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A Clinical Prediction Rule to Identify Patients with Low Back Pain Who

Are Likely to Experience Short-Term Success Following Lumbar

Stabilization Exercises – A Randomized Controlled Validation Study

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
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Koby Pizem, BPT, Giora Physical Therapy Clinic, Clalit Health Services, Israel

Ruthy Dickstein, PT, DSc, Department of Physical Therapy, Faculty of Social

Welfare and Health Sciences, University of Haifa, Israel


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Gali Dar, PT, PhD, Department of Physical Therapy, Faculty of Social Welfare and

Health Sciences, University of Haifa, Israel

Sources of Grant Support: N/A

Institutional Review Board: This study was approved by the Helsinki Committee of Clalit

Health Services.

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Corresponding Author:

Alon Rabin, Ariel University, Department of Physiotherapy, Kiryat Hamada, P. O. Box 3,

Ariel, Israel. E-mail: alonrabin@gmail.com

I affirm that I have no financial affiliation (including research funding) or involvement

with any commercial organization that has a direct financial interest in any matter
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included in this manuscript


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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
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Sivan, Rafi Cohen, Yigal Levran for their contribution and support of this work.

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Study Design: Randomized Controlled Trial

Objective: To determine the validity of a previously suggested clinical prediction rule

(CPR) for identifying patients most likely to experience short-term success following

lumbar stabilization exercises (LSE).

Background: Although LSE are commonly used by physical therapists in the

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

been previously suggested, but has yet to be validated.


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Methods: One hundred-five patients with LBP 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 a LSE program or an intervention consisting of


Journal of Orthopaedic & Sports Physical Therapy®

manual therapy (MT) and range of motion (ROM)/flexibility exercises. Both

interventions included 11 treatment sessions delivered over 8 weeks. LBP related

disability was measured by the modified version of the Oswestry Disability Index

(MODI) at baseline and upon completion of treatment.

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

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(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

treatment received (P=.04).

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,
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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

treatment compared with those receiving MT (P=.005).


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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

established through post-hoc testing, an additional study is recommended to prospectively

test its predictive validity.

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Level of Evidence: Therapy, level 1b.

Key words: Lumbar spine, manual therapy

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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

outcome is generally favorable, some patients go on to experience long-term pain and

disability,31, 40, 78 and recurrence rates are high.17, 78

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

presentation yields improved clinical outcomes.6, 8, 15, 27, 47


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Structural as well as functional impairments, such as decreased and delayed activation of

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

retraining the proper activation and coordination of trunk musculature.58, 64 Stabilization

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

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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,

LSE appear to be advantageous,22, 65 however, when compared with other exercise

interventions, or with manual therapy (MT), no definitive advantage has been

ascertained. 11, 25, 35, 44, 49, 50, 62, 75

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
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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

derivation, a CPR must be validated, or in other words, must be shown to consistently

predict the outcome of interest in a separate, and preferably, prospective investigation.

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

(impact analysis).4, 14, 55

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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

a comparison intervention.4 The use of a comparison intervention is important to

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

comparison intervention should be considered a viable alternative to LSE, rather than a


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sham, or an inert intervention.


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Manual therapy is an intervention frequently used by physical therapists in 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
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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

accurately identifies the correct target patient population.

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

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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),
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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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decreased deep tendon reflexes, myotomal weakness, decreased sensation in a

dermatomal distribution, or a positive SLR, crossed SLR, or a femoral nerve stretch test;

or a history of corticosteroid use, osteoporosis, or rheumatoid arthritis. Patients were also

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.

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Therapists

Sixteen physical therapists were involved in the study. Eleven therapists with between 4

and 12 years of experience in outpatient physical therapy management provided

treatment. Five additional therapists, with between 13 and 25 years of experience,

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
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study (treatment or evaluation). Therapists involved in treating subjects were unaware of

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

(LSE and MT).


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Procedure

After giving their consent, patients underwent a baseline examination which included

collecting data on demographic information, an 11-point (0-10) Numeric Pain Rating

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

LBP was documented followed by a physical examination.

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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

patient was subsequently allocated into (allocation concealment).


