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.

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research report

Journal of Orthopaedic & Sports Physical Therapy® Downloaded from www.jospt.org at on May 24, 2018. For personal use only. No other uses without permission. Copyright © 2014 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.

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 TTSTUDY DESIGN: Randomized controlled trial. TTOBJECTIVE: 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). TTBACKGROUND: 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. TTMETHODS: 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. TTRESULTS: 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 (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 treatment 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). TTCONCLUSION: 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. TTLEVEL 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 TTKEY WORDS: lumbar spine, manual therapy

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ow back pain (LBP) is common among the general population, with a lifetime prevalence and point prevalence estimated to be greater than 80% and 28%, respectively.12 Although short-term outcomes are generally favorable, some patients go on to experience long-term pain and disability,32,40,78 and recurrence rates are high.17,78 Systematic reviews of various physical therapy interventions for LBP do not provide strong support for any particular treatment approach.2,50,51,77 One possible reason is the use of heterogeneous samples of patients in many clinical trials for LBP. Patients with LBP demonstrate both etiologic and prognostic heterogeneity,7,40,45 which makes it unlikely for any single intervention to have a significant advantage over another in a general population with LBP. Classifying patients into more homogeneous subgroups has been previously identified as a top re-

Department 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® 1

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search priority,6 and, in fact, more recent research has suggested that matching patients 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 abdominis and atrophy of the lumbar multifidus,25,34,37,48,69,80 have been identified among patients with LBP. These impairments may result in a reduction in spinal stiffness82 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.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 efficacy of this intervention seems to vary. When compared to sham or no intervention, LSE appears to be advantageous22,65; however, when compared to other exercise 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 success of LSE and in accordance with the aforementioned need to classify patients who have LBP into more homogeneous 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. Four variables were found to possess 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 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 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, that is, shown to consistently predict the outcome of interest in a separate and preferably prospective investigation.26 Given its preliminary nature, and because CPRs do not 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 Validation of the CPR for LSE requires 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 patients 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 meaningful manner, we believe that the comparison intervention should be considered a viable alternative to LSE, rather than a sham or an inert intervention. Manual therapy is an intervention frequently 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, combined 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 comparison intervention for testing the validity 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 positive CPR status would exhibit a better outcome compared to 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 to those who received MT.

METHODS Patients

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ne hundred five patients diagnosed with LBP and referred to physical therapy at 1 of 5 outpatient 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, malignancy, infection, spine fracture, cauda equina syndrome); 2 or more signs suggesting lumbar nerve root compression, such as decreased deep tendon reflexes, myotomal weakness, decreased sensation in a dermatomal distribution, or a positive SLR, crossed SLR, or 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 proceeding associated with their LBP. Prior to participation, all patients signed an informed consent form approved by the Helsinki Committee of Clalit Health Services.

Therapists Sixteen physical therapists were involved

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[ in the study. Eleven therapists, with between 4 and 12 years of experience in outpatient physical therapy patient care, provided treatment, and 5 therapists, with between 13 to 25 years of experience, performed baseline and followup evaluations. Prior to beginning the study, all participating therapists underwent two 4-hour sessions in which the rationale and protocol of the study were presented and the examination and treatment procedures were demonstrated and practiced. Therapists had to pass a written 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 involved 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).

Procedure After giving consent, patients completed a baseline examination that included demographic information, an 11-point (010) 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 history 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 aberrant movement, as defined by Hicks et al,33 was determined; bilateral SLR range of motion; segmental mobility of the lumbar 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 baseline examinations, as well as examiners

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

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 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 moderate to substantial (κ = 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 ensure that adequate numbers of patients with a positive and a negative CPR status would be included in each intervention group. The list was kept by a research assistant who was not involved in patient 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, 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 maintenance organization, which covered all patients participating in the study. Patients in both groups were prescribed a home exercise program consistent with their treatment group; however, no attempt was made to monitor patients’ compliance with the home exercise program.

Lumbar Stabilization Exercises The 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. Patients were initially educated about the structure and function of the trunk musculature, as well as 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.63,64,69,71,73 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, sidelying, 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 exercise 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 included in the derivation study, was added to the program because it has been recommended 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 Therapy The MT intervention included several thrust and nonthrust manipulative techniques 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 stretching of several hip and thigh muscles was performed, as flexibility of the lower extremity is purported to protect the spine from excessive strain.54 Finally, active range-of-motion and stretching exercises were added to the program, as these


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are commonly prescribed in combination 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 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 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 complementary range-of-motion/flexibility exercises, was 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 (available at www.jospt.org).

