Protocol

Movement System Impairment–Based

Classification Versus General Exercise
for Chronic Low Back Pain: Protocol of
a Randomized Controlled Trial
D.C. Azevedo, PT, MSc, Masters
Daniel Camara Azevedo, Linda R. Van Dillen, Henrique de Oliveira Santos, and Doctoral Programs in Physical
Daniel Ribeiro Oliveira, Paulo Henrique Ferreira, Leonardo Oliveira Pena Costa Therapy, Universidade Cidade de
São Paulo, and Physical Therapy
Department, Pontifı́cia Universi-
Background. Low back pain (LBP) is an important health problem in all devel- dade Católica de Minas Gerais,
oped countries and is associated with high levels of disability. Evidence-based clinical Dom José Gaspar 500, Belo Hori-
zonte, MG, Brazil 30535-901.
practice guidelines usually recommend different physical therapy interventions to
Address all correspondence to Mr
manage this condition. However, those interventions usually result in small to mod- Azevedo at: danielazevedo@
erate clinical effects. Recent studies suggest that interventions based on subgroup pucminas.br.
classifications may improve the effect sizes compared with rehabilitation programs
L.R. Van Dillen, PT, PhD, Program
where the same interventions were applied to all patients. in Physical Therapy, Washington
University School of Medicine, St
Objective. This study will investigate the efficacy of treatment based on a Move- Louis, Missouri.
ment System Impairment (MSI)– based classification model for patients with chronic H.O. Santos, PT, Physical Therapy
LBP compared with general exercise. The primary outcomes will be pain intensity Department, Pontifı́cia Universi-
and disability at 2 months after randomization. dade Católica de Minas Gerais.

D.R. Oliveira, PT, Physical Therapy

Design. The study is a 2-arm, prospectively registered, randomized controlled trial Department, Pontifı́cia Universi-
with a blinded assessor. dade Católica de Minas Gerais.

P.H. Ferreira, PT, PhD, Faculty of

Setting. The study setting will be a university physical therapy clinic in Brazil. Health Sciences, University of Syd-
ney, Sydney, Australia.
Participants. A total of 148 individuals with chronic LBP will participate in the L.O.P. Costa, PT, PhD, Masters
study. and Doctoral Programs in Physical
Therapy, Universidade Cidade de
Intervention. Included individuals will be randomly allocated to participate in an São Paulo, and Musculoskeletal
8-week treatment program based on the MSI-based classification or a general exercise Division, The George Institute for
program of stretching and strengthening exercises. Global Health, Sydney, Australia.

[Azevedo DC, Van Dillen LR, San-

Measurements. Pain intensity, disability, and global impression of recovery will tos HO, et al. Movement System
be assessed by a blinded assessor at baseline and at follow-up appointments after Impairment– based classification
versus general exercise for chronic
treatment (2 months) and 4 and 6 months after randomization. low back pain: protocol of a ran-
domized controlled trial. Phys
Limitations. Therapists will not be blinded. Ther. 2015;95:1287–1294.]

© 2015 American Physical Therapy

Conclusions. The results of this study may contribute to a better understanding Association
of the efficacy of treatments based on classification of participants with chronic LBP
Published Ahead of Print:
into subgroups.
April 30, 2015
Accepted: April 19, 2015
Submitted: December 11, 2014

