Exercise for Rehabilitation and Treatment: Summary of Research

Exercise for Rehabilitation and Treatment: Summary of Research Summarizing research findings to evaluate the effectiveness of exercise for rehabilitation and treatment of orthopedic conditions Summary 11: McKenzie Method for Low Back Pain August 2009 Q: Among individuals with non-specific low back pain, can the McKenzie method or extension-oriented exercises reduce pain and improve function more than other rehabilitation strategies? A: To answer this question, we performed a comprehensive search of the PubMed database (March 2009) for randomized, controlled trials and systematic reviews that addressed this specific research question. 1 Five studies met the criteria for inclusion in this review, as follows: Extension exercise (EE) with and without manipulation (1); McKenzie treatment (MT) compared to manual therapy (2) or strengthening (ST) (6); and EE versus strengthening (3) or mobilization (5) in specific patient subgroups. Three studies evaluated the effect of EE on pain and/or function (1,3,5). Four wks of EE with or without manipulation reduced pain for up to 1 yr of follow up, with no additional effect of manipulation (1). Among a subgroup of subjects proposed to benefit from extension, a 4-wk intervention showed that EE resulted in a significant improvement in function for up to 6 mos after treatment compared to ST, though pain was only significantly reduced at 1 wk (3). When compared to mobilization, EE significantly decreased pain and function after 3 treatments among subjects classified as having lumbar derangement (5). Two studies evaluated the effect of MT on pain and function (2,6). Compared to advice-only in a 1-yr trial, MT significantly reduced pain and improved function, while manual therapy did not (2). In an 8-wk intervention comparing MT to ST, MT significantly reduced pain only among a subgroup of subjects completing treatments (6). A review of research conducted prior to 2003 evaluated MT for low back pain and concluded that MT did not result in "clinically worthwhile" changes over other treatments (4). However, 4 of the 6 studies included in the review did not utilize a classification-based system to determine treatment, and the authors concluded that the effectiveness of MT is still uncertain. Based on the current review, there is some evidence supporting the use of EE, particular among subgroups proposed to benefit from EE, while evidence in support of classification based McKenzie is still needed. Sample exercises from VHI PC-Kits have been provided based on examples from these studies. Prone on elbows from VHI PC-Kits: Orthopedic, Back #1 Backward bend (standing) from VHI PC-Kits: Orthopedic, Back #44 Page 1 of 10

Exercise for Rehabilitation and Treatment: Summary of Research Summary 11: McKenzie Method for Low Back Pain August 2009 Table 1: Overview of Research Studies 1 Study 2 Overview Description of Intervention Results & Conclusions 3 1) Rasmussen, 2008 Hypothesis/Aim: To determine the effect of manipulation, in addition to extension exercise, among patients with chronic, unspecific low back pain (LBP) Subjects: 72 adults (34 male; 38 female) meeting the following criteria: 18-60 yrs; LBP >3 mos; and without LBP caused by major accident, pain extending below knee, excessive pain distribution, neurological disease, or other significant medical issues Groups: 1. Extension exercise (n=37) 2. Extension exercise + Manipulation (n=35) Duration: The length of the intervention was 4 wks. Assessments were completed at baseline, 2 and 4 wks; a questionnaire was completed after 1 yr. Extension exercise: All subjects completed 2 extension exercises, prone extension supported by elbows and standing extension supported by hands placed on a table while leaning the body in toward the table. Patients were instructed to perform 4-6 sets of 3-5 repetitions of each exercise every 30 min during the day (minimum of every hr). Extension + manipulation: Subjects received manual manipulation at baseline, and at 2 and 4 wk follow-ups. The manipulation was performed in side lying and was high velocity/low amplitude at the spinal level corresponding to reduced movement. Subjects were not specifically told whether they received the manipulation. Subjects also completed the same extension exercises as described above for the duration of the study. Outcome Measures: 1. Pain: Patients rated the worst low back and leg pain within the last 48 hrs using a visual analog scale from 0-10. Results: Pain. Among both groups, back and leg pain decreased from baseline to the 4 wk and 1 yr follow ups. However, this decrease was not statistically assessed. No significant differences were found between the 2 groups at either time point. Conclusions: Patient rating of low back and leg pain decreased with the use of extension exercises; however, no additional benefit occurred when manipulation was added to the treatment. These findings should be considered with caution considering the absence of statistical analysis between assessment periods. Page 2 of 10

