a clinical prediction rule to identify patients with …...lumbar spine, manual therapy 1 department...

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6 |  january 2014  |  volume 44  |  number 1  |  journal of orthopaedic & sports physical therapy L ow back pain (LBP) is common among the general population, with a lifetime prevalence and point pre- valence estimated to be greater than 80% and 28%, respectively. 12 Although short-term outcomes are gen- erally favorable, some patients go on to experience long-term pain and disabil- ity, 32,40,78 and recurrence rates are high. 17,78 Systematic reviews of various physi- cal therapy interventions for LBP do not provide strong support for any particu- lar treatment approach. 2,50,51,77 One pos- sible reason is the use of heterogeneous samples of patients in many clinical trials for LBP. Patients with LBP demonstrate both etiologic and prognostic hetero- geneity, 7,40,45 which makes it unlikely for any single intervention to have a signifi- cant advantage over another in a general population with LBP. Classifying patients into more homogeneous subgroups has been previously identified as a top re- T T STUDY DESIGN: Randomized controlled trial. T T 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 exercise (LSE). T T BACKGROUND: Although LSE is commonly used by physical therapists in the management of low back pain, it does not seem to be more effective than other interventions. A 4-item CPR for identifying patients most likely to benefit from LSE has been previously suggested but has yet to be validated. T T METHODS: One hundred five patients with low back pain underwent a baseline examination to determine their status on the CPR (positive or negative). Patients were stratified by CPR status and then randomized to receive an LSE program or an intervention consisting of manual therapy (MT) and range-of-motion/ flexibility exercises. Both interventions included 11 treatment sessions delivered over 8 weeks. Low back pain–related disability was measured by the modified version of the Oswestry Disability Index at baseline and upon completion of treatment. T T 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 nega- tive CPR status (P = .02). Also, among patients with a positive CPR status, those receiving LSE experienced less disability by the end of treatment compared with those receiving MT (P = .03). In addition, there were main effects for treatment and CPR status. Patients receiving LSE experienced less disability by the end of treatment compared to patients receiving MT (P = .05), and patients with a positive CPR status experienced less disability by the end of treatment compared to patients with a negative CPR status, regardless of the treatment received (P = . 04). When a modified version of the CPR (mCPR) containing only the presence of aberrant movement and a positive prone instability test was used, a significant interaction with treat- ment was found for final disability (P = .02). Of the patients who received LSE, those with a positive mCPR status experienced less disability by the end of treatment compared to those with a negative mCPR status (P = .02), and among patients with a positive mCPR status, those who received LSE experienced less disability by the end of treatment compared to those who received MT (P = .005). T T CONCLUSION: The previously suggested CPR for identifying patients likely to benefit from LSE could not be validated in this study. However, due to its relatively low level of power, this study could not invalidate the CPR, either . A modified version of the CPR that contains only 2 items may possess a better predictive validity to identify those most likely to succeed with an LSE program. Because this modified version was established through post hoc testing, an additional study is recommended to prospectively test its predictive validity. T T LEVEL OF EVIDENCE: Prognosis, level 1b–. J Orthop Sports Phys Ther 2014;44(1):6-18. Epub 21 November 2013. doi:10.2519/jospt.2014.4888 T T KEY WORDS: lumbar spine, manual therapy 1 Department of Physiotherapy, Ariel University, Ariel, Israel. 2 Bat-Yamon Physical Therapy Clinic, Clalit Health Services, Israel. 3 Giora Physical Therapy Clinic, Clalit Health Services, Israel. 4 Department of Physical Therapy, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel. This study was approved by the Helsinki Committee of Clalit Health Services. The authors certify that they have no affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in the article. Address correspondence to Dr Alon Rabin, Ariel University, Department of Physiotherapy, Kiryat Hamada, PO Box 3, Ariel, Israel. E-mail: [email protected] T Copyright ©2014 Journal of Orthopaedic & Sports Physical Therapy ® ALON RABIN, DPT, PhD 1 ANAT SHASHUA, BPT, MS 2 KOBY PIZEM, BPT 3 RUTHY DICKSTEIN, PT, DSc 4 GALI DAR, PT, PhD 4 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 [ RESEARCH REPORT ] Journal of Orthopaedic & Sports Physical Therapy® Downloaded from www.jospt.org at on June 18, 2014. For personal use only. No other uses without permission. Copyright © 2014 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

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Page 1: A Clinical Prediction Rule to Identify Patients With …...lumbar spine, manual therapy 1 Department of Physiotherapy, Ariel University, Ariel, Israel. 2 Bat-Yamon Physical Therapy

6  |  january 2014  |  volume 44  |  number 1  |  journal of orthopaedic & sports physical therapy

Low back pain (LBP) is common among the general population, with a lifetime prevalence and point pre-

valence estimated to be greater than 80% and 28%, respectively.12

Although short-term outcomes are gen-erally favorable, some patients go on to experience long-term pain and disabil-ity,32,40,78 and recurrence rates are high.17,78

Systematic reviews of various physi-cal therapy interventions for LBP do not provide strong support for any particu-lar treatment approach.2,50,51,77 One pos-sible reason is the use of heterogeneous samples of patients in many clinical trials for LBP. Patients with LBP demonstrate both etiologic and prognostic hetero-geneity,7,40,45 which makes it unlikely for any single intervention to have a signifi-cant advantage over another in a general population with LBP. Classifying patients into more homogeneous subgroups has been previously identified as a top re-

TT STUDY DESIGN: Randomized controlled trial.TT 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 exercise (LSE).

TT BACKGROUND: Although LSE is commonly used by physical therapists in the management of low back pain, it does not seem to be more effective than other interventions. A 4-item CPR for identifying patients most likely to benefit from LSE has been previously suggested but has yet to be validated.

TT METHODS: One hundred five patients with low back pain underwent a baseline examination to determine their status on the CPR (positive or negative). Patients were stratified by CPR status and then randomized to receive an LSE program or an intervention consisting of manual therapy (MT) and range-of-motion/flexibility exercises. Both interventions included 11 treatment sessions delivered over 8 weeks. Low back pain–related disability was measured by the modified version of the Oswestry Disability Index at baseline and upon completion of treatment.

TT 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 nega-tive CPR status (P = .02). Also, among patients with a positive CPR status, those receiving LSE experienced less disability by the end of treatment

compared with those receiving MT (P = .03). In addition, there were main effects for treatment and CPR status. Patients receiving LSE experienced less disability by the end of treatment compared to patients receiving MT (P = .05), and patients with a positive CPR status experienced less disability by the end of treatment compared to patients with a negative CPR status, regardless of the treatment received (P = .04). When a modified version of the CPR (mCPR) containing only the presence of aberrant movement and a positive prone instability test was used, a significant interaction with treat-ment was found for final disability (P = .02). Of the patients who received LSE, those with a positive mCPR status experienced less disability by the end of treatment compared to those with a negative mCPR status (P = .02), and among patients with a positive mCPR status, those who received LSE experienced less disability by the end of treatment compared to those who received MT (P = .005).

TT CONCLUSION: The previously suggested CPR for identifying patients likely to benefit from LSE could not be validated in this study. However, due to its relatively low level of power, this study could not invalidate the CPR, either. A modified version of the CPR that contains only 2 items may possess a better predictive validity to identify those most likely to succeed with an LSE program. Because this modified version was established through post hoc testing, an additional study is recommended to prospectively test its predictive validity.

