simple
self-management strategies that require
adherence to home exercises and main-
tenance of correct postures.11,12
Although the MDT approach attempts to
improve outcomes in people with LBP
by targeting interventions to the 3 sub-
groups, systematic reviews conclude
that MDT has relatively small effect sizes
and is not superior to other approaches
for NSLBP.12,13 One possible reason for
this conclusion is that the vast majority
of patients are classified as being in the
derangement group and, therefore, most
get a similar approach to treatment.14 For
example, in our recent trial comparing
MDT with Back School, more than 85%
of participants were classified as having a
2 f Physical Therapy Volume 96 Number X
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derangement.15,16 Anecdotally, some cli-
nicians report that within this large
derangement group, some patients
respond well to MDT, whereas others do
not. If a group of patients classified as
having a derangement who respond best
to MDT can be identified, the outcomes
of using the MDT approach in these
patients could be improved, and those
patients who are unlikely to respond
well could be treated with a different
approach.
The treatment-based classification sys-
tem7–9 is an example of a hybrid sub-
grouping system for LBP that attempts to
identify a subset of patients with a direc-
tional preference for specific exercise
direction, whereas other patients are rec-
ommended for other interventions such
as manipulation or stabilization exer-
cises. A limitation of the treatment-based
classifiction system is that patients
assigned to the specific exercise (MDT
category) are tested in one plane only
and are not subjected to the multitude of
planes of motion assessed and loading
and unloading strategies characteristic of
MDT. The recommended intervention
for the specific exercise subset is similar
to that used for the derangement syn-
drome in the MDT approach. A previous
secondary analysis of a randomized con-
trolled trial (RCT) by Sheets et al17 inves-
tigated responders to MDT in a group of
patients with acute LBP. They investi-
gated 6 potential effect modifiers (base-
line pain, pain changes with position or
movement, presence of leg pain, con-
stant pain, pain worse with flexion, and
patient expectation) that could influence
the clinical response of patients treated
with MDT.17 This study showed that
these potential effect modifiers did not
predict more favorable response to
MDT.17 A limitation of this study was that
only patients in the MDT group under-
went a MDT assessment, so it was not
possible to investigate whether clinical
examination findings such as centraliza-
tion predicted response to MDT.17
Another study18 included only patients
with a changeable lumbar condition, (ie,
centralization or peripheralization) and
investigated those more likely to benefit
from the MDT method or spinal manip-
ulation. This study18 included 350
patients with chronic LBP and showed
that patients with nerve root involve-
ment and peripheralization may have
clinically important differences in
response to MDT compared with spinal
manipulation.
Some patients classified by the MDT
method clearly centralize on assessment,
whereas others have a directional prefer-
ence but do not actually demonstrate
centralization.11,19,20 To our knowledge,
no previous study has investigated
whether the presence of clear centraliza-
tion compared with directional prefer-
ence alone is an important effect modi-
fier for MDT. The purpose of this
hypothesis-setting, secondary analysis
was to investigate whether baseline char-
acteristics of patients with chronic LBP,
already classified as derangement syn-
drome, can identify those who respond
better to MDT compared with Back
School.
Method
Study Design
This study was a secondary analysis of
data from a 3-arm RCT that investigated
the effect of MDT compared with Back
School in patients with chronic LBP.15,16
To increase the validity of the current
subgroup analysis, it was performed
using the approach recommended by
Sun et al,21 which included investigating
a limited number of prespecified predic-
tor variables, prespecification of the
hypothesized direction of subgroup
effects, and use of interaction terms.
Study Population
This study was conducted in the outpa-
tient physical therapy clinic of the Uni-
versidade Cidade de São Paulo, São
Paulo, Brazil, between July 2010 and July
2012. To be eligible, patients seeking
care had to have NSLBP with a duration
of at least 12 weeks22 and be aged
between 18 and 80 years. Patients with
any contraindication to physical exer-
cise, based on the recommendations of
the guidelines of the American College of
Sports Medicine23; serious spinal pathol-
ogy (eg, tumors, fractures, inflammatory
diseases); previous spinal surgery; nerve
root compromise; cardiorespiratory ill-
nesses; or pregnancy were excluded.
Month 2016

