Running Head: Movement System and General Exercise in Chronic Low Back Pain Protocol Movement System Impairment‒Based Classification Versus General Exercise for Chronic Low Back Pain: Protocol of a Randomized Controlled Trial

Daniel Camara Azevedo, Linda R. Van Dillen, Henrique de Oliveira Santos, Daniel Ribeiro Oliveira, Paulo Henrique Ferreira, Leonardo Oliveira Pena Costa

D.C. Azevedo, PT, MSc, Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, and Physical Therapy Department, Pontifícia Universidade Católica de Minas Gerais, Dom José Gaspar 500, Belo Horizonte, MG, Brazil 30535-901. Address all correspondence to Mr Azevedo at: [email protected].

L.R. Van Dillen, PT, PhD, Program in Physical Therapy, Washington University School of Medicine, St Louis, Missouri.

H.O. Santos, PT, Physical Therapy Department, Pontifícia Universidade Católica de Minas Gerais.

D.R. Oliveira, PT, Physical Therapy Department, Pontifícia Universidade Católica de Minas Gerais.

P.H. Ferreira, PT, PhD, Faculty of Health Sciences, University of Sydney, Sydney, Australia.

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L.O.P. Costa, PT, PhD, Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, and Musculoskeletal Division, The George Institute for Global Health, Sydney, Australia.

[Azevedo DC, Van Dillen LR, Santos HO, et al. Movement System Impairment‒based classification versus general exercise for chronic low back pain: protocol of a randomized controlled trial. Phys Ther. 2015;95:xxx–xxx.]

© 2015 American Physical Therapy Association Published Ahead of Print: xxxx Accepted: April 19, 2015 Submitted: December 11, 2014

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ABSTRACT Background: Low back pain (LBP) is an important health problem in all developed countries and is associated with high levels of disability. Evidence-based clinical practice guidelines usually recommend different physical therapy interventions to manage this condition. However, those interventions usually result in small to moderate clinical effects. Recent studies suggest that interventions based on subgroup classifications may improve the effect sizes compared to rehabilitation programs where the same interventions were applied to all patients. Objective: To investigate the efficacy of treatment based on a movement system impairment (MSI) based classification model for patients with chronic LBP compared to general exercise. The primary outcomes will be pain intensity and disability at two months after randomization. Design: The study is a two-arm, prospectively registered, randomized controlled trial with a blinded assessor. Setting: The study setting will be a university physical therapy clinic in Brazil. Participants: A total of 148 subjects with chronic LBP will participate in the study. Intervention: Subjects will be randomly allocated to participate in an 8-week treatment based upon the MSI based classification or a general exercise program of stretching and strengthening exercises. Measurements: Pain intensity, disability and global impression of recovery will be assessed by a blinded assessor at baseline and at follow up appointments after treatment (two months) and four and six months after randomization.

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Limitation: Therapists will not be blinded. Conclusions: The results of this study may contribute to a better understanding of the efficacy of treatments based on classification of subjects with chronic LBP into subgroups.

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Introduction

Chronic LBP (CLBP) has reached epidemic proportions1, 2. The 1-year prevalence of a LBP episode is 38% in the general population2. LBP has been recorded in 17.1% of all patients diagnosed with any musculoskeletal condition3. Estimates of recurrence at one year range from 24% to 80%4. LBP is the world’s major cause of disability5. In Brazil, this condition is the 2nd most prevalent health problem6. In the United States, patients with LBP had total medical care costs that were $1,015 (US) greater ($3,498 (US) vs. $2,178 (US)) than those without LBP7. The total costs related to LBP in the U.S. is estimated at $84.1 to $624.8 billion7.

LBP is usually classified into acute – when the duration of the episode is less than 6 weeks; subacute - when the duration of the episode ranges from six to 12 weeks, and CLBP - when the duration of the pain episode is longer than three months1. When looking at the clinical course of persistent LBP, although most patients show a marked reduction in mean pain and disability in the first six weeks, they could present persistent pain with moderate levels of pain and disability between six and 52 weeks8. Most guidelines and systematic reviews for CLBP treatment recommend active physical therapy interventions, for example, exercise9-11. Specifically, manual therapy, trunk coordination, strengthening, endurance, and directional preference exercises are recommended based on strong evidence1, 11.

