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8/12/2019 Clinical Prediction Rule to Identify Patients Likely to Responde to Lumbar Spine Stabilization Exercisess: A Random
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6 | january2014 | volume44 | number1 | journaloforthopaedic&sportsphysicaltherapy
Low back pain (LBP) is
common among the generalpopulation, with a lifetimeprevalence and point pre-
valence estimated to be greaterthan 80% and 28%, respectively.12
Although short-term outcomes are gen-
erally favorable, some patients go on to
experience long-term pain and disabil-
ity,32,40,78and recurrence rates are high.17,78
Systematic reviews of various physi-
cal therapy interventions for LBP do not
provide strong support for any particu-
lar treatment approach.2,50,51,77 One pos-
sible reason is the use of heterogeneous
samples of patients in many clinical trials
for LBP. Patients with LBP demonstrate
both etiologic and prognostic hetero-geneity,7,40,45which makes it unlikely for
any single intervention to have a signifi-
cant advantage over another in a general
population with LBP. Classifying patients
into more homogeneous subgroups has
been previously identified as a top re-
STUDY DESIGN:Randomized controlled trial.
OBJECTIVE:To determine the validity of apreviously suggested clinical prediction rule (CPR)
for identifying patients most likely to experience
short-term success following lumbar stabilization
exercise (LSE).
BACKGROUND:Although LSE is commonlyused by physical therapists in the management
of low back pain, it does not seem to be more
effective than other interventions. A 4-item CPR
for identifying patients most likely to benefit from
LSE has been previously suggested but has yet to
be validated.
METHODS:One hundred five patients with
low back pain underwent a baseline examination
to determine their status on the CPR (positive or
negative). Patients were stratified by CPR status
and then randomized to receive an LSE program
or an intervention consisting of manual therapy
(MT) and range-of-motion/flexibility exercises.
Both interventions included 11 treatment sessions
delivered over 8 weeks. Low back painrelated
disability was measured by the modified version of
the Oswestry Disability Index at baseline and upon
completion of treatment.
RESULTS:The statistical significance for the2-way interaction between treatment group and
CPR status for the level of disability at the end
of the intervention was P= .17. However, amongpatients receiving LSE, those with a positive CPR
status experienced less disability by the end of
treatment compared with those with a nega-
tive CPR status (P= .02). Also, among patients
with a positive CPR status, those receiving LSE
experienced less disability by the end of treatment
compared with those receiving MT (P= .03). In
addition, there were main effects for treatment and
CPR status. Patients receiving LSE experienced
less disability by the end of treatment compared to
patients receiving MT (P= .05), and patients with
a positive CPR status experienced less disability
by the end of treatment compared to patients with
a negative CPR status, regardless of the treatment
received (P= .04). When a modified version of
the CPR (mCPR) containing only the presence of
aberrant movement and a positive prone instability
test was used, a significant interaction with treat-
ment was found for final disability (P= .02). Of the
patients who received LSE, those with a positive
mCPR status experienced less disability by the endof treatment compared to those with a negative
mCPR status (P= .02), and among patients with
a positive mCPR status, those who received LSE
experienced less disability by the end of treatment
compared to those who received MT (P= .005).
CONCLUSION:The previously suggested CPRfor identifying patients likely to benefit from LSE
could not be validated in this study. However, due
to its relatively low level of power, this study could
not invalidate the CPR, either. A modified version
of the CPR that contains only 2 items may possess
a better predictive validity to identify those most
likely to succeed with an LSE program. Because
this modified version was established through posthoc testing, an additional study is recommended
to prospectively test its predictive validity.
LEVEL OF EVIDENCE:Prognosis, level 1b. JOrthop Sports Phys Ther 2014;44(1):6-18. Epub 21
November 2013. doi:10.2519/jospt.2014.4888
KEY WORDS:lumbar spine, manual therapy
1Department of Physiotherapy, Ariel University, Ariel, Israel. 2Bat-Yamon Physical Therapy Clinic, Clalit Health Services, Israel. 3Giora Physical Therapy Clinic, Clalit Health
Services, Israel. 4Department of Physical Therapy, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel. This study was approved by the Helsinki
Committee of Clalit Health Services. The authors certify that they have no affiliations with or financial involvement in any organization or entity with a direct financial interest
in the subject matter or materials discussed in the article. Address correspondence to Dr Alon Rabin, Ariel University, Department of Physiotherapy, Kiryat Hamada, PO Box 3,
Ariel, Israel. E-mail: [email protected] 2014 Journal of Orthopaedic & Sports Physical Therapy
ALON RABIN, DPT, PhD1 ANAT SHASHUA, BPT, MS2 KOBY PIZEM, BPT3
RUTHY DICKSTEIN, PT, DSc4 GALI DAR, PT, PhD4
A Clinical Prediction Rule to IdentifyPatients With Low Back Pain Who AreLikely to Experience Short-Term Success
Following Lumbar Stabilization Exercises:A Randomized Controlled Validation Study
[RESEARCHREPORT]
Copyright2014JournalofOrthopaedic&S
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rtsPhysicalTherapy.Allrightsreserved.
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search priority,6and, in fact, more recent
research has suggested that matching pa-
tients with interventions based on their
specific clinical presentation may yield
improved clinical outcomes.8,10,15,27,47Structural as well as functional
impairments, such as decreased and
delayed activation of the transversus ab-
dominis and atrophy of the lumbar mul-
tifidus,25,34,37,48,69,80 have been identified
among patients with LBP. These impair-
ments may result in a reduction in spinal
stiffness82and possibly render the spine
more vulnerable to excessive deforma-
tion and pain. Lumbar stabilization ex-
ercises (LSE) attempt to address these
impairments by retraining the properactivation and coordination of trunk
musculature.58,64 Stabilization exercises
are widely used by physical therapists in
the management of LBP.8,11,22,24,35,44,49,50,62,65
Although some evidence exists to support
the remediating effects of LSE on some
of the muscle impairments identified in
patients with LBP,36,73,74 the clinical ef-
ficacy of this intervention seems to vary.