2) Paatelma, 2008 Hypothesis/Aim: To compare the effect of manual therapy, the McKenzie method, and adviceonly among patients with non-specific LBP Subjects: 134 adults (87 male; 47 female) meeting the following criteria: 18-65 yrs; acute or chronic non-specific LBP with or without radiating leg pain; and without pregnancy, low back surgery <2 mos prior, or indications of spinal pathology Groups: Subjects were randomly assigned to: 1. Manual therapy (n=45) 2. McKenzie method (MT, n=52) 3. Control (n=37) Duration: The intervention period consisted of 3-7 visits in the manual therapy and MT groups and only 1 visit in the control group. Assessments were completed at baseline, 3, 6, and 12 mos. Manual therapy: Subjects were treated with 3-7 sessions (average 6) of manual therapy, including: translatoric manipulation of thoracolumbar junction and lumbar spine, and manipulation of the sacroiliac joint. Patients also completed 3-5 home exercises each day, including low back mobilization, lumbar stabilization, and stretching exercise. McKenzie treatment: Subjects were classified into mechanical syndromes, and the appropriate treatment principle was followed. Subjects received the same number of visits as the manual therapy group (range 3-7, average 6). Home exercises were repeated 10-15 times every 1-2 hr, and education materials were provided (Treat Your Own Back). If improvements were not being made, a physical therapist applied over-pressure or mobilization within the same treatment goal. High velocity-low amplitude manipulation was avoided. Control: Subjects received a 45-60 min session of advice regarding pain, medication, return to work, and activity from a physical therapist. Subjects were recommended to maintain a usual routine within the limits of pain. Outcome Measures: 1. Pain: Pain in the low back and leg was assessed with a visual analog scale. 2. Function: Function was assessed with the Roland-Morris Disability Questionnaire (level of back pain related disability in daily activities during the prior 3 mos). Results: Pain. At 6 mos, the subjects treated with MT showed significant reductions in leg pain (p=0.04) and back pain (p=0.009) compared to the control group. The manual therapy group also showed greater reductions in leg and back pain compared to the control group, but these reductions were not significant (p=0.08, p=0.1). After 12 mos however, the reductions in leg pain (p=0.3 manual therapy; p=0.1 MT) and back pain (p=0.7 for both treatment groups) were no longer significant compared to the control group. No group differences were observed at the 3-mos follow-up. Function. After 6 mos, the MT group showed a significant decrease in the disability index compared to the control (p=0.003), while the manual therapy group's reduction did not meet the criteria for significance (p=0.07). After 12 mos the results were similar, with significant differences from the control group only being shown with MT (p=0.03). No group differences were observed at the 3-mos follow-up. Conclusions: The authors concluded that all 3 groups showed clinically significant reductions in pain and disability after 1 yr, and only a slight benefit of treatment was found. A high drop-out rate (control, 30%; McKenzie, 14%; and manual therapy, 22%) was a significant limitation of the study. Despite the long-term outcomes being similar across all 3 groups, the reduced pain and disability in the short-term with the MT should be favorably considered. Hypothesis/Aim: To compare the effectiveness of extension-oriented treatment to lumbar strengthening among a subgroup of patients with LBP that demonstrate centralization of symptoms with lumbar extension Both groups completed 6 physical therapy sessions over 4 Page 3 of 10