Several studies have compared the effectiveness of different physical therapy strategies in patients with CLBP12, 13. These studies have shown that the strategies usually result in small to moderate clinical effects and that no treatment strategies are clearly superior in the longterm14-21. A major issue in these studies could be related to sample heterogeneity, since most

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people with CLBP are often labeled with the diagnosis of non-specific LBP22. Usually, LBP is classified as specific or non-specific LBP. Specific LBP is defined as symptoms caused by a specific pathophysiological mechanism, such as hernia nuclei pulposi (with nerve root compromise), inflammatory diseases (such as ankylosing spondylitis), infection, osteoporosis, rheumatoid arthritis, fracture, or tumor. Non-specific LBP is defined as symptoms without a clear specific cause23. The non-specific classification includes 90% of all patients with LBP and it is based on exclusion of specific pathology23. Several authors have suggested that the classification of non-specific LBP into more homogenous subgroups will lead to specific interventions for those subgroups that could enhance treatment effects24-27. In fact, a few studies have already shown that using specific classification rules to guide treatment of patients with acute LBP28, 29 and CLBP30-32 can improve the short-term treatment effects. Recommendations for future research in LBP include investigations on the effect of treatment strategies based on subgrouping1, 33, 34.

Different models for classification and diagnosis have been described to guide LBP treatment25, 35-40. Classification using the Movement System Impairment based classification (MSI) model41-43 involves interpreting data from a standardized examination to assign a patient to a LBP subgroup. The clinician identifies mechanically-based impairments and associated symptoms across a series of tests of movements and positions to decide on the patient's LBP classification. One of the differences between the MSI model and other classification systems is the assessment of the patient's ability to maintain a stable lumbopelvic region when performing lower and upper limbs movement tests43, 44. During each movement test, the examiner makes a judgment about the timing and the magnitude of lumbopelvic region movement. The effect of the movement test on LBP symptoms is also assessed. Tests that are symptom provoking are immediately followed by standardized

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modifications to determine the role of lumbopelvic movement on the patient's symptoms. Overall, the modification involves minimizing or restricting lumbar movement during the test movement and encouraging movement in other joints to accomplish the movement goal. An improvement in LBP symptoms with the modification indicates that the initially identified lumbopelvic movement is an important contributor to the person's LBP symptoms43, 44.

Some studies have demonstrated that it is possible to discriminate specific LBP subgroups from healthy people using the MSI based classification43-46. Scholtes et al.45 reported that patients with LBP involved in sports that require trunk rotation may move their lumbopelvic region earlier and to a greater extent during lower limb movement tests than back-healthy people. Increased lumbopelvic movement could be related both to the increased demand on lumbar spine structures and to the symptoms46.

The validity of MSI-based classification model for LBP has been previously determined38. It has also been shown that the MSI classification model can be reliably applied by trained clinicians47-50, even if those clinicians have limited clinical experience50-52. Several case reports have shown promising results when the MSI model was used to guide LBP treatment53-56. However, the efficacy of this model in a high-quality randomized controlled clinical trial design still needs to be tested.

Objective The objective of this study is to investigate the efficacy of a treatment based on the MSI model for patients with CLBP in a randomized controlled clinical trial with blinded assessors.

Methods

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Study design The study is a two-arm, prospectively registered, randomized controlled clinical trial with a blinded assessor. Study setting The study setting will be a university physical therapy clinic in Brazil. Eligibility criteria Subjects of both sexes between 18 and 65 years of age with chronic (pain for more than three months) non-specific LBP with a pain intensity of at least three points measured by a 0-10 point verbal numeric pain rating scale57, 58 will participate in the study. Subjects should be able to stand and walk independently and be literate in Portuguese. The exclusion criteria include any contraindications to physical exercise according to the guidelines of the American College of Sports Medicine59; major depression (i.e., scored ≥21 points measured by the depression, anxiety and stress scale – DASS60, 61), serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis); nerve root compromise (disc herniation, spinal stenosis, spondylolisthesis and other diagnoses associated with nerve compromise); serious cardiorespiratory diseases, previous back surgery or pregnancy, and cannot be classified into any of the five categories of the MSI model upon initial assessment37

Procedures The subjects will be recruited from orthopedic outpatient clinics as well by advertising in radio media. The blinded assessor will screen the eligibility of each subject based on the previously described eligibility criteria. All eligible subjects will receive information about the study and will sign an informed consent form before participation. The assessor will collect the baseline data prior to randomization, and at two, four, and six months after

