Movement System Impairment-Based Classification Treatment Versus General Exercises for Chronic Low Back Pain: Randomized Controlled Trial

Movement System Impairment-Based Classification Treatment Versus General Exercises for Chronic... Abstract Background Treatment for chronic low back pain (LBP) includes different forms of exercises, that to date have resulted in only small to moderate treatment effects. To enhance the treatment effects, different classification systems have been developed to classify people with LBP into more homogeneous subgroups leading to specific treatments for each subgroup. Objective The purpose of this study was to compare the efficacy of a treatment based on the Movement System Impairment (MSI) model with a treatment consisting of symptom-guided stretching and strengthening exercises in people with chronic LBP. Design The study was a 2-arm, prospectively registered, randomized controlled trial with a blinded assessor. Setting The study setting was a university physical therapy clinic in Brazil. Patients A total of 148 participants with chronic LBP participated in the study. Interventions Participants were randomly allocated to an 8-week treatment of either treatment based on the MSI-based classification system or symptom-guided stretching and strengthening exercises. Measurements Measures of pain intensity, disability, and global impression of recovery were obtained by a blinded assessor at baseline and at follow-up appointments at 2, 4, and 6 months after randomization. Results There were no significant between-group differences for the primary outcomes of pain intensity at 2 months (mean difference = 0.05, 95% CI = –0.90 to 0.80) and disability at 2 months (mean difference = 0.00, 95% CI = –1.55 to 1.56). There also were no statistically significant differences between treatment groups for any of the secondary outcome measures. Limitations Participants and physical therapists were not masked. Conclusions People with chronic LBP had similar improvements in pain, disability, and global impression of recovery with treatment consisting of symptom-guided stretching and strengthening exercises and treatment based on the MSI model. Low back pain (LBP) is the leading cause of years lived with disability in 86 countries, and is either the second or third leading cause in 67 countries.1 The global age-standardized point prevalence of LBP in 2010 was estimated to be 9.4%.2 LBP is considered recurrent in nature,3 with recurrence rates ranging from 20% to 65% depending on the follow-up time.4–7 The clinical course of chronic LBP is characterized by moderate levels of pain and disability that persist after a follow-up of 12 months.8 Treatment for chronic LBP includes different forms of exercise3,9–12 that, to date, have resulted in only small to moderate treatment effects.13–20 A possible explanation for the limitation in size of treatment effects could be related to sample heterogeneity.21 About 90% of all patients with LBP receive the diagnosis of nonspecific LBP, which is based on exclusion of specific pathologies.22 To enhance treatment effects, different classification systems have been developed to assign people with LBP to more homogeneous subgroups leading to specific treatments for each subgroup.23–28 Assessing the treatment effects of classifying and treating people with LBP based on their classification is a top priority in LBP research.3,29,30 The Movement System Impairment (MSI)-based classification model31–33 is one of the classification systems available to guide treatment of LBP. The MSI classification system involves a standardized examination with several tests of movements and positions to identify mechanically based impairments. It allows the classification of people with LBP into 1 of 5 possible subgroups. The treatment based on the MSI model includes education and exercise prescription to correct classification-specific impairments of movements and postures that are associated with LBP symptoms. The primary objective of treatment based on the MSI model is to minimize specific lumbar spine movements, encourage movement in other joints, and avoid extreme lumbar spine postures in specific directions. Although validity34 of the subgroups and reliability35–39 of clinicians to classify based on the MSI classification model have been previously reported, randomized clinical trials involving this classification system are limited.40 Therefore, the objective of this study was to compare the efficacy of a treatment based on the MSI classification model with a treatment consisting of symptom-guided stretching and strengthening exercises in people with chronic LBP. Exercise therapy including stretching and strengthening exercises was chosen as the comparison group because it is recommended as a first-line treatment in the management of patients with chronic LBP.9,11 Our hypothesis was that treatment based on the MSI model would result in greater improvements in pain and disability than treatment consisting of symptom-guided stretching and strengthening exercises. Methods Design Overview This study was a 2-arm, prospectively registered, randomized controlled trial with a blinded assessor. The methods used in this study were previously described in the published protocol.41 Settings and Participants This trial was conducted in an outpatient physical therapy clinic in the Pontificia Universidade Catolica de Minas Gerais, Belo Horizonte, Brazil. To be included, participants of both sexes, between 18 and 65 years of age, had to have nonspecific LBP for more than 3 months and a current minimum pain intensity of 3 on an 11-point numeric pain rating scale.42,43 They also had to be able to stand and walk independently and be literate in Portuguese. The participants were recruited from orthopedic outpatient clinics and by advertising on radio media. Potential participants were told to contact the blinded assessor by phone or email. They were screened for eligibility at their first visit to the university clinic. Participants were excluded if they presented any contraindications to exercise according to the guidelines of the American College of Sports Medicine,44 serious cardio-respiratory diseases, previous spinal surgery, serious spinal pathologies (fractures, tumors, or inflammatory pathologies), nerve root compromise (diagnosed by clinical examination of sensibility, power, and reflexes), major depression (measured by the Depression, Anxiety, and Stress scale45,46), pregnancy, or if they could not be classified into 1 of the 5 categories of the MSI model31–33 at the first visit. The physical examination was performed by the first author, who has 13 years of experience with use of the MSI model in clinical practice. The examination included (1) assessment of signs and symptoms associated with clinical tests of different movements and positions, and (2) tests assessing the effects of correcting movements and postures during the clinical tests on the participant's LBP symptoms (Tab. 1). A detailed description of the procedures and rules used to classify have been published elsewhere.36 All participants received information about the study and signed the informed consent form. The study was approved by the Ethics Committee of the Pontificia Universidade Catolica de Minas Gerais, Brazil, and was prospectively registered at www.clinicaltrials.gov (NCT02221609). Table 1. Physical Examination Used for MSI Model Classification.34,36 Position  Symptom Behavior With Movementa  Judgment of Alignment or Movementb  Standing  Standing  Shape of the lumbar curve Asymmetry and regularity of the lumbar spine Swayback  Posterior pelvic tilt against wall    Forward bending  Lumbar flexion Lumbar extension Relative flexibilityc  Corrected forward bending    Return from forward bending  Hip extension Lumbar extension Pelvic and shoulder sway  Corrected return from forward bending    Side bending  Asymmetrical lumbar region movement  Sitting  Sitting with lumbar flat    Sitting with lumbar region flexed    Sitting with lumbar region extended    Knee extension  Lumbar or pelvic rotation  Corrected active knee extension    Supine  Hips and knees flexed    Hips and knees extended    Hook lying  Hip abduction with lateral rotation  Relative flexibility  Corrected hip abduction with lateral rotation    Prone  Prone    Corrected prone    Knee flexion  Relative flexibility Asymmetrical pelvic rotation  Hip rotation  Relative flexibility Asymmetrical pelvic rotation  Hip extension    Quadruped  Natural alignment  Lumbar region alignment Asymmetry of the lumbar region Alignment of hip joint  Corrected alignment    Arm lifting  Asymmetrical lumbar region rotation  Rocking backward  Relative flexibility Pelvic rotation or tilt  Corrected rocking backward    Rocking forward    Position  Symptom Behavior With Movementa  Judgment of Alignment or Movementb  Standing  Standing  Shape of the lumbar curve Asymmetry and regularity of the lumbar spine Swayback  Posterior pelvic tilt against wall    Forward bending  Lumbar flexion Lumbar extension Relative flexibilityc  Corrected forward bending    Return from forward bending  Hip extension Lumbar extension Pelvic and shoulder sway  Corrected return from forward bending    Side bending  Asymmetrical lumbar region movement  Sitting  Sitting with lumbar flat    Sitting with lumbar region flexed    Sitting with lumbar region extended    Knee extension  Lumbar or pelvic rotation  Corrected active knee extension    Supine  Hips and knees flexed    Hips and knees extended    Hook lying  Hip abduction with lateral rotation  Relative flexibility  Corrected hip abduction with lateral rotation    Prone  Prone    Corrected prone    Knee flexion  Relative flexibility Asymmetrical pelvic rotation  Hip rotation  Relative flexibility Asymmetrical pelvic rotation  Hip extension    Quadruped  Natural alignment  Lumbar region alignment Asymmetry of the lumbar region Alignment of hip joint  Corrected alignment    Arm lifting  Asymmetrical lumbar region rotation  Rocking backward  Relative flexibility Pelvic rotation or tilt  Corrected rocking backward    Rocking forward    a For each of the items, the participant assumes a position or performs a movement and reports the status of their LBP symptoms (symptoms increased, symptoms decreased, or symptoms remained the same). Positions or movements associated with increased symptoms are followed by corrected alignment or movement involving minimizing lumbar movement that occurs in the early part of the range of motion or that is excessive, while increasing movement in other joints (ie, hip joint). An improvement in the symptoms indicates that the movement or alignment impairment in a specific direction (ie, extension) is associated with the patient's symptoms and helps to decide on the participant's MSI classification. b For each of the items, the examiner judges the alignment of the lumbar region in different positions and/or looks for incorrect timing and/or magnitude of lumbar movement during trunk and limb movements. Alignment of lumbar region in a specific direction (ie, extension) in different positions and incorrect timing and/or magnitude of lumbar movement in a specific direction help to decide on the participant's MSI classification. c Relative flexibility refers to motion of adjoining segments occurring more readily in 1 of the joints (lumbar region in this case) even if the motion should be occurring in the other joint. In general, a patient exhibits a relative flexibility impairment if the lumbar region moves in the first 50% of the range of the overall movement or excessively during the overall movement. During the MSI classification procedure, greater weight is given to symptoms behavior information than alignment and movement judgment. View Large Randomization and Interventions A researcher (L.C.) who was not involved in the participants’ recruitment, assessment, and treatment was responsible for generating a randomization schedule in Excel