When compared to sham or no interven-
tion, LSE appears to be advantageous22,65;
however, when compared to other exer-cise interventions or to manual therapy
(MT), no definitive advantage has been
ascertained.11,24,35,44,49,50,62,75
In light of the variable clinical suc-
cess of LSE and in accordance with the
aforementioned need to classify patients
who have LBP into more homogeneous
subgroups, Hicks et al33suggested a clini-
cal prediction rule (CPR) to specifically
identify patients with LBP who are likely
to exhibit short-term improvement with
LSE. Four variables were found to pos-sess the greatest predictive power for
treatment success: (1) age less than 40
years, (2) average straight leg raise (SLR)
of 91 or greater, (3) the presence of aber-
rant lumbar movement, and (4) a positive
prone instability test.33When at least 3
of the 4 variables were present, the posi-
tive likelihood ratio for achieving a suc-
cessful outcome was 4.0, increasing the
probability of success from 33% to 67%.33
The study by Hicks et al33comprises the
first stage in establishing a CPR, the deri-
vation stage.4,14,55Following derivation, a
CPR must be validated, that is, shown to
consistently predict the outcome of inter-
est in a separate and preferably prospec-tive investigation.26Given its preliminary
nature, and because CPRs do not typi-
cally perform as well on new samples of
patients,21,30,67,68modification of the CPR
may also be necessary to achieve satisfac-
tory predictive validity. Once validated,
CPRs can move into the final stage of
their determination, which includes an
investigation into their impact on clini-
cal practice (impact analysis).4,14,55
Validation of the CPR for LSE re-
quires a randomized controlled trial inwhich patients with a different status on
the CPR (positive or negative) undergo
an LSE program, as well as a comparison
intervention.4 The use of a comparison
intervention is important to determine
whether the CPR can truly identify pa-
tients who will benefit specifically from
LSE, as opposed to patients who have a
favorable prognosis irrespective of the
treatment received.66Finally, to validate
the CPR in the most clinically meaning-
ful manner, we believe that the compari-son intervention should be considered a
viable alternative to LSE, rather than a
sham or an inert intervention.
Manual therapy is an intervention fre-
quently used by physical therapists in the
management of patients with LBP39,46,56
and is recommended by several clinical
practice guidelines and systematic reviews
for the management of acute, subacute,
and chronic LBP.1,9,19,76These factors, com-
bined with the fact that LSE programs
have previously demonstrated variedlevels of success compared to MT,11,24,50,62
suggest that MT may be a suitable com-
parison intervention for testing the validi-
ty of the CPR. In contrast to its use among
heterogeneous samples,11,24,50,62 LSE
should demonstrate a clearer advantage
among patients with LBP who also satisfy
the CPR, if the CPR accurately identifies
the correct target patient population.
The purpose of this investigation was
to determine the validity of, or to possibly
modify, the previously suggested CPR for
identifying patients most likely to benefit
from LSE. We hypothesized that among
patients receiving LSE, those with a posi-
tive CPR status would exhibit a betteroutcome compared to those with a nega-
tive CPR status. We also hypothesized
that among patients with a positive CPR
status, those who received LSE would ex-
hibit a better outcome compared to those
who received MT.
METHODS
Patients
One hundred five patients diag-
nosed with LBP and referred tophysical therapy at 1 of 5 outpa-
tient clinics of Clalit Health Services in
the Tel-Aviv metropolitan area, Israel,
were recruited for this study. Subjects
were included if they were 18 to 60 years
of age, had a primary complaint of LBP
with or without associated leg symptoms
(pain, paresthesia), and had a minimum
score of 24% on the Hebrew version of
the modified Oswestry Disability Index
(MODI) outcome measure. Patients
were excluded if they presented with ahistory suggesting any red flags (eg, ma-
lignancy, infection, spine fracture, cauda
equina syndrome); 2 or more signs sug-
gesting lumbar nerve root compression,
such as decreased deep tendon reflexes,
myotomal weakness, decreased sensation
in a dermatomal distribution, or a posi-
tive SLR, crossed SLR, or femoral nerve
stretch test; or a history of corticosteroid
use, osteoporosis, or rheumatoid arthri-
tis. Patients were also excluded if they
were pregnant, received chiropracticor physical therapy care for LBP in the
preceding 6 months, could not read or
write in the Hebrew language, or had a
pending legal proceeding associated with
their LBP. Prior to participation, all pa-
tients signed an informed consent form
approved by the Helsinki Committee of
Clalit Health Services.
TherapistsSixteen physical therapists were involved
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[RESEARCHREPORT]
in the study. Eleven therapists, with be-
tween 4 and 12 years of experience in
outpatient physical therapy patient care,
provided treatment, and 5 therapists,
with between 13 to 25 years of experi-ence, performed baseline and follow-
up evaluations. Prior to beginning the
study, all participating therapists under-
went two 4-hour sessions in which the
rationale and protocol of the study were
presented and the examination and treat-
ment procedures were demonstrated and
practiced. Therapists had to pass a writ-
ten examination of the study procedures
prior to data collection. Finally, each
therapist received a manual describing
treatment and evaluation procedures,based on the therapists role in the study
(treatment or evaluation). Therapists in-
volved in treating patients were unaware
of the concept of the CPR throughout the
study, to avoid bias from this knowledge
during treatment. All treating therapists
provided both treatments of the study
(LSE and MT).
ProcedureAfter giving consent, patients completed
a baseline examination that included de-mographic information, an 11-point (0-
10) numeric pain rating scale (NPRS),
on which 0 was no pain and 10 was
the worst imaginable pain, the Hebrew
version of the MODI,3,28and the Hebrew
version of the Fear-Avoidance Beliefs
Questionnaire. 38,79 In addition, the his-
tory of the present and any past LBP
was documented, followed by a physical
examination.