3) Browder, 2007 lumbar extension Subjects: 48 adults (33 male; 15 female) meeting the following criteria: 18-60 yrs; LBP extending distally beyond the buttock in at least one LE; presence of centralization (lumbar extension eliminates or causes symptoms to move proximally toward midline of lumbar spine); Oswestry Low Back Pain Disability Questionnaire >30%; and without pathological conditions, pregnancy, or lumbar spine surgery within past 6 mos Groups: Subjects were randomly assigned to: 1. Extensionoriented treatment approach (EOTA, n=26) 2. Lumbar strengthening (LS, n=22) Duration: The length of the intervention was 4 wks. Assessments were completed at baseline, 1 wk, 4 wks, and 6 mos. wks and received home exercises (written/pictorial) to perform on the days they did not attend physical therapy. EOTA: Subjects received exercises and mobilization to encourage symptom centralization. Exercises included: lumbar extension, progressing from static prone lumbar extension to repeated end-range prone and standing lumbar extension (3 sets of 10 reps each, holding for 2-3 sec at end-range); and prone (standing if prone not possible) press-up exercise (10 reps every 2-3 hrs). Posterior-to-anterior lumbar mobilization (Maitland) was performed by a physical therapist. Subjects also received instruction on proper lordosis while seated, to avoid sitting >30 min, and to avoid positions that cause an increase in or peripheralization of symptoms. LSS: Subjects performed strengthening exercises once daily for the deep abdominal and primary stabilizing muscles of the spine. Exercises included: abdominal bracing in supine, standing and bridging; quadruped arm and leg lifts; and side bridging. Outcome Measures: 1. Pain: Pain was assessed with the Numeric Pain Rating Scale (NPRS). 2. Function: Function was measured with a modified Oswestry Low Back Pain Disability Questionnaire (ODQ). Results: Pain. The EOTA group showed a significantly greater improvement in NPRS at 1 wk (p=0.007). There was no difference between the groups' NPRS scores after 4 wks and 6 mos. Function. The EOTA group showed a significantly greater improvement in the ODQ score compared to the LS group at 1 wk (p=0.01), 4 wks (p=0.004), and 6 mos (p=0.005). Conclusions: The authors concluded that patients who demonstrate centralization of symptoms may benefit more from a treatment program focused on repeated extension (EOTA). However, although the EOTA resulted in improved disability scores compared to the strengthening program, there was no significant difference in pain. The authors suggest that perhaps the subgrouping classification should have been more inclusive (e.g., directional preference for extension). Additional study limitations included a high drop out rate by 6 mos, particularly in the EOTA group (58%) compared to the strengthening group (73%), and a history of lumbar spine surgery (19%) only within the EOTA group. Background: The McKenzie method had not been properly evaluated in research studies due to the lack of consistency among studies in properly classifying patients. Often, extension exercise is equated Methods: Studies included in this review were randomized controlled trials published prior to August 2003 examining the effect of McKenzie treatment, or an intervention utilizing McKenzie principles, on nonspecific low back pain. Eleven studies were Results: Results were summarized according to the control intervention that was utilized by the study. Studies that compared McKenzie to passive therapy (education, rest, massage), showed a significant decrease in pain and disability after 1 wk with McKenzie, but no difference after 4 wks (disability only). In comparison to "advice to stay active", after 12 wks there was no difference in pain and a significant decrease in disability among the advice-only group. When McKenzie was compared to flexion exercises, there was a favorable short term (5 day) effect on disability with McKenzie, but minimal difference in pain Page 4 of 10

4) Machado, 2006 Review Article with the McKenzie method without proper classification of the patient according to the McKenzie guidelines. Purpose: The purpose of this review article was to evaluate randomized controlled trials that evaluated a classification based McKenzie approach among patients with chronic low back pain. back pain. Eleven studies were included with 6 trials identified as "classification based" where the treatment was based on directional preferences as outlined by McKenzie and 4 were a "generic McKenzie approach" where treatment was assigned without classification but included extension exercises with or without lateral bending or flexion. Outcomes: Studies included in this review reported on