for Windows. Allocations were concealed using sealed, opaque, and sequentially numbered envelopes. After the initial assessment, the participants were allocated into 1 of the 2 treatment groups (treatment consisting of strengthening and stretching exercises or treatment based on the MSI model) by opening the next available envelope. Both treatment programs consisted of 12 physical therapy sessions over an 8-week period (2 sessions per week for the first 4 weeks and 1 session per week for the second 4 weeks). Each treatment session duration was 45 to 60 minutes and was supervised by trained physical therapists. Specific details of the exercise protocol and progression of exercises are provided in eAppendixes 1 and 2 (available at https://academic.oup.com/ptj). Two physical therapists with the same duration of clinical experience (2 years) were involved in delivering the treatments. One delivered the strengthening and stretching treatment; the other, the treatment based on the MSI model. They participated in a 16-hour course (lecture) involving the principles of MSI classification and treatment or reviewing the principles of strength and stretching exercises used in patients with LBP. They also practiced their treatment protocols with patients at the university clinic over a month under supervision of the first author. The first author also periodically audited the interventions through revision of patient home exercise charts and direct oversight during treatment sessions. Treatment consisting of symptom-guided stretching and strengthening exercises. After walking or pedaling a stationary bicycle for 5 minutes, participants performed stretching exercises addressing the lumbar and abdominal muscles (lumbar flexors, extensors, lateral flexors, and rotators) and lower limb muscles (hip flexors, extensors, rotators, abductors, and adductors). Each static stretching exercise consisted of 1 repetition of 30 seconds. Participants were instructed to perform each stretching movement until a mild stretching sensation was achieved or until normal range of motion was achieved.47 If there was an increase of LBP, the specific stretch was suspended. During subsequent treatment sessions, the physical therapist attempted to include the previously suspended stretching exercises. If onset or increase of LBP was still observed, the stretching exercise was removed from the treatment program. Participants also performed strengthening exercises involving the abdominal and paraspinal muscles.10,48 Each strengthening exercise consisted of 3 sets of 10 repetitions with a load high enough to produce fatigue after completion of 10 repetitions.49 In the case that the participant complained of onset or increased LBP during the exercises, the same decision-making procedure used for prescription and progression of the stretching exercise was used for the strengthening exercises. All participants were told to perform the exercises at least 3 times a week, including the treatment sessions at the clinic. After each treatment session, participants received an exercise chart of instructions and figures displaying the home exercises. A participant's ability to perform his home exercise program was evaluated during each treatment session using an instrument adapted from a previous study.50 All participants were monitored for any adverse event and for any exacerbation (onset or increase) in LBP due to the home exercises at each of the treatment sessions. Participants were instructed to keep performing the exercises after the 2-month treatment period. For complete description, see eAppendix 1 (available at https://academic.oup.com/ptj). Treatment based on the MSI model. Treatment based on the MSI model included (1) patient education, (2) analysis and modification of performance of daily activities, and (3) prescription of specific exercises.51–53 Patient education consisted of teaching the participant which altered movement or posture (eg, flexion, extension, rotation) to modify that also was related to symptoms. Participants received information about the importance of avoiding extremes of those postures and controlling the altered movements as a fundamental part of the treatment. Patient education was included in the first treatment session and could be repeated during the following sessions (eAppendix 2, available at https://academic.oup.com/ptj). Analysis and modification of performance of daily activities were guided by the participant's MSI classification. Based on the classification, the examiner assessed the performance of activities reported by the participant to be limited due to LBP. Altered postures and movements observed during the assessment were followed by instruction in how to modify the patterns of posture and movement to be less painful or pain free. Participants were instructed to repeat the modified movements and postures throughout their day. Modification of performance of daily activities was initiated during the first treatment session and was revised during the follow-up sessions based on the participant's performance. The prescription of specific exercises included performing modifications of the movement tests from the initial assessment per the participant's LBP classification. Painful movement tests or movement tests in which the person displayed an altered pattern were included in the specific exercise prescription. During treatment sessions, participants were taught to perform the movements pain free or with lower pain levels by reducing or changing the timing of the lumbar spine movement and increasing or changing the timing of movement of the adjacent joints. A home exercise chart including pictures of the exercises and performance of daily activities with written instructions was given to each participant. Participants were advised to perform the home program at least once a day on the days in which no treatment sessions were scheduled. The participant's ability to perform the home exercises was also assessed as described in the strengthening and stretching exercises treatment.50 Participants were monitored for any adverse event and any onset or increase in symptoms with the home program in each treatment session and were instructed to keep performing the exercises and daily activities after the 2-month treatment period. For complete description, see eAppendix 2 (available at https://academic.oup.com/ptj). Outcomes and Follow-Up Participant characteristics (age, gender, location, and duration of symptoms), clinical outcome prognosis using the STarT Back Screening Tool classification,54 pain intensity, disability, and the participant's global impression of recovery were assessed at baseline. Pain intensity, disability, and global impression of recovery assessments were also measured at 2 (ie, immediately after treatment), 4, and 6 months after randomization. The primary outcomes were mean pain intensity and disability at 2 months after randomization. Secondary outcomes were mean pain intensity and disability at 4 and 6 months after randomization and global impression of recovery at 2, 4, and 6 months after randomization. Treatment adherence was assessed by recording the number of treatment sessions at the clinic and the number of days performing the home program for each participant. The number of days performing the home program were documented by each participant in an exercise diary. Mean pain intensity was assessed using the Numeric Pain Rating Scale (NPRS).42,43 Disability was assessed using the Roland Morris Disability Questionnaire.42,43,55,56 Participant's global impression of recovery was assessed by the Global Perceived Effect scale42 (Tab. 2). All outcomes used in this clinical trial were translated and cross-culturally adapted into Brazilian Portuguese.42,43,55 A blinded assessor performed the assessment of outcome measures at baseline and follow-ups. Due to the nature of the treatments, blinding of treatment providers and participants was not possible. Table 2. Outcome Measures. Outcome Measure  Description  Verbal Numeric Pain Rating Scale42,43  The Numeric Pain Rating Scale assesses the pain intensity levels perceived by the participant in the last 7 days using an 11-point scale (ranging from 0 to 10), with 0 representing “no pain” and 10 representing “the worst possible pain.”  Roland Morris Disability Questionnaire42,43,55,56  The Roland Morris Disability Questionnaire assesses disability associated with LBP. It has 24 questions that describe daily tasks that the participants have difficulty performing due to their LBP. The total score ranges from 0 to 24 points and is the sum of the points obtained. Higher scores indicate higher disability.  Global Perceived Effect scale42  The Global Perceived Effect scale assesses participants' 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). Participants 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 recovery.  Outcome Measure  Description  Verbal Numeric Pain Rating Scale42,43  The Numeric Pain Rating Scale assesses the pain intensity levels perceived by the participant in the last 7 days using an 11-point scale (ranging from 0 to 10), with 0 representing “no pain” and 10 representing “the worst possible pain.”  Roland Morris Disability Questionnaire42,43,55,56  The Roland Morris Disability Questionnaire assesses disability associated with LBP. It has 24 questions that describe daily tasks that the participants have difficulty performing due to their LBP. The total score ranges from 0 to 24 points and is the sum of the points obtained. Higher scores indicate higher disability.  Global Perceived Effect scale42  The Global Perceived Effect scale assesses participants' 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). Participants 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 recovery.  View Large Sample Size Calculation The study was designed to detect a 1-point between-group difference for the primary outcomes of the NPRS outcome with an estimated standard deviation of 1.84 points42 and a 4-point between-group difference for the disability (Roland Morris Disability Questionnaire) outcome with an estimated standard deviation of 4.9 points42,43,55 immediately after treatment. Considering a statistical power of 80%, an alpha of 5%, and a 15% dropout rate, 74 participants were needed in each treatment group. Statistical Analysis All data were double entered to check for possible data entry errors. The statistical analyses were performed by an assessor blinded to the treatment groups using a numerical code for each treatment group. Descriptive statistics were calculated for participant characteristics and to verify normality of the outcome measures data. Possible between-group differences for the primary and secondary outcomes were tested using linear mixed models. The analysis adjusts the treatment groups’ mean differences considering all time points (including baseline) and missing data. The statistical analyses were conducted using an intention-to-treat approach.57 The IBM SPSS 19 statistical package for Windows (IBM Corp, Armonk, New York) was used for the analyses. Role of Funding Source The first author of the study is a doctoral candidate funded by Coordenacao de Aperfeicoamento de Pessoal de Nıvel Superior (CAPES). This study was funded by Conselho Nacional de Desenvolvimento Cientifico e Tecnologico/Brazil (CNPQ grant number 470273/2013-5). The funder played no role in the conduct of this study. Results A total of 231 participants volunteered to take part in the study. After the first assessment, 83 participants were excluded and 148 participants were assessed at baseline and enrolled in the trial. A total of 145 participants completed the 2-, 4-, and 6-month follow-up assessment (Fig. 1). All data was self-reported, including all outcomes that were collected at baseline and in all follow-up time points. Missing data information is provided in the flow diagram. Participants’ characteristics at baseline are presented in Table 