The physical examination included a
neurological screen to rule out lumbarnerve root compression; lumbar active
motion, during which the presence of ab-
errant movement, as defined by Hicks et
al,33was determined; bilateral SLR range
of motion; segmental mobility of the lum-
bar spine; and the prone instability test.
The patients status on the CPR (positive
or negative) was established based on the
findings of the physical examination.
Examiners who performed the base-
line examinations, as well as examiners
who screened patients for eligibility to
participate in the study, were blinded to
the intervention allocation of the patients.
ReliabilityThe reliability of the individual physical
examination items comprising the CPR,
as well as that of the entire CPR, has been
reported previously.60In that study,60the
interrater reliability for determining CPR
status was excellent (= 0.86), and the
interrater reliability of each of the items
comprising the CPR ranged from moder-
ate to substantial (= 0.64-0.73).60
Randomization
At the conclusion of the physical exami-nation, each patient was randomized to
receive LSE or MT. Randomization was
based on a computer-generated list of
random numbers, stratified by CPR status
to ensure that adequate numbers of pa-
tients with a positive and a negative CPR
status would be included in each interven-
tion group. The list was kept by a research
assistant who was not involved in patient
recruitment, examination, or treatment.
InterventionPatients in both groups received 11 treat-ment sessions over an 8-week period.
Each patient was seen twice a week dur-
ing the first 4 weeks, then once a week
for 3 additional weeks. A 12th session
(usually on the eighth week) consisted
of a final evaluation. The total number
of sessions (12) matched the maximum
number of physical therapy visits allowed
annually per condition under the policy
of the Clalit Health Services health main-
tenance organization, which covered allpatients participating in the study. Pa-
tients in both groups were prescribed a
home exercise program consistent with
their treatment group; however, no at-
tempt was made to monitor patients
compliance with the home exercise
program.
Lumbar Stabilization ExercisesThe LSE program was largely based on
the program described by Hicks et al,33
with a few minor changes in the order of
the exercises and a few additional levels
of difficulty for some of the exercises. Pa-
tients were initially educated about the
structure and function of the trunk mus-culature, as well as common impairments
in these muscles among patients with
LBP. Patients were then taught to per-
form an isolated contraction of the trans-
versus abdominis and lumbar multifidus
through an abdominal drawing-in ma-
neuver (ADIM) in the quadruped, stand-
ing, and supine positions.63,64,69,71,73Once
a proper ADIM was achieved (most likely
by the second or third visit), additional
loads were placed on the spine through
various upper extremity, lower extremity,and trunk movement patterns. Exercises
were performed in the quadruped, sidely-
ing, supine, and standing positions, with
the goal of recruiting a variety of trunk
muscles.18,53,54In each position, exercises
were ordered by their level of difficulty,
and patients progressed from one exer-
cise to the next after satisfying specific
predetermined criteria. In the seventh
treatment session, functional movement
patterns were incorporated into the
training program while performing anADIM and maintaining a neutral lumbar
spine. This stage, which was not includ-
ed in the derivation study, was added to
the program because it has been recom-
mended by others.22,58,62The exercises in
each stage of the LSE program, as well as
the specific criteria for progression from
one exercise to the next, are outlined in
APPENDIX A(available atwww.jospt.org).
Manual Therapy
The MT intervention included severalthrust and nonthrust manipulative tech-
niques directed at the lumbar spine that
have been used previously with some
degree of success in various groups with
LBP.10,15,20,59In addition, manual stretch-
ing of several hip and thigh muscles was
performed, as flexibility of the lower ex-
tremity is purported to protect the spine
from excessive strain.54 Finally, active
range-of-motion and stretching exercis-
es were added to the program, as these
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are commonly prescribed in combina-
tion with MT to maintain or improve the
mobility gains resulting from the manual
procedures.10,15,20,47The exercises included
were selected to minimize trunk muscleactivation and to avoid duplication be-
tween the 2 interventions.
All manual procedures and exercises
were prescribed based on the clinical
judgment of the treating therapist; how-
ever, each session could include up to 3
manual techniques, 1 of which had to be
a thrust manipulative technique directed
at the lumbar spine, and an additional
technique that had to include a manual
stretch of a lower extremity muscle. The
third technique, as well as the comple-mentary range-of-motion/flexibility ex-
ercises, was given at the discretion of the
treating therapist. The MT techniques, as
well as all exercises used in the MT proto-
col, are described in APPENDIX B(available
atwww.jospt.org).
EvaluationThe MODI served as the primary out-
come measure in this investigation. The
MODI is scored from 0 to 100 and has a
minimal clinically important difference(MCID) of 10 points among patients with
LBP.57The secondary outcome measure
was the NPRS, which has an MCID of 2
points among patients with LBP.16Both
measures were administered before the
beginning of treatment and immediately
after the last treatment session by an in-
vestigator not involved in patient care.
Sample SizeSample size was calculated to detect a be-
tween-group difference of 12 points in thefinal score of the MODI, based on the in-
teraction between treatment group (LSE
versus MT) and CPR status (positive ver-
sus negative), with an alpha level of .05
and a power of 70%. Based on a 16-point
standard deviation, it was determined
that 20 patients were needed in each cell.
Pilot data suggested that the prevalence
of patients with a positive status on the
CPR was approximately 33%. Therefore,
it was estimated that 120 patients would
be necessary to include 40 patients with
a positive CPR status; however, 40 such
patients were included after 105 patients
were recruited, and recruitment was
stopped at that point.
Statistical AnalysisDescriptive statistics, including frequen-
cy counts for categorical variables and
measures of central tendency and dis-
persion for continuous variables, were
used to summarize the data. All baseline
variables were assessed for normal distri-
bution using the Shapiro-Wilk test. Base-
line variables were compared between
treatment groups (LSE versus MT), CPR
status (positive versus negative), andthe resulting 4 subgroups using a 2-way
analysis of variance and chi-square tests
for continuous and categorical variables,
respectively.