Evaluation The MODI served as the primary outcome 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 investigator not involved in patient care.

Sample Size Sample size was calculated 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, 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 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-Wilk test. Baseline 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 covariance (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 status, as well as the 2-way interaction between these factors on the final MODI and NPRS scores, were evaluated. The a priori level of significance for these analyses was P≤.05. Two pairwise comparisons were planned following the ANCOVA: (1) a comparison of differences between patients 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 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 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 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 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” 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 perprotocol analysis was performed as well. All statistical analyses were performed using 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

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ive hundred 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 were admitted 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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Excluded, n = 297: • MODI .26). TABLE 3 presents the adjusted final disability and pain scores for all groups and subgroups, and TABLE 4 presents the differences in final disability and pain among the different groups and subgroups.


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TABLE 1

Characteristic Sex (female), n (%) Age, y*† BMI, kg/m2‡

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

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)

25 (52.1)

31 (54.4)

22 (55.0)

34 (52.3)

10 (55.6)

15 (50.0)

12 (54.5)

19 (54.3)

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

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


High school

2 (4.2)

0 (0)

0 (0)

2 (3.1)

0 (0)

2 (6.7)

0 (0)

0 (0)

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)

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)

8/16 (50.0)

8/28 (28.6)

6/20 (30.0)

Work status (employed§), n (%) Smoker, n (%)§

16/44 (36.4)

11/53 (20.8)

14/36 (38.9)

13/61 (21.3)

58.7 (41.8, 82.4)

67.4 (48.9, 92.9)

63.8 (44.2, 92.2)

62.0 (46.5, 82.7)

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)

14 (29.2)

16 (28.1)

8 (20.0)

22 (33.8)

2 (11.1)

12 (40.0)

6 (27.3)

10 (28.6)

Duration (days since onset)‡

Symptoms below knee, n (%)

52.0 (30.5, 88.6) 66.3 (43.6, 101.0) 78.4 (47.3, 130.0)

5/33 (15.2) 57.9 (39.1, 85.9)

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

Abbreviations: BMI, body mass index; CPR–, patients with a negative status on the clinical prediction rule; CPR+, patients with a positive status on the clinical 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.

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 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 of 91° or greater, 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 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 receiving LSE, those with a positive mCPR status (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 positive mCPR status, those receiving LSE (n = 20) experienced less disability by the end of treatment compared to those receiving 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 interaction or main effects were noted for final pain level when using the mCPR (P>.09). 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).

Per-Protocol Analysis Similar to analysis by intention to treat,


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[


Group

45 40

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

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.

TABLE 3

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

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)

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.

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 to patients with a negative CPR status, regardless of the treatment received. No main effect was noted for treatment (P = .06). The preplanned pairwise comparisons 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 status, those receiving LSE experienced less disability by the end of treatment compared to those receiving MT (P = .03). No 2-way interaction or main effect was 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 to patients with a negative CPR status, regardless of the treatment received (P = .04).

MODI Score, %

TABLE 2

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×

35 30 25

×

20 15 10 5 0 Baseline

Final

LSE CPR+

LSE CPR–

MT CPR+

× MT CPR–

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.

The 2-way interaction between treatment group and the mCPR on final disability 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 status, those receiving LSE experienced less disability at the conclusion of the intervention compared to those receiving MT (P = .006). No 2-way interaction or main effect was noted for pain level when using the mCPR (P>.13). Finally, although a greater proportion of patients with a positive mCPR receiving LSE achieved a successful outcome compared to the other 3 subgroups, this difference was not significant (P = .17).

DISCUSSION

T

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


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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

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+.

dated in our investigation. Nevertheless, we believe the CPR may hold promise in identifying patients most likely to experience success following LSE. Despite the absence of a CPR-by-treatment interaction, 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) experienced less disability compared to those with a negative CPR status receiving LSE or to patients with a positive CPR status receiving MT (an unmatched intervention). 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% confidence intervals were above zero (TABLE 4). The extra noise created by the multiple computations of the ANCOVA might have prevented a significant CPR-bytreatment 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 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

patients would have been required to achieve 80% power for detecting an interaction between treatment group and CPR status, a sample size that was unrealistic 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 unreasonable 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 differences in sample characteristics, in the application of the CPR itself, in the administration of the intervention, and 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 derivation study,33 which resulted in relatively similar samples. However, patients in the current study demonstrated 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 prognosis32,40,72; however, this effect was not expected to differ be-

Success Rate, %

TABLE 4

Baseline Adjusted Mean Differences in Final Disability (MODI) and Pain (NPRS) Between the Different Groups and Subgroups

90 80 70 60 50 40 30 20 10 0 LSE CPR+

LSE CPR–

MT CPR+

MT CPR–

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.

tween 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 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 prevalence 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 success 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.