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randomization. With the exception of the baseline assessment, all other assessments will be collected over the telephone. All data entry will be coded, entered into an Excel spreadsheet and doubled-checked prior to the analysis. Outcomes The subject’s assessment will include the following instruments: 1) questionnaire of subject characteristics (age, gender, history of LBP, factors that alleviate or aggravate symptoms, location and duration of symptoms); 2) physical examination using the MSI-based classification model for subjects with LBP47; 3) a 0-10 Verbal Numeric Pain Rating Scale (NRS); 4) the 24-item Roland Morris Disability Questionnaire, and 5) the 11-item Global Perceived Effect Scale57, 58. The primary outcomes will be pain intensity and disability at two months after randomization. The secondary outcomes will be pain intensity and disability at four and six months after randomization and global impression of recovery at two, four and six months after randomization. All scales and questionnaires have been translated and crossculturally adapted into Brazilian Portuguese, and their respective measurement properties have been described57, 58. A detailed description of each of the instruments is given below.

Physical examination using the MSI- based classification model for patients with LBP The physical examination for classification based on the MSI model includes 1) reports of symptoms associated with various positions and movements, and 2) judgments of movements and postures during clinical tests performed in different positions. For each of' the tests (posture or movement) that provoked symptoms, the subject either assumes a modified posture or performs a corrected movement (spinal or lower extremity) and then reports a possible change in his LBP symptoms62. After the examination, the examiner will classify each subject into one of five possible categories (flexion, extension, rotation, flexion with rotation or extension with rotation syndromes) based on the rules described by Harris-Hayes

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and Van Dillen47. All subjects will be classified before randomization by the main author using the MSI model.

Verbal Numeric Pain Rating Scale (NRS) The pain numerical rating scale assesses the pain intensity levels perceived by the subject in the last seven days using an 11-point scale (ranging from 0 to 10), with 0 representing “no pain” and 10 representing “the worst possible pain”57, 58.

Roland Morris Disability Questionnaire The Roland Morris Disability Questionnaire assesses disability associated with LBP63. It has 24 questions that describe daily tasks that the subjects have difficulty performing due to their LBP57, 58, 64. The total score ranges from 0 to 24 points and is the sum of the points obtained. Higher scores indicated higher disability.

Global Perceived Effect Scale The Global Perceived Effect Scale assesses subjects’ global impression of recovery comparing the onset of symptoms to the last few days. It is an 11-point numerical scale ranging from -5 (vastly worse) to 0 (unchanged) to +5 (completely recovered)65. Subjects will respond to the following question: “Compared to when this episode first started, how would you describe your back these days?”. Higher scores indicate better recovery57.

Random allocation The subjects will be randomly allocated to one of two groups (treatment based on MSI model or general exercise) using a computer-generated randomization conducted by a researcher who has no contact with the subjects. Subject concealed allocation will be kept in sealed,

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opaque envelopes using a random numerical sequence. The examiner responsible for the treatment will open the envelope in front of the subject and tell the subject to which treatment group he has been randomized.

Blinding Because of the study design, only the assessor will be blinded to treatment group assignment. Figure 1 depicts the study design.

Figure 1. Study flow diagram

Interventions The therapists responsible for the treatment (MSI model or general exercise) will be trained by the first author, who had 16 years of experience in orthopedic physical therapy and had been using the MSI model in practice for 11 years. Training consisted of a 16-hour course (lecture) and the opportunity to practice both treatment protocols over a one month period with supervision from the principal investigator. The principal investigator also will periodically audit the interventions through revision of patient home exercise charts and direct oversight during treatment sessions. Treatment based on MSI model Treatment based on the MSI model consists of 12 treatment sessions with an estimated duration between 45-60 minutes per session (two sessions per week for the first four weeks and one session per week in the last four weeks). Treatment based on the MSI model includes 1) patient education, 2) analysis and modification of performance of daily activities, and 3) prescription of specific exercises53-55.

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Patient education will involve teaching the subject how performance of daily activities are related to his LBP symptoms. One assumption of the MSI model is that the development and course of a person’s LBP is related to the repetition of altered movements and maintenance of prolonged postures associated with a specific direction, e.g., flexion, extension, rotation. Subjects also will receive information about the importance of controlling the postures and movements on a daily basis. The principles will be taught to subjects in the first treatment session.