Post a Rapid Response to

this article at:
ptjournal.apta.org

September 2015 Volume 95 Number 9 Physical Therapy f 1287

Movement System and General Exercise in Chronic Low Back Pain
C
hronic low back pain (CLBP)
has reached epidemic propor-
tions.1,2 The 1-year prevalence
of an episode of low back pain (LBP)
is 38% in the general population.2
Low back pain has been recorded in
17.1% of all patients diagnosed with
any musculoskeletal condition.3 Esti-
mates of recurrence at 1 year range
from 24% to 80%.4 Low back pain is
the world’s major cause of disabil-
ity.5 In Brazil, this condition is the
second most prevalent health prob-
lem.6 In the United States, patients
with LBP had total medical care costs
that were $1,320 greater than those
without LBP ($3,498 versus $2,178,
respectively).7 The total costs related
to LBP in the United States is esti-
mated at $84.1 billion to $624.8
billion.7
Low back pain is usually classified as
acute (when the duration of the epi-
sode is less than 6 weeks), subacute
(when the duration of the episode
ranges from 6 to 12 weeks), and
chronic (when the duration of the
episode is longer than 3 months).1
When looking at the clinical course
of persistent LBP, although most
patients show a marked reduction in
mean pain and disability in the first 6
weeks, they could present persistent
pain, with moderate levels of pain
and disability between 6 and 52
weeks.8 Most guidelines and system-
atic reviews for CLBP treatment rec-
ommend active physical therapy
interventions (eg, exercise).9 –11 Spe-
cifically, manual therapy, trunk coor-
dination, strengthening, endurance,
and directional preference exercises
are recommended based on strong
evidence.1,11
Some studies have compared the
effectiveness of different physical
therapy strategies in patients with
CLBP.12,13 Other studies have shown
that the strategies usually result in
small-to-moderate clinical effects and
that no treatment strategies are
clearly superior in the long
1288 f Physical Therapy Volume 95
term.14 –21 A major issue in these
studies could be related to sample
heterogeneity, as most people with
CLBP are often labeled with the diag-
nosis of nonspecific LBP.22 Usually,
LBP is classified as specific or non-
specific LBP. Specific LBP is defined
as symptoms caused by a specific
pathophysiological mechanism,
such as hernia nuclei pulposi (with
nerve root compromise), inflamma-
tory diseases (eg, ankylosing spondy-
litis), infection, osteoporosis, rheu-
matoid arthritis, fracture, or tumor.
Nonspecific LBP is defined as symp-
toms without a clear specific
cause.23 The nonspecific classifica-
tion includes 90% of all patients with
LBP and is based on exclusion of
specific pathology.23 Several authors
have suggested that the classification
of nonspecific LBP into more homog-
enous subgroups will lead to specific
interventions for those subgroups
that could enhance treatment
effects.24 –27 A few studies have
already shown that using specific
classification rules to guide treat-
ment of patients with acute LBP28,29
and CLBP30 –32 can improve the
short-term treatment effects. Recom-
mendations for future re-
search in LBP include investigations
on the effect of treatment strategies
based on subgrouping.1,33,34
Different models for classification
and diagnosis have been described
to guide LBP treatment.25,35– 40 Clas-
sification using the Movement
System Impairment (MSI)– based
classification model41– 43 involves
interpreting data from a standardized
examination to assign a patient to an
LBP subgroup. The clinician identi-
fies mechanically based impairments
and associated symptoms across a
series of tests of movements and
positions to decide on the patient’s
LBP classification. One of the differ-
ences between the MSI model and
other classification systems is the
assessment of the patient’s ability to
maintain a stable lumbopelvic region
Number 9
when performing lower and upper
limb movement tests.43,44 During
each movement test, the examiner
makes a judgment about the timing
and magnitude of lumbopelvic
region movement. The effect of the
movement test on LBP symptoms
also is assessed. Tests that are symp-
tom provoking are immediately fol-
lowed by standardized modifications
to determine the role of lumbopelvic
movement on the patient’s symp-
toms. Overall, the modification
involves minimizing or restricting
lumbar movement during the test
movement and encouraging move-
ment in other joints to accomplish
the movement goal. An improve-
ment in LBP symptoms with the
modification indicates that the ini-
tially identified lumbopelvic move-
ment is an important contributor to
the person’s LBP symptoms.43,44
Some studies have demonstrated
that it is possible to discriminate spe-
cific LBP subgroups from healthy
people using the MSI-based
classification.43– 46 Scholtes et al45
reported that patients with LBP
involved in sports that require trunk
rotation may move their lumbo-
pelvic region earlier and to a greater
extent during lower limb movement
tests compared with people with
healthy backs. Increased lumbo-
pelvic movement could be related
both to the increased demand on
lumbar spine structures and to the
symptoms.46
The validity of MSI-based classifica-
tion model for LBP has been previ-
ously determined.38 It also has been
shown that the MSI classification
model can be reliably applied by
trained clinicians,47–50 even if those
clinicians have limited clinical ex-
perience.50 –52 Several case reports
have shown promising findings
when the MSI model was used to
guide LBP treatment.53–56 However,
the efficacy of this model in a high-
September 2015