Randomization
Participants were allocated to 1 of 2
intervention groups—Back School (a
group-based treatment approach) or
MDT (an individually based treatment
approach)— by a simple randomization
sequence computer generated using
Microsoft Excel (Microsoft Corp, Red-
mond, Washington). The randomization
sequence was conducted by one of the
investigators of the study who was not
directly involved with the assessments
and treatment of patients. The allocation
was concealed by using consecutively
numbered, sealed, opaque envelopes.
Interventions
Participants from both groups received 4
one-hour sessions over 1 month, once a
week. The number of sessions was cho-
sen following the recommendations
from the original Back School manual
method.24 Therefore, the same number
of sessions was used for the MDT group.
Patients treated with Back School
method received advice about anatomy
and spinal biomechanics, epidemiology,
physiopathology of the most frequent
back disorders, posture, ergonomics,
and common treatment modalities and
practiced exercises (breathing, stretch-
ing legs, trunk strengthening, and pelvic
mobility) for the maintenance of a
“healthy back.”16,24 Participants in the
MDT group practiced specific exercises
according to their mechanical diagnosis
and were instructed to follow the recom-
mendations of the book titled Treat Your
Own Back.25 The care provider, who
treated the patients in both groups, com-
pleted MDT training part A certified by
the McKenzie Institute of Brazil, has 1
year of experience, and received exten-
sive Back School training during her
undergraduate training program.
Outcome Measures
The outcome measures for this study
were (1) pain intensity, as measured with
the pain numerical rating scale (NRS),26
and (2) disability, as measured with the
Roland-Morris Disability Questionnaire
(RMDQ),27,28 at 1 month after random-
ization. These were the same outcome
measures as in the primary study.15,16
The NRS has good levels of reliability
(intraclass correlation coefficient [ICC
(2,1)]!.85; 95% confidence interval
Month 2016
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Chronic Low Back Pain and Mechanical Diagnosis and Therapy
[CI]!.77, .90), responsiveness (standard-
ized effect size!1.16), and construct
validity.26 The RMDQ has good levels
of internal consistency (Cronbach
alpha!.90, reliability [ICC (2,1)!.94;
95% CI!.91, .96], responsiveness [stan-
dardized effect size!0.70], and con-
struct validity).26
Variables of Interest
Four potential effect modifiers for treat-
ment were selected after consideration
of the theoretical rationale and consulta-
tion with an educator in the MDT
approach.29 The variables selected were:
(1) clear centralization versus directional
preference only, (2) baseline pain loca-
tion, (3) baseline pain intensity, and (4)
age.
Clear centralization versus di-
rectional preference only. We
hypothesized that patients with clear
centralization would respond better to
MDT than to Back School. Centralization
is considered a more “positive” response
to MDT assessment than directional pre-
fence alone. Patients were considered to
have centralization of symptoms if their
pain referred in a peripheral location
moved to the central lower back and was
progressively abolished, whereas if their
pain just decreased but did not move to
the central lower back, they were con-
sidered to have directional preference
without centralization. Symptom dia-
gram and patient report of the location
of symptoms were used to determine
whether centralization had occurred.
Baseline pain location. We hypothe-
sized that patients with pain located
below the knee would respond better to
MDT than to Back School. Some prelim-
inary studies suggest people with leg
pain may respond well to the MDT
approach,30 –32 and there is little ratio-
nale why Back School would specifically
help these people. The MDT approach
focuses on achieving centralization of
pain from the periphery into the low
back. Whether patients had pain extend-
ing below the knee was determined
using a body chart and patient self-report
during the baseline assessment.
Baseline pain intensity. We hypothe-
sized that patients with higher baseline
Volume 96 Number X
pain intensity (using median split) would
respond better to MDT than to Back
School. This hypothesis was based on
clinical experience rather than any
strong existing evidence.
Age. We hypothesized that patients
with younger age (using median split)
would respond better to MDT than to
Back School. The rationale was that they
might be able to move further into the
range of motion and, therefore, better
achieve an end-of-range position. Move-
ment to end of range is proposed to be
important to optimize response to MDT
in people classified as having a derange-
ment syndrome.11,20 This information
was determined during baseline
assessment.
Data Analysis
We investigated baseline patient charac-
teristics associated with greater effect of
MDT versus Back School separately for
outcomes of pain and disability. Each of
the 4 predictor variables was investi-
gated in separate univariate models.
The continuous effect modifiers of pain
intensity and age were dichotomized
using the median split method, as other
methods where optimal thresholds are
used have been shown to be substan-
tially biased and are recommended
against.33 Thresholds dichotomizing pain
intensity and age have been used pre-
viosly18; however, these thresholds were
not specifically intended for our pur-