3. There were no differences between participants in the 2 treatment groups with regard to baseline characteristics. Figure 1. View largeDownload slide Study flow diagram. DASS = Depression Anxiety Stress Scale. Figure 1. View largeDownload slide Study flow diagram. DASS = Depression Anxiety Stress Scale. Table 3. Participants’ Characteristics at Baseline.a   Strengthening and Stretching Exercise (n = 74)  Movement System Impairment-Based Treatment (n = 74)  Age (y)  40.4 (13.4)  43.4 (12.5)  Sex      Male  31 (41.9%)  26 (35.1%)  Female  43 (58.1%)  48 (64.9%)  Weight (kg)  72.0 (16.8)  70.8 (16.1)  Height (cm)  167.6 (10)  166.0 (9.4)  Body Mass Index (kg/m2)  25.5 (5.3)  25.5 (4.4)  Marital status      Single  27 (36.5%)  21 (28.4%)  Married  38 (51.4%)  38 (51.4%)  Widowed  7 (9.5%)  10 (13.5%)  Divorced  2 (2.7%)  5 (6.8%)  Educational status      Elementary degree  7 (9.5%)  14 (18.9%)  High school  46 (62.2%)  39 (52.7%)  University  11 (14.9%)  15 (20.3%)  Graduate degree  10 (13.5%)  6 (8.2%)  Income (in USD/hr)  8.6 (6.7)  7.9 (8.2)  Absenteeismb (current)      No  73 (98.6%)  68 (91.9%)  Yes  1 (1.4%)  6 (8.1%)  Smoker      No  69 (93.2%)  64 (86.5%)  Yes  5 (6.8%)  10 (13.5%)  Physically activec      No  44 (59.5%)  49 (66.2%)  Yes  30 (40.5%)  25 (33.8%)  Physical activity durationd (mo)  38.5 (59.9)  32.0 (66.9)  Physical activity frequencye (d/wk)  3.3 (1.5)  2.8 (1.4)  Current use of medication      No  43 (58.1%)  45 (60.8%)  Yes  31 (41.9%)  29 (39.2%)  Pain location      Lumbar  59 (79.7%)  57 (77.0%)  Lumbar and above knee  10 (13.5%)  7 (9.5%)  Lumbar and below knee  5 (6.8%)  10 (13.5%)  History of LBP (months)  75.2 (74.0)  94.9 (96.7)  STarT Back Screening Tool classificationf      Low risk  25 (33.8%)  24 (32.4%)  Medium risk  32 (43.2%)  33 (44.6%)  High risk  17 (23.0%)  17 (23.0%)  MSI classification      Flexion  10 (13.5%)  12 (16.2%)  Extension  21 (28.4%)  25 (33.8%)  Rotation  4 (5.4%)  1 (1.4%)  Flexion and rotation  18 (24.3%)  7 (9.5%)  Extension and rotation  21 (28.4%)  29 (39.2%)  Mean pain intensity (0–10)g  6.5 (1.9)  6.6 (1.8)  Disability (0–24)h  10.2 (5.0)  10.7 (5.1)  Global impression of recoveryi  –1.8 (2.5)  –1.0 (2.8)    Strengthening and Stretching Exercise (n = 74)  Movement System Impairment-Based Treatment (n = 74)  Age (y)  40.4 (13.4)  43.4 (12.5)  Sex      Male  31 (41.9%)  26 (35.1%)  Female  43 (58.1%)  48 (64.9%)  Weight (kg)  72.0 (16.8)  70.8 (16.1)  Height (cm)  167.6 (10)  166.0 (9.4)  Body Mass Index (kg/m2)  25.5 (5.3)  25.5 (4.4)  Marital status      Single  27 (36.5%)  21 (28.4%)  Married  38 (51.4%)  38 (51.4%)  Widowed  7 (9.5%)  10 (13.5%)  Divorced  2 (2.7%)  5 (6.8%)  Educational status      Elementary degree  7 (9.5%)  14 (18.9%)  High school  46 (62.2%)  39 (52.7%)  University  11 (14.9%)  15 (20.3%)  Graduate degree  10 (13.5%)  6 (8.2%)  Income (in USD/hr)  8.6 (6.7)  7.9 (8.2)  Absenteeismb (current)      No  73 (98.6%)  68 (91.9%)  Yes  1 (1.4%)  6 (8.1%)  Smoker      No  69 (93.2%)  64 (86.5%)  Yes  5 (6.8%)  10 (13.5%)  Physically activec      No  44 (59.5%)  49 (66.2%)  Yes  30 (40.5%)  25 (33.8%)  Physical activity durationd (mo)  38.5 (59.9)  32.0 (66.9)  Physical activity frequencye (d/wk)  3.3 (1.5)  2.8 (1.4)  Current use of medication      No  43 (58.1%)  45 (60.8%)  Yes  31 (41.9%)  29 (39.2%)  Pain location      Lumbar  59 (79.7%)  57 (77.0%)  Lumbar and above knee  10 (13.5%)  7 (9.5%)  Lumbar and below knee  5 (6.8%)  10 (13.5%)  History of LBP (months)  75.2 (74.0)  94.9 (96.7)  STarT Back Screening Tool classificationf      Low risk  25 (33.8%)  24 (32.4%)  Medium risk  32 (43.2%)  33 (44.6%)  High risk  17 (23.0%)  17 (23.0%)  MSI classification      Flexion  10 (13.5%)  12 (16.2%)  Extension  21 (28.4%)  25 (33.8%)  Rotation  4 (5.4%)  1 (1.4%)  Flexion and rotation  18 (24.3%)  7 (9.5%)  Extension and rotation  21 (28.4%)  29 (39.2%)  Mean pain intensity (0–10)g  6.5 (1.9)  6.6 (1.8)  Disability (0–24)h  10.2 (5.0)  10.7 (5.1)  Global impression of recoveryi  –1.8 (2.5)  –1.0 (2.8)  a Continuous variables are expressed as mean (SD). Categorical variables are expressed as n (%). MSI = Movement System Impairment. b Proportion of participants unable to work due to low back pain (LBP). c Number of participants who consider themselves to be physically active. d If participants considered themselves to be currently physically active, they were asked, “How long have you been practicing (any physical activity)?” e If participants considered themselves to be currently physically active, they were asked, “How many days per week are you practicing (any physical activity)?” f STarT Back Screening Tool classification.54 g Numeric Pain Rating Scale.42,43 h Roland Morris Disability Questionnaire for low back pain.42,43,55,56 i Global Perceived Effect scale.42 View Large There was no significant difference between treatment groups for the primary outcome measures of mean NPRS at 2 months (mean difference = 0.05, 95% CI = –0.90 to 0.80) and disability at 2 months (mean difference = 0.00, 95% CI = –1.55 to 1.56). There were also no statistically significant differences between treatment groups for any of the secondary outcome measures (Tab. 4). No adverse effects were observed for both groups. Table 4. Unadjusted Mean Values (SD) and Adjusted Between-Group Differences (95% CI) for the Outcomes of Mean Pain Intensity, Disability, and Global Impression of Recovery.a Outcomes  Strengthening and Stretching Exercise Mean (SD)  Movement System Impairment-Based Treatment Mean (SD)  Adjusted Between-Group Differences (95% CI)  p  Pain intensity (0–10)b          Baseline  6.51 (1.92)  6.61 (1.84)      2 months  3.86 (3.05)  3.68 (2.59)  –0.05 (–0.90 to 0.80)  P = .91  4 months  3.79 (2.94)  4.19 (2.95)  –0.23 (–1.08 to 0.61)  P = .59  6 months  3.70 (3.06)  3.81 (2.64)  0.24 (–0.61 to 1.08)  P = .58  Disability (0–24)c          Baseline  10.19 (5.04)  10.64 (5.04)      2 months  5.38 (5.59)  5.49 (5.02)  0.00 (–1.55 to 1.56)  P = .99  4 months  4.82 (4.97)  5.33 (4.65)  –0.07 (–1.62 to 1.49)  P = .93  6 months  4.79 (5.37)  5.16 (5.05)  0.21 (–1.35 to 1.76)  P = .79  Global impression of recovery (–5 to+5)d          Baseline  –1.75 (2.48)  –1.03 (2.76)      2 months  2.49 (2.42)  2.62 (2.19)  0.48 (–0.43 to 1.39)  P = .30  4 months  2.16 (2.53)  2.14 (2.72)  0.80 (–0.14 to 1.68)  P = .09  6 months  2.22 (2.61)  2.51 (2.32)  0.66 (–0.25 to 1.57)  P = .15  Outcomes  Strengthening and Stretching Exercise Mean (SD)  Movement System Impairment-Based Treatment Mean (SD)  Adjusted Between-Group Differences (95% CI)  p  Pain intensity (0–10)b          Baseline  6.51 (1.92)  6.61 (1.84)      2 months  3.86 (3.05)  3.68 (2.59)  –0.05 (–0.90 to 0.80)  P = .91  4 months  3.79 (2.94)  4.19 (2.95)  –0.23 (–1.08 to 0.61)  P = .59  6 months  3.70 (3.06)  3.81 (2.64)  0.24 (–0.61 to 1.08)  P = .58  Disability (0–24)c          Baseline  10.19 (5.04)  10.64 (5.04)      2 months  5.38 (5.59)  5.49 (5.02)  0.00 (–1.55 to 1.56)  P = .99  4 months  4.82 (4.97)  5.33 (4.65)  –0.07 (–1.62 to 1.49)  P = .93  6 months  4.79 (5.37)  5.16 (5.05)  0.21 (–1.35 to 1.76)  P = .79  Global impression of recovery (–5 to+5)d          Baseline  –1.75 (2.48)  –1.03 (2.76)      2 months  2.49 (2.42)  2.62 (2.19)  0.48 (–0.43 to 1.39)  P = .30  4 months  2.16 (2.53)  2.14 (2.72)  0.80 (–0.14 to 1.68)  P = .09  6 months  2.22 (2.61)  2.51 (2.32)  0.66 (–0.25 to 1.57)  P = .15  a Primary outcomes are highlighted in gray. All treatment estimates were adjusted for baseline data using linear mixed models. b Numeric Pain Rating Scale.42,43 c Roland Morris Low Back Pain Disability Questionnaire.42,43,55,56 d Global Perceived Effect scale.42 View Large Treatment Adherence Treatment adherence data, including number of treatment sessions performed at the clinic and number of days performing the home program, is presented in Table 5. Considering the total expected number of treatment days (treatment session days plus number of days performing the home program), the strengthening and stretching group adhered more to the treatment when compared to the MSI model group (mean difference = 17.8%, 95% CI = 8.4% to 27.1%). The strengthening and stretching group performed 16.1 days of exercise (total number of days expected = 24 days, mean adherence = 67.0%, SD = 24.6%), while the MSI model group performed 27.6 days of treatment (total number of days expected = 56, mean adherence = 49.3%, SD = 32.3%) (P<.001). Table 5. Treatment Adherence. Treatment Adherence  Strengthening and Stretching Exercise  Movement System Impairment-Based Treatment  Number of treatment sessions at the clinica mean (SD) [expected number]  10.6 (2.6) [12]  9.7 (3.5) [12]  Number of days performing the home programb mean (SD) [expected number]  5.5 (4.1) [12]  17.9 (15.9) [44]  Treatment adherencec mean (SD)  67.0% (24.6%)  49.3% (32.3%)  Treatment Adherence  Strengthening and Stretching Exercise  Movement System Impairment-Based Treatment  Number of treatment sessions at the clinica mean (SD) [expected number]  10.6 (2.6) [12]  9.7 (3.5) [12]  Number of days performing the home programb mean (SD) [expected number]  5.5 (4.1) [12]  17.9 (15.9) [44]  Treatment adherencec mean (SD)  67.0% (24.6%)  49.3% (32.3%)  a Both groups are supposed to receive the same number of treatment sessions at the clinic. b Both groups are supposed to have different number of days performing the home program. Participants from the MSI group were advised to perform the home program at least once a day on the days on which no treatment sessions were scheduled. Participants in the strengthening and stretching group were instructed to perform the home exercises at least 1 or 2 days a week, in addition to treatment session days. c Treatment adherence was calculated by the following formula: number of treatment sessions + number of days performing the home program / expected number of treatment sessions + expected number of days performing the home program. View Large Discussion The purpose of this study was to compare the efficacy of a treatment based on the MSI model with a treatment consisting of symptom-guided stretching and strengthening exercises for patients with chronic LBP. No significant differences in mean pain, disability, or global impression of recovery were observed between groups at any of the follow-up time points. The strengthening and stretching group adhered more to the treatment when compared to the MSI model group. A previous study showed similar efficacy of a classification-specific treatment based on the MSI model when compared to a nonclassification-specific treatment in patients with chronic nonspecific LBP.40 The non–classification-specific treatment was based on strengthening and stretching exercises and teaching the participants to maintain a balanced spinal alignment when performing daily activities. The authors hypothesized that the lack of difference in outcomes between both groups could be related to the similarities found in both treatment programs and the fact that participants in both groups adhered more to that which was similar in both treatments. Both treatment programs had people perform everyday activities in which they decreased the amount of lumbar spine movement, increased the amount of movement of other joints, and avoided end-range positioning of the lumbar spine. The specific direction of lumbar spine movement and alignment to be corrected, however, was only informed to participants in the classification-specific treatment group. The current study compared a treatment based on the MSI model with a treatment consisting of symptom-guided stretching and strengthening exercises. Although the strengthening and stretching group was not given instructions to modify specific lumbar spine movements or alignments, the exercises prescribed were adjusted based on pain behavior. Participants were supposed to perform exercises involving movements in all directions, but decision-making by the clinician allowed for the