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[


]

Baseline Adjusted Final Disability (MODI) and Pain (NPRS) Among the Different Groups and Subgroups Based on the mCPR*

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)

Comparison

Baseline Adjusted Mean Differences in Final Disability (MODI) and Pain (NPRS) Between the Different Groups and Subgroups Based on the mCPR 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

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+).

Manual therapy seemed to be a suitable comparison intervention because it is frequently 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 impairments that are the focus of LSE programs, such as increased activation of the

90 80 70 60 50 40 30 20 10 0 LSE mCPR+ LSE 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.

TABLE 6

Success Rate, %

TABLE 5

research report

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, 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 (pain and

MT mCPR+

MT mCPR–

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.

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 did not seem to be consistently sustained 3 to 4 days after the application of the technique.42 Therefore, we do not believe the manipulation techniques in our study were likely to produce 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 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 interaction effect with treatment, and the 2 corresponding pairwise comparisons indicated a better outcome for patients with a positive mCPR status treated with


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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 occurred by chance alone. We believe, however, that several factors point against this possibility. First, the mCPR is still composed 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. Third, we believe this 2-item version may even possess a clearer biomechanical plausibility 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 demonstrate decreased control of lumbar segmental mobility during midrange lumbar motion. This difference may represent an altered motor control strategy, which suggests that an LSE program may be most beneficial under those circumstances. Furthermore, Hebert et al31 demonstrated 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, regardless 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 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 might 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 that the better predictive power of the mCPR may not simply be a matter of sample size but may be inherent in patients presenting with the 2 specific items comprising the mCPR. In summary, 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 nature, an additional investigation is recommended to prospectively establish the predictive validity of the mCPR.

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 maintaining a neutral lumbar posture and an ADIM. It seems, however, that this approach 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 assessed 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 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.

Study Limitations

T

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 dropout rate was fairly high, in particular 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 outpatient physical therapy for common musculoskeletal conditions.23 The greater dropout rate among the LSE group also suggests that patients receiving this intervention may not have perceived it to

CONCLUSION he 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 indicated an advantage for patients with a positive CPR treated by LSE, and because 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 specifically following LSE and may serve as a valid alternative. Future study is recommended to prospectively validate the


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[ 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 relatively large dropout rate (22.8%) and lack of a long-term follow-up. t


KEY POINTS FINDINGS: Although not validated, the previously suggested CPR for identifying patients most likely to succeed following 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 presenting 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.

research report

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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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APPENDIX A

LUMBAR STABILIZATION EXERCISE PROGRAM


Exercise or Activity/Criteria for Progression Stage 1 ADIM in quadruped; 30 repetitions

Description Following exhalation, the patient tightens the abdominal 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 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.

ADIM in supine; 30 repetitions

Following exhalation, the patient 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.

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APPENDIX A

Exercise or Activity/Criteria for Progression Stage 2


Supine ADIM with heel slide; 20 repetitions with each leg

Description During stage 2, the patient progresses from one exercise to the next in 4 different positions: supine lying, sidelying, quadruped, and standing. Starting in a hook-lying position, feet flat on the supporting 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 starting position.

Supine ADIM with bridging (2 legs); 30 repetitions

The patient performs an ADIM and raises the buttocks 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 performs an ADIM and straightens 1 knee. The patient then raises the buttocks off the table using the opposite leg. The position is held for 8 seconds, and the patient returns to the starting position.

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APPENDIX A


Exercise or Activity/Criteria for Progression Stage 2 (continued) Supine ADIM with curl-up: 1 (elbows on the table); 30 repetitions

Description 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 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 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 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 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.


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APPENDIX A


Exercise or Activity/Criteria for Progression Description Stage 2 (continued) Horizontal side support, knees The patient performs an ADIM and raises the hips straight; 30 repetitions on each side 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.


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APPENDIX A


Exercise or Activity/Criteria for Progression Description Stage 2 (continued) Quadruped with contralateral arm and The patient performs an ADIM and then straightens 1 leg backward, along with a contralateral arm raise, leg raise; 30 repetitions with each while maintaining a neutral lumbar position. The arm and leg 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 straightens 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.


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APPENDIX A


Exercise or Activity/Criteria for Progression Stage 2 (continued) Walking; patient progresses to 10 minutes

Stage 3

Sit-to-stand transfer; 30 repetitions

Rolling from side to side; 30 repetitions

Squatting; 30 repetitions

Lifting; 30 repetitions

Description The patient alternates between performing an ADIM for 8 seconds and relaxing for 10 seconds, while walking.