pose, and by using a median split, we
enhanced our statistical power by creat-
ing equal-sized groups positive and neg-
ative for the predictor. Each model
included terms for group, predictor, and
the interaction term, group " predictor.
The interaction term was used to quan-
tify size of the effect modification.
It has been estimated that the detection
of a statistically significant subgroup
interaction effect in an RCT requires a
sample size approximately 4 times that
required to detect a main effect of the
same size.34 Previous authors have sug-
gested secondary analysis of RCTs as an
approach to develop hypotheses for
potentially important effect modifiers
that can then be tested in suitably large
trials.35,36 As the current hypothesis-
Physical Therapy f 3
Chronic Low Back Pain and Mechanical Diagnosis and Therapy
Figure.
Flow of patients within the study. MDT!Mechanical Diagnosis and Therapy.
setting study was underpowered, we
focused on the estimated effect size
rather than statistical significance. If the
interaction was greater than 1.0 points
on the NRS or 3 points on the RMDQ, we
proceeded to investigate the potential
clinical importance by assessing the
effect of intervention (MDT compared
with Back School) separately for those
positive for the subgroup and those neg-
ative for the subgroup. This was done by
calculating the marginal means for the
subgroups.35 These thresholds are some-
what arbitrary, as it is difficult to deter-
mine exactly what a clinically important
interaction effect is. Previous work
suggests this is influenced by the main
treatment effect18,37 as well as the poten-
tial harms and benefits of the
interventions.38
Ethics
This secondary analysis was based on
existing data collected for an RCT15
approved by the Ethics Committee in
Research of the Universidade Cidade de
São Paulo (number 134699394). The
RCT also was prospectively registered
with the Australian and New Zealand
Clinical Trials Registry
(ACTRN12610000435088). The research
protocol was published elsewhere.16
Role of the Funding Source
This study was funded by Fundação de
Amparo à Pesquisa do Estado de São
Paulo (FAPESP), Coordenação de Aper-
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feiçoamento de Pessoal de Nı́vel Supe-
rior (CAPES), and International Mechan-
ical Diagnosis and Therapy Research
Foundation (IMDTRF).
Results
Between July 2010 and January 2012, a
total of 182 patients who were seeking
care for LBP in the physical therapy
clinic of the Universidade Cidade de São
Paulo were screened for potential entry
into the study. Of these patients, 148
were considered eligible and random-
ized (74 to each treatment group). The
reasons for ineligibility were cardiorespi-
ratory illnesses (n!8), age over 80 years
(n!5), acute LBP (n!4), nerve root com-
promise (n!4), neck pain instead LBP
(n!3), grade II spondylolisthesis (n!2),
vertebral fracture (n!1), rib fracture
(n!1), deep vein thrombosis (n!1),
abdominal tumor (n!1), advanced osteo-
porosis (n!1), metabolic myopathy
(n!1), colitis (n!1), and urinary tract
infection (n!1). All patients received the
treatments as allocated. A total of 148
patients were included in the main RCT.
However, 8 patients were not classified
as having directional preference and
were excluded from the analysis of this
study. Therefore, 140 patients were
included in this secondary analysis
(Figure).
After dichotomizing, the average age of
older patients was 64.81 years
(SD!5.95) (MDT group: mean
age!65.16 years, SD!6.23; Back School
group: mean age!64.54 years,
SD!7.78), and the average age of
younger people was 43.47 years
(SD!9.60) (MDT group: mean
age!44.28 years, SD!9.50; Back School
group: mean age!42.45 years,
SD!9.78). The average score for higher
pain intensity was 8.07 points (SD!1.0)
(MDT group: mean!8.07 points,
SD!1.0; Back School group: mean!8.07
points, SD!1.16), and the average score
for low level of pain intensity 4.35 points
(SD!1.69) (MDT group: mean!4.40
points, SD!1.52; Back School group:
mean!4.3 points, SD!1.87). The base-
line characteristics of both groups,
including effect modifiers investigated in
this study, were similar. Nearly 75% of
the patients were women, and the aver-
age symptom duration was approxi-
mately 2 years. Patients generally had
moderate levels of pain and disability
(Tab. 1).
The results of the linear regression anal-
yses for the outcomes of pain and disabil-
ity are shown in Tables 2 and 3, respec-
tively. As expected in this hypothesis-
setting study, none of the interaction
terms for any findings for these out-
comes were statistically significant. The
interaction term (#1.27) for age
exceeded our prespecified threshold of
$1 for the outcome of pain (Tab. 2).
However, the direction of effect was
opposite to our hypothesis. Older people
appeared to benefit more from MDT
compared with Back School. For the out-
come of disability, the interaction term
for age was #2.39 and, therefore, did not
meet out threshold for clinical impor-
tance of $3 (Tab. 3). Interaction terms
for the other 3 effect modifiers (clear
centralization, pain below knee, and
high pain intensity) were below our
thresholds for potential clinical
importance.
Table 4 shows the effect of MDT com-
pared with Back School separately for
patients younger and older than 54 years.
Older people improved 1.42 points for
pain intensity and 3.51 points for disabil-
ity, more than younger people, from
MDT compared with Back School.
Month 2016
 Chronic Low Back Pain and Mechanical Diagnosis and Therapy