TT LEVEL OF EVIDENCE: Prognosis, level 1b–. J Orthop Sports Phys Ther 2014;44(1):6-18. Epub 21 November 2013. doi:10.2519/jospt.2014.4888

TT KEY WORDS: lumbar spine, manual therapy

1Department of Physiotherapy, Ariel University, Ariel, Israel. 2Bat-Yamon Physical Therapy Clinic, Clalit Health Services, Israel. 3Giora Physical Therapy Clinic, Clalit Health Services, Israel. 4Department of Physical Therapy, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel. This study was approved by the Helsinki Committee of Clalit Health Services. The authors certify that they have no affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in the article. Address correspondence to Dr Alon Rabin, Ariel University, Department of Physiotherapy, Kiryat Hamada, PO Box 3, Ariel, Israel. E-mail: [email protected] T Copyright ©2014 Journal of Orthopaedic & Sports Physical Therapy®

ALON RABIN, DPT, PhD1 • ANAT SHASHUA, BPT, MS2 • KOBY PIZEM, BPT3

RUTHY DICKSTEIN, PT, DSc4 • GALI DAR, PT, PhD4

A Clinical Prediction Rule to Identify Patients With Low Back Pain Who Are

Likely to Experience Short-Term Success Following Lumbar Stabilization Exercises: A Randomized Controlled Validation Study

[ research report ]

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journal of orthopaedic & sports physical therapy | volume 44 | number 1 | january 2014 | 7

search priority,6 and, in fact, more recent research has suggested that matching pa-tients with interventions based on their specific clinical presentation may yield improved clinical outcomes.8,10,15,27,47

Structural as well as functional impairments, such as decreased and delayed activation of the transversus ab-dominis and atrophy of the lumbar mul-tifidus,25,34,37,48,69,80 have been identified among patients with LBP. These impair-ments may result in a reduction in spinal stiffness82 and possibly render the spine more vulnerable to excessive deforma-tion and pain. Lumbar stabilization ex-ercises (LSE) attempt to address these impairments by retraining the proper activation and coordination of trunk musculature.58,64 Stabilization exercises are widely used by physical therapists in the management of LBP.8,11,22,24,35,44,49,50,62,65 Although some evidence exists to support the remediating effects of LSE on some of the muscle impairments identified in patients with LBP,36,73,74 the clinical ef-ficacy of this intervention seems to vary. When compared to sham or no interven-tion, LSE appears to be advantageous22,65; however, when compared to other exer-cise interventions or to manual therapy (MT), no definitive advantage has been ascertained.11,24,35,44,49,50,62,75

In light of the variable clinical suc-cess of LSE and in accordance with the aforementioned need to classify patients who have LBP into more homogeneous subgroups, Hicks et al33 suggested a clini-cal prediction rule (CPR) to specifically identify patients with LBP who are likely to exhibit short-term improvement with LSE. Four variables were found to pos-sess the greatest predictive power for treatment success: (1) age less than 40 years, (2) average straight leg raise (SLR) of 91° or greater, (3) the presence of aber-rant lumbar movement, and (4) a positive prone instability test.33 When at least 3 of the 4 variables were present, the posi-tive likelihood ratio for achieving a suc-cessful outcome was 4.0, increasing the probability of success from 33% to 67%.33 The study by Hicks et al33 comprises the

first stage in establishing a CPR, the deri-vation stage.4,14,55 Following derivation, a CPR must be validated, that is, shown to consistently predict the outcome of inter-est in a separate and preferably prospec-tive investigation.26 Given its preliminary nature, and because CPRs do not typi-cally perform as well on new samples of patients,21,30,67,68 modification of the CPR may also be necessary to achieve satisfac-tory predictive validity. Once validated, CPRs can move into the final stage of their determination, which includes an investigation into their impact on clini-cal practice (impact analysis).4,14,55

Validation of the CPR for LSE re-quires a randomized controlled trial in which patients with a different status on the CPR (positive or negative) undergo an LSE program, as well as a comparison intervention.4 The use of a comparison intervention is important to determine whether the CPR can truly identify pa-tients who will benefit specifically from LSE, as opposed to patients who have a favorable prognosis irrespective of the treatment received.66 Finally, to validate the CPR in the most clinically meaning-ful manner, we believe that the compari-son intervention should be considered a viable alternative to LSE, rather than a sham or an inert intervention.

Manual therapy is an intervention fre-quently used by physical therapists in the management of patients with LBP39,46,56 and is recommended by several clinical practice guidelines and systematic reviews for the management of acute, subacute, and chronic LBP.1,9,19,76 These factors, com-bined with the fact that LSE programs have previously demonstrated varied levels of success compared to MT,11,24,50,62 suggest that MT may be a suitable com-parison intervention for testing the validi-ty of the CPR. In contrast to its use among heterogeneous samples,11,24,50,62 LSE should demonstrate a clearer advantage among patients with LBP who also satisfy the CPR, if the CPR accurately identifies the correct target patient population.

The purpose of this investigation was to determine the validity of, or to possibly

modify, the previously suggested CPR for identifying patients most likely to benefit from LSE. We hypothesized that among patients receiving LSE, those with a posi-tive CPR status would exhibit a better outcome compared to those with a nega-tive CPR status. We also hypothesized that among patients with a positive CPR status, those who received LSE would ex-hibit a better outcome compared to those who received MT.

METHODS

Patients

One hundred five patients diag-nosed with LBP and referred to physical therapy at 1 of 5 outpa-

tient clinics of Clalit Health Services in the Tel-Aviv metropolitan area, Israel, were recruited for this study. Subjects were included if they were 18 to 60 years of age, had a primary complaint of LBP with or without associated leg symptoms (pain, paresthesia), and had a minimum score of 24% on the Hebrew version of the modified Oswestry Disability Index (MODI) outcome measure. Patients were excluded if they presented with a history suggesting any red flags (eg, ma-lignancy, infection, spine fracture, cauda equina syndrome); 2 or more signs sug-gesting lumbar nerve root compression, such as decreased deep tendon reflexes, myotomal weakness, decreased sensation in a dermatomal distribution, or a posi-tive SLR, crossed SLR, or femoral nerve stretch test; or a history of corticosteroid use, osteoporosis, or rheumatoid arthri-tis. Patients were also excluded if they were pregnant, received 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 proceeding associated with their LBP. Prior to participation, all pa-tients signed an informed consent form approved by the Helsinki Committee of Clalit Health Services.

TherapistsSixteen physical therapists were involved

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[ research report ]in the study. Eleven therapists, with be-tween 4 and 12 years of experience in outpatient physical therapy patient care, provided treatment, and 5 therapists, with between 13 to 25 years of experi-ence, performed baseline and follow-up evaluations. Prior to beginning the study, all participating therapists under-went two 4-hour sessions in which the rationale and protocol of the study were presented and the examination and treat-ment procedures were demonstrated and practiced. Therapists had to pass a writ-ten examination of the study procedures prior to data collection. Finally, each therapist received a manual describing treatment and evaluation procedures, based on the therapist’s role in the study (treatment or evaluation). Therapists in-volved in treating patients were unaware of the concept of the CPR throughout the study, to avoid bias from this knowledge during treatment. All treating therapists provided both treatments of the study (LSE and MT).

ProcedureAfter giving consent, patients completed a baseline examination that included de-mographic information, an 11-point (0-10) numeric pain rating scale (NPRS), on which 0 was “no pain” and 10 was the “worst imaginable pain,” the Hebrew version of the MODI,3,28 and the Hebrew version of the Fear-Avoidance Beliefs Questionnaire.38,79 In addition, the his-tory of the present and any past LBP was documented, followed by a physical examination.

The physical examination included a neurological screen to rule out lumbar nerve root compression; lumbar active motion, during which the presence of ab-errant movement, as defined by Hicks et al,33 was determined; bilateral SLR range of motion; segmental mobility of the lum-bar spine; and the prone instability test. The patients’ status on the CPR (positive or negative) was established based on the findings of the physical examination.

Examiners who performed the base-line examinations, as well as examiners

who screened patients for eligibility to participate in the study, were blinded to the intervention allocation of the patients.

ReliabilityThe reliability of the individual physical examination items comprising the CPR, as well as that of the entire CPR, has been reported previously.60 In that study,60 the interrater reliability for determining CPR status was excellent (κ = 0.86), and the interrater reliability of each of the items comprising the CPR ranged from moder-ate to substantial (κ = 0.64-0.73).60

RandomizationAt the conclusion of the physical exami-nation, each patient was randomized to receive LSE or MT. Randomization was based on a computer-generated list of random numbers, stratified by CPR status to ensure that adequate numbers of pa-tients with a positive and a negative CPR status would be included in each interven-tion group. The list was kept by a research assistant who was not involved in patient recruitment, examination, or treatment.