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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

LSE or MT. Randomization was based on a computer-generated list of random numbers,

stratified by CPR status to assure an adequate number of patients with a positive and a

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negative CPR status would be included in each intervention group. The list was kept by a

research assistant not involved in subject recruitment, examination, or treatment.

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.

Lumbar Stabilization Exercises


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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

trunk musculature, as well as on common impairments in these muscles among patients

with LBP. Patients were then taught to perform an isolated contraction of the transversus

abdominis and lumbar multifidus through an abdominal drawing-in maneuver (ADIM) in

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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progression from one exercise to the next are outlined in APPENDIX A.


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Manual Therapy

The MT intervention included several thrust and non-thrust manipulative techniques

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
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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,

to avoid duplication between the 2 interventions.

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

third technique, as well as the complementing ROM/flexibility exercises, were given at

the discretion of the treating therapist. The MT techniques, as well as all exercises used in

the MT protocol, are described in APPENDIX B.

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
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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

investigator not involved in patient care.


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Sample Size

Sample size was calculated in an attempt to detect a between group difference of 12

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

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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

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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 include a comparison between patients receiving a

matched intervention (CPR-positive patients receiving LSE) and patients receiving an

unmatched intervention (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
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similarly tested to identify whether any such combination would enhance the predictive

validity of the original version.


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Finally, the outcome was also dichotomized as successful or unsuccessful based on a

previously established cutoff threshold of 50% reduction in the baseline score of the

MODI.33 The proportion of patients achieving a successful outcome was compared


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among the resulting 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 multiple

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

rejected, Expectation-Maximization was used to predict missing values. A per-protocol

analysis was performed as well. All statistical analyses were performed using JMP

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version 10 statistical package (SAS Institute, Cary, NC), as well SPSS statistical package,

version 19 (SPSS, Chicago, IL)

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

recruitment and retention throughout the study.


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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

to account for this expected difference.

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).

Therefore, Expectation-Maximization was used to replace missing values.

Completers versus non-completers


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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.

Non-completers exhibited a higher baseline score on the FABQ-physical activity (FABQ-

PA) versus completers (17.2 versus 15.1, P=.04). Non-completers also had a lower level
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of education compared with completers (P=.03). No other differences were detected

between the completers and non-completers.

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

the end of treatment compared with those receiving MT (P=.03). FIGURE 2 is a


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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
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different groups and subgroups in the study.

The proportion of patients achieving 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 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

demonstrate a main effect for final disability (P=.27)


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No 2-way interaction or main effects were noted for final pain level when using the

mCPR (P>.09).
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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

the subgroups based on mCPR status (P=.30) (FIGURE 4).

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Per-Protocol Analysis

Similar to analysis by intention-to-treat, there was no 2-way interaction between CPR

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
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end of treatment compared with those receiving MT (P=.03). No 2-way interaction or

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®

treatment received (P=.04).

The 2-way interaction between treatment group and the mCPR on final disability was

retained in the per-protocol analysis (P=.02). The pre-planned pair-wise comparisons

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

3 subgroups, this difference was not significant (P=.17).

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

the absence of a CPR-by-treatment interaction, the 2 pair-wise comparisons most relevant


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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

positive CPR status receiving MT (ie, unmatched interventions). Furthermore, effects

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
Journal of Orthopaedic & Sports Physical Therapy®

noise created by the multiple computations of the ANCOVA, may have prevented a

significant CPR-by-treatment interaction effect despite the relevant pair-wise

comparisons demonstrating a consistent advantage for patients with a positive CPR

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

to succeed with LSE.


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Among other potential reasons for the inability to validate a CPR are differences in
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

sample characteristics, differences in the application of the CPR itself, differences in the

administration of the intervention, and differences in the definition of the outcome

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
Journal of Orthopaedic & Sports Physical Therapy®

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

differ between the treatment groups or subgroups.

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

hinder the ability to validate the CPR.