Table 1. $1 for the outcome of pain, suggesting

Baseline Characteristics (n!140)a older people may benefit more from
MDT compared with Back School. How-
Back School
Variables Group MDT Group
ever, the direction of effect was opposite
to our initial hypothesis, and as expected
Categorical variables
the effect was not statistically significant,
Effect modifiers so caution is required when interpreting
Clear centralization 40 (57.1) 35 (50.0) this finding. The presence of clear cen-
tralization, pain located below the knee
Pain below the knee 23 (32.9) 25 (35.7)
and, pain intensity were not found to be
High pain intensity ($7 points) 25 (35.7) 30 (42.9) effect modifiers for response to MDT
Marital status compared with Back School.
Single 11 (15.7) 17 (24.3)

Married 42 (60) 38 (54.3)

Strengths and Weaknesses
of the Study
Divorced 5 (7.1) 5 (7.1)
A strength of our study was that the data
Widowed 11 (15.7) 9 (13) were derived from a high-quality RCT.15
Other 1 (1.4) 1 (1.4) The trial collected important potential
Education status
treatment effect modifiers from all
patients that are likely to influence the
Elementary degree 27 (38.6) 26 (37.1)
response to MDT. Only 4 potential effect
High school 30 (43) 32 (46) modifiers were selected a priori after
University 13 (18.6) 11 (16) consideration of the theoretical rationale
and consultation with a specialist muscu-
Illiterate 0 1 (1.4)
loskeletal physical therapist who is a cre-
Use of medication 51 (74) 18 (26) dentialed MDT therapist.29 This therapist
Physically active 26 (37.1) 19 (27.1) has been an educator of the McKenzie
Smoker 5 (7.5) 8 (12) Institute since 1986 and has been the
International Director of Education for
Recent low back pain episode 45 (64.3) 46 (66)
the McKenzie Institute International
Continuous variables since 1999.29 She is currently the only
Sex (female) 50 (71.4) 56 (80) teaching member of the McKenzie Insti-
Age (y) 54.76 (13.50) 53.53 (13.26)
tute in Australia and teaches MDT
courses internationally.29 We avoided
Duration of symptoms (mo)* 67.60 (99.58) 42.20 (82.20)
selecting a higher number of effect mod-
Weight (kg) 73.81 (13.93) 70.19 (12.72) ifiers in order to minimize the chance of
Height (m) 1.64 (0.09) 1.61 (0.90) spurious findings.39 The methodological
approach of this study, based on recom-
Pain intensity (0–10) 6.67 (2.34) 6.76 (2.14)
mendations in the literature, can act as a
Disability (0–24) 11.29 (5.91) 11.26 (4.95) model for subgroup studies within RCTs
Quality of life (0–100) in the rehabilitation field. Another con-
Physical domain 51.68 (17.49) 52 (14.58) tribution of this study is the interpreta-
tion of the actual findings leading to
Psychological domain 59.46 (15.90) 62.91 (15.95)
hypotheses that can be tested in future
Social domain 62.50 (20.15) 64.16 (17.70) trials. The main limitation of this study
Environmental domain 54.06 (16.41) 55.27 (13.27) was the lack of statistical power for an
Trunk flexion range of motion (°) 78.45 (22.89) 80.10 (17.21)
ideal subgroup analysis. Our sample
(n!140) was powered to detect the
a
Categorical variables are expressed as number (%); continuous variables are expressed as mean (SD). main effects of treatment but not to
MDT!Mechanical Diagnosis and Therapy. *Duration of symptoms is expressed as median (interquartile
range). detect the interactions of the potential
treatment effect modifiers.40 For this rea-
son, this study was set up as a
hypothesis-generating study, and the
Discussion tion, pain intensity, and age) of patients
focus was on estimated effect size rather
Statement of Principal Findings with chronic LBP can identify those who
than statistical significance.
The purpose of this hypothesis-setting, respond better to MDT compared with
secondary analysis was to investigate Back School. Based on our results, the
interaction term of #1.27 for age We used a simple analysis that did not
whether 4 baseline characteristics (pres-
exceeded our prespecified threshold of contain any covariates. This approach
ence of clear centralization, pain loca-

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Chronic Low Back Pain and Mechanical Diagnosis and Therapy

