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Alon Rabin, DPT, PhD, Faculty Member, Department of Physiotherapy, Ariel University,
Israel
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Anat Shashua, BPT, MS, Bat-Yamon Physical Therapy Clinic, Clalit Health Services,
Israel
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Koby Pizem, BPT, Giora Physical Therapy Clinic, Clalit Health Services, Israel
Gali Dar, PT, PhD, Department of Physical Therapy, Faculty of Social Welfare and
Institutional Review Board: This study was approved by the Helsinki Committee of Clalit
Health Services.
1
Corresponding Author:
with any commercial organization that has a direct financial interest in any matter
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Acknowledgment:
The authors would like to 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, Naomi
Journal of Orthopaedic & Sports Physical Therapy®
Sivan, Rafi Cohen, Yigal Levran for their contribution and support of this work.
2
Study Design: Randomized Controlled Trial
(CPR) for identifying patients most likely to experience short-term success following
management of low back pain (LBP), they do not seem more effective than other
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interventions. A 4-item CPR for identifying patients most likely to benefit from LSE has
determine their status on the CPR (positive or negative). Patients were stratified by CPR
disability was measured by the modified version of the Oswestry Disability Index
Results: The statistical significance for the 2-way interaction between treatment group
and CPR status for the level of disability at the end of the intervention was P=.17.
However, among patients receiving LSE, those with a positive CPR status experienced
less disability by the end of treatment compared with those with a negative CPR status
3
(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 treatment compared with patients
receiving MT (P=.05), and patients with a positive CPR status experienced less disability
by the end treatment compared with patients with a negative CPR status, regardless of the
When a modified version of the CPR (mCPR), containing only the presence of aberrant
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movement and a positive prone instability test (PIT) was used, a significant interaction
with treatment was found for final disability (P=.02). Among patients receiving LSE,
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
those with a positive mCPR status experienced less disability by the end of treatment
compared with those with a negative mCPR status (P=.02), and among patients with a
positive mCPR status those receiving LSE experienced less disability by the end of
Conclusion: The previously suggested CPR for identifying patients likely to benefit from
LSE could not be validated in this study. However, due to the relatively low level of
power this study should not invalidate the CPR either. A modified version of the CPR,
containing only 2 of its items, may possess a better predictive validity in identifying those
most likely to succeed with a LSE program. Because this modified version was
4
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5
Low back pain (LBP) is common among the general population with a lifetime and point
prevalence estimated at greater than 80% and 28%, respectively.13 Although short-term
Systematic reviews of various physical therapy interventions for LBP do not provide
strong support in favor of any particular treatment approach.2, 50, 51, 76 One possible reason
is the use of heterogeneous samples of patients in many clinical trials for LBP. Patients
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with LBP demonstrate both etiologic and prognostic heterogeneity,10, 40, 46 which makes it
unlikely for any single intervention to have a significant advantage over another when
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used on an entire population with LBP. Classifying patients into more homogeneous
subgroups has been previously defined a top research priority, 9 and in fact, more recent
research suggests that matching patients with interventions based on their specific clinical
the transversus abdominis and atrophy of the lumbar multifidus,24, 34, 37, 48, 70, 80 have been
identified among patients with LBP. These impairments may result in a reduction in
spinal stiffness,82 and possibly render the spine more vulnerable to excessive deformation
and pain. Lumbar stabilization exercises (LSE) attempt to address these impairments by
exercises are widely used by physical therapists in the management of LBP.6, 11, 22, 25, 35, 44,
49, 50, 62, 65
Although some evidence exists to support the remediating effects of LSE on
6
some of the muscle impairments identified in patients with LBP,36, 73, 74 the clinical
efficacy of this intervention seems to vary. When compared with sham or no intervention,
In light of the variable clinical success of LSE, and in accordance with the
aforementioned need to classify patients who have LBP into more homogeneous
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subgroups, Hicks et al33 suggested a clinical prediction rule (CPR) to specifically identify
patients with LBP who are likely to exhibit short-term improvement with LSE.33 Four
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
variables were found to possess the greatest predictive power for treatment success: 1)
age < 40 years, 2) average straight leg raise (SLR) ≥ 910, 3) the presence of aberrant
lumbar movement, and 4) a positive prone instability test.33 When at least 3 of the 4
variables were present the positive likelihood ratio for achieving a successful outcome
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was 4.0, increasing the probability of success from 33% to 67%. 33 The study by Hicks et
al33 comprises the first stage in establishing a CPR, the derivation stage.4, 14, 55 Following
Given its preliminary nature, and because CPRs don't typically perform as well on new
samples of patients,21, 30, 67, 68 modification of the CPR may also be necessary to achieve
satisfactory predictive validity. Once validated, CPRs can move into the final stage of
their determination which includes an investigation into their impact on clinical practice
7
Validation of the CPR for LSE requires a randomized controlled trial in which patients
with different status on the CPR (positive or negative) undergo a LSE program, as well as
ascertain that the CPR truly identifies patients who will benefit specifically from LSE,
rather than patients with a favorable prognosis, irrespective of the treatment received.66
Finally, to validate the CPR in the most clinically meaningful manner, we believe the
management of patients with LBP,39, 45, 56 and is also recommended by several clinical
practice guidelines and systematic reviews for the management of acute, sub-acute, and
chronic LBP.1, 7, 19, 77 These factors, combined with the fact that LSE programs have
Journal of Orthopaedic & Sports Physical Therapy®
previously demonstrated a varied level of success when compared with MT,11, 25, 50, 62
suggest that MT is a suitable comparison intervention for testing the validity of the CPR.