The primary aim of the study was
tested using 2 separate analyses of cova-
riance (ANCOVAs), with the final MODI
score serving as the dependent variable in
1 model and the final NPRS score serving
as the dependent variable in the second
model. In both models, treatment group
and CPR status served as independentvariables, and the baseline MODI score
(or baseline NPRS score) was used as
a covariate. The residuals of all models
were tested for violations of the ANCOVA
assumptions and for outliers. The main
effects of treatment group and CPR sta-
tus, as well as the 2-way interaction be-
tween these factors on the final MODI
and NPRS scores, were evaluated. The a
priori level of significance for these analy-
ses wasP.05. Two pairwise comparisons
were planned following the ANCOVA: (1)a comparison of differences between pa-
tients with a positive CPR receiving LSE
and those with a negative CPR receiving
LSE, and (2) a comparison of differences
between patients with a positive CPR
receiving LSE and those with a positive
CPR receiving MT. These 2 comparisons
were deemed the most relevant for the
purpose of validating the CPR, as both
included a comparison between patients
receiving a matched intervention (CPR-
positive patients receiving LSE) and
patients receiving an unmatched inter-
vention (either CPR-negative patients
receiving LSE or CPR-positive patients
receiving MT).The individual items of the CPR, as
well as different combinations of these
items, were similarly tested to identify
whether any such combination would
enhance the predictive validity of the
original version. Finally, the outcome was
also dichotomized as successful or unsuc-
cessful based on a previously established
cutoff threshold of 50% reduction in the
baseline score of the MODI.33The pro-
portion of patients achieving a success-
ful outcome was compared among theresulting subgroups (LSE CPR+, LSE
CPR, MT CPR+, and MT CPR) using
chi-square analysis.
An intention-to-treat approach was
performed for all analyses by using mul-
tiple imputations for any missing val-
ues of the 2 outcome measures (MODI,
NPRS). First, Littles missing completely
at random test was performed to test the
hypothesis that missing values were ran-
domly distributed. If this hypothesis could
not be rejected, expectation maximizationwas used to predict missing values. A per-
protocol analysis was performed as well.
All statistical analyses were performed us-
ing the JMP Version 10 statistical package
(SAS Institute Inc, Cary, NC), as well as
the SPSS Version 19 statistical package
(SPSS Inc, Chicago, IL).
RESULTS
Five hundred thirty-one poten-
tial candidates were screened foreligibility between March 2010 and
April 2012. Two hundred ninety-seven pa-
tients did not meet the inclusion criteria,
and another 129 declined participation.
The remaining 105 patients were admit-
ted into the study. Forty patients had a
positive CPR status, whereas 65 had a
negative status. Forty-eight patients were
randomized to the LSE group, whereas 57
patients were randomized to receive MT.
All patients underwent treatment accord-
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[RESEARCHREPORT]
ing to their allocated treatment group.
Sixteen patients did not complete the
LSE intervention, and 8 patients did not
complete the MT intervention (P= .02).
FIGURE 1presents patient recruitment and
retention throughout the study.
TABLE 1presents baseline demographic,
history, and self-reported variables for all
groups and subgroups. All baseline vari-
ables were normally distributed, with theexception of body mass index and dura-
tion of LBP. Log transformations were
thus performed on body mass index and
duration of LBP, resulting in a better dis-
tribution pattern. As a result, the geomet-
ric mean with 95% confidence interval is
reported for these variables, as opposed
to meanSD for all other baseline vari-
ables (TABLE 1). No baseline differences
were noted between the different groups
and subgroups other than for age. Pa-
tients with a positive CPR status were
younger than patients with a negative
CPR status (P= .0006). This difference
was expected, as 1 of the items comprising
the CPR is being less than 40 years of age.
Therefore, we did not correct our model
to account for this expected difference.
Littles "missing completely at ran-
dom" test indicated that the hypothesis
that final MODI and NPRS scores wererandomly missing could not be rejected
(P= .76 for the MODI and P= .52 for the
NPRS). Therefore, expectation maximi-
zation was used to replace missing values.
Completers Versus NoncompletersAll baseline demographic, history, and
self-reported variables were compared
between patients who completed the
intervention (completers, n = 81) and
patients who dropped out prior to com-
pleting the intervention (noncompleters,
n = 24) using Wilcoxon and Fisher ex-
act tests for continuous and categorical
variables, respectively. Noncompleters
exhibited a higher baseline score onthe Fear-Avoidance Beliefs Question-
naire physical activity subscale versus
completers (17.2 versus 15.1, P = .04).
Noncompleters also had a lower level
of education compared to completers
(P = .03). No other differences were
detected between the completers and
noncompleters.
Analysis by Intention to TreatThe baseline and final MODI and NPRS
scores for each treatment group and sub-group are summarized in TABLE 2. When
assessing final disability level, the statisti-
cal level of significance for the 2-way in-
teraction between treatment group and
CPR status wasP= .17. A main effect was
detected for treatment (P= .05), which
indicated that patients receiving LSE
experienced less disability by the end
of treatment compared to the patients
who received MT. A main effect was also
detected for CPR status (P= .04), indi-
cating that patients with a positive CPRstatus experienced less disability by the
end of treatment compared to those with
a negative CPR status, regardless of the
treatment received. The 2 preplanned
pairwise comparisons indicated that (1)
among patients receiving LSE, those with
a positive CPR status experienced less dis-
ability at the end of the intervention com-
pared to those with a negative CPR status
(P= .02); and (2) among patients with a
positive CPR status, those receiving LSE
experienced less disability by the endof treatment compared to those receiv-
ing MT (P= .03). The change in MODI
between baseline and the end of treat-
ment for the 4 subgroups is represented
in FIGURE 2. No interactions or main ef-
fects were noted for pain (P>.26). TABLE 3
presents the adjusted final disability and
pain scores for all groups and subgroups,
and TABLE 4presents the differences in fi-
nal disability and pain among the differ-
ent groups and subgroups.