Table 2. between the 2 interventions in younger

Results of Linear Regression Models in Pain Intensitya people (1.12; 95% CI!#1.11, 3.35). We
only investigated treatment effects (MDT
Beta
Variables Coefficient P 95% CI
versus Back School) within subgroups
where the interaction met our criteria for
Clear centralization
clinical importance to reduce the chance
Treatment 0.84 .28 #0.70, 2.40 of spurious findings.40
Clear centralizer 0.33 .66 #1.18, 1.85

Interaction: treatment " clear centralizer #0.33 .75 #2.45, 1.78

Constant
Pain below the knee
Treatment
Pain below the knee
Interaction: treatment " pain below the knee
Constant
High pain intensity
Treatment
High pain intensity
Interaction: treatment " high pain intensity
Constant
Age younger than 54 y
Treatment
Age younger than 54 y
Interaction: treatment " age younger than 54 y
Constant
a
Interaction terms provide the critical information for assessing whether effect modification exists.
Positive interactions mean that the direction of the effect was in favor of the study%s hypothesis.
Negative interactions mean the effect was in the opposite direction to that hypothesized.
CI!confidence interval.
was chosen to minimize the risk of over-
fitting the model and because the result-
ing interaction effect size is exactly equal
to the difference between treatment
effect in one subgroup (eg, older age)
and treatment effect in the other sub-
group (eg, younger age),18,35–37 which
makes the finding easier to interpret.
However, to test potential confounding,
we conducted a post hoc analysis for the
predictor of age in which we added sex
and duration of symptoms to the models.
For both pain and disability models, this
analysis resulted in the interaction effect
becoming marginally greater (#2.85;
95% CI!#5.90, 0.20 for pain and #1.35;
95% CI!#3.45, 0.74 for disability) than
in the simple models.
Meaning of the Study and
Comparison With Other Studies
Our study showed that patients who
were older than 54 years and received
We initially hypothesized that MDT
would be more effective in younger
1.89 .00 0.75, 3.04
patients, as they might be able to move
further into range of lumbar spine
0.66 .31 #0.62, 1.94 motion and, therefore, gain more bene-
fit. Our findings suggesting that MDT
0.63 .44 #0.98, 2.24
may be more effective in older people
#0.10 .92 #2.33, 2.12 raise the question of the potential mech-
1.89 .00 0.99, 2.79 anism underlying this hypothesis. One
possibility is that older people were
more adherent to the approach that is
0.28 .65 #0.97, 1.54
almost entirely a self-management inter-
2.05 .00 0.59, 3.51 vention. Another possibility is that pain
0.50 .62 #1.51, 2.51 has a somewhat different physiological
1.36 .00 0.49, 2.23
basis in older people and responds better
to MDT. However, we do not have data
to support these theories. These results
1.42 .05 #0.04, 2.89 may simply be spurious findings due to
#0.57 .43 #2.04, 0.89 lack of statistical power. We recommend
the investigation of age as a potential
#1.27 .22 #3.33, 0.79
effect modifier in future rehabilitation tri-
2.35 .00 1.36, 3.34 als, including but not limited to those
investigating MDT for spinal pain.
There are 2 previous studies that tested
possible treatment effect modifiers for
MDT.17,18 The first study recruited
patients with acute LBP who received
MDT compared with Back School expe-
either MDT or usual care.17 This study
rienced an additional reduction in pain
tested baseline pain, pain changes with
of 1.27 points compared with young
position or movement, and presence of
people. It is important to note that the
leg pain as potential effect modifiers. The
interaction does not define the main
authors found that these potential effect
effect of the interventions, but rather the
modifiers did not predict a more favor-
difference in effect of treatment for older
able response to MDT. The second
patients compared with young patients.6
study18 compared MDT with spinal
The treatment effect within a subgroup
manipulation in 350 patients with
is a combination of the interaction and
chronic back pain. The authors included
the main treatment effect.37 The findings
6 predictor variables: centralization, age
presented in Table 4 show that MDT was
below 40 years, duration of symptoms
statistically more effective for pain (1.42;
more than 1 year, leg pain, pain below
95% CI!0.02, 2.83) compared with Back
the knee, signs of nerve root involve-
School in the subgroup of older people,
ment. and pain response.18 They con-
whereas there was no difference
cluded that it was not possible to find
between the 2 interventions in younger
any statistically significant predictive fac-
people (0.15; 95% CI!#1.38, 1.68). Sim-
tor that identified a better response to
ilarly, for disability, MDT was statistically
either MDT or spinal manipulation. The
more effective for disability in the sub-
difference in our findings regarding age
group of older people (3.51; 95%
as an effect modifier may be due to a
CI!1.42, 5.60) compared with Back
different control intervention or popula-
School, whereas there was no difference