participant to eliminate an exercise if it was not tolerated due to onset or increased LBP. Thus, participants may have ended up performing only the exercises that were not symptom-provoking. Performing exercises involving spine movements in directions that are not symptom-provoking may be a common element between the 2 treatment groups and may explain the similar improvements found in both groups in the current study. Different absolute amounts of participation in the home exercise programs were found between the 2 treatment groups. Treatment based on the MSI model group had more home exercise practice prescribed compared to the strengthening and stretching group treatment. This difference was expected because participants in the MSI model group were instructed to perform the home exercises at least 5 or 6 days a week, in addition to treatment session days. Participants in the strengthening and stretching group were instructed to perform the home exercises at least 1 or 2 days a week, in addition to treatment session days. The MSI model is based on movement and alignment education and training, thus it is believed that more practice is needed,27 while stretching and strengthening programs are performed usually 3 times a week.49 However, when considering the total expected number of treatment days (treatment session days plus number of days performing the home program), the strengthening and stretching group adhered more to the treatment when compared to the MSI model group. It is not possible to predict if a higher adherence by the MSI model group would result in an increased treatment effect, although previous studies have associated higher levels of adherence to treatment with better outcomes.40,58,59 Our study also did not assess adherence of the MSI model group to exercise separate from adherence to performance of daily activities. Thus, it is not possible to know which component the participants adhered to and whether this had an impact on the lack of a difference between the 2 treatment groups. This can be considered a limitation since a previous study showed that people adhered more to performance of daily activities than exercise, and the more they adhered to daily activity performance the greater improvement in function compared to adherence to exercise.40 Different studies have found different proportions of the MSI syndromes identified in people with LBP.34,53,60,61 While some studies excluded participants who were in an acute flare-up during initial assessment,34,53 others,60,61 including the current study, did not exclude people who were in an acute flare-up. This difference in exclusion criteria may have influenced the different proportions of the MSI syndromes found in those studies. Different classification systems are available to guide LBP treatment.23–28 The idea behind subgrouping patients with LBP is to classify them into more homogeneous subgroups and then match the patients to treatments specific to their classification. The goal of the matching is to increase the treatment effect size.21,62,63 Promising results related to this approach were previously described.28,51,53,64–69 However, most of the classification systems failed to show clinically significant differences in outcomes when compared to other therapies not based on subgrouping in randomized controlled trials involving people with chronic, nonspecific LBP.40,62,70–73 Although the combination of physical and cognitive/behavioral treatments in patients with back pain seems not to result in better outcomes when compared to isolated physical or cognitive/behavioral treatments,74 the inclusion of cognitive/behavioral factors into movement-based classification described by O’Sullivan25 has shown greater treatment effects when compared to therapies not based on subgrouping (exercise and manual therapy).69 Limitations of this study,69 however, included important follow-up loss and no intention to treat analysis. Thus, replication of the O’Sullivan study results is needed. The lack of between-group differences in outcomes found in the current study could also be explained by the similar distribution of participants in both groups who may be at high, medium, and low risk for poor prognosis according to the STarT Back Screening Tool classification. The use of prognostic factors to guide physical therapy treatment in LBP has been supported by different studies.75–77 Those studies raise the possibility that prognostic factors may be more important in determining the treatment success than diagnostic/classification factors. The current study is the largest prospectively registered randomized controlled trial involving the efficacy of a treatment based on the MSI model in patients with chronic, nonspecific LBP.41 Loss to follow-up was minimal and statistical analyses were performed according to intention-to-treat principles. The physical therapists responsible for the treatments had similar clinical experience and were trained by a senior physical therapist with experience in the concepts underlying the MSI model and application of the classification system and treatment. However, our trial has some limitations. Due to the nature of the study, it was not possible to blind participants and physical therapists responsible for the treatments to group assignment. The physical therapist responsible for the treatment based on MSI model was not responsible for the MSI classification procedure, which is not common in clinical practice. The MSI classification was done by the first author before the randomization procedure because it was part of the inclusion/exclusion criteria. The treating therapist received the filled forms used for MSI classification before the beginning of treatment. This trial also had only 1 treating therapist per arm, which can limit its external validity. Although the treatment consisting of strengthening and stretching exercises did not include explicit movement and alignment education and training, it is possible that participants may have received this information. For example, the physical therapist may have had to answer participants’ questions such as what is the best position to assume to sleep. The physical therapist responsible for the treatment consisting of strengthening and stretching exercises had no previous information or training in the MSI model. The physical therapist was, however, instructed to give very concise and basic information when asked about correct alignment and movement. This study also did not include a control group receiving no treatment. Therefore, it is possible that the improvements observed in the outcomes were attributed to natural history of back pain.78 The results of this study showed that people with chronic nonspecific LBP might have the same improvement in pain, disability, and global impression of recovery by receiving a treatment based on progressive strengthening and stretching exercises that was directed by participant symptom response or by a treatment based on the MSI model after a 6-month follow-up. It is possible that specific participant characteristics may identify people who respond better to treatment based on the MSI model compared to treatment consisting of symptom-guided stretching and strengthening exercises. These secondary analyses are being performed on the data from the current trial. The efficacy and effectiveness of treatment based on the MSI model still need to be tested in people with acute and subacute LBP. Author Contributions Concept/idea/research design: D.C. Azevedo, L.O.P. Costa H. de Oliveira Santos, D.R. Oliveira, J.V.L. de Souza Writing: D.C. Azevedo, L.O.P. Costa P.H. Ferreira, H. de Oliveira Santos, D.R. Oliveira, J.V.L. de Souza Data collection: D.C. Azevedo, H. de Oliveira Santos, D.R. Oliveira, J.V.L. de Souza Data analysis: D.C. Azevedo, L.O.P. Costa Project management: L.O.P. Costa Fund procurement: L.O.P. Costa Providing participants: D.C. Azevedo Providing facilities/equipment: D.C. Azevedo Consultation (including review of manuscript before submitting): D.C. Azevedo, P.H. Ferreira, H. de Oliveira Santos, D.R. Oliveira, J.V.L. de Souza Ethics Approval The study was approved by the Ethics Committee of the Pontificia Universidade Catolica de Minas Gerais, Brazil. Funding The first author of the study is a doctoral candidate funded by Coordenacao de Aperfeicoamento de Pessoal de Nıvel Superior (CAPES). This study was funded by Conselho Nacional de Desenvolvimento Cientifico e Tecnologico/Brazil (CNPQ grant number 470273/2013-5). 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A comparison of mckenzie therapy with electrophysical agents for the treatment of work related low back pain: A randomized controlled trial. J Back Musculoskelet Rehabil . 2015; 28( 2): 247– 253. Google Scholar CrossRef Search ADS PubMed  69. Vibe Fersum K, O’Sullivan P, Skouen JS, Smith A, Kvale A. Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: a randomized controlled trial. Eur J Pain . 2013; 17( 6): 916– 928. Google Scholar CrossRef Search ADS PubMed  70. Apeldoorn AT, Ostelo RW, van Helvoirt H et al.   A randomized controlled trial on the effectiveness of a classification-based system for subacute and chronic low back pain. Spine (Phila Pa 1976) . 2012; 37( 16): 1347– 1356. Google Scholar CrossRef Search ADS PubMed  71. Garcia AN, Costa LD, da Silva TM et al.   Effectiveness of back school versus McKenzie exercises in patients with chronic nonspecific low back pain: a randomized controlled trial. Phys Ther . 2013; 93( 6): 729– 747. Google Scholar CrossRef Search ADS PubMed  72. Halliday MH, Pappas E, Hancock MJ et al.   A randomized controlled trial comparing the McKenzie Method to motor control exercises in people with chronic low back pain and a directional preference. J Orthop Sports Phys Ther . 2016; 46( 7): 514– 522. Google Scholar CrossRef Search ADS PubMed  73. Henry SM, Van Dillen LR, Ouellette-Morton RH et al.   Outcomes are not different for patient-matched versus nonmatched treatment in subjects with chronic recurrent low back pain: a randomized clinical trial. Spine J . 2014; 14( 12): 2799– 2810. Google Scholar CrossRef Search ADS PubMed  74. O’Keeffe M, Purtill H, Kennedy N et al.   Comparative effectiveness of conservative interventions for nonspecific chronic spinal pain: physical, behavioral/psychologically informed, or combined? A systematic review and meta-analysis. J Pain . 2016; 17( 7): 755– 774. Google Scholar CrossRef Search ADS PubMed  75. Cook CE, Showalter C, Kabbaz V, O’Halloran B. Can a within/between-session change in pain during reassessment predict outcome using a manual therapy intervention in patients with mechanical low back pain? Man Ther . 2012; 17( 4): 325– 329. Google Scholar CrossRef Search ADS PubMed  76. Cook CE, Learman KE, O’halloran BJ et al.   Which prognostic factors for low back pain are generic predictors of outcome across a range of recovery domains? Phys Ther . 2013; 93( 1): 32– 40. Google Scholar CrossRef Search ADS PubMed  77. Rodeghero J, Cook C, Cleland J, Mintken P. Risk stratification of patients with low back pain seen in physical therapy practice. Man Ther . 2015; 20( 6): 855– 860. Google Scholar CrossRef Search ADS PubMed  78. Artus M, van der Windt DA, Jordan KP, Hay EM. Low back pain symptoms show a similar pattern of improvement following a wide range of primary care treatments: a systematic review of randomized clinical trials. Rheumatology . 2010; 49( 12): 2346– 2356. Google Scholar CrossRef Search ADS PubMed  © 2017 American Physical Therapy Association http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Physical Therapy Oxford University Press

Movement System Impairment-Based Classification Treatment Versus General Exercises for Chronic Low Back Pain: Randomized Controlled Trial

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Oxford University Press
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© 2017 American Physical Therapy Association
ISSN
0031-9023
eISSN
1538-6724
D.O.I.