In contrast to its use among heterogeneous sample,11, 25, 50, 62 LSE should demonstrate a
clearer advantage among patients with LBP who also satisfy the CPR, if the CPR
The purpose of this investigation was to determine the validity, or 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 positive CPR status will
8
exhibit a better outcome compared with those with a negative CPR status. We also
hypothesized that among patients with a positive CPR status, those who received LSE
would exhibit a better outcome compared with those who received MT.
METHODS
Patients
One hundred and five patients with a diagnosis of LBP referred to physical therapy to 1
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of the 5 outpatient clinics of Clalit Health Services in the Tel-Aviv Metropolitan area
were recruited for this study. Subjects were included if they were 18 to 60 years old, had
a main complaint of LBP with or without associated leg symptoms (pain, paresthesia),
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
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: a history suggesting any red flags, (ie, malignancy, infection, spine fracture, cauda
equina syndrome); 2 or more signs suggesting lumbar nerve root compression such as
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dermatomal distribution, or a positive SLR, crossed SLR, or a femoral nerve stretch test;
excluded if they were pregnant, received chiropractic or physical therapy care for LBP in
the preceding 6 months, could not read or write in the Hebrew language, or had a pending
legal procedure associated with their LBP. Prior to participation, all patients signed an
informed consent form approved by The Helsinki Committee of Clalit Health Services.
9
Therapists
Sixteen physical therapists were involved in the study. Eleven therapists with between 4
performed baseline and follow-up evaluations. Prior to beginning the study all
participating therapists underwent two 4-hour sessions in which the rational and protocol
of the study were presented and all examination and treatment procedures were
demonstrated and practiced. Therapists had to pass a written examination regarding all
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study procedures prior to participating in data collection. Finally, each therapist received
a manual describing all treatment and evaluation procedures, based on his/her role in the
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
the concept of the CPR throughout the study in an attempt to avoid any bias based on this
knowledge during treatment. All treating therapists provided both treatments of the study
Procedure
After giving their consent, patients underwent a baseline examination which included
Scale (NPRS) with “0” equaling “No pain” and “10” equaling “Worst imaginable pain”,
the Hebrew version of the MODI,3, 28 and the Hebrew version of the Fear-Avoidance
Beliefs Questionnaire (FABQ).38, 79 In addition, the history of the present and any past
10
The physical examination included: a neurological screen to rule out lumbar nerve root
compression; lumbar active motion, during which the presence of aberrant movement, as
defined by Hicks et al33 was determined; bilateral SLR range of motion; segmental
mobility of the lumbar spine; and the prone instability test. The subject’s status on the
CPR (positive or negative) was established based on the findings of the physical
examination.
Examiners that performed the baseline examinations, as well as examiners that screened
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patients for eligibility to participate in the study, did not know the intervention that the
Reliability
The reliability of the individual physical examination items comprising the CPR, as well
as that of the entire CPR has been reported previously.60 In this previous study, the
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interrater reliability for determining CPR status was excellent (kappa[қ]= 0.86) while the
interrater reliability of each of the items comprising the CPR ranged from moderate to
substantial (қ=0.64-0.73).60
Randomization
At the conclusion of the physical examination, each patient was randomized to receive
stratified by CPR status to assure an adequate number of patients with a positive and a
11
negative CPR status would be included in each intervention group. The list was kept by a
Intervention
Patients in both groups received 11 treatment sessions over an 8-week period. Each
patient was seen twice a week during the first 4 weeks, and then once a week for 3
additional weeks. A 12th session (usually on the 8th week) consisted of a final evaluation.