Screened for eligibility, n = 531
Randomized, n = 105
Lumbar stabilization exercises,n = 48
Excluded, n = 297:
MODI
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The proportion of patients who
achieved a successful outcome, defined
as a reduction of at least 50% in disability
as measured by the MODI, did not differ
among the 4 subgroups (P= .31) (FIGURE 3
).When examining the interaction of
treatment group with each of the indi-
vidual items comprising the CPR on fi-
nal disability, no significant effects were
noted (aberrant movement,P= .07; prone
instability test, P= .16; age less than 40
years,P= .72; SLR of 91 or greater, P=
.79). However, when combining the pres-
ence of aberrant movement and a positive
prone instability test (n = 44), a signifi-
cant 2-way interaction between treatment
group and the modified version of the CPR
(mCPR) was found for final disability (P
= .02). When the 2 pairwise comparisons
were repeated using the mCPR, findings
indicated that (1) among patients receiv-ing LSE, those with a positive mCPR sta-
tus (n = 20) experienced less disability by
the end of treatment compared to those
with a negative mCPR status (n = 28,P=
.02); and (2) among patients with a posi-
tive mCPR status, those receiving LSE (n
= 20) experienced less disability by the
end of treatment compared to those re-
ceiving MT (n = 24,P= .005). Unlike the
original version of the CPR, the mCPR
did not demonstrate a main effect for fi-
nal disability (P= .27). No 2-way interac-
tion or main effects were noted for final
pain level when using the mCPR (P>.09).
TABLE 5presents the adjusted final disabil-
ity and pain scores of the different groupsand subgroups based on the mCPR, and
TABLE 6 presents the differences in final
disability and pain among the groups and
subgroups based on the mCPR.
Finally, the proportion of patients
achieving a successful outcome did not
differ between the subgroups based on
mCPR status (P= .30) (FIGURE 4).
Per-Protocol AnalysisSimilar to analysis by intention to treat,
TABLE 1 Baseline Demographic, History, and Self-Report Variables for All Groups
Abbreviations: BMI, body mass index; CPR, patients with a negative status on the clinical prediction rule; CPR+, patients with a positive status on the clini-cal prediction rule; FABQ-PA, Fear-Avoidance Beliefs Questionnaire physical activity subscale; FABQ-W, Fear-Avoidance Beliefs Questionnaire work subscale;
LBP, low back pain; LSE, patients treated with lumbar stabilization exercises; MODI, modified Oswestry Disability Index; MT, patients treated with manual
therapy; NPRS, numeric pain rating scale.
*Values are meanSD.CPR greater than CPR+ (P = .0006).Values are mean (95% confidence interval).Numbers provided when data not available on all patients.
Characteristic LSE (n = 48) MT (n = 57) CPR+ (n = 40) CPR (n = 65)LSE CPR+(n = 18)
LSE CPR(n = 30)
MT CPR+(n = 22)
MT CPR(n = 35)
Sex (female), n (%) 25 (52.1) 31 (54.4) 22 (55.0) 34 (52.3) 10 (55.6) 15 (50.0) 12 (54.5) 19 (54.3)
Age, y* 38.310.5 35.59.1 32.87.5 39.210.3 32.77.4 41.610.7 32.87.7 37.29.6
BMI, kg/m2 24.4 (22.9, 25.9) 25.8 (24.3, 27.3) 24.2 (22.6, 25.9) 25.9 (24.7, 27.3) 22.9 (20.7, 25.4) 25.9 (24.0, 27.9) 25.6 (23.3, 28.1) 26.0 (24.3, 27.8)
Education, n (%)
Less than high school 2 (4.2) 0 (0) 0 (0) 2 (3.1) 0 (0) 2 (6.7) 0 (0) 0 (0)
High school 21 (43.7) 15 (26.3) 9 (22.5) 27 (41.5) 5 (27.8) 16 (53.3) 4 (18.2) 11 (31.4)
Some postsecondary 8 (16.7) 15 (26.3) 9 (22.5) 14 (21.5) 3 (16.7) 5 (16.7) 6 (27.3) 9 (25.7)
Bachelor 13 (27.1) 17 (29.8) 18 (45.0) 12 (18.5) 8 (44.4) 5 (16.7) 10 (45.5) 7 (20.0)
Master 3 (6.2) 9 (15.8) 4 (10.0) 8 (12.3) 2 (11.1) 1 (3.3) 2 (9.0) 7 (20.0)
Doctorate 1 (2.1) 1 (1.8) 0 (0) 2 (3.1) 0 (0) 1 (3.3) 0 (0) 1 (2.8)
Work status (employed),
n (%)
38/43 (88.4) 41/53 (77.4) 28/36 (77.8) 51/60 (85.0) 13/16 (81.3) 25/27 (92.6) 15/20 (75.0) 26/33 (78.8)
Smoker, n (%) 16/44 (36.4) 11/53 (20.8) 14/36 (38.9) 13/61 (21.3) 8/16 (50.0) 8/28 (28.6) 6/20 (30.0) 5/33 (15.2)
Duration (days since
onset)58.7 (41.8, 82.4) 67.4 (48.9, 92.9) 63.8 (44.2, 92.2) 62.0 (46.5, 82.7) 52.0 (30.5, 88.6) 66.3 (43.6, 101.0) 78.4 (47.3, 130.0) 57.9 (39.1, 85.9)
Use of analgesics, n (%) 22/42 (52.4) 32/53 (60.4) 23/36 (63.9) 31/59 (52.5) 9/16 (56.3) 13/26 (50.0) 14/20 (70.0) 18/33 (54.6)
Past LBP, n (%) 34/48 (70.8) 35/56 (62.5) 27/39 (69.2) 42/65 (64.6) 13/18 (72.2) 21/30 (70.0) 14/21 (66.7) 21/35 (60.0)
Symptoms below knee,
n (%)
14 (29.2) 16 (28.1) 8 (20.0) 22 (33.8) 2 (11.1) 12 (40.0) 6 (27.3) 10 (28.6)
NPRS (0-10)* 4.91.7 5.31.7 4.91.7 5.31.7 4.41.7 5.21.6 5.21.6 5.41.8
MODI (0-100)* 37.810.6 37.612.5 40.012.8 36.310.6 37.89.4 37.711.4 41.815.0 35.09.9
FABQ-PA (0-24)* 16.24.4 15.14.9 14.95.3 16.04.3 15.94.3 16.34.6 14.15.8 15.74.2
FABQ-W (0-42)* 18.19.9 19.410.3 19.910.5 18.19.9 18.911.0 17.69.4 20.710.3 18.610.4
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dated in our investigation. Nevertheless,
we believe the CPR may hold promise in
identifying patients most likely to experi-
ence success following LSE. Despite the
absence of a CPR-by-treatment interac-
tion, the 2 pairwise comparisons most
relevant for validating the CPR indicated
that, by the end of treatment, patients
with a positive CPR status who received
LSE (a matched intervention) experi-
enced less disability compared to thosewith a negative CPR status receiving
LSE or to patients with a positive CPR
status receiving MT (an unmatched in-
tervention). Furthermore, effect sizes for
both of these comparisons were very close
to the MCID of the MODI (10 points),
and the lower bounds of the 95% confi-
dence intervals were above zero (TABLE 4).