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 Chronic Low Back Pain and Mechanical Diagnosis and Therapy

Table 3. future investigation that we would

Results of Linear Regression Models in Disabilitya recommend.
Beta
Variables Coefficient P 95% CI In conclusion, we conducted a second-
ary analysis of an RCT to determine
Clear centralization
whether potential treatment effect mod-
Treatment 2.06 .73 #0.19, 4.31 ifiers for MDT could be identified in
Clear centralizer 0.66 .55 1.54, 2.86 patients with chronic LBP and with a
Interaction: treatment " clear centralizer 0.88 .57 #2.19, 3.95
directional preference. We found that
patients who were older appeared to
Constant 2.31 .07 0.64, 4.0
respond better to MDT compared with
Pain below the knee Back School (the direction of effect was
Treatment 2.76 .004 0.89, 4.64 opposite to our initial hypothesis). Clear
centralization, pain below the knee, and
Pain below the knee 1.62 .18 #0.74, 4.0
high pain intensity do not appear to be
Interaction: treatment " pain below the knee #1.09 .51 #4.35, 2.16 useful effect modifiers. The results of this
Constant 2.19 .001 0.88, 3.50 hypothesis-setting, secondary analysis
High pain intensity have to be interpreted cautiously
because of the small sample size. These
Treatment 1.68 .09 #2.64, 3.64
findings, particularly of the potential
High pain intensity 0.28 .80 #1.99, 2.55 effect modification effect of age, need
Interaction: treatment " high pain intensity 1.74 .27 #1.39, 4.87 testing in larger trials and with different
Constant 2.60 .00 1.24, 3.94
comparisons.

Age younger than 54 y

Treatment 3.50 .00 1.35, 5.66
Age younger than 54 y 2.70 .01 0.54, 4.85
Interaction: treatment " age younger than 54 y #2.39 .12 #5.42, 0.64
Constant 1.46 .49 0.00, 2.91
a
Interaction terms provide the critical information for assessing whether effect modification exists.
Positive interactions mean that the direction of the effect was in favor of the study%s hypothesis.
Negative interactions mean the effect was in the opposite direction to that hypothesized (ie, we found
an effect modification, but it was opposite to our hypothesis). CI!confidence interval.
tion or may simply be a spurious finding. to identify powerful effect modifiers for
Subgroup effects within trials are always MDT. This difficulty may be due to the
specific to the control group.37 We rec- fact that the MDT approach already uses
ommend that our results be interpreted a stratified approach to care. Interest-
carefully and that adequately powered ingly, the existing studies have not inves-
replication studies are needed. These tigated psychosocial characteristics as
studies together suggest that it is difficult effect modifiers, and this is an area of
All authors provided concept/idea/research
design. Ms Garcia, Dr Hancock, and Dr Leon-
ardo Costa provided writing and data anal-
ysis. Ms Garcia and Dr Luciola Costa pro-
vided data collection, project management,
and consultation (including review of man-
uscript before submission). Dr Hancock and
Dr Leonardo Costa provided fund procure-
ment. Dr Leonardo Costa provided partici-
pants and institutional liaisons.
This study was funded by Fundação de
Amparo à Pesquisa do Estado de São Paulo
(FAPESP), Coordenação de Aperfeiçoamento
de Pessoal de Nı́vel Superior (CAPES), and
International Mechanical Diagnosis and
Therapy Research Foundation (IMDTRF).
DOI: 10.2522/ptj.20150295

Table 4.
Effects of MDT Compared With Back School for Subgroups Based on Agea

Back Treatment Effect (MDT Compared

MDT School With Back School)
Variables X (SD) X (SD) Mean Difference (95% CI)

Changes in pain (NRS)

Age older than 54 y 3.77 (3.06) 2.35 (2.75) 1.42 (0.02, 2.83)

Age younger than 54 y 1.92 (3.56) 1.77 (2.65) 0.15 (–1.38, 1.68)
Changes in disability (RMDQ)

Age older than 54 y 4.97 (4.78) 1.46 (3.85) 3.51 (1.42, 5.60)
Age younger than 54 y 5.28 (4.94) 4.16 (4.24) 1.12 (–1.11, 3.35)
a
MDT!Mechanical Diagnosis and Therapy, NRS!numerical rating scale, RMDQ!Roland-Morris Disability Questionnaire, CI!confidence interval.