pain, disability, quality of life, return to work/sick leave, or recurrence. disability with McKenzie, but minimal difference in pain after longer follow up (2 and 8 wks). Vs spinal manipulative therapy, results were split with McKenzie favored for the reduction of pain in one study, and manipulation favored for reduction in disability in another study. Compared to back school, the McKenzie method showed lower pain and higher rate of return to work. Finally, when comparing McKenzie to strengthening exercise, there was no difference in pain or disability after 8 wks. Conclusions: The authors concluded that according to the reviewed studies, the McKenzie method did not necessarily produce "clinically worthwhile changes in pain and disability". However, a limitation of this review is that it allowed the inclusion of "generic" or nonclassification based McKenzie studies due to an insufficient number of classification-based trials. Therefore, the efficacy of classification-based McKenzie treatment still needs to be determined. 5) Schenk, 2003 Hypothesis/Aim: To compare joint mobilization and extension exercise among patients experiencing LBP and classified as having lumbar derangement according to the Lumbar Spine Index (LSI) Subjects: 25 adults (10 male; 15 female, aged 21-76 yrs) meeting the following criteria: experiencing subacute LBP and classified as posterior lumbar disc derangement using the Lumbar Spine Index (LSI) Groups: Subjects were randomly assigned to: 1. Extension exercise (EE, n=15) 2. Joint mobilization (n=10) Both groups completed 3 physical therapy visits. The visits included postural correction, treadmill walking, and either therapeutic exercise or mobilization. Extension exercise: Subjects received exercises based on the results of repeated movement testing. Exercise included repetitions of lumbar extension or lumbar extension with the hips offset (5 sets of 10 repetitions). Joint mobilization: Subjects received mobilization based on the results of the active, repeated and passive mobility testing. Subjects received 5 sets of 10 repetitions of passive mobilization to the spinal segments. Outcome Measures: 1. Pain: Verbal analog pain scale 2. Function: Oswestry Low Back Pain Disability Questionnaire Results: Pain. After 3 physical therapy treatments, both groups showed a decrease in pain, although the extension exercise group had a significantly greater decrease (exercise 3.9-1.5; mobilization 3.8-3.5, p=0.04). Function. Similar to the results for pain, after 3 physical therapy treatments, both groups showed a decrease in disability, yet the exercise group improved significantly more than the mobilization group (exercise 9.1 decrease; mobilization 6.2, p=0.05). Conclusions: Among patients classified with lumbar posterior derangement according to the LSI classification system, extension exercise therapy is more effective than mobilization in relieving pain and improving function. Limitations of this study include a small sample size and unequal distribution of subjects between the groups. Duration: The length of the intervention was 3 Page 5 of 10

physical therapy visits. Assessments were completed prior to and following the 3 visits. 6) Petersen, 2002 Hypothesis/Aim: To compare the effectiveness of McKenzie treatment with intensive dynamic strength training among patients with subacute or chronic low back pain Subjects: 260 adults (142 male; 118 female) meeting the following criteria: 18-60 yrs; low back pain with or without leg pain for more than 8 wks; radiograph, CT scan, or MRI completed within the last 2 yrs; and without previous treatment with McKenzie or strengthening, unaffected nerve root, osteoporosis, spondylolisthesis, fracture, referred pain, psychological or other disease Groups: Subjects were randomly assigned to: 1. McKenzie treatment (MT, n=132) 2. Intensive dynamic strength training (n=128) Duration: The length of the intervention was 8 wks of clinical treatment plus 2 mos of home exercise. Assessments were completed post- Both groups completed a maximum of 15 treatments at an outpatient clinic over 8 wks, followed by a 2 mos continuation of the self-administered exercises at home. McKenzie treatment: After an initial assessment, subjects received treatment according to the McKenzie principles. The treatments were about 30 min in duration and consisted of "selfmobilizing repeated movements or sustained positions performed in specific movement directions, the application of manual overpressure, and/or mobilization by a therapist." Intensive dynamic strength training: Subjects performed group sessions of 60-90 min duration. Sessions included a warmup (5-10 min cycling and 10 min of low resistance lumbopelvic flexion, extension, and rotation); 50-100 repetitions (sets of 10 reps with 1 min rest) of 4 strengthening exercises (prone isometric back extension, supine isometric abdominal contractions, supine sit-ups, supine curl-ups); and a cool down (10 min stretching for trunk and hip muscles). Outcome Measures: 1. Pain: Pain was assessed by Manniche's Low Back Pain Rating Scale. Back and leg pain "at the moment", the "worst pain within the past 2 wks", and "average pain within the past 2 wks". 2. Function: Function was also assessed by Manniche's Low Back Pain Rating Scale and included ratings of difficulty for 15 items of daily living and social life. Results: Pain. No significant group differences were present regarding the change in back or leg pain scores after treatment (p=0.6), or 2 mos (p=0.4) or 8 mos of follow up (p=0.8). In a subgroup analysis of only those subjects who completed the intervention (n=180), the change in back and leg pain scores was significantly better in the MT group after treatment (p=0.02) and at the 2 mos follow up (p=0.01), but not after 8 mos (p=0.2). Function. No significant group differences were present regarding the change in disability scores after treatment (p=0.4). At the 2 mos follow up, however, the MT group showed greater improvement compared to strength training (p=0.04). This difference between groups was no longer significant by the 8 mos follow up (p=0.9). The subgroup analysis of completers did not show significant differences between the groups at any time point, although scores tended to be better in the MT group. Conclusions: The authors concluded that the training programs were equally effective, although in a subgroup analysis of patients completing the treatment programs, there was a tendency for MT to show more improvement in pain scores. Caution should be used in regard to the subgroup analysis, as the potential for bias is greater. Long term follow up: The Low Back Pain Rating Scale was completed 14 mos after the completion of treatment. For the entire group and the subgroup of "completers" there were no differences found between treatments in the change in function (p=0.4) or the change in pain (p=0.2). Page 6 of 10

treatment and 2 and 8 mos later. Exercise for Rehabilitation and Treatment: Summary of Research Summary 11: McKenzie Method for Low Back Pain August 2009 Table 2: Additional Exercises from VHI Exercise Kits The exercises included in this newsletter are intended only as a sampling of exercises from the different VHI exercise collections that might be relevant to the topic discussed. Their inclusion in this newsletter does not represent any rehabilitation protocol or any suggested exercise progression that could be used with patients. Using the order of the exercises to create a rehabilitation program for patients is inappropriate and could result in serious injury. Level: Beginning-Intermediate Level: Beginning-Intermediate Kit Tab Exercise # Kit Tab Exercise # Orthopedic Back 2 Spinal Stabilization Lower Trunk 1 Level: Beginning-Intermediate Level: Beginning-Intermediate Kit Tab Exercise # Kit Tab Exercise # Orthopedic Trunk Stability 17 Orthopedic Trunk Stability 9 Page 7 of 10

Exercise for Rehabilitation and Treatment: Summary of Research Summary 11: McKenzie Method for Low Back Pain August 2009 Table 2: Additional Exercises from VHI Exercise Kits (cont.) The exercises included in this newsletter are intended only as a sampling of exercises from the different VHI exercise collections that might be relevant to the topic discussed. Their inclusion in this newsletter does not represent any rehabilitation protocol or any suggested exercise progression that could be used with patients. Using the order of the exercises to create a rehabilitation program for patients is inappropriate and could result in serious injury. Level: Intermediate-Advanced Level: Intermediate-Advanced Kit Tab Exercise # Kit Tab Exercise # Orthopedic Back 11 Orthopedic Back 10 Level: Intermediate-Advanced Level: Intermediate-Advanced Kit Tab Exercise # Kit Tab Exercise # Page 8 of 10