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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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used in the current study. A MT intervention seemed to be a suitable comparison

intervention as it is frequently used in the management of LBP, it is advocated by several

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

programs such as increased activation of the transversus abdominis and lumbar

multifidi.42, 61 It is possible, therefore, that the manipulation techniques included in the

MT intervention contributed to facilitation of the deep spinal musculature and

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

stabilization CPR,41 no effects were observed on the activation of the transversus

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
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affect long lasting, or clinically significant, changes in recruitment of the spinal

musculature of our patients.

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

success following LSE.

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.

movements, and a positive prone instability test, demonstrate a decreased control of

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

be most beneficial under these circumstances. Furthermore, Hebert et al32 demonstrated


Journal of Orthopaedic & Sports Physical Therapy®

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

been previously associated with a generally favorable prognosis following an episode of

LBP. 5, 12, 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 regardless of the treatment

26
received. Likewise it seems less intuitive, why a greater SLR range of motion would

predict a better outcome specifically following LSE.

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

specifically following LSE, the mCPR carries a stronger biomechanical plausibility as a

predictor of success following this intervention. Nevertheless, due to its retrospective


Journal of Orthopaedic & Sports Physical Therapy®

nature, an additional investigation is warranted in order to prospectively establish the

predictive validity of the mCPR.

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.

compliance among the 2 groups. An intention-to-treat analysis was used in an attempt to

minimize the effect of the drop out rate on our findings.

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

recommended to prospectively validate the mCPR as a predictor of success with LSE in


Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

individuals with LBP. Alternatively, in order to validate the original version of the CPR,

a larger, repeat study is recommended in an attempt to overcome the insufficient power

of the current study. The findings of this study are further limited by a relatively large

drop out rate (22.8%) and lack of a long-term follow-up.


Journal of Orthopaedic & Sports Physical Therapy®

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

a positive prone instability test) demonstrated a better predictive validity in identifying

those most likely to succeed with LSE.

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

out rate, and the lack of a long-term follow-up.

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66. Stanton TR, Hancock MJ, Maher CG et al. Critical Appraisal of Clinical

Prediction Rules That Aim to Optimize Treatment Selection for Musculoskeletal


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Conditions. Phys Ther 2010;90:843-854.

67. Stiell IG, Greenberg GH, Wells GA et al. Prospective Validation of a Decision

Rule for the Use of Radiography in Acute Knee Injuries. JAMA 1996;275:611-
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615.

68. Stiell IG, Greenberg GH, McKnight RD et al. Decision Rules for the Use of

Radiography in Acute Ankle Injuries: Refinement and Prospective Validation.

JAMA 1993;269:1127-1132.

69. Teyhen DS, Miltenberger CE, Henry HM et al. The Use of Ultrasound Imaging of

the Abdominal Drawing-in Maneuver in Subjects With Low Back Pain. J Orthop

Sports Phys Ther 2005;35:346-355.

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70. Teyhen DS, Bluemle LN, Dolbeer JA et al. Changes in Lateral Abdominal

Muscle Thickness During the Abdominal Drawing-in Maneuver in Those With

Lumbopelvic Pain. J Orthop Sports Phys Ther 2009;39:791-798.

71. Teyhen DS, Flynn TW, Childs JD, Abraham LD. Arthrokinematics in a Subgroup

of Patients Likely to Benefit From a Lumbar Stabilization Exercise Program.

Phys Ther 2007:87:313-325.


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72. Thomas E, Silman AJ, Croft PR, Papageorgiou AC, Jayson MIV, Macfarlane GJ.
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Predicting Who Develops Low Back Pain in Primary Care: A Prospective Study.

BMJ 1999;318:1662-1667.

73. Tsao H, Druitt TR, Schollum TM et al. Motor Training of the Lumbar Paraspinal
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Muscles Induces Immediate Changes in Motor Coordination in Patients With

recurrent Low Back Pain. J of Pain 2010;11:1120-1128.

74. Tsao H, Hodges PW. Immediate Changes in Feedforward Postural Adjustments

Following Voluntary Motor training. Exp Brain Res. 2007;181:537-546.

75. Unsgaard-Tondel M, Fladmark AM, Salvesen O, Vasseljen O. Motor Control

Exercises, Sling Exercises, and General Exercises for Patients With Chronic Low

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Back Pain: A Randomized Controlled Trial With 1-Year Follow-up. Phys Ther

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76. van Tulder M, Malmivaara A, Esmail R et. al. Exercise Therapy for Low Back

Pain: A Systematic Review Within the Framework of the Cochrane Collaboration

Back Review Group. Spine 2000;25:2784-2796.

77. van Tulder M, Becker A, Bekkering T et al. Chapter 3: European guidelines for
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the Management of Acute Nonspecific Low Back Pain in Primary Care. Eur

Spine J 2006;15:S169-S191.
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78. Von Korff M, Saunders KJD. The Course of Back Pain in Primary Pain. Spine

1996;21:2833-2837.
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79. Waddell G, Newton M, Henderson I et al. A Fear-Avoidance Beliefs

Questionnaire (FABQ) and the Role of Fear-Avoidance Beliefs in Chronic Low

Back Pain and Disability. Pain 1993;52:157-168.

80. Wallwork TL, Warren RS, Freke M et al. The Effect of Chronic Low Back Pain

on Size and Contraction of the Lumbar Multifidus Muscle. Man Ther

2009;14:496-500.

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81. Wells PS, Hirsh J, Anderson DR et al. A Simple Clinical Model for the Diagnosis

of deep Vein Thrombosis Combined With Impedance Plethysmography: Potential

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1998;243:15-23.

82. Wilke HJ, Wolf S, Claes LE et al. Stability Increase of the Lumbar Spine

With Different Muscle Groups. Spine 1995;20:192-198.


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44
FIGURE 1. Flow Diagram of Participants Recruitment and Retention.

Screened for eligibility Excluded (n=297)


(n=531) • 151: mODI < 24%
• 28: Prior physical therapy
• 26: Nerve root compression
• 24: Pending legal proceeding
Randomized • 68: Did not meet other
(n=105) inclusion criteria

Declined participation (129)

Lumbar stabilization Manual therapy


exercises (n=57)
(n=48)
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8-week follow-up (n=32) 8-week follow-up (n=49)


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16 dropped out 8 dropped out

Analyzed Analyzed
(n=48) (n=57)
Journal of Orthopaedic & Sports Physical Therapy®

CPR+ CPR- CPR+ CPR-


(n=18) (n=30) (n=22) (n=35)
FIGURE2. Change in Disability From Baseline to the End of Treatment for the

4 Subgroups. Abbreviations: LSE (CPR+), Lumbar stabilization (Clinical

Prediction Rule +); LSE (CPR-), Lumbar Stabilization (Clinical Prediction Rule -);

MODI, Modified Oswestry Disability Index; MT (CPR+), Manual Therapy

(Clinical Prediction Rule +); MT (CPR-), Manual Therapy (Clinical Prediction

Rule -)
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Journal of Orthopaedic & Sports Physical Therapy®
FIGURE 3. Rate of Success (%) Among the 4 Subgroups Based on a Cutoff

Threshold of 50% Decrease in Baseline Modified Oswestry Disability Index

Score.

Abbreviations: LSE (CPR+), Lumbar stabilization (Clinical Prediction Rule +);

LSE (CPR-), Lumbar Stabilization (Clinical Prediction Rule -); MT (CPR+),

Manual Therapy (Clinical Prediction Rule +); MT (CPR-), Manual Therapy

(Clinical Prediction Rule -)


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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 Sccore.

Abbreviations: LSE (mCPR+), Lumbar stabilization Exercises (Modified Clinical

Prediction Rule +); LSE (mCPR-), Lumbar Stabilization Exercises (Modified Clinical

Prediction Rule -); mCPR, Modified Clinical Prediction Rule; MT (mCPR+), Manual

Therapy (Modified Clinical Prediction Rule +); MT (mCPR-), Manual Therapy

(Modified Clinical Prediction Rule -)


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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-)
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(n=48) (n=57) (n=40) (n=65) (n=18) (n=30) (n=22) (n=35)

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

High school 21 (43.7) 15 (26.3) 9 (22.5) 27 (41.5) 5 (27.8) 16 (53.3) 4 (18.2) 11

Some post-secondary 8 (16.7) 15 (26.3) 9 (22.5) 14 (21.5) 3 (16.7) 5 (16.7) 6 (27.3) 9

Bachelor 13 (27.1) 17 (29.8) 18 (45.0) 12 (18.5) 8 (44.4) 5 (16.7) 10 (45.5) 7

Master 3 (6.2) 9 (15.8) 4 (10.0) 8 (12.3) 2 (11.1) 1 (3.3) 2 (9.0) 7

Doctorate 1 (2.1) 1 (1.8) 0 (0) 2 (3.1) 0 (0) 1 (3.3) 0 (0) 1


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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)

Duration 58.7 67.4 63.8 62.0 52.0 66.3 78.4 57.9

(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
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(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®

§ Numbers provided when data not available on all subjects.


TABLE 2. Baseline and Final Disability (MODI) and Pain (NPRS) scores for

All Groups and Subgroups.*†

Group Baseline MODI Final MODI Baseline NPRS Final NPRS

(0-100) (0-100) (0-10) (0-10)

LSE (n=48) 37.8 ± 10.6 16.1 ± 11.2 4.9 ± 1.7 2.4 ± 1.8

MT (n=57) 37.6 ± 12.5 20.2 ± 16.0 5.3 ± 1.7 3.1 ± 2.5

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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MT (CPR+) 41.8 ± 15.0 21.5 ± 20.9 5.2 ± 1.6 3.1 ± 2.8

(n=22)

MT (CPR-) 35.0 ± 9.9 19.4 ± 12.3 5.4 ± 1.8 3.1 ± 2.4

(n=35)
Journal of Orthopaedic & Sports Physical Therapy®

Abbreviations: CPR, clinical prediction rule; LSE, lumbar stabilization exercises;

LSE (CPR+), Lumbar stabilization exercises (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; SD, Standard Deviation.

* Data are means ± standard deviations

† Data based on intention-to-treat analysis


TABLE 3. Baseline Adjusted Mean (95% CI) Final Disability (MODI) and Pain

(NPRS) Among the Different Groups and Subgroups.*

Group MODI NPRS

(0-100) (0-10)

LSE (n=48) 15.0 (11.4, 18.6) 2.5 (1.9, 3.1)

MT (n=57) 20.0 (16.7, 23.3) 3.0 (2.4, 3.5)

CPR+ (n=40) 14.9 (11.0, 18.8) 2.7 (2.1, 3.4)

CPR- (n=65) 20.1 (17.1, 23.1) 2.8 (2.3, 3.3)

LSE (CPR+) (n=18) 10.7 (4.9, 16.4) 2.4 (1.4, 3.3)


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LSE (CPR-) (n=30) 19.3 (14.9, 23.8) 2.6 (1.9, 3.4)

MT (CPR+) (n=22) 19.1 (13.9, 24.4) 3.0 (2.2, 3.9)

MT (CPR-) (n=35) 20.9 (16.7, 25.0) 2.9 (2.2, 3.6)


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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®

prediction rule -) NPRS, Numeric Pain Rating Scale.


* Data are provided based on intention-to-treat analysis.
TABLE 4. Mean Differences (95% CI) of Baseline Adjusted Final Disability

(MODI) and Pain (NPRS) Between the Different Groups and Subgroups.

Comparison MODI P-value NPRS P-value

(0-100) (0-10)

LSE vs. MT * 5.0 .05 0.5 .26

(0.1, 9.9) (-0.3, 1.3)

CPR+ vs. CPR- * 5.2 .04 0.1 .88

(0.2, 10.2) (-0.7, 0.9)

LSE (CPR+) vs. 8.7 .02 0.3 .67


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LSE (CPR-) * (1.4, 15.9) (-0.9, 1.5)

LSE (CPR+) vs. 8.5 .03 0.7 .31

MT (CPR+) * (0.7, 16.3) (-0.6, 1.9)


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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, Numeric Pain Rating Scale.


* Positive values indicate an advantage to LSE, CPR+ and LSE (CPR+).
TABLE 5. Baseline Adjusted Mean (95% CI) Final Disability (MODI) and Pain

(NPRS) Among the Different Groups and Subgroups Based on the mCPR.*

Group MODI NPRS

(0-100) (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)


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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)


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Abbreviations: CI, confidence interval; LSE, lumbar stabilization exercises; LSE


(mCPR+), lumbar stabilization exercises (modified clinical prediction rule +); LSE
(MCPR-),lumbar stabilization exercises (modified clinical prediction rule -); mCPR,
modified clinical prediction rule; MODI, Modified Oswestry Disability Index; MT,
manual therapy; MT (mCPR+), manual therapy (modified clinical prediction rule +);
Journal of Orthopaedic & Sports Physical Therapy®

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.*

Comparison MODI P-value NPRS P-value

(0-100) (0-10)

LSE vs. MT † 5.0 .04 0.5 .18

(0.2, 9.9) (-0.2, 1.3)

mCPR+ vs. mCPR-† 2.7 .27 0.2 .67

(-2.2, 7.7) (-0.6, 1.0)


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LSE (mCPR+) vs. 8.4 .02 0.8 .16

LSE (mCPR-) † (1.3, 15.5) (-0.3, 2.0)


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LSE (mCPR+) vs. 10.7 .005 1.2 .05

MT (mCPR+) † (3.4, 18.1) (0.0, 2.4)

Abbreviations: CI, confidence interval; LSE, lumbar stabilization exercises; LSE


(mCPR+), Lumbar stabilization exercises (modified clinical prediction rule +); LSE
(mCPR-), Lumbar stabilization exercises (modified clinical prediction rule -); mCPR,
Journal of Orthopaedic & Sports Physical Therapy®

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

Exercise/ Description Picture


Criteria for
progression

Abdominal Following exhalation, the patient


drawing-in tightens the abdominal muscles and
(ADIM) in draws the belly button up toward
quadruped / the spine while maintaining a
30 repetitions neutral lumbar spine position. The
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(reps) contraction is held for 8 seconds.

ADIM in Following exhalation, the patient


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standing / tightens the abdominal muscles and


30 reps draws the belly button in toward the
spine while maintaining a neutral
lumbar spine position. The
contraction is held for 8 seconds.
Journal of Orthopaedic & Sports Physical Therapy®

ADIM in supine Following exhalation, the patient


/ 30 reps tightens the abdominal muscles and
draws the belly button in toward the
spine while maintaining a neutral
lumbar spine position. The
contraction is held for 8 seconds.
Stage 2
During stage 2 the patient progresses from one exercise to the next in 4 different
positions: supine lying, side lying, quadruped, and standing.

Exercise/ Description Picture


Criteria for
progression

Supine ADIM Starting in a hook-lying position,


with heel slide / feet flat on the supporting surface,
20 reps with the patient performs an ADIM and
each leg slides 1 heel on the supporting
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surface until the knee is straight. The


position is held for 4 seconds, and
the leg is returned to the starting
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position. The movement is repeated


alternating between legs.

Supine ADIM The patient performs an ADIM and


with leg lift / raises one foot 10 cm off the
20 reps with supporting surface. The position is
Journal of Orthopaedic & Sports Physical Therapy®

each leg held for 4 seconds, and the leg is


returned to the starting position.

Supine ADIM The patient performs an ADIM and


with bridging (2 raises the buttocks off the supporting
legs) / 30 reps. surface. The position is held for 8
seconds, and the patient returns to
the starting position.

Supine ADIM Starting in a hook-lying position, the


with single leg patient performs an ADIM and
bridge / straightens one knee. The patient
30 reps with then raises the buttocks off the table
each leg. using the opposite leg. 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 – 1 position with one leg straight and the
(elbows on 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
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maintain a neutral pelvic and lumbar


position). Patient performs an ADIM
and raises the head and shoulders off
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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 – 2 position with one leg straight and the
Journal of Orthopaedic & Sports Physical Therapy®

(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.

Horizontal side The patient performs an ADIM and


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support – Knees raises the hips and trunk off the


bent / 30 reps on supporting surface. The position is
each side. held for 8 seconds, and the patient
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returns to the starting position.

Horizontal side The patient performs an ADIM and


support – Knees raises the hips and trunk off the
straight / 30 reps supporting surface. The position is
on each side. held for 8 seconds and the patient
Journal of Orthopaedic & Sports Physical Therapy®

returns to the starting position.


Horizontal side The patient performs an ADIM and
support – raises the hips and trunk off the
Advanced 1 / table. The patient then rotates the
30 reps on each trunk backward and forward
side. (4 times in each direction), and then
returns to the starting position.

Side lying The patient performs an ADIM and


Horizontal side raises the hips and trunk off the
support – table. The patient then rolls over
Advanced 2 / onto the opposite elbow while
30 reps. maintaining a neutral spine. The
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patient then rolls back to the


starting position.
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Quadruped with The patient performs an ADIM and


leg raise / then straightens one leg backward
30 reps with each while maintaining a neutral lumbar
leg. spine position. The position is held
for 8 seconds before returning to
Journal of Orthopaedic & Sports Physical Therapy®

the starting position.

Quadruped with The patient performs an ADIM and


contralateral arm then straightens one leg backward
and leg raise / along with a contralateral arm raise,
30 reps with each while maintaining a neutral lumbar
arm and leg. position. The position is held for 8
seconds before returning to the
starting position.
Quadruped – The patient performs an ADIM
Advanced / and then straightens one leg back
30 reps with each along with a contralateral arm
arm and leg. raise (shoulder flexion), while
maintaining a neutral lumbar
position. The position is held for 8
seconds. The patient then lowers
the arm and leg without replacing
them back on the supporting
surface and then straightens the
arm and leg back to a horizontal
position.
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Standing rowing / The patient performs an ADIM


30 reps with each and then pulls a 1-1.5 kg weight in
arm. a rowing motion, until the weight
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is at chest level. The position is


held for 6 seconds and the patient
then returns the weight to the
starting position.
Walking / The patient alternates between
Journal of Orthopaedic & Sports Physical Therapy®

Patient progresses performing an ADIM for 8


to 10 minutes. seconds and relaxing for 10
seconds, while walking.
Stage 3
The patient continues with the exercises from stage 2 and begins to practice the
following functional activities

Activity/ Criteria Description


for progression

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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then returns to the starting position.

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®

position is held for 5 seconds and the patient returns to the


starting position.

Lifting The patient stands in front of a standard chair. The patient


performs an ADIM and then picks up a 2-3 kg weight placed on
30 reps. the chair and lifts it to shoulder level. The weight is then
returned to the chair and the patient returns to the starting
position. The patient maintains a neutral position of the lumbar
spine throughout the performance of the activity.
Journal of Orthopaedic & Sports Physical Therapy®
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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:

Technique/ Description Picture


Dosage

Lumbosacral The therapist side bends the subject


thrust toward the side to be manipulated, and
manipulation / rotates the trunk in an opposite
Up to 2 thrusts direction until the pelvis lifts off the
on each side table. The therapist then places his/her
hand on the anterior superior iliac
spine (ASIS) on the side to be
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manipulated, takes up the slack and


applies a high velocity low amplitude
thrust in the direction of the table.
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Lumbar thrust The therapist flexes the hip until


manipulation / motion is detected at the L4-5
Up to 2 thrusts segment. The therapist then rotates the
on each side upper trunk backward until motion is
Journal of Orthopaedic & Sports Physical Therapy®

detected at the L4-5 segment. The


therapist then rolls the patient toward
him/her and stretches the segment to
its end of range. The therapist then
applies a high velocity low amplitude
thrust.
Upper lumbar The patient places both arms on top of
thrust the therapist’s shoulder. The therapist
manipulation / places the hypothenar eminence of
Up to 2 thrusts one hand over the transverse process
on each side of the segment to be manipulated. The
therapist then rotates the patient
toward him/her and side bends away.
The therapist then applies a high
velocity low amplitude thrust in a
forward direction (rotating the subject
toward him/her).
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Posterior - The therapist places the thenar


anterior (PA) eminence of one hand (mobilizing
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non-thrust hand) over the spinous process of the


mobilization / segment to be mobilized. The
40 seconds X 3 therapist places the opposite hand
over each over the dorsum of the mobilizing
segment at the hand and locks his/her elbows. The
highest grade therapist then applies a PA force over
Journal of Orthopaedic & Sports Physical Therapy®

tolerated. the segment in an oscillatory fashion


with 1-2 oscillations per second.
Stretch/ Description Picture
Dosage

Hamstring The therapist flexes the hip to 900 and


stretch / then extends the knee until the patient
30 seconds X 3 reports a stretching sensation behind
reps on each his/her knee.
leg.

Quadriceps The patient maintains one knee close


stretch / to his/her chest. The therapist lowers
30 seconds X 3 the opposite leg over the edge of the
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reps on each table into hip extension and knee


leg. flexion, until a stretching sensation is
experienced by the patient.
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Tensor Fascia The patient maintains one knee close


Lata stretch / to his/her chest. The therapist lowers
30 seconds X 3 the opposite leg over the edge of the
reps on each table into hip extension and knee
leg. flexion. The therapist then uses his/her
Journal of Orthopaedic & Sports Physical Therapy®

leg to externally rotate and adduct the


patient’s hip until a stretching
sensation is reported.
Iliopsoas The patient maintains one knee close
stretch / to his/her chest. The therapist lowers
30 seconds X 3 the opposite leg over the edge of the
reps on each table into hip extension (while keeping
leg. the knee straight), until a stretching
sensation is reported by the patient.

Piriformis The therapist flexes the patient’s hip


stretch / and knee to 900 and then fully
30 seconds X 3 externally rotates the patient’s hip.
reps on each The therapist then stretches the hip
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leg. into further flexion and adduction


(pointing the knee toward the opposite
shoulder of the patient). The motion
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continues until the patient reports a


stretching sensation over the
ipsilateral buttock.

Range of motion and flexibility exercises:


Journal of Orthopaedic & Sports Physical Therapy®

Exercise/ Description Picture


Dosage

Cat – horse / The patient curls his/her back up and


30 reps X 4 down in a comfortable, pain-free
range.
Prone press up The patient presses up on both hands,
/10 seconds X extending his/her spine in a pain-free
10 reps. range. The patient holds this position
for 10 seconds and returns to the
starting position.

Standing The patient leans back and extends


lumbar the lumbar spine in a pain-free range.
extension / The patient holds the position for 3
3 seconds X 10 seconds and returns to the starting
reps. position.
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Quadruped From a quadruped position the patient


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flexion / brings his/her buttocks toward the


10 seconds X heels to create flexion of the lumbar
10 reps. spine. The patient holds the position
for 10 seconds and returns to the
starting position.
Journal of Orthopaedic & Sports Physical Therapy®

Side lying The patient presses the upper knee


trunk rotation / down to rotate the pelvis toward the
10 seconds X table, while rotating the shoulders up
10 reps on each (toward the ceiling) to create maximal
side. trunk rotation. The patient holds the
position for 10 seconds and returns to
the starting position.
Hip flexor The patient performs a posterior pelvic
stretch / tilt and then leans forward until a
30 seconds X 3 stretch is felt in the front of the hip.
reps on each leg. The patient holds the position for 30
seconds and returns to the starting
position.

Quadriceps The patient uses a towel/belt to pull the


stretch / foot up toward his/her buttock (knee
30 seconds X 3 flexion), until a stretch is felt in the
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reps on each leg. anterior thigh. The patient holds the


position for 30 seconds and returns to
the starting position.
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Hamstring The patient extends the knee until a


stretch / stretch is felt in the posterior aspect of
30 seconds X 3 the knee/ thigh. The patient holds the
reps on each leg. position for 30 seconds and returns to
Journal of Orthopaedic & Sports Physical Therapy®

the starting position.

Piriformis stretch The patient crosses one leg over the


/ 30 seconds X 3 opposite flexed knee. The patient uses
reps on each leg. a towel to pull the bottom knee toward
his/her shoulder, until a stretch is felt
in the opposite buttock. The patient
holds the position for 30 seconds and
returns to the starting position.

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