The extra noise created by the multiple
computations of the ANCOVA might
have prevented a significant CPR-by-
treatment interaction effect, despite theconsistent advantage for patients with a
positive CPR treated with LSE.
It seems, therefore, that the inability
to validate the CPR in this study is most
likely related to its level of power. Our
a priori sample-size calculation was de-
signed to detect a 12-point difference in
the MODI, with = .05 and a power of
70%. Therefore, it could be argued that
our study was somewhat underpowered.
However, based on our findings, 314
patients would have been required to
achieve 80% power for detecting an in-
teraction between treatment group and
CPR status, a sample size that was un-
realistic under the circumstances of the
present study. We therefore believe that,
although our results cannot validate the
CPR, they do not invalidate it but, in fact,
seem to imply its potential. It is not un-
reasonable to assume that the CPR in its
current form may still be able to indicatewhich patients would most likely succeed
with LSE.
Among other potential reasons for
the inability to validate a CPR are dif-
ferences in sample characteristics, in the
application of the CPR itself, in the ad-
ministration of the intervention, and in
the definition of the outcome between the
derivation and validation studies. With
regard to sample characteristics, the in-
clusion/exclusion criteria in the current
study were fairly similar to those of thederivation study,33which resulted in rela-
tively similar samples. However, patients
in the current study demonstrated a high-
er level of disability at baseline (MODI
score, 37% versus 29% in the derivation
study33) and a somewhat longer duration
of symptoms (68 versus 40 days). The
longer duration of LBP in the current
sample could have had a negative effect
on the overall prognosis32,40,72; however,
this effect was not expected to differ be-
tween the treatment groups or subgroups.
As for the application of the CPR it-
self, the sample of the current study in-
cluded a higher proportion of patients
with a positive CPR status compared to
the derivation study (38% versus 28%).33
A likely reason for this difference is the
younger age of our sample (37 versus 42
years). Another possible reason is thehigher prevalence of a positive prone
instability test in our study (71% versus
52% in the derivation study33). Because
we used the same testing technique and
rating criteria as outlined by Hicks et al,33
we cannot explain the difference in prev-
alence rates of a positive prone instability
test. In any event, we do not believe that
the higher rate of a positive CPR status in
our study was likely to hinder the ability
to validate the CPR.
The LSE program used in the currentstudy was very similar to that used in the
derivation study. In addition, the criteria
for dichotomizing the outcomes as suc-
cess or failure were identical to those
used in the derivation study.33Therefore,
we do not believe these factors would
likely explain the inability to validate the
CPR, either.
Finally, the inability to validate the
CPR may be related to the comparison
intervention used in the current study.
TABLE 4
Baseline Adjusted Mean Differences in Final
Disability (MODI) and Pain (NPRS) Between
the Different Groups and Subgroups
Abbreviations: CPR, patients with a negative status on the clinical prediction rule; CPR+, patients
with a positive status on the clinical prediction rule; LSE, patients treated with lumbar stabilization
exercises; MODI, modified Oswestry Disability Index; MT, patients treated with manual therapy;
NPRS, numeric pain rating scale.
*Values are mean difference (95% confidence interval).Positive values indicate an advantage to LSE.Positive values indicate an advantage to CPR+.Positive values indicate an advantage to LSE CPR+.
Comparison MODI (0-100)* PValue NPRS (0-10)* PValue
LSE versus MT 5.0 (0.1, 9.9) .05 0.5 (0.3, 1.3) .26
CPR+ versus CPR 5.2 (0.2, 10.2) .04 0.1 (0.7, 0.9) .88
LSE CPR+ versus LSE CPR 8.7 (1.4, 15.9) .02 0.3 (0.9, 1.5) .67
LSE CPR+ versus MT CPR+ 8.5 (0.7, 16.3) .03 0.7 (0.6, 1.9) .31
010
LSE CPR+ LSE CPR MT CPR+ MT CPR
2030
405060708090
Succ
essRate,
%
FIGURE 3. Rate of success (%) among the 4
subgroups based on the original clinical prediction
rule and a cutoff threshold of 50% decrease in
baseline modified Oswestry Disability Index score.
Abbreviations: LSE CPR, patients with a negative
status on the clinical prediction rule treated with
lumbar stabilization exercises; LSE CPR+, patients
with a positive status on the clinical prediction rule
treated with lumbar stabilization exercises; MT
CPR, patients with a negative status on the clinical
prediction rule treated with manual therapy; MT
CPR+, patients with a positive status on the clinical
prediction rule treated with manual therapy.
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Manual therapy seemed to be a suitable
comparison intervention because it is fre-quently used in the management of LBP,
it is advocated by several clinical practice
guidelines,1,19,76and it has previously been
shown to have a varied level of success
when compared to LSE in heterogeneous
samples of patients with LBP.11,24,50,62
Despite this rationale, recent evidence
suggests that spinal manipulation may
result in remediation of some muscle im-
pairments that are the focus of LSE pro-
grams, such as increased activation of the
transversus abdominis and lumbar mul-
tifidi.