The total number of sessions (12) matched the maximum number of physical therapy
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visits allowed annually per condition under the policy of the Clalit Health Services HMO
which covered all patients participating in the study. Subjects in both groups were
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prescribed with a home exercise program (HEP) consistent with their treatment group,
however, no attempt was made to track subjects’ compliance with the HEP.
The LSE program was largely based on the program described by Hicks et al33 with a few
minor changes in the order of the exercises and a few additional levels of difficulty for
some of the exercises. Patients were initially educated on the structure and function of the
with LBP. Patients were then taught to perform an isolated contraction of the transversus
the quadruped, standing, and supine positions.63, 64, 69, 70, 73 Once proper ADIM was
achieved (most likely by the 2nd or 3rd visit), additional loads were superimposed on the
spine through various upper extremity, lower extremity, and trunk movement patterns.
12
Exercises were performed in the quadruped, side-lying, supine and standing positions,
with the goal to recruit a variety of trunk muscles.18, 53, 54 In each position, exercises were
ordered by their level of difficulty and patients progressed from one exercise to the next
after satisfying specific pre-determined criteria. On the 7th treatment session, functional
movement patterns were incorporated into the training program while performing ADIM
and maintaining a neutral lumbar spine. This stage, which was not included in the
derivation study, was added to the program because it is recommended by others.22, 58, 62
The exercises in each stage of the LSE program, as well as the specific criteria for
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Manual Therapy
directed at the lumbar spine that have been used previously with some degree of success
in various groups with LBP.8, 15, 20, 59 In addition, manual stretching of several hip and
Journal of Orthopaedic & Sports Physical Therapy®
thigh muscles was performed, as flexibility of the lower extremity is purported to protect
the spine from excessive strain.53 Finally, active range of motion and stretching exercises
were added to the program as they are commonly prescribed in combination with MT to
maintain or improve the mobility gains resulting from the manual procedures.8, 15, 20, 47
The exercises included were selected in an attempt to minimize trunk muscle activation,
All manual procedures and exercises were prescribed based on the clinical judgment of
the treating therapist, however each session could include up to 3 manual techniques, 1 of
13
which had to be a thrust manipulative technique directed at the lumbar spine, and an
additional technique had to include a manual stretch of a lower extremity muscle. The
the discretion of the treating therapist. The MT techniques, as well as all exercises used in
Evaluation
The MODI served as the primary outcome measure in this investigation. The MODI is
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scored from 0-100 and has a minimal clinically important difference (MCID) of 10 points
among patients with LBP.57 The secondary outcome measure was the NPRS with an
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
MCID of 2-points among patients with LBP.16 Both measures were administered before
the beginning of treatment and immediately after the last treatment session by an
Sample Size
points in the final score of the MODI based on the interaction between treatment group
(LSE versus MT) and CPR status (positive versus 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, we expected 120
patients would be necessary to recruit 40 patients with a positive CPR status. This
14
number was eventually obtained after recruiting 105 patients, at which point recruitment
was completed.
Statistical Analysis
Descriptive statistics including frequency counts for categorical variables and measures
of central tendency and dispersion for continuous variables were used to summarize the
data. All baseline variables were assessed for normal distribution using the Shapiro-Wilks
test. Baseline variables were compared between treatment groups (LSE versus MT), CPR
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status (positive versus negative), and the resulting 4 subgroups, using 2-way analysis of
variance (ANOVA) and chi square tests for continuous and categorical variables,
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respectively.