Modification of daily activities will begin with analysis of the activities that the subject reports as symptom-provoking. During the analysis, the examiner will observe the subject performing the specific activities limited by the subject’s LBP. Subjects will be taught how to modify the movements and postures that are associated with their symptoms and that are proposed to contribute to accumulation of stress concentrations in the lumbar region. The analysis of daily activities is driven by the person’s LBP classification. For example, a subject classified as lumbar flexion might be taught how to assume sitting and move from sit to stand without flexing the lumbar spine and without an increase in LBP. Modification of daily activities will be initiated in the first treatment session. During the follow-up sessions, the examiner will revise the instructions according to patient progress.

The prescription of specific exercises also will be directed by the subject’s LBP classification. The exercises consist of practicing the movement tests performed during the initial assessment. However now the movements will be modified to emphasize control of lumbar spine movement and to increase movement of the adjacent joints. Movement tests that were pain-free but that the subject displayed an altered movement pattern may also be prescribed. During each treatment session, subjects will perform the exercises while being

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monitored for any increase in symptoms. They also will be advised to perform the exercises at home at least once a day. To facilitate the execution of the home exercises, each subject will receive pictures of the exercises with written instructions. The subject’s ability to perform his home exercise program will be assessed during each treatment session. The assessment is an adaptation from Harris-Hayes et al66 and includes judgments about the subject’s cognition (knowledge of key concept of the exercise or activity prescribed by the physical therapist) and psychomotor skill (performance of the exercise or activity prescribed by the physical therapist). The assessment does not result in additional time in treatment and standardizes the progression of the home program. Subjects will register their home exercise in an exercise diary and are monitored for any exacerbation in symptoms in each treatment session. Treatment based on general exercise The general exercise program consists of 12 treatment sessions with an estimated duration between 45-60 minutes per session (two sessions per week for the first four weeks and one session per week in the last four weeks). Each session will be conducted by a trained physical therapist. The subjects will perform an exercise program that starts with pedaling a stationary bike or walking for 5 minutes to warm-up then followed by stretching exercises. The stretching exercises will address the lumbar and abdominal muscles (lumbar flexors, extensors, lateral flexors and rotators) and the lower limbs muscles (hip flexors, extensors, rotators, adductors and abductors, hamstrings, quadriceps and calves). The subject also will perform strengthening exercises for the abdominal and paraspinal muscles10, 67. The subject may progress through increased load to keep inducing muscle fatigue after completion of 10 repetitions per set68. He will also be advised to perform the exercises at home (three times a week) and receive figures of the exercises with written instructions. The subject’s ability to perform his home exercise program66 will also be assessed during each treatment session.

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The exercise program will be prescribed according to American College of Sports Medicine recommendations68. Subjects will register their home exercise in an exercise diary and are monitored for any exacerbation in symptoms in each treatment session.

Statistical methods

Sample size calculation Seventy-four subjects are needed per treatment condition based on a sample size calculation considering a statistical power of 80%, an alpha of 5%, and a 15% drop-out rate. The calculation was based on the detection of a one-point between-group difference for the 1-item Pain Numerical Rating Scale57 (estimated standard deviation of 1.84) outcome and a fourpoint between group difference for the Roland Morris Disability Questionnaire57, 58, 64 (estimated standard deviation of 4.9 points) outcome.

Analysis of the effects of treatment Descriptive statistics will be calculated to check for data normality. The between-group comparisons to obtain the effects of the treatments will be conducted by means of interaction terms (group versus time interactions) using a Linear Mixed Models. We will also perform subgroup analysis using the MSI classification as a potential treatment effect modifier. All data will be given to the examiner who will perform the statistical analysis in a coded form. The statistical analysis will be performed according to an intention to treat69 approach. The statistic package IBM SPSS 19 will be used for these analyses.

Ethics Study approval and registration

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Subjects will be informed about the study and will sign an informed consent form before participating in the trial. This study was approved by Ethics Committee of the Pontificia Universidade Catolica de Minas Gerais, Brazil (17660913.0.0000.5137), and was prospectively registered at www.ClinicalTrials.gov (NCT02221609). Possible protocol modifications will be registered with the Ethics Committee as well as in the trial registry. Data will be stored at the Universidade Cidade de São Paulo, Brazil.