quality randomized controlled trial
design still needs to be tested.
The objective of this study will be
to investigate the efficacy of a treat-
ment based on the MSI model for
patients with CLBP in a randomized
controlled trial with blinded
assessors.
Method
Study Design
The study will be a 2-arm, prospec-
tively registered randomized con-
trolled trial with a blinded assessor.
Study Setting
The study setting will be a university
physical therapy clinic in Brazil.
Eligibility Criteria
Individuals of both sexes, between
18 and 65 years of age, with chronic
(pain for more than 3 months) non-
specific LBP with a pain intensity of
at least 3 points measured using a 0-
to 10-point verbal numeric pain rat-
ing scale57,58 will participate in the
study. Participants should be able to
stand and walk independently and
be literate in Portuguese. The exclu-
sion criteria include any contraindi-
cations to physical exercise accord-
ing to the guidelines of the American
College of Sports Medicine,59 major
depression (ie, scored ⱖ21 points on
the Depression, Anxiety and Stress
Scale [DASS]60,61), serious spinal
pathologies (fractures, tumors, and
inflammatory pathologies such as
ankylosing spondylitis), nerve root
compromise (disk herniation, spinal
stenosis, spondylolisthesis, and
other diagnoses associated with
nerve compromise), serious cardio-
respiratory diseases, previous back
surgery or pregnancy, and cannot
be classified into any of the 5 cate-
gories of the MSI model on initial
assessment.37
Procedure
The participants will be recruited
from orthopedic outpatient clinics
September 2015
Movement System and General Exercise in Chronic Low Back Pain
and by advertising in radio media.
The blinded assessor will screen the
eligibility of each participant based
on the previously described eligibil-
ity criteria. All eligible participants
will receive information about the
study and will sign an informed con-
sent form before participation. The
assessor will collect the baseline data
prior to randomization and at 2, 4,
and 6 months after randomization.
With the exception of the baseline
assessment, data for all other
assessments will be collected over
the telephone. All data entry will be
coded, and data will be entered onto
an Excel (Microsoft Corp, Redmond,
Washington) spreadsheet and
doubled-checked prior to the
analysis.
Outcome Measures
Each participant’s assessment will
include the following instruments:
(1) a questionnaire of participant
characteristics (age, sex, history of
LBP, factors that alleviate or aggra-
vate symptoms, location and dura-
tion of symptoms), (2) a physical
examination using the MSI-based
classification model for people with
LBP,47 (3) a verbal numeric pain rat-
ing scale (0 –10 points), (4) the
24-item Roland-Morris Disability
Questionnaire, and (5) the 11-item
Global Perceived Effect Scale.57,58
The primary outcome measures will
be pain intensity and disability at 2
months after randomization. The
secondary outcome measures will be
pain intensity and disability at 4 and
6 months after randomization and
global impression of recovery at 2, 4,
and 6 months after randomization.
All scales and questionnaires have
been translated and cross-culturally
adapted into Brazilian Portuguese,
and their respective measurement
properties have been described.57,58
A detailed description of each of the
instruments is given below.
Volume 95
Physical examination using the
MSI– based classification model
for patients with LBP. The phys-
ical examination for classification
based on the MSI model includes: (1)
reports of symptoms associated with
various positions and movements
and (2) judgments of movements
and postures during clinical tests
performed in different positions. For
each of the tests (posture or move-
ment) that provoked symptoms, the
participant either assumes a modi-
fied posture or performs a corrected
movement (spinal or lower extrem-
ity) and then reports a possible
change in his or her LBP symp-
toms.62 After the examination, the
examiner will classify each partici-
pant into 1 of 5 possible categories
(flexion, extension, rotation, flexion
with rotation, or extension with rota-
tion syndromes) based on the rules
described by Harris-Hayes and Van
Dillen.47 All participants will be clas-
sified before randomization by the
main author using the MSI model.
Numeric pain rating scale. The
numeric pain rating scale assesses
the pain intensity levels perceived by
the participant in the past 7 days
using an 11-point scale ranging from
0 (“no pain”) to 10 (“worst possible
pain”).57,58
Roland-Morris Disability Ques-
tionnaire. The Roland-Morris Dis-
ability Questionnaire assesses disabil-
ity associated with LBP.63 It has 24
questions that describe daily tasks
that participants have difficulty per-
forming due to their LBP.57,58,64 The
total score ranges from 0 to 24 points
and is the sum of the points
obtained. Higher scores indicate
higher disability.
Global Perceived Effect Scale.
The Global Perceived Effect Scale
assesses an individual’s global
impression of recovery, comparing
the onset of symptoms with the last
few days. It is an 11-point numeric
Number 9 Physical Therapy f 1289
Movement System and General Exercise in Chronic Low Back Pain