The primary aim of the study was tested using 2 separate analyses of covariance
(ANCOVA), with the final MODI score serving as the dependent variable in 1 model and
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the final NPRS score serving as the dependent variable in the second model. In both
models treatment group and CPR status served as independent variables, and the baseline
MODI score (or baseline NPRS score) was used as a covariate. The residuals of all
models were tested for any violations of the ANCOVA assumptions and for outliers. The
main effects of treatment group and CPR status were evaluated, as well as the 2-way
interaction between these factors on the final MODI and NPRS scores. The a-priori level
of significance for these analyses was P≤.05. Two pair-wise comparisons were planned
following the ANCOVA: 1.) comparison of differences between patients with a positive
CPR receiving LSE and those with a negative CPR receiving LSE, and 2.) comparison of
15
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
The individual items of the CPR, as well as different combinations of these items were
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similarly tested to identify whether any such combination would enhance the predictive
previously established cutoff threshold of 50% reduction in the baseline score of the
imputations for any missing values of the 2 outcome measures (MODI, NPRS). First,
Little’s “Missing Completely at Random” (MCAR) test was performed to test the
hypothesis that missing values were randomly distributed. If this hypothesis could not be
analysis was performed as well. All statistical analyses were performed using JMP
16
version 10 statistical package (SAS Institute, Cary, NC), as well SPSS statistical package,
RESULTS
Five hundred and thirty-one potential candidates were screened for eligibility between
March 2010 and April 2012. Two-hundred ninety-seven patients did not meet the
inclusion criteria and another 129 declined participation. The remaining 105 patients
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were admitted into the study. Forty patients had a positive CPR status, while 65 had a
negative status. Forty-eight patients were randomized to the LSE group, while 57 patients
were randomized to receive MT. All patients underwent treatment according to their
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allocated treatment group. Sixteen patients did not complete the LSE intervention, while
8 patients did not complete the MT intervention (P=.02). FIGURE 1 presents subject
TABLE 1 presents baseline demographic, history, and self-reported variables for all
groups and subgroups. All baseline variables were normally distributed with the
exception of body mass index and duration of LBP. Log transformations were thus
performed on body mass index and duration of LBP resulting in a better distribution
pattern. As a result, the geometric means with 95% confidence interval (CI) are reported
for these variables as opposed to means ± SD for all other baseline variables (TABLE 1).
No baseline differences were noted between the different groups and subgroups other
than for age. Patients 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
17
comprising the CPR is age less than 40 years old. Therefore, we didn't correct our model
Little’s MCAR test indicated that the hypothesis that final MODI and NPRS scores were
randomly missing could not be rejected (P=.76 for MODI, and P=.52 for NPRS).
All baseline demographic, history, and self-reported variables were compared between
patients who completed the intervention (ie, completers, [n=81]) and patients who
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dropped out prior to completing the intervention (ie, non-completers, [n=24]) using
Wilcoxon and Fisher exact tests for continuous and categorical variables, respectively.
PA) versus completers (17.2 versus 15.1, P=.04). Non-completers also had a lower level
Journal of Orthopaedic & Sports Physical Therapy®
Analysis by Intention-to-Treat
The baseline and final MODI and NPRS scores for each treatment group and subgroup
are summarized in TABLE 2. When assessing final disability level, the statistical level of
significance for the 2-way interaction between treatment group and CPR status was
P=.17. A main effect was detected for treatment (P=.05), indicating that patients
receiving LSE experienced less disability by the end of treatment compared with patients
18
receiving MT. A main effect was also detected for CPR status (P=.04) indicating that
patients with a positive CPR status experienced less disability by the end of treatment
compared with patients with a negative CPR status, regardless of the treatment received.
The 2 pre-planned pair-wise comparisons indicated that: 1.) among patients receiving
LSE, those with a positive CPR status experienced less disability at the end of the
intervention compared with those with a negative CPR status (P=.02), and 2.) among
patients with a positive CPR status, those receiving LSE experienced less disability by
graphical representation of the change in MODI between baseline and the end of
treatment for the 4 subgroups. No interactions or main effects were noted for pain
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(P>.26).
TABLE 3 presents the adjusted final disability and pain scores for all groups and
subgroups. TABLE 4 presents the differences in final disability and pain among the
Journal of Orthopaedic & Sports Physical Therapy®
least 50% in disability as measured by the MODI, did not differ among the 4 subgroups
When examining the interaction of treatment group with each of the individual items
comprising the CPR on final disability, no significant effects were noted (aberrant
movement, P=.07; prone instability test, P=.16; age less than 40 years, P=.72; SLR ≥ 910,
19
P=.79). However, when combining the presence of aberrant movement and a positive
prone instability test, (n=44), a significant 2-way interaction between treatment group and
this modified version of the CPR (mCPR) was found for final disability (P=.02). When
the 2 pair-wise comparisons were repeated using the mCPR, findings indicated that: 1.)
among patients receiving LSE, those with a positive mCPR status (n=20) experienced
less disability by the end of treatment compared with those with a negative mCPR status
(n=28, P=.02), and 2.) among patients with a positive mCPR status, those receiving LSE
(n=20) experienced less disability by the end of treatment compared with those receiving
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MT (n=24, P=.005). Unlike the original version of the CPR, the mCPR did not
No 2-way interaction or main effects were noted for final pain level when using the
mCPR (P>.09).