Month 2016 Volume 96 Number X Physical Therapy f 7

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Chronic Low Back Pain and Mechanical Diagnosis and Therapy
References
1 Tulder MV. Chapter 1. European guide-
lines. Eur Spine J. 2006;15:134 –135.
2 Waddell G. The Back Pain Revolution.
2nd ed. Edinburgh, United Kingdom:
Churchill Livingstone; 2004.
3 Menezes Costa Lda C, Maher CG, Hancock
MJ, et al. The prognosis of acute and per-
sistent low-back pain: a meta-analysis.
CMAJ. 2012;184:E613–E624.
4 Kent P, Hancock M, Petersen DH, Mjosund
HL. Clinimetrics corner: choosing appro-
priate study designs for particular ques-
tions about treatment subgroups. J Man
Manip Ther. 2011;18:147–152.
5 Kent P, Keating JL. Classification in non-
specific low back pain: what methods do
primary care clinicians currently use?
Spine (Phila Pa 1976). 2005;30:1433–
1440.
6 Kent P, Keating JL, Leboeuf-Yde C.
Research methods for subgrouping low
back pain. BMC Med Res Methodol. 2010;
10:62.
7 Henry SM, Fritz JM, Trombley AR, Bunn JY.
Reliability of a treatment-based classifica-
tion system for subgrouping people with
low back pain. J Orthop Sports Phys Ther.
2012;42:797– 805.
8 Stanton TR, Hancock MJ, Appeldoorn AT,
et al. What characterizes people who have
an unclear classification using a treatment-
based classification algorithm for low back
pain? A cross-sectional study. Phys Ther.
2013;93:345–355.
9 Hebert JJ, Koppenhaver SL, Walker BF.
Subgrouping patients with low back pain:
a treatment-based approach to classifica-
tion. Sports Health. 2011;3:534 –542.
10 Beneciuk JM, Robinson ME, George SZ.
Subgrouping for patients with low back
pain: a multidimensional approach incor-
porating cluster analysis and the STarT
Back Screening Tool. J Pain. 2015;16:19 –
30.
11 McKenzie R, May S. The Lumbar Spine:
Mechanical Diagnosis & Therapy. Vol 1.
2nd ed. Waikanae, New Zealand: Spinal
Publications Ltd; 2003.
12 Clare HA, Adams R, Maher CG. A system-
atic review of efficacy of McKenzie ther-
apy for spinal pain. Aust J Physiother.
2004;50:209 –216.
13 Machado LA, de Souza MS, Ferreira PH,
Ferreira ML. The McKenzie method for
low back pain: a systematic review of the
literature with a meta-analysis approach.
Spine (Phila Pa 1976). 2006;31:254 –262.
14 Hefford C. McKenzie classification of
mechanical spinal pain: profile of syn-
dromes and directions of preference. Man
Ther. 2008;13:75– 81.
15 Garcia AN, Costa Lda C, da Silva TM, et al.
Effectiveness of Back School versus
McKenzie exercises in patients with
chronic nonspecific low back pain: a ran-
domized controlled trial. Phys Ther. 2013;
93:729 –747.
8 f Physical Therapy Volume 96 Number X
Downloaded from http://ptjournal.apta.org/ at Fisher Library on January 26, 2016
16 Garcia AN, Gondo FL, Costa RA, et al.
Effectiveness of the Back School and
McKenzie techniques in patients with
chronic non-specific low back pain: a pro-
tocol of a randomised controlled trial.
BMC Musculoskelet Disord. 2011;12:179.
17 Sheets C, Machado LA, Hancock M, Maher
C. Can we predict response to the
McKenzie method in patients with acute
low back pain? A secondary analysis of a
randomized controlled trial. Eur Spine J.
2011;21:1250 –1256.
18 Petersen T, Christensen R, Juhl C. Predict-
ing a clinically important outcome in
patients with low back pain following
McKenzie therapy or spinal manipulation:
a stratified analysis in a randomized con-
trolled trial. BMC Musculoskelet Disord.
2015;16:74 – 80.
19 Machado L, van Tulder MW, Lin CW, et al.
The McKenzie method for chronic non-
specific low back pain: study protocol.
Cochrane Database Syst Rev. 2012;3:
CD009712.
20 McKenzie R, May S. The Lumbar Spine:
Mechanical Diagnosis & Therapy. Vol 2.
2nd ed. Waikanae, New Zealand: Spinal
Publications Ltd; 2003.
21 Sun X, Briel M, Busse JW, et al. Subgroup
Analysis of Trials Is Rarely Easy (SATIRE): a
study protocol for a systematic review to
characterize the analysis, reporting, and