InterventionPatients in both groups received 11 treat-ment sessions over an 8-week period. Each patient was seen twice a week dur-ing the first 4 weeks, then once a week for 3 additional weeks. A 12th session (usually on the eighth week) consisted of a final evaluation. The total number of sessions (12) matched the maximum number of physical therapy visits allowed annually per condition under the policy of the Clalit Health Services health main-tenance organization, which covered all patients participating in the study. Pa-tients in both groups were prescribed a home exercise program consistent with their treatment group; however, no at-tempt was made to monitor patients’ compliance with the home exercise program.

Lumbar Stabilization ExercisesThe LSE program was largely based on the program described by Hicks et al,33

with a few minor changes in the order of the exercises and a few additional levels of difficulty for some of the exercises. Pa-tients were initially educated about the structure and function of the trunk mus-culature, as well as common impairments in these muscles among patients with LBP. Patients were then taught to per-form an isolated contraction of the trans-versus abdominis and lumbar multifidus through an abdominal drawing-in ma-neuver (ADIM) in the quadruped, stand-ing, and supine positions.63,64,69,71,73 Once a proper ADIM was achieved (most likely by the second or third visit), additional loads were placed on the spine through various upper extremity, lower extremity, and trunk movement patterns. Exercises were performed in the quadruped, sidely-ing, supine, and standing positions, with the goal of recruiting a variety of trunk muscles.18,53,54 In each position, exercises were ordered by their level of difficulty, and patients progressed from one exer-cise to the next after satisfying specific predetermined criteria. In the seventh treatment session, functional movement patterns were incorporated into the training program while performing an ADIM and maintaining a neutral lumbar spine. This stage, which was not includ-ed in the derivation study, was added to the program because it has been recom-mended by others.22,58,62 The exercises in each stage of the LSE program, as well as the specific criteria for progression from one exercise to the next, are outlined in APPENDIX A (available at www.jospt.org).

Manual TherapyThe MT intervention included several thrust and nonthrust manipulative tech-niques directed at the lumbar spine that have been used previously with some degree of success in various groups with LBP.10,15,20,59 In addition, manual stretch-ing of several hip and thigh muscles was performed, as flexibility of the lower ex-tremity is purported to protect the spine from excessive strain.54 Finally, active range-of-motion and stretching exercis-es were added to the program, as these

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journal of orthopaedic & sports physical therapy | volume 44 | number 1 | january 2014 | 9

are commonly prescribed in combina-tion with MT to maintain or improve the mobility gains resulting from the manual procedures.10,15,20,47 The exercises included were selected to minimize trunk muscle activation and to avoid duplication be-tween the 2 interventions.

All manual procedures and exercises were prescribed based on the clinical judgment of the treating therapist; how-ever, each session could include up to 3 manual techniques, 1 of which had to be a thrust manipulative technique directed at the lumbar spine, and an additional technique that had to include a manual stretch of a lower extremity muscle. The third technique, as well as the comple-mentary range-of-motion/flexibility ex-ercises, was given at the discretion of the treating therapist. The MT techniques, as well as all exercises used in the MT proto-col, are described in APPENDIX B (available at www.jospt.org).

EvaluationThe MODI served as the primary out-come measure in this investigation. The MODI is scored from 0 to 100 and has a minimal clinically important difference (MCID) of 10 points among patients with LBP.57 The secondary outcome measure was the NPRS, which has an 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 in-vestigator not involved in patient care.

Sample SizeSample size was calculated to detect a be-tween-group difference of 12 points in the final score of the MODI, based on the in-teraction between treatment group (LSE versus MT) and CPR status (positive ver-sus negative), with an alpha level of .05 and a power of 70%. Based on a 16-point standard deviation, it was determined that 20 patients were needed in each cell. Pilot data suggested that the prevalence of patients with a positive status on the CPR was approximately 33%. Therefore, it was estimated that 120 patients would

be necessary to include 40 patients with a positive CPR status; however, 40 such patients were included after 105 patients were recruited, and recruitment was stopped at that point.

Statistical AnalysisDescriptive statistics, including frequen-cy counts for categorical variables and measures of central tendency and dis-persion for continuous variables, were used to summarize the data. All baseline variables were assessed for normal distri-bution using the Shapiro-Wilk test. Base-line variables were compared between treatment groups (LSE versus MT), CPR status (positive versus negative), and the resulting 4 subgroups using a 2-way analysis of variance and chi-square tests for continuous and categorical variables, respectively.

The primary aim of the study was tested using 2 separate analyses of cova-riance (ANCOVAs), with the final MODI score serving as the dependent variable in 1 model and the final NPRS score serving as the dependent variable in the second model. In both models, treatment group and CPR status served as independent variables, and the baseline MODI score (or baseline NPRS score) was used as a covariate. The residuals of all models were tested for violations of the ANCOVA assumptions and for outliers. The main effects of treatment group and CPR sta-tus, as well as the 2-way interaction be-tween these factors on the final MODI and NPRS scores, were evaluated. The a priori level of significance for these analy-ses was P≤.05. Two pairwise comparisons were planned following the ANCOVA: (1) a comparison of differences between pa-tients with a positive CPR receiving LSE and those with a negative CPR receiving LSE, and (2) a comparison of differences between patients with a positive CPR receiving LSE and those with a positive CPR receiving MT. These 2 comparisons were deemed the most relevant for the purpose of validating the CPR, as both included a comparison between patients receiving a matched intervention (CPR-

positive patients receiving LSE) and patients receiving an unmatched inter-vention (either CPR-negative patients receiving LSE or CPR-positive patients receiving MT).

The individual items of the CPR, as well as different combinations of these items, were similarly tested to identify whether any such combination would enhance the predictive validity of the original version. Finally, the outcome was also dichotomized as successful or unsuc-cessful based on a previously established cutoff threshold of 50% reduction in the baseline score of the MODI.33 The pro-portion of patients achieving a success-ful outcome was compared 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 mul-tiple imputations for any missing val-ues of the 2 outcome measures (MODI, NPRS). First, Little’s “missing completely at random” test was performed to test the hypothesis that missing values were ran-domly distributed. If this hypothesis could not be rejected, expectation maximization was used to predict missing values. A per-protocol analysis was performed as well. All statistical analyses were performed us-ing the JMP Version 10 statistical package (SAS Institute Inc, Cary, NC), as well as the SPSS Version 19 statistical package (SPSS Inc, Chicago, IL).

RESULTS

Five hundred thirty-one poten-tial candidates were screened for eligibility between March 2010 and

April 2012. Two hundred ninety-seven pa-tients did not meet the inclusion criteria, and another 129 declined participation. The remaining 105 patients were admit-ted into the study. Forty patients had a positive CPR status, whereas 65 had a negative status. Forty-eight patients were randomized to the LSE group, whereas 57 patients were randomized to receive MT. All patients underwent treatment accord-

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[ research report ]

ing to their allocated treatment group. Sixteen patients did not complete the LSE intervention, and 8 patients did not complete the MT intervention (P = .02). FIGURE 1 presents patient recruitment and retention throughout the study.

TABLE 1 presents baseline demographic, history, and self-reported variables for all groups and subgroups. All baseline vari-ables were normally distributed, with the exception of body mass index and dura-tion of LBP. Log transformations were thus performed on body mass index and duration of LBP, resulting in a better dis-tribution pattern. As a result, the geomet-ric mean with 95% confidence interval is reported for these variables, as opposed to mean SD for all other baseline vari-ables (TABLE 1). No baseline differences were noted between the different groups and subgroups other than for age. Pa-

tients with a positive CPR status were younger than patients with a negative CPR status (P = .0006). This difference was expected, as 1 of the items comprising the CPR is being less than 40 years of age. Therefore, we did not correct our model to account for this expected difference.

Little’s "missing completely at ran-dom" test indicated that the hypothesis that final MODI and NPRS scores were randomly missing could not be rejected (P = .76 for the MODI and P = .52 for the NPRS). Therefore, expectation maximi-zation was used to replace missing values.

Completers Versus NoncompletersAll baseline demographic, history, and self-reported variables were compared between patients who completed the intervention (completers, n = 81) and patients who dropped out prior to com-

pleting the intervention (noncompleters, n = 24) using Wilcoxon and Fisher ex-act tests for continuous and categorical variables, respectively. Noncompleters exhibited a higher baseline score on the Fear-Avoidance Beliefs Question-naire physical activity subscale versus completers (17.2 versus 15.1, P = .04). Noncompleters also had a lower level of education compared to completers (P = .03). No other differences were detected between the completers and noncompleters.