Therapeutic Ball Spine 38 Therapeutic Ball Spine 45 Exercise for Rehabilitation and Treatment: Summary of Research Summary 11: McKenzie Method for Low Back Pain August 2009 Disclaimer Warning! This newsletter is intended to be viewed only by licensed medical professionals, in accordance with the Terms of Use Agreement. Do not employ any treatment or technique set forth in the newsletter before consulting your doctor or other appropriate licensed medical professional; by violating these instructions, you hereby release and discharge VHI from all claims, demands, damages, costs, expenses, injuries, and causes of action arising from any act or occurrence relating to the use of the information set forth in this Newsletter. References 1. Rasmussen J, Laetgaard J, Lindecrona AL, Qvistgaard E, Bliddal H. Manipulation does not add to the effect of extension exercises in chronic low-back pain (LBP). A randomized, controlled, double blind study. Joint Bone Spine. 2008 Dec;75(6):708-13. 2. Paatelma M, Kilpikoski S, Simonen R, Heinonen A, Alen M, Videman T. Orthopaedic manual therapy, McKenzie method or advice only for low back pain in working adults: a randomized controlled trial with one year follow-up. J Rehabil Med. 2008 Nov;40(10):858-63. 3. Browder DA, Childs JD, Cleland JA, Fritz JM. Effectiveness of an extension-oriented treatment approach in a subgroup of subjects with low back pain: a randomized clinical trial. Phys Ther. 2007 Dec;87(12):1608-18; discussion 1577-9. 4. Machado LA, de Souza MS, Ferreira PH, Ferreira ML. The McKenzie method for low back pain: a systematic review of the literature with a meta-analysis approach. Spine. 2006 Apr 20;31(9):E254-62. Review. 5. Schenk R, Jozefczyk C, Kopf A. A randomized trial comparing interventions in patients with lumbar posterior derangement. J Man Manipulative Ther. 2003;11(2):95-102. 6. Petersen T, Kryger P, Ekdahl C, Olsen S, Jacobsen S. The effect of McKenzie therapy as compared with that of intensive strengthening training for the treatment of patients with subacute or chronic low back pain: A randomized controlled trial. Spine. 2002 Aug 15;27(16):1702-9. Page 9 of 10

a. Follow up: Petersen T, Larsen K, Jacobsen S. One-year follow-up comparison of the effectiveness of McKenzie treatment and strengthening training for patients with chronic low back pain: outcome and prognostic factors. Spine. 2007 Dec 15;32(26):2948-56. Animations were created as part of a Phase I SBIR grant from the National Institutes of Health (NIH) "Internet Delivery of Animated Rehabilitation Exercises" Copyright 2009 Visual Health Information (VHI) 800-356-0709 1 PubMed database was used to identify peer-reviewed research publications that addressed the specific clinical question (population, diagnosis, treatment, and outcome). For inclusion, studies must be a randomized controlled trial (RCTs) and published in English. A maximum of 10 RCTs were reviewed, with strength of design and publication year determining which studies to include. 2 No study footnotes needed. 3 Statistical definitions: 1) P-value (p) denotes the level of significance, where p<0.05 indicates a statistically significant result. 2) 95% Confidence Interval (95% CI): a range that contains the true population estimate 95% of the time. A smaller range indicates an estimate that is more precise. 3) Relative Risk (RR) is a ratio of proportions (ProportionTreatment / ProportionControl). RR less than 1.0 indicates the treatment group has a decreased risk of developing the condition/disease compared to the control group, while RR greater than 1.0 indicates the treatment group has an increased risk. 4) Incidence Risk Ratio (IRR) is the ratio of two incidence rates; the incidence rate among the treatment group divided by the incidence rate in the control group. IRR gives a relative measure of the effect of a given treatment with values less than 1.0 favoring the treatment. 5) Hazard Ratio (HR) is the relative likelihood of experiencing a particular event; an HR of 0.5 indicates that one group has half the risk of the other group. HR is broadly equivalent to RR, but is useful when the risk is not constant with respect to time as it uses information collected at different times. 6) Odds Ratio (OR) is the odds of an event happening in the treatment group expressed as a proportion of the odds of an event happening in the control group and can be interpreted similar to the RR. 7) Likelihood Ratio (LR) is the likelihood that a given test result would be expected in a patient with the target disorder compared to the likelihood that the same result would be expected in a patient without that disorder. The LR is used to assess how good a diagnostic test is and to help in selecting an appropriate diagnostic test(s) or sequence of tests. Page 10 of 10