scale ranging from ⫺5 (“vastly

worse”) to 0 (“unchanged”) to ⫹5
(“completely recovered”).65 Partici-
pants will respond to the following
question: “Compared with when this
episode first started, how would you
describe your back these days?”
Higher scores indicate better
recovery.57

Random Allocation
The participants will be randomly
allocated to 1 of 2 groups (treatment
based on MSI model or general exer-
cise) using a computer-generated
randomization conducted by a
researcher who has no contact with
the participants. Participants’ con-
cealed allocations will be kept in
sealed, opaque envelopes using a
random numerical sequence. The
examiner responsible for the treat-
ment will open each envelope in
front of the participant and tell the
participant to which treatment
group he or she has been randomly
assigned.

Blinding
Because of the study design, only the
assessor will be blinded to treatment
group assignment. The Figure
depicts the study design.

Interventions
The therapists responsible for the
treatment (MSI model or general
exercise) will be trained by the first
author, who has 16 years of experi-
ence in orthopedic physical therapy
and has been using the MSI model in
practice for 11 years. Training will
consist of a 16-hour course (lecture)
and the opportunity to practice both
treatment protocols over a 1-month
period with supervision from the
principal investigator. The principal
investigator also will periodically
audit the interventions through revi-
sion of patient home exercise charts
and direct oversight during treat-
ment sessions.
Figure.
Study flow diagram. MSI⫽Movement System Impairment.
Treatment Based on the
MSI Model
Treatment based on the MSI model
will consist of 12 treatment sessions
with an estimated duration between
45 and 60 minutes per session (2
sessions per week for the first 4
weeks and 1 session per week in the
last 4 weeks). Treatment based on
the MSI model includes: (1) patient
education, (2) analysis and modifica-
tion of performance of daily activi-
ties, and (3) prescription of specific
exercises.53–55
Patient education will involve teach-
ing each participant how perfor-
mance of daily activities is related to
his or her LBP symptoms. One
assumption of the MSI model is that
the development and course of a per-
son’s LBP is related to the repetition
of altered movements and mainte-
nance of prolonged postures associ-
ated with a specific direction (eg,
flexion, extension, rotation). Partici-
pants also will receive information
about the importance of controlling
the postures and movements on a