Journal of Orthopaedic & Sports Physical Therapy®
TABLE 5 presents the adjusted final disability and pain scores of the different groups
and 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
20
Per-Protocol Analysis
status and treatment on final disability (P=.14). In addition, a main effect was retained for
CPR status on final disability (P=.04), indicating that patients with a positive CPR status
experienced less disability by the end of treatment compared with patients with a negative
CPR status regardless of the treatment received. No main effect was noted for treatment
(P=.06). The pre-planned pair-wise comparisons indicated that: 1.) among all patients
receiving LSE, those with a positive CPR status experienced less disability by the end of
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treatment compared with 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
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
main effects were noted for pain (P>.21). Chi square analysis indicated that the
proportion of patients achieving a successful outcome was greater among patients with a
positive CPR status compared with patients with a negative CPR status, regardless of the
Journal of Orthopaedic & Sports Physical Therapy®
The 2-way interaction between treatment group and the mCPR on final disability was
indicated that: 1.) among patients receiving LSE, those with a positive mCPR status
experienced less disability at the conclusion of the intervention compared with those with
a negative mCPR status (P=.03), and 2.) among patients with a positive mCPR status,
those receiving LSE experienced less disability at the conclusion of the intervention
compared with those receiving MT (P=.006). No 2-way interactions or main effects were
noted for pain level when using the mCPR (P>.13). Finally, although a greater proportion
21
of patients with a positive mCPR achieved a successful outcome compared with the other
DISCUSSION
The previously suggested CPR for predicting a successful outcome following LSE33
could not be validated in our investigation. Nevertheless, we believe the CPR holds
promise in identifying patients most likely to experience success following LSE. Despite
for validating the CPR still indicated that by the end of treatment, patients with a positive
CPR status that received LSE (ie, a matched intervention) experienced less disability
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compared with patients with a negative CPR status receiving LSE, or patients with a
sizes for both of these comparisons were very close to the MCID of the MODI
(10 points) and the lower bounds of the 95% CI were above 0 (TABLE 4). The extra
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noise created by the multiple computations of the ANCOVA, may have prevented a
treated by 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 designed to detect a
12-point difference in the MODI with α=.05 and a power of 70%. Therefore, it could be
argued that our study was somewhat underpowered. However, based on our findings, 314
22
patients would have been required to achieve 80% power for detecting an interaction
between treatment group and CPR status. This number is unrealistic under our
circumstances.
We therefore believe that, although our results cannot validate the CPR, they do not
invalidate it either, and in fact, they seem to infer its potential. It is not unreasonable to
assume that the CPR in its current form may still indicate which patients are most likely
Among other potential reasons for the inability to validate a CPR are differences in
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sample characteristics, differences in the application of the CPR itself, differences in the
between the derivation and validation studies. With regard to sample characteristics, the
inclusion/exclusion criteria in the current study were fairly similar to those of the
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derivation study.33 This resulted in relatively similar samples. However, patients in the
current study did demonstrate a higher 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 prognosis,31, 40, 72 however, this effect was not expected to
As for the application of the CPR itself, the sample of the current study included a higher
proportion of patients with a positive CPR status compared with the derivation study
23
(38% versus 28%).33 A likely reason for this difference is the younger age of our sample
(37 years versus 42 years). Another possible reason is the higher 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 prevalence rates of a positive prone instability test. In any event,
we do not believe the higher rate of a positive CPR status in our study was likely to
The LSE program used in the current study was very similar to the one used in the
derivation study. In addition, the criteria for categorizing the outcome dichotomously as
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
success or failure were identical to the ones used in the derivation study.33 Therefore, we
do not believe these factors are likely to explain the inability to validate the CPR either.