claim of subgroup effects in randomized
trials. Trials. 2009;10:101–111.
22 Airaksinen O, Brox JI, Cedraschi C, et al.
Chapter 4. European guidelines for the
management of chronic nonspecific low
back pain. Eur Spine J. 2006;15:192–300.
23 Kenney LW, Humphrey RH, Mahler DA.
ACSM’s Guidelines for Exercise Testing
and Prescription. Baltimore, MD: Wil-
liams & Wilkins; 1995.
24 Heymans MW, van Tulder MW, Esmail R,
et al. Back schools for nonspecific low
back pain: a systematic review within the
framework of the Cochrane Collaboration
Back Review Group. Spine (Phila Pa
1976). 2005;30:2153–2163.
25 McKenzie R. Trate Você Mesmo a Sua
Coluna. Waikanae, New Zealand: Spinal
Publication Ltd; 1998.
26 Costa LO, Maher CG, Latimer J, et al. Clini-
metric testing of three self-report outcome
measures for low back pain patients in
Brazil: which one is the best? Spine (Phila
Pa 1976). 2008;33:2459 –2463.
27 Costa LO, Maher CG, Latimer J, et al. Psy-
chometric characteristics of the Brazilian-
Portuguese versions of the Functional Rat-
ing Index and the Roland-Morris Disability
Questionnaire. Spine (Phila Pa 1976).
2007;32:1902–1907.
28 Nusbaum L, Natour J, Ferraz MB, Golden-
berg J. Translation, adaptation and valida-
tion of the Roland-Morris questionnaire:
Brazil Roland-Morris. Braz J Med Biol Res.
2001;34:203–210.
29 Dr Helen Clare. McKenzie Institute Austra-
lia. Available at: www.mckenziemdt.org.
au/event/host/dr-helen-clare/. Accessed
September 9, 2015.
30 Paatelma M, Kilpikoski S, Simonen R, et al.
Orthopaedic manual therapy, McKenzie
method or advice only for low back pain
in working adults: a randomized con-
trolled trial with one year follow-up.
J Rehabil Med. 2008;40:858 – 863.
31 Albert HB, Hauge E, Manniche C. Central-
ization in patients with sciatica: are pain
responses to repeated movement and
positioning associated with outcome or
types of disc lesions? Eur Spine J. 2012;
21:630 – 636.
32 Long A, May S, Fung T. The comparative
prognostic value of directional preference
and centralization: a useful tool for front-
line clinicians? J Man Manip Ther. 2008;
16:248 –254.
33 Altman DG, Royston P. The cost of
dichotomising continuous variables. BMJ.
2006;332:1080.
34 Brookes ST, Whitely E, Egger M, et al. Sub-
group analyses in randomized trials: risks
of subgroup-specific analyses; power and
sample size for the interaction test. J Clin
Epidemiol. 2004;57:229 –236.
35 Hancock M, Herbert RD, Maher CG. A
guide to interpretation of studies investi-
gating subgroups of responders to physi-
cal therapy interventions. Phys Ther.
2009;89:698 –704.
36 Kamper SJ, Maher CG, Hancock MJ, et al.
Treatment-based subgroups of low back
pain: a guide to appraisal of research stud-
ies and a summary of current evidence.
Best Pract Res Clin Rheumatol. 2010;24:
181–191.
37 Hancock MJ, Kjaer P, Korsholm L, Kent P.
Interpretation of subgroup effects in pub-
lished trials. Phys Ther. 2013;93:852– 859.
38 Ferreira ML, Herbert RD, Ferreira PH, et al.
A critical review of methods used to deter-
mine the smallest worthwhile effect of
interventions for low back pain. J Clin Epi-
demiol. 2012;65:253–261.
39 Sun X, Briel M, Walter SD, Guyatt GH. Is a
subgroup effect believable? Updating cri-
teria to evaluate the credibility of sub-
group analyses. BMJ. 2010;340:c117.
40 Brookes ST, Whitley E, Peters TJ, et al.
Subgroup analyses in randomised con-
trolled trials: quantifying the risks of false-
positives and false-negatives. Health Tech-
nol Assess. 2001;5:1–56.
Month 2016
 Identifying Patients With Chronic Low Back Pain
Who Respond Best to Mechanical Diagnosis and
Therapy: Secondary Analysis of a Randomized
Controlled Trial
Alessandra Narciso Garcia, Luciola da Cunha Menezes
Costa, Mark Hancock and Leonardo Oliveira Pena Costa
PHYS THER. Published online October 22, 2015
Originally published online October 22, 2015
doi: 10.2522/ptj.20150295

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