42,61
It is possible, therefore, that themanipulation techniques included in the
MT intervention contributed to facilita-
tion of the deep spinal musculature and,
consequently, exerted an effect similar to
that attributed to LSE. Be that as it may,
when spinal manipulation has been pre-
viously performed specifically on patients
who meet the stabilization CPR,41no ef-
fects were observed on the activation of
the transversus abdominis or internal
oblique, and the clinical effects (pain and
disability) did not exceed the minimal
clinically important threshold.41Further-
more, another study indicated that none
of the variables comprising the stabiliza-
tion CPR was associated with increased
activation of the lumbar multifidus fol-
lowing spinal manipulation.43
Finally,any changes in activation of the lumbar
multifidus that were observed immedi-
ately after manipulation did not seem to
be consistently sustained 3 to 4 days after
the application of the technique.42There-
fore, we do not believe the manipulation
techniques in our study were likely to
produce long-lasting or clinically signifi-
cant changes in recruitment of the spinal
musculature of our patients.
During the process of CPR validation,
it is not unusual to attempt to modifyan original version of a CPR by adding,
omitting, or combining several of its
items.67,68,81 Our findings indicate that a
modified version of the CPR (mCPR),
containing only 2 of the original 4 items,
yielded a better predictive validity. The
mCPR did result in a significant inter-
action effect with treatment, and the 2
corresponding pairwise comparisons
indicated a better outcome for patients
with a positive mCPR status treated with
TABLE 5
BaselineAdjusted FinalDisability(MODI)
andPain(NPRS)AmongtheDifferentGroups
andSubgroupsBasedon themCPR*
Abbreviations: LSE, patients treated with lumbar stabilization exercises; mCPR, patients with a
negative status on the modified clinical prediction rule; mCPR+, patients with a positive status on the
modified clinical prediction rule; MODI, modified Oswestry Disability Index; MT, patients treated
with manual therapy; NPRS, numeric pain rating scale.*Values are mean (95% confidence interval) and are provided based on intention-to-treat analysis.
Group MODI (0-100) NPRS (0-10)
LSE (n = 48) 15.4 (11.8, 18.9) 2.5 (1.9, 3.0)
MT (n = 57) 20.4 (17.2, 23.7) 3.0 (2.5, 3.5)
mCPR+ (n = 44) 16.5 (12.8, 20.3) 2.7 (2.1, 3.3)
mCPR (n = 61) 19.3 (16.1, 22.4) 2.8 (2.3, 3.3)
LSE mCPR+ (n = 20) 11.2 (5.7, 16.6) 2.0 (1.1, 2.9)
LSE mCPR (n = 28) 19.6 (15.0, 24.2) 2.9 (2.1, 3.6)
MT mCPR+ (n = 24) 21.9 (16.9, 26.9) 3.3 (2.5, 4.1)
MT mCPR (n = 33) 19.0 (14.7, 23.2) 2.8 (2.1, 3.4)
TABLE 6
BaselineAdjusted MeanDifferences
in FinalDisability(MODI)andPain
(NPRS)BetweentheDifferentGroups
andSubgroupsBasedon themCPR
Abbreviations: LSE, patients treated with lumbar stabilization exercises; mCPR, patients with a
negative status on the modified clinical prediction rule; mCPR+, patients with a positive status on the
modified clinical prediction rule; MODI, modified Oswestry Disability Index; MT, patients treated
with manual therapy; NPRS, numeric pain rating scale.
*Values are mean difference (95% confidence interval) and are provided based on intention-to-treat
analysis.Positive values indicate an advantage to LSE.Positive values indicate an advantage to mCPR+.Positive values indicate an advantage to LSE (mCPR+).
Comparison MODI (0-100)* PValue NPRS (0-10)* PValue
LSE versus MT 5.0 (0.2, 9.9) .04 0.5 (0.2, 1.3) .18
mCPR+ versus mCPR 2.7 (2.2, 7.7) .27 0.2 (0.6, 1.0) .67
LSE mCPR+ versus LSE mCPR
8.4 (1.3, 15.5) .02 0.8 (0.3, 2.0) .16LSE mCPR+ versus MT mCPR+ 10.7 (3.4, 18.1) .005 1.2 (0.0, 2.4) .05
010
LSE mCPR+ LSE mCPR M T mCPR+ M T mCPR
2030
405060708090
SuccessRate,
%
FIGURE 4. Rate of success (%) among the 4
subgroups based on the mCPR and a cutoff
threshold of 50% decrease in baseline modified
Oswestry Disability Index score. Abbreviations:
LSE mCPR, patients with a negative status on the
modified clinical prediction rule treated with lumbar
stabilization exercises; LSE mCPR+, patients with
a positive status on the modified clinical prediction
rule treated with lumbar stabilization exercises;
mCPR, modified clinical prediction rule; MT mCPR,
patients with a negative status on the modified
clinical prediction rule treated with manual therapy;
MT mCPR+, patients with a positive status on the
modified clinical prediction rule treated with manual
therapy.
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journal of orthopaedic &sports physical therapy | volume 44 | number 1 | january 2014 | 15
LSE compared to patients treated with
unmatched interventions. Effect sizes
for these comparisons were either above
or slightly below the MCID of the MODI
(TABLE 6). These findings seem to suggestthat the mCPR may be a more accurate
predictor of success following LSE.
It is acknowledged that because the
mCPR was derived retrospectively, its
effect on final disability could have oc-
curred by chance alone. We believe, how-
ever, that several factors point against
this possibility. First, the mCPR is still
composed of items that have been previ-
ously linked to success following LSE in
the derivation study.33Second, no other
combination of items from the originalCPR produced similar findings. Third,
we believe this 2-item version may even
possess a clearer biomechanical plau-
sibility compared to the original CPR.