Finally, the inability to validate the CPR may be related to the comparison intervention
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clinical practice guidelines,1, 19, 77 and it has previously been shown to have a varied level
of success when compared with LSE among heterogeneous samples of patients with
LBP.11, 25, 50, 62 Despite this rationale, recent evidence suggests that spinal manipulation
may result in remediation in some of the muscle impairments that are the focus of LSE
24
consequently exerted an effect similar to that attributed to LSE. Be that as it may, when
spinal manipulation has been previously performed specifically on patients who meet the
abdominis or internal oblique, and the clinical effects (ie, pain and disability) did not
exceed the minimal clinically important threshold.41 Furthermore, another study indicated
that none of the variables comprising the stabilization CPR was associated with increased
activation of the lumbar multifidus following spinal manipulation.43 Finally, any changes
in activation of the lumbar multifidus that were observed immediately after manipulation
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did not seem to be consistently sustained 3-4 days after the application of the technique.42
Therefore, we do not believe the manipulation techniques in our study were likely to
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
During the process of CPR validation, it is not unusual to attempt to modify an original
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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, yields a better predictive validity. The mCPR did result in a significant
interaction effect with treatment, with the 2 corresponding pair-wise comparisons also
indicating a better outcome for patients with a positive mCPR status treated by LSE
compared with 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 suggest that the mCPR may be a more accurate predictor of
25
It is acknowledged that because the mCPR was derived retrospectively, its effect on final
disability could have occurred by chance alone. We believe, however, that several factors
point against this possibility. First, the mCPR is still comprised of items that have been
previously linked to success following LSE in the derivation study.33 Second, no other
combination of items from the original CPR produced similar findings. And third, we
believe this 2-item version may even possess a clearer biomechanical plausibility
compared with the original CPR. The mCPR status is considered positive when both
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aberrant lumbar movement and a positive prone instability test are present. Teyhen et al71
demonstrated that, compared with healthy individuals, patients with LBP, aberrant
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
lumbar segmental mobility during mid-range lumbar motion.71 This difference may
represent an altered motor control strategy, which may suggest that a LSE program would
that individuals with LBP and a positive prone instability test displayed decreased
automatic activation of their lumbar multifidi compared with healthy controls.32 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
LBP. 5, 12, 29, 52, 72 This finding may help to explain why the CPR in its original version
26
received. Likewise it seems less intuitive, why a greater SLR range of motion would
Finally, our entire sample included 40 patients with a positive CPR status according 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 may
have simply increased the power to detect an interaction with treatment group. However,
as only 31 patients had a positive status according to both versions of the CPR, it seems
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that the better predictive power of the mCPR is not simply a matter of sample size, but is
inherent to patients presenting with the 2 specific items comprising the mCPR.
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Therefore, we believe, that in addition to its stronger statistical association with success
Study Limitations
In 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 drop out rate
was fairly high, in particular among the LSE group. Overall, 24 patients (22.8%) did not
complete the study. The drop out rate was greater among patients receiving LSE
(33% versus 14%). We believe the overall drop out rate in the current study partly
27
reflects the reality of outpatient physical therapy services among the Israeli population. A
recent publication reported a 31% drop out rate among Israeli patients receiving
outpatient physical therapy for common musculoskeletal conditions.23 The fact that the
drop out rate was greater among the LSE group also suggests that patients receiving this
intervention 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, may have contributed to better compliance. Because this was
suspected, treating clinicians were encouraged to provide patients receiving LSE with
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continuous verbal, as well as manual cueing for maintaining a neutral lumbar posture and
an ADIM. It seems, however, that this approach still failed to produce a similar level of
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Longer-term outcomes should be assessed to determine whether the CPR in its original or
Journal of Orthopaedic & Sports Physical Therapy®
modified versions has any long-term effects on patients in the various subgroups. In
addition, the external validity of our findings needs to be considered, as only 105 patients
were recruited after screening 531 potential participants. Most participants were excluded
for not meeting the minimal level of disability required for inclusion (FIGURE 1).
Therefore, findings are limited to patients with LBP with at least a moderate level of
disability.
28
CONCLUSION
The previously suggested CPR for identifying patients most likely to succeed following
LSE could not be validated in this study. However, because the subgroup comparisons
most relevant for the validity of the CPR still indicated an advantage for patients with a
positive CPR treated by LSE, and because of a relatively low level of power, our findings
still suggest the current CPR holds potential in predicting success following LSE.
Furthermore, a modified version of the original CPR including only 2 of its items
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(aberrant movement and prone instability test), was able to predict a successful outcome
specifically following LSE and may serve as a valid alternative. A future study is
individuals with LBP. Alternatively, in order to validate the original version of the CPR,
of the current study. The findings of this study are further limited by a relatively large
KEY POINTS
Findings: Although not validated, the previously suggested CPR for identifying patients
most likely to succeed following LSE seems promising. Furthermore, a modified version
of the CPR containing only 2 of its original 4 items (presence of aberrant movement and
29
Implication: Patients with LBP presenting with aberrant lumbar movement as well as a
positive prone instability test may benefit most from a LSE program.