Analysis by Intention to TreatThe baseline and final MODI and NPRS scores for each treatment group and sub-group are summarized in TABLE 2. When assessing final disability level, the statisti-cal level of significance for the 2-way in-teraction between treatment group and CPR status was P = .17. A main effect was detected for treatment (P = .05), which indicated that patients receiving LSE experienced less disability by the end of treatment compared to the patients who received MT. A main effect was also detected for CPR status (P = .04), indi-cating that patients with a positive CPR status experienced less disability by the end of treatment compared to those with a negative CPR status, regardless of the treatment received. The 2 preplanned pairwise comparisons indicated that (1) among patients receiving LSE, those with a positive CPR status experienced less dis-ability at the end of the intervention com-pared to those with a negative CPR status (P = .02); and (2) among patients with a positive CPR status, those receiving LSE experienced less disability by the end of treatment compared to those receiv-ing MT (P = .03). The change in MODI between baseline and the end of treat-ment for the 4 subgroups is represented in FIGURE 2. No interactions or main ef-fects were noted for pain (P>.26). TABLE 3 pre sents the adjusted final disability and pain scores for all groups and subgroups, and TABLE 4 presents the differences in fi-nal disability and pain among the differ-ent groups and subgroups.

Screened for eligibility, n = 531

Randomized, n = 105

Lumbar stabilization exercises, n = 48

Excluded, n = 297:• MODI <24%, n = 151• Prior physical therapy, n = 28• Nerve root compression, n = 26• Pending legal proceeding, n = 24• Did not meet other inclusion criteria, n = 68Declined participation, n = 129

Manual therapy, n = 57

8-wk follow-up, n = 3216 dropped out

8-wk follow-up, n = 498 dropped out

Analyzed, n = 48

CPR+, n = 18

Analyzed, n = 57

CPR–, n = 30 CPR+, n = 22 CPR–, n = 35

FIGURE 1. Flow diagram of participant recruitment and retention. Abbreviations: CPR, clinical prediction rule; MODI, modified Oswestry Disability Index.

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journal of orthopaedic & sports physical therapy | volume 44 | number 1 | january 2014 | 11

The proportion of patients who achieved a successful outcome, defined as a reduction of at least 50% in disability as measured by the MODI, did not differ among the 4 subgroups (P = .31) (FIGURE 3).

When examining the interaction of treatment group with each of the indi-vidual items comprising the CPR on fi-nal disability, no significant effects were noted (aberrant movement, P = .07; prone instability test, P = .16; age less than 40 years, P = .72; SLR of 91° or greater, P = .79). However, when combining the pres-ence of aberrant movement and a positive prone instability test (n = 44), a signifi-cant 2-way interaction between treatment

group and the modified version of the CPR (mCPR) was found for final disability (P = .02). When the 2 pairwise comparisons were repeated using the mCPR, findings indicated that (1) among patients receiv-ing LSE, those with a positive mCPR sta-tus (n = 20) experienced less disability by the end of treatment compared to those with a negative mCPR status (n = 28, P = .02); and (2) among patients with a posi-tive mCPR status, those receiving LSE (n = 20) experienced less disability by the end of treatment compared to those re-ceiving MT (n = 24, P = .005). Unlike the original version of the CPR, the mCPR did not demonstrate a main effect for fi-

nal disability (P = .27). No 2-way interac-tion or main effects were noted for final pain level when using the mCPR (P>.09). TABLE 5 presents the adjusted final disabil-ity 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).

Per-Protocol AnalysisSimilar to analysis by intention to treat,

TABLE 1 Baseline Demographic, History, and Self-Report Variables for All Groups

Abbreviations: BMI, body mass index; CPR–, patients with a negative status on the clinical prediction rule; CPR+, patients with a positive status on the clini-cal prediction rule; FABQ-PA, Fear-Avoidance Beliefs Questionnaire physical activity subscale; FABQ-W, Fear-Avoidance Beliefs Questionnaire work subscale; LBP, low back pain; LSE, patients treated with lumbar stabilization exercises; MODI, modified Oswestry Disability Index; MT, patients treated with manual therapy; NPRS, numeric pain rating scale.*Values are mean SD.†CPR– greater than CPR+ (P = .0006).‡Values are mean (95% confidence interval).§Numbers provided when data not available on all patients.

Characteristic LSE (n = 48) MT (n = 57) CPR+ (n = 40) CPR– (n = 65)LSE CPR+ (n = 18)

LSE CPR– (n = 30)

MT CPR+ (n = 22)

MT CPR– (n = 35)

Sex (female), n (%) 25 (52.1) 31 (54.4) 22 (55.0) 34 (52.3) 10 (55.6) 15 (50.0) 12 (54.5) 19 (54.3)

Age, y*† 38.3 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 (22.9, 25.9) 25.8 (24.3, 27.3) 24.2 (22.6, 25.9) 25.9 (24.7, 27.3) 22.9 (20.7, 25.4) 25.9 (24.0, 27.9) 25.6 (23.3, 28.1) 26.0 (24.3, 27.8)

Education, n (%)

Less than high school 2 (4.2) 0 (0) 0 (0) 2 (3.1) 0 (0) 2 (6.7) 0 (0) 0 (0)

High school 21 (43.7) 15 (26.3) 9 (22.5) 27 (41.5) 5 (27.8) 16 (53.3) 4 (18.2) 11 (31.4)

Some postsecondary 8 (16.7) 15 (26.3) 9 (22.5) 14 (21.5) 3 (16.7) 5 (16.7) 6 (27.3) 9 (25.7)

Bachelor 13 (27.1) 17 (29.8) 18 (45.0) 12 (18.5) 8 (44.4) 5 (16.7) 10 (45.5) 7 (20.0)

Master 3 (6.2) 9 (15.8) 4 (10.0) 8 (12.3) 2 (11.1) 1 (3.3) 2 (9.0) 7 (20.0)

Doctorate 1 (2.1) 1 (1.8) 0 (0) 2 (3.1) 0 (0) 1 (3.3) 0 (0) 1 (2.8)

Work status (employed§), n (%)

38/43 (88.4) 41/53 (77.4) 28/36 (77.8) 51/60 (85.0) 13/16 (81.3) 25/27 (92.6) 15/20 (75.0) 26/33 (78.8)

Smoker, n (%)§ 16/44 (36.4) 11/53 (20.8) 14/36 (38.9) 13/61 (21.3) 8/16 (50.0) 8/28 (28.6) 6/20 (30.0) 5/33 (15.2)

Duration (days since onset)‡

58.7 (41.8, 82.4) 67.4 (48.9, 92.9) 63.8 (44.2, 92.2) 62.0 (46.5, 82.7) 52.0 (30.5, 88.6) 66.3 (43.6, 101.0) 78.4 (47.3, 130.0) 57.9 (39.1, 85.9)

Use of analgesics, n (%)§ 22/42 (52.4) 32/53 (60.4) 23/36 (63.9) 31/59 (52.5) 9/16 (56.3) 13/26 (50.0) 14/20 (70.0) 18/33 (54.6)

Past LBP, n (%)§ 34/48 (70.8) 35/56 (62.5) 27/39 (69.2) 42/65 (64.6) 13/18 (72.2) 21/30 (70.0) 14/21 (66.7) 21/35 (60.0)

Symptoms below knee, n (%)

14 (29.2) 16 (28.1) 8 (20.0) 22 (33.8) 2 (11.1) 12 (40.0) 6 (27.3) 10 (28.6)

NPRS (0-10)* 4.9 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

FABQ-PA (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

FABQ-W (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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[ research report ]

there was no 2-way interaction between CPR status and treatment on final disabil-ity (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 dis-ability by the end of treatment compared to patients with a negative CPR status, regardless of the treatment received. No main effect was noted for treatment (P = .06). The preplanned pairwise compari-sons indicated that (1) among all patients receiving LSE, those with a positive CPR status experienced less disability by the

end of treatment compared to those with a negative CPR status (P = .02); and (2) among patients with a positive CPR sta-tus, those receiving LSE experienced less disability by the end of treatment com-pared to those receiving MT (P = .03). No 2-way interaction or main effect was noted for pain (P>.21). Chi-square analy-sis indicated that the proportion of pa-tients achieving a successful outcome was greater among patients with a positive CPR status compared to patients with a negative CPR status, regardless of the treatment received (P = .04).

The 2-way interaction between treat-ment group and the mCPR on final dis-ability was retained in the per-protocol analysis (P = .02). The preplanned 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 to those with a negative mCPR status (P = .03); and (2) among patients with a positive mCPR sta-tus, those receiving LSE experienced less disability at the conclusion of the inter-vention compared to those receiving MT (P = .006). No 2-way interaction or main effect was noted for pain level when us-ing the mCPR (P>.13). Finally, although a greater proportion of patients with a posi-tive mCPR receiving LSE achieved a suc-cessful outcome compared to the other 3 subgroups, this difference was not signifi-cant (P = .17).

DISCUSSION

The  previously  suggested  CPR for predicting a successful outcome following LSE33 could not be vali-

TABLE 2Baseline and Final Disability (MODI) and Pain (NPRS) Scores for All Groups and Subgroups*

Abbreviations: CPR–, patients with a negative status on the clinical prediction rule; CPR+, patients with a positive status on the clinical prediction rule; LSE, patients treated with lumbar stabilization exercises; MODI, modified Oswestry Disability Index; MT, patients treated with manual therapy; NPRS, numeric pain rating scale.*Values are mean SD and are based on intention-to-treat analysis.

Group Baseline MODI (0-100) Final MODI (0-100) Baseline NPRS (0-10) Final NPRS (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+ (n = 18) 37.8 9.4 10.7 9.8 4.4 1.7 1.9 1.6

LSE CPR– (n = 30) 37.7 11.4 19.4 10.8 5.2 1.6 2.7 1.9

MT CPR+ (n = 22) 41.8 15.0 21.5 20.9 5.2 1.6 3.1 2.8

MT CPR– (n = 35) 35.0 9.9 19.4 12.3 5.4 1.8 3.1 2.4

TABLE 3Baseline Adjusted Final Disability   (MODI) and Pain (NPRS) Among the   Different Groups and Subgroups*

Abbreviations: CPR–, patients with a negative status on the clinical prediction rule; CPR+, patients with a positive status on the clinical prediction rule; LSE, patients treated with lumbar stabilization exercises; MODI, modified Oswestry Disability Index; MT, patients treated with manual therapy; NPRS, numeric pain rating scale.*Values are mean (95% confidence interval) and are provided based on intention-to-treat analysis.

Group MODI (0-100) NPRS (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)

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)

0

5

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LSE CPR+ LSE CPR–

MO

DI S

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, %

Final

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20

25

30

35

40

45

×

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×

FIGURE 2. Change in disability from baseline to the end of treatment for the 4 subgroups. Abbreviations: LSE CPR–, patients with a negative status on the clinical prediction rule treated with lumbar stabilization exercises; LSE CPR+, patients with a positive status on the clinical prediction rule treated with lumbar stabilization exercises; MODI, modified Oswestry Disability Index; MT CPR–, patients with a negative status on the clinical prediction rule treated with manual therapy; MT CPR+, patients with a positive status on the clinical prediction rule treated with manual therapy.

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dated in our investigation. Nevertheless, we believe the CPR may hold promise in identifying patients most likely to experi-ence success following LSE. Despite the absence of a CPR-by-treatment interac-tion, the 2 pairwise comparisons most relevant for validating the CPR indicated that, by the end of treatment, patients with a positive CPR status who received LSE (a matched intervention) experi-enced less disability compared to those with a negative CPR status receiving LSE or to patients with a positive CPR status receiving MT (an unmatched in-tervention). Furthermore, effect sizes for both of these comparisons were very close to the MCID of the MODI (10 points), and the lower bounds of the 95% confi-dence intervals were above zero (TABLE 4). The extra noise created by the multiple computations of the ANCOVA might have prevented a significant CPR-by-treatment interaction effect, despite the consistent advantage for patients with a positive CPR treated with LSE.

It seems, therefore, that the inability to validate the CPR in this study is most likely related to its level of power. Our a priori sample-size calculation was de-signed to detect a 12-point difference in the MODI, with α = .05 and a power of 70%. Therefore, it could be argued that our study was somewhat underpowered. However, based on our findings, 314

patients would have been required to achieve 80% power for detecting an in-teraction between treatment group and CPR status, a sample size that was un-realistic under the circumstances of the present study. We therefore believe that, although our results cannot validate the CPR, they do not invalidate it but, in fact, seem to imply its potential. It is not un-reasonable to assume that the CPR in its current form may still be able to indicate which patients would most likely succeed with LSE.

Among other potential reasons for the inability to validate a CPR are dif-ferences in sample characteristics, in the application of the CPR itself, in the ad-ministration of the intervention, and in the definition of the outcome between the derivation and validation studies. With regard to sample characteristics, the in-clusion/exclusion criteria in the current study were fairly similar to those of the derivation study,33 which resulted in rela-tively similar samples. However, patients in the current study demonstrated a high-er level of disability at baseline (MODI score, 37% versus 29% in the derivation study33) and a somewhat longer duration of symptoms (68 versus 40 days). The longer duration of LBP in the current sample could have had a negative effect on the overall prognosis32,40,72; however, this effect was not expected to differ be-

tween the treatment groups or subgroups.As for the application of the CPR it-

self, the sample of the current study in-cluded a higher proportion of patients with a positive CPR status compared to the derivation study (38% versus 28%).33 A likely reason for this difference is the younger age of our sample (37 versus 42 years). Another possible reason is 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 prev-alence rates of a positive prone instability test. In any event, we do not believe that the higher rate of a positive CPR status in our study was likely to hinder the ability to validate the CPR.

The LSE program used in the current study was very similar to that used in the derivation study. In addition, the criteria for dichotomizing the outcomes as suc-cess or failure were identical to those used in the derivation study.33 Therefore, we do not believe these factors would likely explain the inability to validate the CPR, either.

Finally, the inability to validate the CPR may be related to the comparison intervention used in the current study.

TABLE 4Baseline Adjusted Mean Differences in Final

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

Abbreviations: CPR–, patients with a negative status on the clinical prediction rule; CPR+, patients with a positive status on the clinical prediction rule; LSE, patients treated with lumbar stabilization exercises; MODI, modified Oswestry Disability Index; MT, patients treated with manual therapy; NPRS, numeric pain rating scale.*Values are mean difference (95% confidence interval).†Positive values indicate an advantage to LSE.‡Positive values indicate an advantage to CPR+.§Positive values indicate an advantage to LSE CPR+.

Comparison MODI (0-100)* P Value NPRS (0-10)* P Value

LSE versus MT† 5.0 (0.1, 9.9) .05 0.5 (–0.3, 1.3) .26

CPR+ versus CPR–‡ 5.2 (0.2, 10.2) .04 0.1 (–0.7, 0.9) .88

LSE CPR+ versus LSE CPR–§ 8.7 (1.4, 15.9) .02 0.3 (–0.9, 1.5) .67

LSE CPR+ versus MT CPR+§ 8.5 (0.7, 16.3) .03 0.7 (–0.6, 1.9) .31

010

LSE CPR+ LSE CPR– MT CPR+ MT CPR–

2030405060708090

Succ

ess

Rate

, %

FIGURE 3. Rate of success (%) among the 4 subgroups based on the original clinical prediction rule and a cutoff threshold of 50% decrease in baseline modified Oswestry Disability Index score. Abbreviations: LSE CPR–, patients with a negative status on the clinical prediction rule treated with lumbar stabilization exercises; LSE CPR+, patients with a positive status on the clinical prediction rule treated with lumbar stabilization exercises; MT CPR–, patients with a negative status on the clinical prediction rule treated with manual therapy; MT CPR+, patients with a positive status on the clinical prediction rule treated with manual therapy.

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Manual therapy seemed to be a suitable comparison intervention because it is fre-quently used in the management of LBP, it is advocated by several clinical practice guidelines,1,19,76 and it has previously been shown to have a varied level of success when compared to LSE in heterogeneous samples of patients with LBP.11,24,50,62 Despite this rationale, recent evidence suggests that spinal manipulation may result in remediation of some muscle im-pairments that are the focus of LSE pro-grams, such as increased activation of the

transversus abdominis and lumbar mul-tifidi.42,61 It is possible, therefore, that the manipulation techniques included in the MT intervention contributed to facilita-tion of the deep spinal musculature and, consequently, exerted an effect similar to that attributed to LSE. Be that as it may, when spinal manipulation has been pre-viously performed specifically on patients who meet the stabilization CPR,41 no ef-fects were observed on the activation of the transversus abdominis or internal oblique, and the clinical effects (pain and

disability) did not exceed the minimal clinically important threshold.41 Further-more, another study indicated that none of the variables comprising the stabiliza-tion CPR was associated with increased activation of the lumbar multifidus fol-lowing spinal manipulation.43 Finally, any changes in activation of the lumbar multifidus that were observed immedi-ately after manipulation did not seem to be consistently sustained 3 to 4 days after the application of the technique.42 There-fore, we do not believe the manipulation techniques in our study were likely to produce long-lasting or clinically signifi-cant changes in recruitment of the spinal musculature of our patients.

During the process of CPR validation, it is not unusual to attempt to modify an original version of a CPR by adding, omitting, or combining several of its items.67,68,81 Our findings indicate that a modified version of the CPR (mCPR), containing only 2 of the original 4 items, yielded a better predictive validity. The mCPR did result in a significant inter-action effect with treatment, and the 2 corresponding pairwise comparisons indicated a better outcome for patients with a positive mCPR status treated with

TABLE 5Baseline Adjusted Final Disability (MODI) 

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

Abbreviations: LSE, patients treated with lumbar stabilization exercises; mCPR–, patients with a negative status on the modified clinical prediction rule; mCPR+, patients with a positive status on the modified clinical prediction rule; MODI, modified Oswestry Disability Index; MT, patients treated with manual therapy; NPRS, numeric pain rating scale.*Values are mean (95% confidence interval) and are provided based on intention-to-treat analysis.

Group MODI (0-100) NPRS (0-10)

LSE (n = 48) 15.4 (11.8, 18.9) 2.5 (1.9, 3.0)

MT (n = 57) 20.4 (17.2, 23.7) 3.0 (2.5, 3.5)

mCPR+ (n = 44) 16.5 (12.8, 20.3) 2.7 (2.1, 3.3)

mCPR– (n = 61) 19.3 (16.1, 22.4) 2.8 (2.3, 3.3)

LSE mCPR+ (n = 20) 11.2 (5.7, 16.6) 2.0 (1.1, 2.9)

LSE mCPR– (n = 28) 19.6 (15.0, 24.2) 2.9 (2.1, 3.6)

MT mCPR+ (n = 24) 21.9 (16.9, 26.9) 3.3 (2.5, 4.1)

MT mCPR– (n = 33) 19.0 (14.7, 23.2) 2.8 (2.1, 3.4)

TABLE 6

Baseline Adjusted Mean Differences   in Final Disability (MODI) and Pain   

(NPRS) Between the Different Groups   and Subgroups Based on the mCPR

Abbreviations: LSE, patients treated with lumbar stabilization exercises; mCPR–, patients with a negative status on the modified clinical prediction rule; mCPR+, patients with a positive status on the modified clinical prediction rule; MODI, modified Oswestry Disability Index; MT, patients treated with manual therapy; NPRS, numeric pain rating scale.*Values are mean difference (95% confidence interval) and are provided based on intention-to-treat analysis.†Positive values indicate an advantage to LSE.‡Positive values indicate an advantage to mCPR+.§Positive values indicate an advantage to LSE (mCPR+).

Comparison MODI (0-100)* P Value NPRS (0-10)* P Value

LSE versus MT† 5.0 (0.2, 9.9) .04 0.5 (–0.2, 1.3) .18

mCPR+ versus mCPR–‡ 2.7 (–2.2, 7.7) .27 0.2 (–0.6, 1.0) .67

LSE mCPR+ versus LSE mCPR–§ 8.4 (1.3, 15.5) .02 0.8 (–0.3, 2.0) .16

LSE mCPR+ versus MT mCPR+§ 10.7 (3.4, 18.1) .005 1.2 (0.0, 2.4) .05

010

LSE mCPR+ LSE mCPR– MT mCPR+ MT mCPR–

2030405060708090

Succ

ess

Rate

, %

FIGURE 4. Rate of success (%) among the 4 subgroups based on the mCPR and a cutoff threshold of 50% decrease in baseline modified Oswestry Disability Index score. Abbreviations: LSE mCPR–, patients with a negative status on the modified clinical prediction rule treated with lumbar stabilization exercises; LSE mCPR+, patients with a positive status on the modified clinical prediction rule treated with lumbar stabilization exercises; mCPR, modified clinical prediction rule; MT mCPR–, patients with a negative status on the modified clinical prediction rule treated with manual therapy; MT mCPR+, patients with a positive status on the modified clinical prediction rule treated with manual therapy.

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LSE compared to patients treated with unmatched interventions. Effect sizes for these comparisons were either above or slightly below the MCID of the MODI (TABLE 6). These findings seem to suggest that the mCPR may be a more accurate predictor of success following LSE.

It is acknowledged that because the mCPR was derived retrospectively, its effect on final disability could have oc-curred by chance alone. We believe, how-ever, that several factors point against this possibility. First, the mCPR is still composed of items that have been previ-ously linked to success following LSE in the derivation study.33 Second, no other combination of items from the original CPR produced similar findings. Third, we believe this 2-item version may even possess a clearer biomechanical plau-sibility compared to the original CPR. The mCPR status is considered positive when both aberrant lumbar movement and a positive prone instability test are present. Teyhen et al70 demonstrated that, compared to healthy individuals, patients with LBP, aberrant movements, and a positive prone instability test dem-onstrate decreased control of lumbar segmental mobility during midrange lumbar motion. This difference may rep-resent an altered motor control strategy, which suggests that an LSE program may be most beneficial under those circum-stances. Furthermore, Hebert et al31 dem-onstrated that individuals with LBP and a positive prone instability test displayed decreased automatic activation of their lumbar multifidi compared to healthy controls. Given the remediating effects of LSE on muscle activation patterns,73,74 it seems reasonable that LSE would be most beneficial for patients presenting with such activation deficits. In contrast, it seems much less clear why patients under the age of 40 would preferentially benefit from LSE as opposed to MT or any other intervention. In fact, a younger age has been previously associated with a generally favorable prognosis following an episode of LBP.5,13,29,52,72 This finding may help to explain why the CPR in its

original version seemed to be consistently associated with a better outcome, regard-less of the treatment received. Likewise, it seems less intuitive why a greater SLR range of motion would predict a better outcome specifically following LSE.

Finally, our entire sample included 40 patients with a positive CPR status ac-cording to the original (4-item) version and 44 patients with a positive mCPR status. It could therefore be argued that the slightly larger number of patients with a positive mCPR might have simply increased the power to detect an inter-action with treatment group. However, as only 31 patients had a positive status according to both versions of the CPR, it seems that the better predictive power of the mCPR may not simply be a matter of sample size but may be inherent in pa-tients presenting with the 2 specific items comprising the mCPR.

In summary, we believe that, in addi-tion to its stronger statistical association with success specifically following LSE, the mCPR carries a stronger biomechani-cal plausibility as a predictor of success following this intervention. Nevertheless, due to its retrospective nature, an addi-tional investigation is recommended to prospectively establish the predictive va-lidity of the mCPR.

Study LimitationsIn addition to the aforementioned issues of power and the retrospective nature of some of the findings, the current study has several additional limitations. First, the dropout rate was fairly high, in par-ticular among the LSE group. Overall, 24 patients (22.8%) did not complete the study. The dropout rate was greater among patients receiving LSE (33% versus 14%). We believe that the overall dropout rate of the current study may partly reflect the dropout rate (31%) among Israeli patients receiving outpa-tient physical therapy for common mus-culoskeletal conditions.23 The greater dropout rate among the LSE group also suggests that patients receiving this in-tervention may not have perceived it to

be as valuable as MT. The manual contact included in the MT intervention could have created an attention effect in favor of this intervention, which, in turn, might have contributed to better compliance. Because this was suspected, the treating clinicians were encouraged to provide patients receiving LSE with continuous verbal as well as manual cuing for main-taining a neutral lumbar posture and an ADIM. It seems, however, that this ap-proach still failed to produce a similar level of compliance among the 2 groups. An intention-to-treat analysis was used in an attempt to minimize the effect of the dropout rate on our findings.