10.1093/ptj/pzx094
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Abstract

Abstract Background Treatment for chronic low back pain (LBP) includes different forms of exercises, that to date have resulted in only small to moderate treatment effects. To enhance the treatment effects, different classification systems have been developed to classify people with LBP into more homogeneous subgroups leading to specific treatments for each subgroup. Objective The purpose of this study was to compare the efficacy of a treatment based on the Movement System Impairment (MSI) model with a treatment consisting of symptom-guided stretching and strengthening exercises in people with chronic LBP. Design The study was a 2-arm, prospectively registered, randomized controlled trial with a blinded assessor. Setting The study setting was a university physical therapy clinic in Brazil. Patients A total of 148 participants with chronic LBP participated in the study. Interventions Participants were randomly allocated to an 8-week treatment of either treatment based on the MSI-based classification system or symptom-guided stretching and strengthening exercises. Measurements Measures of pain intensity, disability, and global impression of recovery were obtained by a blinded assessor at baseline and at follow-up appointments at 2, 4, and 6 months after randomization. Results There were no significant between-group differences for the primary outcomes of pain intensity at 2 months (mean difference = 0.05, 95% CI = –0.90 to 0.80) and disability at 2 months (mean difference = 0.00, 95% CI = –1.55 to 1.56). There also were no statistically significant differences between treatment groups for any of the secondary outcome measures. Limitations Participants and physical therapists were not masked. Conclusions People with chronic LBP had similar improvements in pain, disability, and global impression of recovery with treatment consisting of symptom-guided stretching and strengthening exercises and treatment based on the MSI model. Low back pain (LBP) is the leading cause of years lived with disability in 86 countries, and is either the second or third leading cause in 67 countries.1 The global age-standardized point prevalence of LBP in 2010 was estimated to be 9.4%.2 LBP is considered recurrent in nature,3 with recurrence rates ranging from 20% to 65% depending on the follow-up time.4–7 The clinical course of chronic LBP is characterized by moderate levels of pain and disability that persist after a follow-up of 12 months.8 Treatment for chronic LBP includes different forms of exercise3,9–12 that, to date, have resulted in only small to moderate treatment effects.13–20 A possible explanation for the limitation in size of treatment effects could be related to sample heterogeneity.21 About 90% of all patients with LBP receive the diagnosis of nonspecific LBP, which is based on exclusion of specific pathologies.22 To enhance treatment effects, different classification systems have been developed to assign people with LBP to more homogeneous subgroups leading to specific treatments for each subgroup.23–28 Assessing the treatment effects of classifying and treating people with LBP based on their classification is a top priority in LBP research.3,29,30 The Movement System Impairment (MSI)-based classification model31–33 is one of the classification systems available to guide treatment of LBP. The MSI classification system involves a standardized examination with several tests of movements and positions to identify mechanically based impairments. It allows the classification of people with LBP into 1 of 5 possible subgroups. The treatment based on the MSI model includes education and exercise prescription to correct classification-specific impairments of movements and postures that are associated with LBP symptoms. The primary objective of treatment based on the MSI model is to minimize specific lumbar spine movements, encourage movement in other joints, and avoid extreme lumbar spine postures in specific directions. Although validity34 of the subgroups and reliability35–39 of clinicians to classify based on the MSI classification model have been previously reported, randomized clinical trials involving this classification system are limited.40 Therefore, the objective of this study was to compare the efficacy of a treatment based on the MSI classification model with a treatment consisting of symptom-guided stretching and strengthening exercises in people with chronic LBP. Exercise therapy including stretching and strengthening exercises was chosen as the comparison group because it is recommended as a first-line treatment in the management of patients with chronic LBP.9,11 Our hypothesis was that treatment based on the MSI model would result in greater improvements in pain and disability than treatment consisting of symptom-guided stretching and strengthening exercises. Methods Design Overview This study was a 2-arm, prospectively registered, randomized controlled trial with a blinded assessor. The methods used in this study were previously described in the published protocol.41 Settings and Participants This trial was conducted in an outpatient physical therapy clinic in the Pontificia Universidade Catolica de Minas Gerais, Belo Horizonte, Brazil. To be included, participants of both sexes, between 18 and 65 years of age, had to have nonspecific LBP for more than 3 months and a current minimum pain intensity of 3 on an 11-point numeric pain rating scale.42,43 They also had to be able to stand and walk independently and be literate in Portuguese. The participants were recruited from orthopedic outpatient clinics and by advertising on radio media. Potential participants were told to contact the blinded assessor by phone or email. They were screened for eligibility at their first visit to the university clinic. Participants were excluded if they presented any contraindications to exercise according to the guidelines of the American College of Sports Medicine,44 serious cardio-respiratory diseases, previous spinal surgery, serious spinal pathologies (fractures, tumors, or inflammatory pathologies), nerve root compromise (diagnosed by clinical examination of sensibility, power, and reflexes), major depression (measured by the Depression, Anxiety, and Stress scale45,46), pregnancy, or if they could not be classified into 1 of the 5 categories of the MSI model31–33 at the first visit. The physical examination was performed by the first author, who has 13 years of experience with use of the MSI model in clinical practice. The examination included (1) assessment of signs and symptoms associated with clinical tests of different movements and positions, and (2) tests assessing the effects of correcting movements and postures during the clinical tests on the participant's LBP symptoms (Tab. 1). A detailed description of the procedures and rules used to classify have been published elsewhere.36 All participants received information about the study and signed the informed consent form. The study was approved by the Ethics Committee of the Pontificia Universidade Catolica de Minas Gerais, Brazil, and was prospectively registered at www.clinicaltrials.gov (NCT02221609). Table 1. Physical Examination Used for MSI Model Classification.34,36 Position  Symptom Behavior With Movementa  Judgment of Alignment or Movementb  Standing  Standing  Shape of the lumbar curve Asymmetry and regularity of the lumbar spine Swayback  Posterior pelvic tilt against wall    Forward bending  Lumbar flexion Lumbar extension Relative flexibilityc  Corrected forward bending    Return from forward bending  Hip extension Lumbar extension Pelvic and shoulder sway  Corrected return from forward bending    Side bending  Asymmetrical lumbar region movement  Sitting  Sitting with lumbar flat    Sitting with lumbar region flexed    Sitting with lumbar region extended    Knee extension  Lumbar or pelvic rotation  Corrected active knee extension    Supine  Hips and knees flexed    Hips and knees extended    Hook lying  Hip abduction with lateral rotation  Relative flexibility  Corrected hip abduction with lateral rotation    Prone  Prone    Corrected prone    Knee flexion  Relative flexibility Asymmetrical pelvic rotation  Hip rotation  Relative flexibility Asymmetrical pelvic rotation  Hip extension    Quadruped  Natural alignment  Lumbar region alignment Asymmetry of the lumbar region Alignment of hip joint  Corrected alignment    Arm lifting  Asymmetrical lumbar region rotation  Rocking backward  Relative flexibility Pelvic rotation or tilt  Corrected rocking backward    Rocking forward    Position  Symptom Behavior With Movementa  Judgment of Alignment or Movementb  Standing  Standing  Shape of the lumbar curve Asymmetry and regularity of the lumbar spine Swayback  Posterior pelvic tilt against wall    Forward bending  Lumbar flexion Lumbar extension Relative flexibilityc  Corrected forward bending    Return from forward bending  Hip extension Lumbar extension Pelvic and shoulder sway  Corrected return from forward bending    Side bending  Asymmetrical lumbar region movement  Sitting  Sitting with lumbar flat    Sitting with lumbar region flexed    Sitting with lumbar region extended    Knee extension  Lumbar or pelvic rotation  Corrected active knee extension    Supine  Hips and knees flexed    Hips and knees extended    Hook lying  Hip abduction with lateral rotation  Relative flexibility  Corrected hip abduction with lateral rotation    Prone  Prone    Corrected prone    Knee flexion  Relative flexibility Asymmetrical pelvic rotation  Hip rotation  Relative flexibility Asymmetrical pelvic rotation  Hip extension    Quadruped  Natural alignment  Lumbar region alignment Asymmetry of the lumbar region Alignment of hip joint  Corrected alignment    Arm lifting  Asymmetrical lumbar region rotation  Rocking backward  Relative flexibility Pelvic rotation or tilt  Corrected rocking backward    Rocking forward    a For each of the items, the participant assumes a position or performs a movement and reports the status of their LBP symptoms (symptoms increased, symptoms decreased, or symptoms remained the same). Positions or movements associated with increased symptoms are followed by corrected alignment or movement involving minimizing lumbar movement that occurs in the early part of the range of motion or that is excessive, while increasing movement in other joints (ie, hip joint). An improvement in the symptoms indicates that the movement or alignment impairment in a specific direction (ie, extension) is associated with the patient's symptoms and helps to decide on the participant's MSI classification. b For each of the items, the examiner judges the alignment of the lumbar region in different positions and/or looks for incorrect timing and/or magnitude of lumbar movement during trunk and limb movements. Alignment of lumbar region in a specific direction (ie, extension) in different positions and incorrect timing and/or magnitude of lumbar movement in a specific direction help to decide on the participant's MSI classification. c Relative