1290 f Physical Therapy Volume 95 Number 9 September 2015


daily basis. The principles will be
taught to participants in the first
treatment session.
Modification of daily activities will
begin with analysis of the activities
that the participant reports as
symptom-provoking. During the
analysis, the examiner will observe
the individual performing the spe-
cific activities limited by his or her
LBP. Participants will be taught how
to modify the movements and pos-
tures that are associated with their
symptoms and that are proposed to
contribute to accumulation of stress
concentrations in the lumbar region.
The analysis of daily activities is
driven by the person’s LBP classifica-
tion. For example, a person classified
as having a lumbar flexion syndrome
might be taught how to assume a
sitting position and to move from a
sitting to a standing position without
flexing the lumbar spine and without
an increase in LBP. Modification of
daily activities will be initiated in the
first treatment session. During the
follow-up sessions, the examiner will
revise the instructions according to
patient progress.
The prescription of specific exer-
cises also will be directed by each
participant’s LBP classification. The
exercises consist of practicing the
movement tests performed during
the initial assessment. However,
now the movements will be modi-
fied to emphasize control of lumbar
spine movement and to increase
movement of the adjacent joints.
Movement tests that were pain-free
but during which a participant dis-
played an altered movement pattern
also may be prescribed. During each
treatment session, participants will
perform the exercises while being
monitored for any increase in symp-
toms. They also will be advised to
perform the exercises at home at
least once a day. To facilitate the
execution of the home exercises,
each participant will receive pic-
September 2015
Movement System and General Exercise in Chronic Low Back Pain
tures of the exercises with written
instructions. The participant’s ability
to perform his or her home exercise
program will be assessed during
each treatment session. The assess-
ment is an adaptation of that used in
the study by Harris-Hayes et al66 and
includes judgments about the per-
son’s cognition (knowledge of key
concept of the exercise or activity
prescribed by the physical therapist)
and psychomotor skill (performance
of the exercise or activity prescribed
by the physical therapist). The
assessment does not result in addi-
tional time in treatment and stan-
dardizes the progression of the home
program. Participants will register
their home exercise in an exercise
diary and will be monitored for any
exacerbation of symptoms in each
treatment session.
Treatment Based on
General Exercise
The general exercise program con-
sists of 12 treatment sessions with an
estimated duration between 45 and
60 minutes per session (2 sessions
per week for the first 4 weeks and 1
session per week in the last 4
weeks). Each session will be con-
ducted by a trained physical thera-
pist. The participants will perform
an exercise program that starts with
pedaling a stationary bicycle or walk-
ing for 5 minutes to warm up, fol-
lowed by stretching exercises. The
stretching exercises will address the
lumbar and abdominal muscles (lum-
bar flexors, extensors, lateral flexors
and rotators) and the lower limb
muscles (hip flexors, extensors, rota-
tors, adductors and abductors, ham-
strings, quadriceps, and calves).
Each participant also will perform
strengthening exercises for the
abdominal and paraspinal mus-
cles.10,67 The participant may prog-
ress through increased load to keep
inducing muscle fatigue after com-
pletion of 10 repetitions per set.68
Participants also will be advised to
perform the exercises at home
Volume 95
(3 times a week) and will receive
figures of the exercises with written
instructions. Their ability to perform
the home exercise program66 also
will be assessed during each treat-
ment session. The exercise program
will be prescribed according to
American College of Sports Medicine
recommendations.68 The partici-
pants will register their home exer-
cise in an exercise diary and will be
monitored for any exacerbation in
symptoms in each treatment session.
Statistical Methods
Sample size calculation. Seventy-
four participants are needed per
treatment condition based on a sam-
ple size calculation considering a sta-
tistical power of 80%, an alpha of 5%,
and a 15% dropout rate. The calcula-
tion was based on the detection of a
1-point between-group difference
for the 11-item numeric pain rating
scale57 (estimated standard deviation
of 1.84) outcome and a 4-point
between-group difference for the
Roland-Morris Disability Question-
naire57,58,64 (estimated standard devi-
ation of 4.9 points) outcome.
Analysis of effects of treatment.
Descriptive statistics will be calcu-
lated to check for data normality.
The between-group comparisons to
obtain the effects of the treatments
will be conducted by means of inter-
action terms (group versus time
interactions) using a linear mixed
model. We also will perform sub-
group analyses using the MSI classi-
fication as a potential treatment
effect modifier. All data will be given
to the examiner, who will perform
the statistical analysis using a coded
form. The statistical analysis will be
performed according to an intention-
to-treat approach.69 The IBM SPSS 19
statistic package (IBM Corp,
Armonk, New York) will be used for
these analyses.
Number 9 Physical Therapy f 1291
Movement System and General Exercise in Chronic Low Back Pain
Ethics
Participants will be informed about