Longer-term outcomes should be as-sessed to determine whether the CPR in its original or modified version has any long-term effects on patients in the various subgroups. In addition, the ex-ternal validity of our findings needs to be considered, as only 105 patients were recruited after screening 531 potential participants. Most participants were ex-cluded for not meeting the minimal level of disability required for inclusion (FIGURE

1). Therefore, findings are limited to pa-tients with LBP with at least a moderate level of disability.

CONCLUSION

The previously suggested CPR for identifying patients most likely to succeed following LSE could not

be validated in this study. However, be-cause the subgroup comparisons most relevant for the validity of the CPR in-dicated an advantage for patients with a positive CPR treated by LSE, and be-cause of a relatively low level of power, our findings suggest that the current CPR still has the potential to predict success following LSE. Furthermore, a modified version of the original CPR that included only 2 of its items (aberrant movement and positive prone instability test) was able to predict a successful outcome spe-cifically following LSE and may serve as a valid alternative. Future study is rec-ommended to prospectively validate the

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[ research report ]mCPR as a predictor of success with LSE in individuals with LBP. Alternatively, to validate the original version of the CPR, a larger, replication study is recommended in an attempt to overcome the insufficient power of the current study. The findings of this study are further limited by a rela-tively large dropout rate (22.8%) and lack of a long-term follow-up. t

KEY POINTSFINDINGS: Although not validated, the previously suggested CPR for identifying patients most likely to succeed follow-ing LSE shows promise. Furthermore, a modified version of the CPR containing only 2 of its original 4 items (presence of aberrant movement and a positive prone instability test) demonstrated a better predictive validity in identifying those most likely to succeed with LSE.IMPLICATIONS: Patients with LBP present-ing with aberrant lumbar movement as well as a positive prone instability test may benefit most from an LSE program.CAUTION: Findings are limited by a relatively small sample size, a relatively large dropout rate, and the lack of a long-term follow-up.

ACKNOWLEDGEMENTS: The authors thank Dr Gregory Hicks, Arnon Ravid, Ori Firsteter, Shai Grinberg, Efrat Laor, Dikla Taif, Alon Ben-Moshe, Mossa Hugirat, Meira Lugasi, Lena Oifman, Liron Laposhner, Beni Mazoz, Fadi Knuati, Lena Kin, Ruthy Bachar, Chen Tel-Avivi, Irit Fridman, Yana Avner, Naomi Sivan, Rafi Cohen, and Yigal Levran for their contribution and support of this work.

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75. Unsgaard-Tøndel M, Fladmark AM, Salvesen O, Vasseljen O. Motor control exercises, sling exercises, and general exercises for patients with chronic low back pain: a randomized controlled trial with 1-year follow-up. Phys Ther. 2010;90:1426-1440. http://dx.doi.org/10.2522/ptj.20090421

76. van Tulder M, Becker A, Bekkering T, et al. Chap-ter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006;15 suppl 2:S169-S191. http://dx.doi.org/10.1007/s00586-006-1071-2

77. van Tulder M, Malmivaara A, Esmail R, Koes B. Exercise therapy for low back pain: a systematic review within the framework of the Cochrane Collaboration back review group. Spine (Phila Pa

1976). 2000;25:2784-2796. 78. Von Korff M, Saunders K. The course of back

pain in primary care. Spine (Phila Pa 1976). 1996;21:2833-2837; discussion 2838-2839.

79. Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Question-naire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157-168.

80. Wallwork TL, Stanton WR, Freke M, Hides JA. The effect of chronic low back pain on size and contraction of the lumbar multifidus muscle. Man Ther. 2009;14:496-500. http://dx.doi.org/10.1016/j.math.2008.09.006

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 for an improve-ment in the diagnostic process. J Intern Med. 1998;243:15-23.

82. Wilke HJ, Wolf S, Claes LE, Arand M, Wiesend A. Stability increase of the lumbar spine with dif-ferent muscle groups. A biomechanical in vitro study. Spine (Phila Pa 1976). 1995;20:192-198.

PUBLISH Your Manuscript in a Journal With International Reach

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journal of orthopaedic & sports physical therapy | volume 44 | number 1 | january 2014 | B1

LUMBAR STABILIZATION EXERCISE PROGRAMExercise or Activity/Criteria for Progression Description

Stage 1

ADIM in quadruped; 30 repetitions Following exhalation, the patient tightens the ab-dominal muscles and draws the belly button up toward the spine, while maintaining a neutral lumbar spine position. The contraction is held for 8 seconds.

ADIM in standing; 30 repetitions Following exhalation, the patient tightens the ab-dominal muscles and draws the belly button in toward the spine, while maintaining a neutral lumbar spine position. The contraction is held for 8 seconds.

ADIM in supine; 30 repetitions Following exhalation, the patient tightens the ab-dominal muscles and draws the belly button in toward the spine, while maintaining a neutral lumbar spine position. The contraction is held for 8 seconds.

APPENDIX A

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Exercise or Activity/Criteria for Progression Description

Stage 2 During stage 2, the patient progresses from one exercise to the next in 4 different positions: supine lying, sidelying, quadruped, and standing.

Supine ADIM with heel slide; 20 repetitions with each leg

Starting in a hook-lying position, feet flat on the sup-porting surface, the patient performs an ADIM and slides 1 heel on the supporting surface until the knee is straight. The position is held for 4 seconds, and the leg is returned to the starting position. The movement is repeated, alternating between legs.

Supine ADIM with leg lift; 20 repetitions with each leg

The patient performs an ADIM and raises 1 foot 10 cm off the supporting surface. The position is held for 4 seconds, and the leg is returned to the start-ing position.

Supine ADIM with bridging (2 legs); 30 repetitions

The patient performs an ADIM and raises the but-tocks off the supporting surface. The position is held for 8 seconds, and the patient returns to the starting position.

Supine ADIM with single-leg bridge; 30 repetitions with each leg

Starting in a hook-lying position, the patient per-forms an ADIM and straightens 1 knee. The patient then raises the buttocks off the table using the op-posite leg. The position is held for 8 seconds, and the patient returns to the starting position.

APPENDIX A

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journal of orthopaedic & sports physical therapy | volume 44 | number 1 | january 2014 | B3

Exercise or Activity/Criteria for Progression Description

Stage 2 (continued)

Supine ADIM with curl-up: 1 (elbows on the table); 30 repetitions

The patient assumes a supine position, with one leg straight and the other leg bent at the knee and hip 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 per-forms 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 with curl-up: 2 (elbows off the table); 30 repetitions

The patient assumes a supine position, with one leg straight and the other leg bent at the knee and hip 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 per-forms 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 with curl-up: 3 (hands over forehead); 30 repetitions

The patient assumes a supine position, with one leg straight and the other leg bent at the knee and hip to maintain a neutral pelvic 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 support, knees bent; 30 repetitions on each side

The patient performs an ADIM and raises the hips and trunk off the supporting surface. The position is held for 8 seconds, and the patient returns to the starting position.

APPENDIX A

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[ research report ]

Exercise or Activity/Criteria for Progression Description

Stage 2 (continued)

Horizontal side support, knees straight; 30 repetitions on each side

The patient performs an ADIM and raises the hips and trunk off the table. The position is held for 8 seconds, and the patient returns to the starting position.

Horizontal side support, advanced 1; 30 repetitions on each side

The patient performs an ADIM and raises the hips and trunk off the table. The patient then rotates the trunk backward and forward (4 times in each direction), and then returns to the starting position.

Sidelying horizontal side support, advanced 2; 30 repetitions

The patient performs an ADIM and raises the hips and trunk off the table. The patient then rolls over onto the opposite elbow while maintaining a neutral spine. The patient then rolls back to the starting position.

Quadruped with leg raise; 30 repetitions with each leg

The patient performs an ADIM and then straightens 1 leg backward, while maintaining a neutral lumbar spine position. The position is held for 8 seconds before returning to the starting position.