flexibility refers to motion of adjoining segments occurring more readily in 1 of the joints (lumbar region in this case) even if the motion should be occurring in the other joint. In general, a patient exhibits a relative flexibility impairment if the lumbar region moves in the first 50% of the range of the overall movement or excessively during the overall movement. During the MSI classification procedure, greater weight is given to symptoms behavior information than alignment and movement judgment. View Large Randomization and Interventions A researcher (L.C.) who was not involved in the participants’ recruitment, assessment, and treatment was responsible for generating a randomization schedule in Excel for Windows. Allocations were concealed using sealed, opaque, and sequentially numbered envelopes. After the initial assessment, the participants were allocated into 1 of the 2 treatment groups (treatment consisting of strengthening and stretching exercises or treatment based on the MSI model) by opening the next available envelope. Both treatment programs consisted of 12 physical therapy sessions over an 8-week period (2 sessions per week for the first 4 weeks and 1 session per week for the second 4 weeks). Each treatment session duration was 45 to 60 minutes and was supervised by trained physical therapists. Specific details of the exercise protocol and progression of exercises are provided in eAppendixes 1 and 2 (available at https://academic.oup.com/ptj). Two physical therapists with the same duration of clinical experience (2 years) were involved in delivering the treatments. One delivered the strengthening and stretching treatment; the other, the treatment based on the MSI model. They participated in a 16-hour course (lecture) involving the principles of MSI classification and treatment or reviewing the principles of strength and stretching exercises used in patients with LBP. They also practiced their treatment protocols with patients at the university clinic over a month under supervision of the first author. The first author also periodically audited the interventions through revision of patient home exercise charts and direct oversight during treatment sessions. Treatment consisting of symptom-guided stretching and strengthening exercises. After walking or pedaling a stationary bicycle for 5 minutes, participants performed stretching exercises addressing the lumbar and abdominal muscles (lumbar flexors, extensors, lateral flexors, and rotators) and lower limb muscles (hip flexors, extensors, rotators, abductors, and adductors). Each static stretching exercise consisted of 1 repetition of 30 seconds. Participants were instructed to perform each stretching movement until a mild stretching sensation was achieved or until normal range of motion was achieved.47 If there was an increase of LBP, the specific stretch was suspended. During subsequent treatment sessions, the physical therapist attempted to include the previously suspended stretching exercises. If onset or increase of LBP was still observed, the stretching exercise was removed from the treatment program. Participants also performed strengthening exercises involving the abdominal and paraspinal muscles.10,48 Each strengthening exercise consisted of 3 sets of 10 repetitions with a load high enough to produce fatigue after completion of 10 repetitions.49 In the case that the participant complained of onset or increased LBP during the exercises, the same decision-making procedure used for prescription and progression of the stretching exercise was used for the strengthening exercises. All participants were told to perform the exercises at least 3 times a week, including the treatment sessions at the clinic. After each treatment session, participants received an exercise chart of instructions and figures displaying the home exercises. A participant's ability to perform his home exercise program was evaluated during each treatment session using an instrument adapted from a previous study.50 All participants were monitored for any adverse event and for any exacerbation (onset or increase) in LBP due to the home exercises at each of the treatment sessions. Participants were instructed to keep performing the exercises after the 2-month treatment period. For complete description, see eAppendix 1 (available at https://academic.oup.com/ptj). Treatment based on the MSI model. Treatment based on the MSI model included (1) patient education, (2) analysis and modification of performance of daily activities, and (3) prescription of specific exercises.51–53 Patient education consisted of teaching the participant which altered movement or posture (eg, flexion, extension, rotation) to modify that also was related to symptoms. Participants received information about the importance of avoiding extremes of those postures and controlling the altered movements as a fundamental part of the treatment. Patient education was included in the first treatment session and could be repeated during the following sessions (eAppendix 2, available at https://academic.oup.com/ptj). Analysis and modification of performance of daily activities were guided by the participant's MSI classification. Based on the classification, the examiner assessed the performance of activities reported by the participant to be limited due to LBP. Altered postures and movements observed during the assessment were followed by instruction in how to modify the patterns of posture and movement to be less painful or pain free. Participants were instructed to repeat the modified movements and postures throughout their day. Modification of performance of daily activities was initiated during the first treatment session and was revised during the follow-up sessions based on the participant's performance. The prescription of specific exercises included performing modifications of the movement tests from the initial assessment per the participant's LBP classification. Painful movement tests or movement tests in which the person displayed an altered pattern were included in the specific exercise prescription. During treatment sessions, participants were taught to perform the movements pain free or with lower pain levels by reducing or changing the timing of the lumbar spine movement and increasing or changing the timing of movement of the adjacent joints. A home exercise chart including pictures of the exercises and performance of daily activities with written instructions was given to each participant. Participants were advised to perform the home program at least once a day on the days in which no treatment sessions were scheduled. The participant's ability to perform the home exercises was also assessed as described in the strengthening and stretching exercises treatment.50 Participants were monitored for any adverse event and any onset or increase in symptoms with the home program in each treatment session and were instructed to keep performing the exercises and daily activities after the 2-month treatment period. For complete description, see eAppendix 2 (available at https://academic.oup.com/ptj). Outcomes and Follow-Up Participant characteristics (age, gender, location, and duration of symptoms), clinical outcome prognosis using the STarT Back Screening Tool classification,54 pain intensity, disability, and the participant's global impression of recovery were assessed at baseline. Pain intensity, disability, and global impression of recovery assessments were also measured at 2 (ie, immediately after treatment), 4, and 6 months after randomization. The primary outcomes were mean pain intensity and disability at 2 months after randomization. Secondary outcomes were mean pain intensity and disability at 4 and 6 months after randomization and global impression of recovery at 2, 4, and 6 months after randomization. Treatment adherence was assessed by recording the number of treatment sessions at the clinic and the number of days performing the home program for each participant. The number of days performing the home program were documented by each participant in an exercise diary. Mean pain intensity was assessed using the Numeric Pain Rating Scale (NPRS).42,43 Disability was assessed using the Roland Morris Disability Questionnaire.42,43,55,56 Participant's global impression of recovery was assessed by the Global Perceived Effect scale42 (Tab. 2). All outcomes used in this clinical trial were translated and cross-culturally adapted into Brazilian Portuguese.42,43,55 A blinded assessor performed the assessment of outcome measures at baseline and follow-ups. Due to the nature of the treatments, blinding of treatment providers and participants was not possible. Table 2. Outcome Measures. Outcome Measure  Description  Verbal Numeric Pain Rating Scale42,43  The Numeric Pain Rating Scale assesses the pain intensity levels perceived by the participant in the last 7 days using an 11-point scale (ranging from 0 to 10), with 0 representing “no pain” and 10 representing “the worst possible pain.”  Roland Morris Disability Questionnaire42,43,55,56  The Roland Morris Disability Questionnaire assesses disability associated with LBP. It has 24 questions that describe daily tasks that the participants have difficulty performing due to their LBP. The total score ranges from 0 to 24 points and is the sum of the points obtained. Higher scores indicate higher disability.  Global Perceived Effect scale42  The Global Perceived Effect scale assesses participants' 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). Participants 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 recovery.  Outcome Measure  Description  Verbal Numeric Pain Rating Scale42,43  The Numeric Pain Rating Scale assesses the pain intensity levels perceived by the participant in the last 7 days using an 11-point scale (ranging from 0 to 10), with 0 representing “no pain” and 10 representing “the worst possible pain.”  Roland Morris Disability Questionnaire42,43,55,56  The Roland Morris Disability Questionnaire assesses disability associated with LBP. It has 24 questions that describe daily tasks that the participants have difficulty performing due to their LBP. The total score ranges from 0 to 24 points and is the sum of the points obtained. Higher scores indicate higher disability.  Global Perceived Effect scale42  The Global Perceived Effect scale assesses participants' 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). Participants 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 recovery.  