the study and will sign an informed
consent form before participating
in the trial. This study was
approved by Ethics Committee of
Pontifı́cia Universidade Católica
de Minas Gerais, Brazil
(17660913.0.0000.5137) and was
prospectively registered at
ClinicalTrials.gov (NCT02221609).
Possible protocol modifications will
be registered with the Ethics Com-
mittee as well as in the trial registry.
Data will be stored at Universidade
Cidade de São Paulo, Brazil.
Discussion
Potential Impact and
Significance of the Study
The wide variability in CLBP clinical
presentations poses a challenge to
physical therapist diagnosis and
treatment. In response to this chal-
lenge, various classification systems
aiming at identifying common pat-
terns of symptoms behavior, cogni-
tive characteristics, or musculo-
skeletal dysfunctions have
emerged.25,35– 40 It is expected that
classifying individuals with CLBP
into more homogeneous subgroups
may enhance treatment effects.
Other classification systems used to
guide conservative treatment in LBP
have been shown to improve treat-
ment effects compared with manual
therapy and general exercise,32 treat-
ment based on electrophysical
agents,31 or back school.30
Although the reliability and validity
of the MSI-based classification model
for patients with LBP have been eval-
uated, the efficacy of the model in a
high-quality randomized controlled
trial design still needs to be assessed.
The current study will compare a
treatment based on the MSI classifi-
cation model with general exercise
that is recommended in most clinical
practice guidelines.1,11
1292 f Physical Therapy Volume 95
Recommendations for studies involv-
ing LBP highlight the need for assess-
ment of treatment effects based on
subgrouping.1,33,34 The results of this
study, therefore, will contribute to
advancing the LBP research agenda
in high-priority areas. If positive, our
findings will inform physical thera-
pists’ decision making on exercise
prescriptions more tailored to
patient-specific musculoskeletal
impairments. Although some other
classification systems also involve
movement-related criteria,25,35,36,40
none of these systems approach the
concept of directional susceptibility
to movement more centrally and sys-
tematically than the MSI system.41– 43
Contribution to the Physical
Therapy Profession and to
Patients
The MSI-based classification model
allows physical therapists with dif-
ferent levels of experience to reliably
classify people with LBP into sub-
groups.47,48,50 –52 The LBP treatment
provided is based on each patient’s
classification and includes education
about how the individual’s daily
activities may contribute to his or
her LBP. Participants also are taught
how to modify their daily activities
by modifying the movements and
postures that appear to increase lum-
bar spine stress and LBP symptoms.
The participants also receive a series
of exercises to be performed at
home. It is expected that patients
will become independent and more
empowered in controlling move-
ments and postures associated with
their LBP.53–55 We expect that
patients receiving treatment based
on the MSI model will have a better
outcome compared with those in the
general exercise group. These find-
ings might help therapists, health
care providers, and people with
CLBP in their choice between a gen-
eral exercise program or a treatment
based on the MSI model.
Number 9
Strengths and
Weaknesses of the Study
The strength of the current study is
that it is a randomized controlled
trial that has been prospectively reg-
istered. The study also includes con-
cealed allocation and an intention-to-
treat approach. The sample size has
been calculated to provide appropri-
ate statistical power to detect differ-
ences in the primary outcome
between the 2 treatment conditions.
The assessor responsible for collect-
ing outcome data will be blinded to
treatment group assignment. Physi-
cal therapists responsible for treat-
ment have similar clinical experi-
ence and have been trained by the
main author of the study. Our study
has some limitations. Participants
and examiners responsible for treat-
ments cannot be blinded. Both exer-
cise programs include home exer-
cises, which depend on each
participant’s motivation. It is not
possible to predict the amount of
home exercises that will be per-
formed by each group.
Future Research
The results of this study may contrib-
ute to future trials comparing the
effects of different classification sys-
tems25,35– 40 used to guide LBP treat-
ment. It also is possible that different
treatment effects would be found
when comparing different sub-
groups in the MSI group. Although
this study might not be powered to
detect those differences, our results
may inform future studies on the
topic.
Mr Azevedo, Dr Van Dillen, Dr Ferreira, and
Dr Costa provided concept/idea/research
design. Mr Azevedo, Dr Van Dillen, Mr San-
tos, Mr Oliveira, and Dr Costa provided writ-
ing. Mr Azevedo, Mr Santos, and Mr Oliveira
provided data collection and analysis. Dr
Costa provided fund procurement. Mr
Azevedo provided facilities/equipment.
Mr Azevedo, Dr Van Dillen, Mr Santos, Mr
Oliveira, and Dr Ferreira provided consulta-
tion (including review of manuscript before
submission).
September 2015

Mr Azevedo is a PhD student funded by
Coordenação de Aperfeiçoamento de Pes-
soal de Nı́vel Superior (CAPES). The authors
also thank Conselho Nacional de Desenvol-
vimento Cientı́fico e Tecnológico/Brazil
(CNPQ grant number 470273/2013-5) for
funding the study.
DOI: 10.2522/ptj.20140555
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