DISCUSSION

Potential impact and significance of the study The wide variability in CLBP clinical presentations pose a challenge to physical therapy diagnosis and treatment. In response to this challenge, various classification systems aiming at identifying common patterns of symptoms behavior, cognitive characteristics or musculoskeletal dysfunctions have emerged25, 35-40. It is expected that classifying subjects with CLBP into more homogeneous subgroups may enhance treatment effects. Other classification systems used to guide conservative treatment in LBP have been shown to improve treatment effects when compared to manual therapy and general exercise32, treatment based on electrophysical agents31 or back school30.

While the MSI-based classification model for patients with LBP has had its reliability and validity evaluated, the efficacy of the model in a high-quality randomized controlled trial design still needs to be assessed. The current study will compare a treatment based on the MSI classification model to general exercise that is recommended in most clinical practice guidelines1, 11.

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Recommendations for studies involving low back pain highlight the need for assessment of treatment effects based on subgrouping1, 33, 34. Results of this study will therefore contribute to advancing the low back pain research agenda in high-priority areas. If positive, our findings will inform physical therapists' decision-making on exercise prescriptions more tailored to patient-specific musculoskeletal impairments. While some other classification systems also involve movement-related criteria25,35-36,40, none of these systems approach the concept of directional susceptibility to movement more centrally and systematically than the MSI system41-43.

Contribution to the physical therapy profession and to patients The MSI-based classification model allows physical therapists with different levels of experience to reliably classify subjects with LBP into subgroups47, 48, 50-52. The LBP treatment provided is based on the subject’s classification and includes subject education about how the subject’s daily activities may contribute to his LBP. Subjects also are taught how to modify their daily activities by modifying the movements and postures that appear to increase lumbar spine stress and LBP symptoms. The subjects also receive a series of exercises to be performed at home. It is expected that subjects will become independent and more empowered in controlling movements and postures associated with their LBP53-55. We expect that subjects receiving treatment based on the MSI model will have a better outcome compared to subjects in the general exercise group. These findings might help therapists, health care providers and subjects with CLBP in their choice between a general exercise program or a treatment based on the MSI model.

Strengths and weaknesses of the study

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The strength of the current study is that it is a randomized controlled trial that has been prospectively registered. The study also includes concealed allocation and an intention to treat approach. The sample size has been calculated to provide appropriate statistical power to detect differences in the primary outcome between the two treatment conditions. The assessor responsible for collecting outcome data will be blinded to treatment group assignment. Physical therapists responsible for treatment have similar clinical experience and have been trained by the main author of the study. Our study has some limitations. Subjects and examiners responsible for treatments cannot be blinded. Both exercise programs include home exercises, which depend on a subject’s motivation. It is not possible to predict the amount of home exercises that will be performed by each group.

Future research The results of this study may contribute to future trials comparing the effects of different classification systems25, 35-40 used to guide LBP treatment. It is also possible that different treatment effects would be found when comparing different subgroups in the MSI group. Although this study may not be powered to detect those differences, our results may inform future studies on the topic.

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Acknowledgements Mr Azevedo, Dr Van Dillen, Dr Ferreira, and Dr Costa provided concept/idea/research design. Mr Azevedo, Dr Van Dillen, Mr Santos, Mr Oliveira, and Dr Costa provided writing. Mr Azevedo, Mr Santos, and Mr Oliveira provided data collection and analysis. Dr Costa provided fund procurement. Mr Azevedo provided facilities/equipment. Mr Azevedo, Dr Van Dillen, Mr Santos, Mr Oliveira, and Dr Ferreira provided consultation (including review of manuscript before submission).

Mr Azevedo is a PhD student funded by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES). The authors also thank Conselho Nacional de Desenvolvimento Científico e Tecnológico/Brazil (CNPQ grant number 470273/2013-5) for funding the study.

DOI: 10.2522/ptj.20140555

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Triage to determine participant eligibility

Baseline data collection (n=148)

Randomization of participants (n=148)

Treatment based on MSI model n=74

Participant allocation

Treatment based on general exercise n=74

Pain, disability and global perceived effect

2-month follow-up

Pain, disability and global perceived effect

Pain, disability and global perceived effect

4-month follow-up

Pain, disability and global perceived effect

Pain, disability and global perceived effect

6-month follow-up

Pain, disability and global perceived effect

Figure 1. Study flow diagram

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