APPENDIX A

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journal of orthopaedic & sports physical therapy | volume 44 | number 1 | january 2014 | B5

Exercise or Activity/Criteria for Progression Description

Stage 2 (continued)

Quadruped with contralateral arm and leg raise; 30 repetitions with each arm and leg

The patient performs an ADIM and then straightens 1 leg backward, along with a contralateral arm raise, while maintaining a neutral lumbar position. The position is held for 8 seconds before returning to the starting position.

Quadruped, advanced; 30 repetitions with each arm and leg

The patient performs an ADIM and then straightens 1 leg back, along with a contralateral arm raise, 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 straight-ens the arm and leg back to a horizontal position.

Standing rowing; 30 repetitions with each arm

The patient performs an ADIM and then pulls a 1- to 1.5-kg weight in a rowing motion until the weight is at chest level. The position is held for 6 seconds, and the patient then returns the weight to the starting position.

APPENDIX A

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[ research report ]

Exercise or Activity/Criteria for Progression Description

Stage 2 (continued)

Walking; patient progresses to 10 minutes

The patient alternates between performing an ADIM for 8 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.

Sit-to-stand transfer; 30 repetitions The patient sits on a standard chair and performs an ADIM 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.

Rolling from side to side; 30 repetitions

The patient is in a sidelying position. The patient performs an ADIM and then rolls from one side to the other, while maintaining a neutral position of the lumbar spine. The patient then returns to the starting position.

Squatting; 30 repetitions The patient leans against a wall and performs an ADIM. The patient then slides down along the wall until the knees are at a 45° angle, while maintain-ing a neutral spine position. The position is held for 5 seconds, and the patient returns to the start-ing position.

Lifting; 30 repetitions The patient stands in front of a standard chair. The patient performs an ADIM and then picks up a 2- to 3-kg weight placed on the chair and lifts it to a shelf at 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.

APPENDIX A

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journal of orthopaedic & sports physical therapy | volume 44 | number 1 | january 2014 | B7

Exercise or Activity/Criteria for Progression Description

Stage 3 (continued)

Vacuuming, swiping; patient progresses to 3 minutes of continuous activity

The patient performs a vacuuming/swiping motion while performing an ADIM and maintaining a neu-tral position of the lumbar spine.

Abbreviation: ADIM, abdominal drawing-in maneuver.

APPENDIX A

MANUAL THERAPY PROGRAM

Manual Techniques

Technique or Stretch/Dosage Description

Lumbosacral thrust manipulation; up to 2 thrusts on each side

The therapist sidebends the patient toward the side to be manipulated and rotates the trunk in an opposite direction until the pelvis lifts off the table. The therapist then places his/her hand on the anterior superior iliac spine on the side to be manipulated, takes up the slack, and applies a high-velocity, low-amplitude thrust in the direction of the table.

Lumbar thrust manipulation; up to 2 thrusts on each side

The therapist flexes the hip until motion is detected at the L4-5 segment. The therapist then rotates the upper trunk backward until motion is detected at the L4-5 segment. The therapist then rolls the patient toward him/her and stretches the segment to its end range. The therapist then applies a high-velocity, low-amplitude thrust.

APPENDIX B

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B8 | january 2014 | volume 44 | number 1 | journal of orthopaedic & sports physical therapy

[ research report ]

Technique or Stretch/Dosage Description

Upper lumbar thrust manipulation; up to 2 thrusts on each side

The patient places both arms on top of the therapist’s shoulder. The therapist places the hypothenar eminence of 1 hand over the transverse process of the segment to be manipulated. The therapist then rotates the patient toward him/her and sidebends away. The therapist then applies a high-velocity, low-amplitude thrust in a forward direction (rotat-ing the patient toward him/her).

Posterior/anterior nonthrust mobilization; 40 seconds, 3 repetitions over each segment at the highest grade tolerated

The therapist places the thenar eminence of 1 hand (mobilizing hand) over the spinous process of the segment to be mobilized. The therapist places the opposite hand over the dorsum of the mobilizing hand and locks his/her elbows. The therapist then applies a posterior/anterior force over the segment in an oscillatory fashion with 1 to 2 oscillations per second.

Hamstring stretch; 30 seconds, 3 repetitions on each leg

The therapist flexes the hip to 90° and then extends the knee until the patient reports a stretching sen-sation behind his/her knee.

APPENDIX B

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journal of orthopaedic & sports physical therapy | volume 44 | number 1 | january 2014 | B9

Technique or Stretch/Dosage Description

Iliopsoas stretch; 30 seconds, 3 repetitions on each leg

The patient maintains 1 knee close to his/her chest. The therapist lowers the opposite leg over the edge of the table into hip extension (while keeping the knee straight) until a stretching sensation is reported by the patient.

Quadriceps stretch; 30 seconds, 3 repetitions on each leg

The patient maintains 1 knee close to his/her chest. The therapist lowers the opposite leg over the edge of the table into hip extension and knee flexion until a stretching sensation is experienced by the patient.

Tensor fascia lata stretch; 30 seconds, 3 repetitions on each leg

The patient maintains 1 knee close to his/her chest. The therapist lowers the opposite leg over the edge of the table into hip extension and knee flexion. The therapist then uses his/her leg to externally rotate and adduct the patient’s hip until a stretch-ing sensation is reported.

APPENDIX B

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Technique or Stretch/Dosage Description

Piriformis stretch; 30 seconds, 3 repetitions on each leg

The therapist flexes the patient’s hip and knee to 90° and then fully externally rotates the patient’s hip. The therapist then stretches the hip into further flexion and adduction (pointing the knee toward the opposite shoulder of the patient). The motion continues until the patient reports a stretching sensation over the ipsilateral buttock.

Range-of-Motion and Flexibility Exercises

Exercise or Stretch/Dosage Description

Cat horse; 30 repetitions, 4 sets The patient curls his/her back up and down in a comfortable, pain-free range.

Prone press-up; 10 seconds, 10 repetitions

The patient presses up on both hands, extending his/her spine in a pain-free range. The patient holds this position for 10 seconds and returns to the starting position.

APPENDIX B

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Exercise or Stretch/Dosage Description

Standing lumbar extension; 3 seconds, 10 repetitions

The patient leans back and extends the lumbar spine in a pain-free range. The patient holds the position for 3 seconds and returns to the starting position.

Quadruped flexion; 10 seconds, 10 repetitions

From a quadruped position, the patient brings his/her buttocks toward the heels to create flexion of the lumbar spine. The patient holds the position for 10 seconds and returns to the starting position.

Sidelying trunk rotation; 10 seconds, 10 repetitions on each side

The patient presses the upper knee down to rotate the pelvis toward the table, while rotating the shoulders up (toward the ceiling) to create maxi-mal trunk rotation. The patient holds the position for 10 seconds and returns to the starting position.

APPENDIX B

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[ research report ]

Exercise or Stretch/Dosage Description

Hip flexor stretch; 30 seconds, 3 repetitions on each leg

From a half-kneeling position, the patient performs a posterior pelvic tilt and then leans forward until a stretch is felt in the front of the hip. The patient holds the position for 30 seconds and returns to the starting position.

Quadriceps stretch; 30 seconds, 3 repetitions on each leg

The patient uses a towel/belt to pull the foot up to-ward his/her buttock (knee flexion) until a stretch is felt in the anterior thigh. The patient holds the position for 30 seconds and returns to the starting position.

APPENDIX B

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Page 26: A Clinical Prediction Rule to Identify Patients With …...lumbar spine, manual therapy 1 Department of Physiotherapy, Ariel University, Ariel, Israel. 2 Bat-Yamon Physical Therapy

journal of orthopaedic & sports physical therapy | volume 44 | number 1 | january 2014 | B13

Exercise or Stretch/Dosage Description

Hamstring stretch; 30 seconds, 3 repetitions on each leg

The patient extends the knee until a stretch is felt in the posterior aspect of the knee/thigh. The patient holds the position for 30 seconds and returns to the starting position.

Piriformis stretch; 30 seconds, 3 repetitions on each leg

The patient crosses 1 leg over the opposite flexed knee. The patient uses 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.

APPENDIX B

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