The mCPR status is considered positive
when both aberrant lumbar movement
and a positive prone instability test are
present. Teyhen et al70 demonstrated
that, compared to healthy individuals,
patients with LBP, aberrant movements,
and a positive prone instability test dem-
onstrate decreased control of lumbarsegmental mobility during midrange
lumbar motion.This difference may rep-
resent an altered motor control strategy,
which suggests that an LSE program may
be most beneficial under those circum-
stances. Furthermore, Hebert et al31dem-
onstrated that individuals with LBP and
a positive prone instability test displayed
decreased automatic activation of their
lumbar multifidi compared to healthy
controls. Given the remediating effects
of LSE on muscle activation patterns,
73,74
it seems reasonable that LSE would be
most beneficial for patients presenting
with such activation deficits. In contrast,
it seems much less clear why patients
under the age of 40 would preferentially
benefit from LSE as opposed to MT or
any other intervention. In fact, a younger
age has been previously associated with
a generally favorable prognosis following
an episode of LBP.5,13,29,52,72 This finding
may help to explain why the CPR in its
original version seemed to be consistently
associated with a better outcome, regard-
less of the treatment received. Likewise,
it seems less intuitive why a greater SLR
range of motion would predict a betteroutcome specifically following LSE.
Finally, our entire sample included 40
patients with a positive CPR status ac-
cording to the original (4-item) version
and 44 patients with a positive mCPR
status. It could therefore be argued that
the slightly larger number of patients
with a positive mCPR might have simply
increased the power to detect an inter-
action with treatment group. However,
as only 31 patients had a positive status
according to both versions of the CPR, itseems that the better predictive power of
the mCPR may not simply be a matter of
sample size but may be inherent in pa-
tients presenting with the 2 specific items
comprising the mCPR.
In summary, we believe that, in addi-
tion to its stronger statistical association
with success specifically following LSE,
the mCPR carries a stronger biomechani-
cal plausibility as a predictor of success
following this intervention. Nevertheless,
due to its retrospective nature, an addi-tional investigation is recommended to
prospectively establish the predictive va-
lidity of the mCPR.
Study LimitationsIn addition to the aforementioned issues
of power and the retrospective nature of
some of the findings, the current study
has several additional limitations. First,
the dropout rate was fairly high, in par-
ticular among the LSE group. Overall,
24 patients (22.8%) did not completethe study. The dropout rate was greater
among patients receiving LSE (33%
versus 14%). We believe that the overall
dropout rate of the current study may
partly reflect the dropout rate (31%)
among Israeli patients receiving outpa-
tient physical therapy for common mus-
culoskeletal conditions.23 The greater
dropout rate among the LSE group also
suggests that patients receiving this in-
tervention may not have perceived it to
be as valuable as MT. The manual contact
included in the MT intervention could
have created an attention effect in favor
of this intervention, which, in turn, might
have contributed to better compliance.Because this was suspected, the treating
clinicians were encouraged to provide
patients receiving LSE with continuous
verbal as well as manual cuing for main-
taining a neutral lumbar posture and an
ADIM. It seems, however, that this ap-
proach still failed to produce a similar
level of compliance among the 2 groups.
An intention-to-treat analysis was used
in an attempt to minimize the effect of
the dropout rate on our findings.
Longer-term outcomes should be as-sessed to determine whether the CPR
in its original or modified version has
any long-term effects on patients in the
various subgroups. In addition, the ex-
ternal validity of our findings needs to
be considered, as only 105 patients were
recruited after screening 531 potential
participants. Most participants were ex-
cluded for not meeting the minimal level
of disability required for inclusion (FIGURE
1). Therefore, findings are limited to pa-
tients with LBP with at least a moderatelevel of disability.
CONCLUSION
The previously suggested CPR
for identifying patients most likely
to succeed following LSE could not
be validated in this study. However, be-
cause the subgroup comparisons most
relevant for the validity of the CPR in-
dicated an advantage for patients with
a positive CPR treated by LSE, and be-cause of a relatively low level of power,
our findings suggest that the current CPR
still has the potential to predict success
following LSE. Furthermore, a modified
version of the original CPR that included
only 2 of its items (aberrant movement
and positive prone instability test) was
able to predict a successful outcome spe-
cifically following LSE and may serve as
a valid alternative. Future study is rec-
ommended to prospectively validate the
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[RESEARCHREPORT]
mCPR as a predictor of success with LSE
in individuals with LBP. Alternatively, to
validate the original version of the CPR, a
larger, replication study is recommended
in an attempt to overcome the insufficientpower of the current study. The findings
of this study are further limited by a rela-
tively large dropout rate (22.8%) and lack
of a long-term follow-up.
KEY POINTSFINDINGS:Although not validated, the
previously suggested CPR for identifying
patients most likely to succeed follow-
ing LSE shows promise. Furthermore, a
modified version of the CPR containing
only 2 of its original 4 items (presence ofaberrant movement and a positive prone
instability test) demonstrated a better
predictive validity in identifying those
most likely to succeed with LSE.
IMPLICATIONS:Patients with LBP present-
ing with aberrant lumbar movement as
well as a positive prone instability test
may benefit most from an LSE program.
CAUTION:Findings are limited by a
relatively small sample size, a relatively
large dropout rate, and the lack of a
long-term follow-up.
ACKNOWLEDGEMENTS: The authors thank Dr
Gregory Hicks, Arnon Ravid, Ori Firsteter,
Shai Grinberg, Efrat Laor, Dikla Taif, Alon
Ben-Moshe, Mossa Hugirat, Meira Lugasi,
Lena Oifman, Liron Laposhner, Beni Mazoz,
Fadi Knuati, Lena Kin, Ruthy Bachar, Chen
Tel-Avivi, Irit Fridman, Yana Avner, Naomi
Sivan, Rafi Cohen, and Yigal Levran for their
contribution and support of this work.
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journal of orthopaedic &sports physical therapy | volume 44 | number 1 | january 2014 | 17
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