The patient continues with the exercises from stage 2 and begins to practice the following functional activities. 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. 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. 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 maintaining a neutral spine position. The position is held for 5 seconds, and the patient returns to the starting position. The patient stands in front of a standard chair. The patient performs an ADIM and then picks up a 2to 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.


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APPENDIX A

Exercise or Activity/Criteria for Progression Stage 3 (continued) Vacuuming, swiping; patient progresses to 3 minutes of continuous activity

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


Abbreviation: ADIM, abdominal drawing-in maneuver.

APPENDIX B

MANUAL THERAPY PROGRAM Manual Techniques Technique or Stretch/Dosage Lumbosacral thrust manipulation; up to 2 thrusts on each side

Description 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 highvelocity, low-amplitude thrust.


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APPENDIX B


Technique or Stretch/Dosage Upper lumbar thrust manipulation; up to 2 thrusts on each side

Description 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 (rotating the patient toward him/her).

Posterior/anterior nonthrust mobilization; The therapist places the thenar eminence of 1 hand (mobilizing hand) over the spinous process of the 40 seconds, 3 repetitions over each segment to be mobilized. The therapist places the segment at the highest grade tolerated 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 sensation behind his/her knee.


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APPENDIX B

Technique or Stretch/Dosage Iliopsoas stretch; 30 seconds, 3 repetitions on each leg

Description 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 stretching sensation is reported.


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APPENDIX B


Technique or Stretch/Dosage Piriformis stretch; 30 seconds, 3 repetitions on each leg

Description 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 Cat horse; 30 repetitions, 4 sets

Description 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.


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APPENDIX B

Exercise or Stretch/Dosage Standing lumbar extension; 3 seconds, 10 repetitions

Description 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 maximal trunk rotation. The patient holds the position for 10 seconds and returns to the starting position.


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APPENDIX B

Exercise or Stretch/Dosage Hip flexor stretch; 30 seconds, 3 repetitions on each leg

Description 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 toward 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.


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APPENDIX B

Exercise or Stretch/Dosage Hamstring stretch; 30 seconds, 3 repetitions on each leg

Description 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.


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Regarding to the article 'effect of lumbar stabilization and dynamic lumbar strengthening exercises in patients with chronic low back pain'.

A reply to the questions regarding to the article 'effect of lumbar stabilization and dynamic lumbar strengthening exercises in patients with chronic low back pain'.

The effect of lumbar stabilization exercises and thoracic mobilization and exercises on chronic low back pain patients.

Chinese massage combined with core stability exercises for nonspecific low back pain: a randomized controlled trial.

Evaluation of a modified clinical prediction rule for use with spinal manipulative therapy in patients with chronic low back pain: a randomized clinical trial.

Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial.

Prospective validation of a clinical decision rule to identify patients presenting to the emergency department with chest pain who can safely be removed from cardiac monitoring.

Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial.

Effects of hip exercises for chronic low-back pain patients with lumbar instability.

Do MRI findings identify patients with chronic low back pain and Modic changes who respond best to rest or exercise: a subgroup analysis of a randomised controlled trial.

Development and validation of a screening tool to predict the risk of chronic low back pain in patients presenting with acute low back pain: a study protocol.

A clinical prediction rule to identify patients at heightened risk for early demise following cardiac resynchronization therapy.

The Effects of Stabilization and Mckenzie Exercises on Transverse Abdominis and Multifidus Muscle Thickness, Pain, and Disability: A Randomized Controlled Trial in NonSpecific Chronic Low Back Pain.

Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain.

Pain education to prevent chronic low back pain: a study protocol for a randomised controlled trial.

Predicting response to motor control exercises and graded activity for patients with low back pain: preplanned secondary analysis of a randomized controlled trial.

Daily exercises and education for preventing low back pain in children: cluster randomized controlled trial.

Effect of functional lumbar stabilization exercises on pain, disability, and kinesiophobia in women with menstrual low back pain: a preliminary trial.

Derivation and validation of a clinical decision rule to identify young children with skull fracture following isolated head trauma.

Effects of lumbar stabilization exercise on functional disability and lumbar lordosis angle in patients with chronic low back pain.

Intensive dynamic back exercises for chronic low back pain: a clinical trial.

Trunk muscle activation during different quadruped stabilization exercises in individuals with chronic low back pain.

External Validation of a Referral Rule for Axial Spondyloarthritis in Primary Care Patients with Chronic Low Back Pain.

The effects of forced breathing exercise on the lumbar stabilization in chronic low back pain patients.