Caution: Findings are limited by a relatively small sample size, a relatively large drop
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44
FIGURE 1. Flow Diagram of Participants Recruitment and Retention.
Analyzed Analyzed
(n=48) (n=57)
Journal of Orthopaedic & Sports Physical Therapy®
Prediction Rule +); LSE (CPR-), Lumbar Stabilization (Clinical Prediction Rule -);
Rule -)
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Journal of Orthopaedic & Sports Physical Therapy®
FIGURE 3. Rate of Success (%) Among the 4 Subgroups Based on a Cutoff
Score.
Prediction Rule +); LSE (mCPR-), Lumbar Stabilization Exercises (Modified Clinical
Prediction Rule -); mCPR, Modified Clinical Prediction Rule; MT (mCPR+), Manual
TABLE 1. Baseline Demographic, History, and Self-Report Variables for All Groups.
Characteristic LSE MT CPR+ CPR- LSE (CPR+) LSE (CPR-) MT (CPR+) MT (CPR-)
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Sex, n (%) female 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) * † 38.3 ± 10.5 35.5 ± 9.1 32.8 ± 7.5 39.2 ± 10.3 32.7 ± 7.4 41.6 ± 10.7 32.8 ± 7.7 37.2 ± 9.6
BMI (kg/m2)‡ 24.4 25.8 24.2 25.9 22.9 25.9 25.6 26.0
Journal of Orthopaedic & Sports Physical Therapy®
(22.9, 25.9) (24.3, 27.3) (22.6, 25.9) (24.7, 27.3) (20.7, 25.4) (24.0, 27.9) (23.3, 28.1) (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
Work status, 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)
(%) employed §
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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)
(days since onset) † (41.8, 82.4) (48.9, 92.9) (44.2, 92.2) (46.5, 82.7) (30.5, 88.6) (43.6, 101.0) (47.3, 130.0) (39.1, 85.9)
Use of analgesics, 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)
Journal of Orthopaedic & Sports Physical Therapy®
n (%) §
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 14 (29.2) 16 (28.1) 8 (20) 22 (33.8) 2 (11.1) 12 (40.0) 6 (27.3) 10 (28.6)
knee, n (%)
NPRS (0-10)* 4.9 ± 1.7 5.3 ± 1.7 4.9 ± 1.7 5.3 ± 1.7 4.4 ± 1.7 5.2 ± 1.6 5.2 ± 1.6 5.4 ± 1.8
MODI (0-100)* 37.8 ± 10.6 37.6 ± 12.5 40.0 ± 12.8 36.3 ± 10.6 37.8 ± 9.4 37.7 ± 11.4 41.8 ± 15.0 35.0 ± 9.9
FABQPA (0-24)* 16.2 ± 4.4 15.1 ± 4.9 14.9 ± 5.3 16.0 ± 4.3 15.9 ± 4.3 16.3 ± 4.6 14.1 ± 5.8 15.7 ± 4.2
FABQW (0-42)* 18.1 ± 9.9 19.4 ± 10.3 19.9 ± 10.5 18.1 ± 9.9 18.9 ± 11.0 17.6 ± 9.4 20.7 ± 10.3 18.6 ± 10.4
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Abbreviations: BMI, body mass index; CPR, clinical prediction rule; FABQPA, Fear-Avoidance Beliefs-Physical Activity Sub-scale; FABQW,
Fear-Avoidance Beliefs-Work Sub-scale; HS, high school; LSE, lumbar stabilization exercises; LSE (CPR+), Lumbar stabilization exercises
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
(clinical prediction rule +); LSE (CPR-); Lumbar stabilization exercises (clinical prediction rule -);MODI, Modified Oswestry Disability Index;
MT, manual therapy; MT (CPR+), Manual therapy (clinical prediction rule +); MT (CPR-), Manual therapy (clinical prediction rule -);NPRS,
Numeric Pain Rating Scale.
* Values are means ± SD.
† CPR- greater than CPR+ (P=.0006).
‡ Values are means with 95% CI.