View Large Sample Size Calculation The study was designed to detect a 1-point between-group difference for the primary outcomes of the NPRS outcome with an estimated standard deviation of 1.84 points42 and a 4-point between-group difference for the disability (Roland Morris Disability Questionnaire) outcome with an estimated standard deviation of 4.9 points42,43,55 immediately after treatment. Considering a statistical power of 80%, an alpha of 5%, and a 15% dropout rate, 74 participants were needed in each treatment group. Statistical Analysis All data were double entered to check for possible data entry errors. The statistical analyses were performed by an assessor blinded to the treatment groups using a numerical code for each treatment group. Descriptive statistics were calculated for participant characteristics and to verify normality of the outcome measures data. Possible between-group differences for the primary and secondary outcomes were tested using linear mixed models. The analysis adjusts the treatment groups’ mean differences considering all time points (including baseline) and missing data. The statistical analyses were conducted using an intention-to-treat approach.57 The IBM SPSS 19 statistical package for Windows (IBM Corp, Armonk, New York) was used for the analyses. Role of Funding Source The first author of the study is a doctoral candidate funded by Coordenacao de Aperfeicoamento de Pessoal de Nıvel Superior (CAPES). This study was funded by Conselho Nacional de Desenvolvimento Cientifico e Tecnologico/Brazil (CNPQ grant number 470273/2013-5). The funder played no role in the conduct of this study. Results A total of 231 participants volunteered to take part in the study. After the first assessment, 83 participants were excluded and 148 participants were assessed at baseline and enrolled in the trial. A total of 145 participants completed the 2-, 4-, and 6-month follow-up assessment (Fig. 1). All data was self-reported, including all outcomes that were collected at baseline and in all follow-up time points. Missing data information is provided in the flow diagram. Participants’ characteristics at baseline are presented in Table 3. There were no differences between participants in the 2 treatment groups with regard to baseline characteristics. Figure 1. View largeDownload slide Study flow diagram. DASS = Depression Anxiety Stress Scale. Figure 1. View largeDownload slide Study flow diagram. DASS = Depression Anxiety Stress Scale. Table 3. Participants’ Characteristics at Baseline.a   Strengthening and Stretching Exercise (n = 74)  Movement System Impairment-Based Treatment (n = 74)  Age (y)  40.4 (13.4)  43.4 (12.5)  Sex      Male  31 (41.9%)  26 (35.1%)  Female  43 (58.1%)  48 (64.9%)  Weight (kg)  72.0 (16.8)  70.8 (16.1)  Height (cm)  167.6 (10)  166.0 (9.4)  Body Mass Index (kg/m2)  25.5 (5.3)  25.5 (4.4)  Marital status      Single  27 (36.5%)  21 (28.4%)  Married  38 (51.4%)  38 (51.4%)  Widowed  7 (9.5%)  10 (13.5%)  Divorced  2 (2.7%)  5 (6.8%)  Educational status      Elementary degree  7 (9.5%)  14 (18.9%)  High school  46 (62.2%)  39 (52.7%)  University  11 (14.9%)  15 (20.3%)  Graduate degree  10 (13.5%)  6 (8.2%)  Income (in USD/hr)  8.6 (6.7)  7.9 (8.2)  Absenteeismb (current)      No  73 (98.6%)  68 (91.9%)  Yes  1 (1.4%)  6 (8.1%)  Smoker      No  69 (93.2%)  64 (86.5%)  Yes  5 (6.8%)  10 (13.5%)  Physically activec      No  44 (59.5%)  49 (66.2%)  Yes  30 (40.5%)  25 (33.8%)  Physical activity durationd (mo)  38.5 (59.9)  32.0 (66.9)  Physical activity frequencye (d/wk)  3.3 (1.5)  2.8 (1.4)  Current use of medication      No  43 (58.1%)  45 (60.8%)  Yes  31 (41.9%)  29 (39.2%)  Pain location      Lumbar  59 (79.7%)  57 (77.0%)  Lumbar and above knee  10 (13.5%)  7 (9.5%)  Lumbar and below knee  5 (6.8%)  10 (13.5%)  History of LBP (months)  75.2 (74.0)  94.9 (96.7)  STarT Back Screening Tool classificationf      Low risk  25 (33.8%)  24 (32.4%)  Medium risk  32 (43.2%)  33 (44.6%)  High risk  17 (23.0%)  17 (23.0%)  MSI classification      Flexion  10 (13.5%)  12 (16.2%)  Extension  21 (28.4%)  25 (33.8%)  Rotation  4 (5.4%)  1 (1.4%)  Flexion and rotation  18 (24.3%)  7 (9.5%)  Extension and rotation  21 (28.4%)  29 (39.2%)  Mean pain intensity (0–10)g  6.5 (1.9)  6.6 (1.8)  Disability (0–24)h  10.2 (5.0)  10.7 (5.1)  Global impression of recoveryi  –1.8 (2.5)  –1.0 (2.8)    Strengthening and Stretching Exercise (n = 74)  Movement System Impairment-Based Treatment (n = 74)  Age (y)  40.4 (13.4)  43.4 (12.5)  Sex      Male  31 (41.9%)  26 (35.1%)  Female  43 (58.1%)  48 (64.9%)  Weight (kg)  72.0 (16.8)  70.8 (16.1)  Height (cm)  167.6 (10)  166.0 (9.4)  Body Mass Index (kg/m2)  25.5 (5.3)  25.5 (4.4)  Marital status      Single  27 (36.5%)  21 (28.4%)  Married  38 (51.4%)  38 (51.4%)  Widowed  7 (9.5%)  10 (13.5%)  Divorced  2 (2.7%)  5 (6.8%)  Educational status      Elementary degree  7 (9.5%)  14 (18.9%)  High school  46 (62.2%)  39 (52.7%)  University  11 (14.9%)  15 (20.3%)  Graduate degree  10 (13.5%)  6 (8.2%)  Income (in USD/hr)  8.6 (6.7)  7.9 (8.2)  Absenteeismb (current)      No  73 (98.6%)  68 (91.9%)  Yes  1 (1.4%)  6 (8.1%)  Smoker      No  69 (93.2%)  64 (86.5%)  Yes  5 (6.8%)  10 (13.5%)  Physically activec      No  44 (59.5%)  49 (66.2%)  Yes  30 (40.5%)  25 (33.8%)  Physical activity durationd (mo)  38.5 (59.9)  32.0 (66.9)  Physical activity frequencye (d/wk)  3.3 (1.5)  2.8 (1.4)  Current use of medication      No  43 (58.1%)  45 (60.8%)  Yes  31 (41.9%)  29 (39.2%)  Pain location      Lumbar  59 (79.7%)  57 (77.0%)  Lumbar and above knee  10 (13.5%)  7 (9.5%)  Lumbar and below knee  5 (6.8%)  10 (13.5%)  History of LBP (months)  75.2 (74.0)  94.9 (96.7)  STarT Back Screening Tool classificationf      Low risk  25 (33.8%)  24 (32.4%)  Medium risk  32 (43.2%)  33 (44.6%)  High risk  17 (23.0%)  17 (23.0%)  MSI classification      Flexion  10 (13.5%)  12 (16.2%)  Extension  21 (28.4%)  25 (33.8%)  Rotation  4 (5.4%)  1 (1.4%)  Flexion and rotation  18 (24.3%)  7 (9.5%)  Extension and rotation  21 (28.4%)  29 (39.2%)  Mean pain intensity (0–10)g  6.5 (1.9)  6.6 (1.8)  Disability (0–24)h  10.2 (5.0)  10.7 (5.1)  Global impression of recoveryi  –1.8 (2.5)  –1.0 (2.8)  a Continuous variables are expressed as mean (SD). Categorical variables are expressed as n (%). MSI = Movement System Impairment. b Proportion of participants unable to work due to low back pain (LBP). c Number of participants who consider themselves to be physically active. d If participants considered themselves to be currently physically active, they were asked, “How long have you been practicing (any physical activity)?” e If participants considered themselves to be currently physically active, they were asked, “How many days per week are you practicing (any physical activity)?” f STarT Back Screening Tool classification.54 g Numeric Pain Rating Scale.42,43 h Roland Morris Disability Questionnaire for low back pain.42,43,55,56 i Global Perceived Effect scale.42 View Large There was no significant difference between treatment groups for the primary outcome measures of mean NPRS at 2 months (mean difference = 0.05, 95% CI = –0.90 to 0.80) and disability at 2 months (mean difference = 0.00, 95% CI = –1.55 to 1.56). There were also no statistically significant differences between treatment groups for any of the secondary outcome measures (Tab. 4). No adverse effects were observed for both groups. Table 4. Unadjusted Mean Values (SD) and Adjusted Between-Group Differences (95% CI) for the Outcomes of Mean Pain Intensity, Disability, and Global Impression of Recovery.a Outcomes  Strengthening and Stretching Exercise Mean (SD)  Movement System Impairment-Based Treatment Mean (SD)  Adjusted Between-Group Differences (95% CI)  p  Pain intensity (0–10)b          Baseline  6.51 (1.92)  6.61 (1.84)      2 months  3.86 (3.05)  3.68 (2.59)  –0.05 (–0.90 to 0.80)  P = .91  4 months  3.79 (2.94)  4.19 (2.95)  –0.23 (–1.08 to 0.61)  P = .59  6 months  3.70 (3.06)  3.81 (2.64)  0.24 (–0.61 to 1.08)  P = .58  Disability (0–24)c          Baseline  10.19 (5.04)  10.64 (5.04)      2 months  5.38 (5.59)  5.49 (5.02)  0.00 (–1.55 to 1.56)  P = .99  4 months  4.82 (4.97)  5.33 (4.65)  –0.07 (–1.62 to 1.49)  P = .93  6 months  4.79 (5.37)  5.16 (5.05)  0.21 (–1.35 to 1.76)  P = .79  Global impression of recovery (–5 to+5)d          Baseline  –1.75 (2.48)  –1.03 (2.76)      2 months  2.49 (2.42)  2.62 (2.19)  0.48 (–0.43 to 1.39)  P = .30  4 months  2.16 (2.53)  2.14 (2.72)  0.80 (–0.14 to 1.68)  P = .09  6 months  2.22 (2.61)  2.51 (2.32)  0.66 (–0.25 to 1.57)  P = .15  Outcomes  Strengthening and Stretching Exercise Mean (SD)  Movement System Impairment-Based Treatment Mean (SD)  Adjusted Between-Group Differences (95% CI)  p  Pain intensity (0–10)b          Baseline  6.51 (1.92)  6.61 (1.84)      2 months  3.86 (3.05)  3.68 (2.59)  –0.05 (–0.90 to 0.80)  P = .91  4 months  3.79 (2.94)  4.19 (2.95)  –0.23 (–1.08 to 0.61)  P = .59  6 months  3.70 (3.06)  3.81 (2.64)  0.24 (–0.61 to 1.08)  P = .58  Disability (0–24)c          Baseline  10.19 (5.04)  10.64 (5.04)      2 months  5.38 (5.59)  5.49 (5.02)  0.00 (–1.55 to 1.56)  P = .99  4 months  4.82 (4.97)  5.33 (4.65)  –0.07 (–1.62 to 1.49)  P = .93  6 months  4.79 (5.37)  5.16 (5.05)  0.21 (–1.35 to 1.76)  P = .79  Global impression of recovery (–5 to+5)d          Baseline  –1.75 (2.48)  –1.03 (2.76)      2 months  2.49 (2.42)  2.62 (2.19)  0.48 (–0.43 to 1.39)  P = .30  4 months  2.16 (2.53)  2.14 (2.72)  0.80 (–0.14 to 1.68)  P = .09  6 months  2.22 (2.61)  2.51 (2.32)  0.66 (–0.25 to 1.57)  P = .15  a Primary outcomes are highlighted in gray. All treatment estimates were adjusted for baseline data using linear mixed models. b Numeric Pain Rating Scale.42,43 c Roland Morris Low Back Pain Disability Questionnaire.42,43,55,56 d Global Perceived Effect scale.42 View Large Treatment Adherence Treatment adherence data, including number of treatment sessions performed at the clinic and number of days performing the home program, is presented in Table 5. Considering the total expected number of treatment days (treatment session days plus number of days performing the home program), the strengthening and stretching group adhered more to the treatment when compared to the MSI model group (mean difference = 17.8%, 95% CI = 8.4% to 27.1%). The strengthening and stretching group performed 16.1 days of exercise (total number of days expected = 24 days, mean adherence = 67.0%, SD = 24.6%), while the MSI model group performed 27.6 days of treatment (total number of days expected = 56, mean adherence = 49.3%, SD = 32.3%) (P<.001). Table 5. Treatment Adherence. Treatment Adherence  Strengthening and Stretching Exercise  Movement System Impairment-Based Treatment  Number of treatment sessions at the clinica mean (SD) [expected number]  10.6 (2.6) [12]  9.7 (3.5) [12]  Number of days performing the home programb mean (SD) [expected number]  5.5 (4.1) [12]  17.9 (15.9) [44]  Treatment adherencec mean (SD)  67.0% (24.6%)  49.3% (32.3%)  Treatment Adherence  Strengthening and Stretching Exercise  Movement System Impairment-Based Treatment  Number of treatment sessions at the clinica mean (SD) [expected number]  10.6 (2.6) [12]  9.7 (3.5) [12]  Number of days performing the home programb mean (SD) [expected number]  5.5 (4.1) [12]  17.9 (15.9) [44]  Treatment adherencec mean (SD)  67.0% (24.6%)  49.3% (32.3%)  a Both groups are supposed to receive the same number of treatment sessions at the clinic. b Both groups are supposed to have different number of days performing the home program. Participants from the MSI group were advised to perform the home program at least once a day on the days on which no treatment sessions were scheduled. Participants in the strengthening and stretching group were instructed to perform the home exercises at least 1 or 2 days a week, in addition to treatment session days. c Treatment adherence was calculated by the following formula: number of treatment sessions + number of days performing the home program / expected number of treatment sessions + expected number of days performing the home program. View Large Discussion The purpose of this study was to compare the efficacy of a treatment based on the MSI model with a treatment consisting of symptom-guided stretching and strengthening exercises for patients with chronic LBP. No significant differences in mean pain, disability, or global impression of recovery were observed between groups at any of the follow-up time points. The strengthening and stretching group adhered more to the treatment when compared to the MSI model group. A previous study showed similar efficacy of a classification-specific treatment based on the MSI model when compared to a nonclassification-specific treatment in patients with chronic nonspecific LBP.40 The non–classification-specific treatment was based on strengthening and stretching exercises and teaching the participants to maintain a balanced spinal alignment when performing daily activities. The authors hypothesized that the lack of difference in outcomes between both groups could be related to the similarities found in both treatment programs and the fact that participants in both groups adhered more to that which was similar in both treatments. Both treatment programs had people perform everyday activities in which they decreased the amount of lumbar spine movement, increased the amount of movement of other joints, and avoided end-range positioning of the lumbar spine. The specific direction of lumbar spine movement and alignment to be corrected, however, was only informed to participants in the classification-specific treatment group. The current study compared a treatment based on the MSI model with a treatment consisting of symptom-guided stretching and strengthening exercises. Although the strengthening and stretching group was not given instructions to modify specific lumbar spine movements or alignments, the exercises prescribed were adjusted based on pain behavior. Participants were supposed to perform exercises involving movements in all directions, but decision-making by the clinician allowed for the participant to eliminate an exercise if it was not tolerated due to onset or increased LBP. Thus, participants may have ended up performing only the exercises that were not symptom-provoking. Performing exercises involving spine movements in directions that are not symptom-provoking may be a common element between the 2 treatment groups and may explain the similar improvements found in both groups in the current study. Different absolute amounts of participation in the home exercise programs were found between the 2 treatment groups. Treatment based on the MSI model group had more home exercise practice prescribed compared to the strengthening and stretching group treatment. This difference was expected because participants in the MSI model group were instructed to perform the home exercises at least 5 or 6 days a week, in addition to treatment session days. Participants in the strengthening and stretching group were instructed to perform the home exercises at least 1 or 2 days a week, in addition to treatment session days. The MSI model is based on movement and alignment education and training, thus it is believed that more practice is needed,27 while stretching and strengthening programs are performed usually 3 times a week.49 However, when considering the total expected number of treatment days (treatment session days plus number of days performing the home program), the strengthening and stretching group adhered more to the treatment when compared to the MSI model group. It is not possible to predict if a higher adherence by the MSI model group would result in an increased treatment effect, although previous studies have associated higher levels of adherence to treatment with better outcomes.40,58,59 Our study also did not assess adherence of the MSI model group to exercise separate from adherence to performance of daily activities. Thus, it is not possible to know which component the participants adhered to and whether this had an impact on the lack of a difference between the 2 treatment groups. This can be considered a limitation since a previous study showed that people adhered more to performance of daily activities than exercise, and the more they adhered to daily activity performance the greater improvement in function compared to adherence to exercise.40 Different studies have found different proportions of the MSI syndromes identified in people with LBP.34,53,60,61 While some studies excluded participants who were in an acute flare-up during initial assessment,34,53 others,60,61 including the current study, did not exclude people who were in an acute flare-up. This difference in exclusion criteria may have influenced the different proportions of the MSI syndromes found in those studies. Different classification systems are available to guide LBP treatment.23–28 The idea behind subgrouping patients with LBP is to classify them into more homogeneous subgroups and then match the patients to treatments specific to their classification. The goal of the matching is to increase the treatment effect size.21,62,63 Promising results related to this approach were previously described.28,51,53,64–69 However, most of the classification systems failed to show clinically significant differences in outcomes when compared to other therapies not based on subgrouping in randomized controlled trials involving people with chronic, nonspecific LBP.40,62,70–73 Although the combination of physical and cognitive/behavioral treatments in patients with back pain seems not to result in better outcomes when compared to isolated physical or cognitive/behavioral treatments,74 the inclusion of cognitive/behavioral factors into movement-based classification described by O’Sullivan25 has shown greater treatment effects when compared to therapies not based on subgrouping (exercise and manual therapy).69 Limitations of this study,69 however, included important follow-up loss and no intention to treat analysis. Thus, replication of the O’Sullivan study results is needed. The lack of between-group differences in outcomes found in the current study could also be explained by the similar distribution of participants in both groups who may be at high, medium, and low risk for poor prognosis according to the STarT Back Screening Tool classification. The use of prognostic factors to guide physical therapy treatment in LBP has been supported by different studies.75–77 Those studies raise the possibility that prognostic factors may be more important in determining the treatment success than diagnostic/classification factors. The current study is the largest prospectively registered randomized controlled trial involving the efficacy of a treatment based on the MSI model in patients with chronic, nonspecific LBP.41 Loss to follow-up was minimal and statistical analyses were performed according to intention-to-treat principles. The physical therapists responsible for the treatments had similar clinical experience and were trained by a senior physical therapist with experience in the concepts underlying the MSI model and application of the classification system and treatment. However, our trial has some limitations. Due to the nature of the study, it was not possible to blind participants and physical therapists responsible for the treatments to group assignment. The physical therapist responsible for the treatment based on MSI model was not responsible for the MSI classification procedure, which is not common in clinical practice. The MSI classification was done by the first author before the randomization procedure because it was part of the inclusion/exclusion criteria. The treating therapist received the filled forms used for MSI classification before the beginning of treatment. This trial also had only 1 treating therapist per arm, which can limit its external validity. Although the treatment consisting of strengthening and stretching exercises did not include explicit movement and alignment education and training, it is possible that participants may have received this information. For example, the physical therapist may have had to answer participants’ questions such as what is the best position to assume to sleep. The physical therapist responsible for the treatment consisting of strengthening and stretching exercises had no previous information or training in the MSI model. The physical therapist was, however, instructed to give very concise and basic information when asked about correct alignment and movement. This study also did not include a control group receiving no treatment. Therefore, it is possible that the improvements observed in the outcomes were attributed to natural history of back pain.78 The results of this study showed that people with chronic nonspecific LBP might have the same improvement in pain, disability, and global impression of recovery by receiving a treatment based on progressive strengthening and stretching exercises that was directed by participant symptom response or by a treatment based on the MSI model after a 6-month follow-up. It is possible that specific participant characteristics may identify people who respond better to treatment based on the MSI model compared to treatment consisting of symptom-guided stretching and strengthening exercises. These secondary analyses are being performed on the data from the current trial. The efficacy and effectiveness of treatment based on the MSI model still need to be tested in people with acute and subacute LBP. Author Contributions Concept/idea/research design: D.C. Azevedo, L.O.P. Costa H. de Oliveira Santos, D.R. Oliveira, J.V.L. de Souza Writing: D.C. Azevedo, L.O.P. Costa P.H. Ferreira, H. de Oliveira Santos, D.R. Oliveira, J.V.L. de Souza Data collection: D.C. Azevedo, H. de Oliveira Santos, D.R. Oliveira, J.V.L. de Souza Data analysis: D.C. Azevedo, L.O.P. Costa Project management: L.O.P. Costa Fund procurement: L.O.P. Costa Providing participants: D.C. Azevedo Providing facilities/equipment: D.C. Azevedo Consultation (including review of manuscript before submitting): D.C. Azevedo, P.H. Ferreira, H. de Oliveira Santos, D.R. Oliveira, J.V.L. de Souza Ethics Approval The study was approved by the Ethics Committee of the Pontificia Universidade Catolica de Minas Gerais, Brazil. Funding The first author of the study is a doctoral candidate funded by Coordenacao de Aperfeicoamento de Pessoal de Nıvel Superior (CAPES). This study was funded by Conselho Nacional de Desenvolvimento Cientifico e Tecnologico/Brazil (CNPQ grant number 470273/2013-5). 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Physical TherapyOxford University Press

Published: Jan 1, 2018

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