Journal of Orthopaedic & Sports Physical Therapy®
LSE (n=48) 37.8 ± 10.6 16.1 ± 11.2 4.9 ± 1.7 2.4 ± 1.8
CPR+ (n=40) 40.0 ± 12.8 16.6 ± 17.5 4.9 ± 1.7 2.6 ± 2.4
CPR- (n=65) 36.3 ± 10.6 19.4 ± 11.5 5.3 ± 1.7 2.9 ± 2.2
LSE (CPR+) 37.8 ± 9.4 10.7 ± 9.8 4.4 ± 1.7 1.9 ± 1.6
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(n=18)
LSE (CPR-) 37.7 ± 11.4 19.4 ± 10.8 5.2 ± 1.6 2.7 ± 1.9
(n=30)
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(n=22)
(n=35)
Journal of Orthopaedic & Sports Physical Therapy®
prediction rule -); NPRS, Numeric Pain Rating Scale; SD, Standard Deviation.
(0-100) (0-10)
Abbreviations: CI, confidence interval; CPR, clinical prediction rule; LSE, lumbar
stabilization exercises; LSE (CPR+), lumbar stabilization exercises (clinical
prediction rule +); LSE (CPR-), lumbar stabilization rule (clinical prediction rule -)
MODI, Modified Oswestry Disability Index; MT, manual therapy; MT (CPR+),
manual therapy (clinical prediction rule +); MT (CPR-), manual therapy (clinical
Journal of Orthopaedic & Sports Physical Therapy®
(MODI) and Pain (NPRS) Between the Different Groups and Subgroups.
(0-100) (0-10)
Abbreviations: CI, confidence interval; CPR, clinical prediction rule; LSE, lumbar
stabilization exercises; LSE (CPR+), lumbar stabilization exercises (clinical prediction
rule +); LSE (CPR-), lumbar stabilization rule (clinical prediction rule -); MODI,
Modified Oswestry Disability Index; MT, manual therapy; MT (CPR+), manual therapy
(clinical prediction rule +); MT (CPR-), manual therapy (clinical prediction rule -);
Journal of Orthopaedic & Sports Physical Therapy®
(NPRS) Among the Different Groups and Subgroups Based on the mCPR.*
(0-100) (0-10)
MT (mCPR-), manual therapy (modified clinical prediction rule -); NPRS, Numeric
Pain Rating Scale.
* Data Provided based on intention-to-treat analysis.
TABLE 6. Mean Differences (95% CI) of Baseline Adjusted Final Disability
(MODI) and Pain (NPRS) Between the Different Groups and Subgroups Based
on the mCPR.*
(0-100) (0-10)
Modified Clinical Prediction Rule; MODI, Modified Oswestry Disability Index; MT,
manual therapy;MT (mCPR+), Manual therapy (modified clinical prediction rule +);
MT (mCPR-), Manual therapy (modified clinical prediction rule -); NPRS, Numeric
Pain Rating Scale.
* Data are provided based on intention-to-treat analysis.
† Positive values indicate an advantage for LSE, mCPR+ and LSE (mCPR+).
APPENDIX A: Lumbar Stabilization Exercise Program
Stage 1
(elbows off the other leg bent at the knee and hip in
table) / 30 reps. order to maintain a neutral pelvic
position (no need to alternate legs).
Patient places both hands under the
lumbar spine (this also helps to
maintain a neutral pelvic and lumbar
position). Patient performs an ADIM
and raises the head and shoulders off
the table. The position is held for 8
seconds, and the patient returns to
the starting position.
Supine ADIM The patient assumes a supine
with curl up – 3 position with one leg straight and the
(hands over other leg bent at the knee and hip in
forehead) / order to maintain a neutral pelvic
30 reps. position (no need to alternate legs).
Patient places both hands over
his/her forehead, performs an ADIM
and raises the head and shoulders off
the table. The position is held for 8
seconds, and the patient returns to
the starting position.
Sit-stand transfer / The patient sits on a standard chair and performs an ADIM
30 reps. while keeping the spine in a neutral position. The patient then
rises to a standing position and then sits back down, while
maintaining the lumbar spine in a neutral position.
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Rolling from side The patient is in a side lying position. The patient performs an
to side / ADIM and then rolls from one side to the other, while
30 reps. maintaining a neutral position of the lumbar spine. The patient
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Squatting / The patient leans against a wall and performs an ADIM. The
30 reps. patient then slides down along the wall until the knees are at a
450 angle, while maintaining a neutral spine position. The
Journal of Orthopaedic & Sports Physical Therapy®
activity.
minutes of
continuous
Vacuuming,
progresses to 3
swiping / patient
lumbar spine.
The patient performs a vacuuming/ swiping motion, while
performing an ADIM and maintaining a neutral position of the
APPENDIX B: Manual Therapy Program.
Manual techniques: