ACCRAC AWARD WINNING PAPER CLINICAL OUTCOMES FOR NEUROGENIC CLAUDICATION USING A MULTIMODAL PROGRAM FOR LUMBAR SPINAL STENOSIS: A RETROSPECTIVE STUDY Carlo Ammendolia, DC, PhD, a, b, c and Ngai Chow, BSc, DC d
ABSTRACT Objective: The purpose of this preliminary study was to assess the effectiveness of a 6-week, nonsurgical, multimodal program that addresses the multifaceted aspects of neurogenic claudication. Methods: In this retrospective study, 2 researchers independently extracted data from the medical records from January 2010 to April 2013 of consecutive eligible patients who had completed the 6-week Boot Camp Program. The program consisted of manual therapy twice per week (eg, soft tissue and neural mobilization, chiropractic spinal manipulation, lumbar flexion-distraction, and muscle stretching), structured home-based exercises, and instruction of self-management strategies. A paired t test was used to compare differences in outcomes from baseline to 6-week follow-up. Outcomes included self-reported pain, disability, walking ability, and treatment satisfaction. Results: A total of 49 patients were enrolled, with a mean age of 70 years. The mean difference in the Oswestry Disability Index was 15.2 (95% confidence interval [CI], 11.39-18.92), and that for the functional and symptoms scales of the Swiss Spinal Stenosis Questionnaire was 0.41 (95% CI, 0.26-0.56) and 0.74 (95% CI, 0.55-0.93), respectively. Numeric pain scores for both leg and back showed statistically significant improvements. Improvements in all outcomes were clinically important. Conclusions: This study showed preliminary evidence for improved outcomes in patients with neurogenic claudication participating in a 6-week nonsurgical multimodal Boot Camp Program. (J Manipulative Physiol Ther 2015;38:188-194) Key Indexing Terms: Spinal Stenosis; Lumbar Vertebrae; Osteoarthritis; Spine; Rehabilitation; Chiropractic; Claudication; Manual Therapy
N
eurogenic claudication is a leading cause of pain, disability, and loss of independence in older adults. 1 It is usually caused by degenerative
a Assistant Professor, Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada. b Associate Scientist, Department of Medicine, Mount Sinai Hospital, Toronto, Canada. c Assistant Professor, Department of Surgery, University of Toronto, Toronto, Canada. d Clinical Resident, Department of Graduate Education and Research, Canadian Memorial Chiropractic College, Toronto, Canada. Submit requests for reprints to: Carlo Ammendolia, DC, PhD, Assistant Professor, 20 Birchcroft Rd, Toronto, Ontario, Canada M9A 2L4. (e-mail: [email protected]). Paper submitted April 10, 2014; in revised form December 21, 2014; accepted December 22, 2014. 0161-4754 Copyright © 2015 by National University of Health Sciences. http://dx.doi.org/10.1016/j.jmpt.2014.12.006
lumbar spinal stenosis (DLSS), which refers to age-related degenerative narrowing of the spinal canals that often lead to compression and ischemia of the spinal nerves (neuroischemia). 2 The clinical syndrome of DLSS is known as neurogenic claudication. This syndrome is characterized by bilateral or unilateral buttock, lower extremity pain, heaviness, numbness, tingling, or weakness, precipitated by walking and standing and 3 relieved by sitting and bending forward. 4,5 Limited walking ability is the dominant functional impairment caused by neurogenic claudication due to DLSS. 4 Those with DLSS have greater walking limitations than individuals with knee or hip osteoarthritis 6 and greater functional limitations than those with congestive heart failure, chronic obstructive lung disease, or systemic lupus erythematosus. 1 Inability to walk among individuals with neurogenic claudication leads to a sedentary lifestyle and a progressive decline in health status. 7–9 The prevalence and economic burden of neurogenic claudication due to DLSS are growing
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exponentially due to the aging population. Although DLSS is the most common reason for spine surgery in individuals older than 65 years, 10 only very few DLSS patients receive surgery. 11 Most individuals with neurogenic claudication due to DLSS receive nonsurgical care. However, what constitutes effective nonsurgical care is unknown. 12–15 Self-management strategies may be a practical and effective means to improve walking ability, functional status, and quality of life in this chronic and often progressive condition. 15 The goal of self management in DLSS is to provide patients with the knowledge, skills, self-confidence, and physical capacity to manage their symptoms and maximize their function on their own. Based on this evidence, a multimodal self-management training program was developed at our institution and is known as the Boot Camp Program for Lumbar Spinal Stenosis; however, the clinical effectiveness of this program is unknown. Therefore, the purpose of this study was to assess the effectiveness of the Boot Camp Program for Lumbar Spinal Stenosis in improving symptoms and functional status among consecutive patients with neurogenic claudication who completed the 6-week program.
Ammendolia and Chow Boot Camp for Lumbar Spinal Stenosis
Inclusion criteria: 1) 50 years of age or older 2) clinical evidence of neurogenic claudication due to lumbar spinal stenosis 3) symptoms for more than 3 months 4) Completed both the Boot Camp Program for Lumbar Spinal Stenosis and the pre- and post-treatment outcome measures and questionnaires. Exclusion criteria: 1) Spondylitis, neoplasm, infection or metabolic diseases 2) Radiculopathy due to lumbar disc herniation 3) Psychiatric and/or cognitive disorders 4) Not able to read or comprehend English sufficiently enough to complete self-report
Figure 1. Inclusion and exclusion criteria for medical record selection.
relaxation, and body positioning. 16,17 Reassurance, positive reinforcement, goal setting, and graded activity were provided to reduce pain-related fear, improve self-efficacy, 16,18 and improve function. 19 The emphasis at each session was on maximizing function particularly walking ability. Patients were instructed on how to reduce the lumbar lordosis when standing and walking using the pelvic tilt (body repositioning techniques).
METHODS A retrospective medical record review was conducted of consecutive patients who enrolled in the Boot Camp Program for Lumbar Spinal Stenosis from January 2010 to April 2013 inclusively. Medical records were selected based on the inclusion and exclusion criteria listed in Figure 1.
Protection of Human Subjects The Research Ethics Board at Mount Sinai Hospital in Toronto (MSH REB13-0058-C) gave approval for this study and exempted informed consent. Description of Program. All patients received the following structured 6-week multimodal and self-management training program. The program consisted of one-on-one treatment sessions with one of the authors (C.A.). Each session was approximately 15 to 20 minutes in duration, and the frequency varied from 1 to 3 times per week depending on the severity of the symptoms and travel time to the clinic. The interventions were tailored and directed to the multifaceted aspects of neurogenic claudication, with an emphasis on instructing patients on self-management. The components of the Boot Camp Program for Lumbar Spinal Stenosis were as follows. Education. Patients received instruction on self-management strategies using a cognitive behavioral approach. 16 They received information on the causes of pain and disability due to DLSS, its natural history, and prognosis. They received instruction on how to manage symptoms and maintain daily routines using problem solving, pacing,
Exercises. Patients received instruction on muscle stretching, strengthening, and conditioning exercises directed at improving overall back and lower extremity fitness and facilitating lumbar flexion. 20,21 Tight muscles that promote lumbar extension were progressively stretched, and muscles that promote and control lumbar flexion were strengthened. Muscles stretching exercises included supine knee to chest and knee to opposite stretches, side posture quadriceps stretches, and standing iliopsoas stretches. 21 Core strengthening exercises included supine pelvic tilt and half sit ups, side posture lateral stabilizer exercises, and prone lumbar and gluteal extension exercises. 21 Exercise instruction was provided and reviewed at each session and was part of a progressive structured home exercise program. Patients who had limited walking ability were instructed in a graduated cycling program using a stationary forward leaning bike. A graduated walk program was implemented among patients who were not limited in their walking ability. The aim of cycle or walk program was to improve lower extremity conditioning and overall fitness and was integrated as part of the home exercise program. 22 A written exercise and conditioning program schedule was provided to patients outlining the type, frequency, and intensity of the exercises to be performed. The exercises were performed twice per day at home, with the number, intensity, and frequency of each exercise increasing each week for a period of 6 weeks. Manual Therapy. All patients received manual therapy aimed at improving the flexibility of the lumbar spine and
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facilitating lumbar spine intersegmental flexion. At each session, manual therapy was directed to the lumbar and thoracic spine, pelvis, and lower extremities. Specific techniques included low-amplitude high-velocity manipulation 20; joint, soft tissue, and neural mobilization 20,23–25; lumbar flexion-distraction 23,26,27 ; and manual muscle stretching. 28 The specific and combination of manual therapy techniques and exercises used was determined by the principal investigator (C.A.) based on identified underlying functional impairments. A typical treatment session consisted of, first, providing education, reassurance, and positive reinforcement when improvements are noted. The patient is then positioned prone on a flexion-distraction table (Leander Model 950; Leander Healthcare Technologies, Lawrence, KS) for about 5 minutes, during which time manually assisted mechanical flexion-distraction is performed. 23,27 During mechanical distraction, a push-relax technique 28 is used to progressively stretch the piriformis, gluteus medius, rectus femoris, adductors, and iliopsoas muscles. Side posture mobilization/manipulation 20 is then performed bilaterally with the lumbar spine in a flexed position. This is followed by supine neuromobilization 20,23–25 of the sciatic nerve. A review of the previous exercises is then performed followed by instruction on 2 to 3 new exercises. This routine would be repeated twice per week for 6 weeks, with the intensity and duration of the home exercises schedule increasing each week.
reflect higher symptom severity. A change in the mean score of at least 0.1 is considered clinically important. 47 The mean unweighted score was calculated at baseline and at 6-week follow-up. Functional Disability. Functional disability was measured using the Oswestry Disability Index (ODI). 31 The ODI is a reliable and validated measure of back-related disability, where 0 represents no disability and 100 represents the worse possible disability. The walking section (ODI walk) of the ODI was scored and recorded separately. The ODI walk score has been shown to be highly correlated to objective walking distance (r = 0.83). 32 The minimally clinically important difference of the ODI is 8 to 12 percentage points. 33 Leg and Back Pain Intensity While Walking. Leg and back pain intensity while walking was independently measured at baseline and at 6-week follow-up with the 11-point numerical rating scale (NRS). The NRS is a global measure of pain intensity anchored by 2 extremes of pain intensity ranging from 0 (referring to “no pain”) to 10 (referring to “pain as bad as it could be”). Minimally clinically important difference for the NRS is estimated to be 1.5 to 2.0. 34 Treatment Satisfaction. This was measured using the treatment satisfaction scale of the SSS questionnaire. A score of less than 2.5 is considered to be clinically important. 29
DATA ANALYSIS DATA COLLECTION, FOLLOW-UP,
AND
OUTCOMES
Data were extracted from eligible patients' medical records by 2 investigators (C.A. and N.C.) independently. Baseline and 6-week follow-up data were collected. The following patient-centered outcome measures were collected:
Demographic Data and Duration of Symptoms for Both Leg and Back Physical Function. This was measured using the physical performance scale of the Swiss Spinal Stenosis questionnaire (SSS). The SSS is a validated condition-specific measure consisting of 3 scales; a physical performance scale, a symptom severity scale, and a patient satisfaction scale. 29,30 The physical performance scale consists of 5 questions related to walking ability. The raw scores range from 5 to 20 and mean scores from 1 to 4. Higher scores reflect lower physical performance. A change in the mean score of at least 0.1 is considered clinically important. 47 The mean unweighted score was calculated at baseline and at 6-week follow-up. Symptom Severity. This was measured using the symptom severity scale of SSS. The symptom scale consists of 7 questions pertaining to overall severity of pain, pain frequency, back pain and, pain in the leg, numbness, weakness, and balance disturbance. The raw scores range from 7 to 35 and the mean scores from 1 to 5. Higher scores
From the medical records that were selected, descriptive statistics were extracted. Improvements in outcomes were assessed by calculating the change in the mean scores from baseline to 6-week follow-up for each outcome measure. The 95% confidence interval of the mean change was calculated and a 2-sided paired t test with an α of .05 was used to assess the statistical significance of the mean change for each outcome. R Project version 3.0.1 statistical software (2009) was used for the analysis. 35
RESULTS Data were extracted from the medical records of 49 consecutive patients who completed the Boot Camp Program for Lumbar Stenosis from January 2010 to April 2013 and completed outcome questionnaires at baseline and at the 6-week follow-up. Table 1 outlines the characteristics of the included patients. The mean age of the sample was 70 years of age, 65% were female, and the mean duration of symptoms was 11 years for back pain and 8.6 years for leg symptoms. Some medical records had missing data which accounts for the variable number of patients for the different outcomes in the analysis. The relative lower number of patients with numeric pain scores for leg or back pain also reflects the variability in symptoms where some patients have back pain but no leg pain or leg pain but no back pain.
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Ammendolia and Chow Boot Camp for Lumbar Spinal Stenosis
Table 1. Baseline Characteristics
Table 2. Mean Difference in Outcomes From Baseline
Baseline Characteristics
n
Means (SD) or %
Age (y) Female sex (%) Duration of back symptoms (y) Duration of leg symptoms (y) ODI ODI—walking item Swiss Spinal Stenosis Symptoms Score Swiss Spinal Stenosis Function Score Numeric Pain Score—leg a Numeric Pain Score—low back a
49 49 46 45 47 46 44 44 35 38
70 (8.6) 65 11 (13.6) 8.6 (12) 51 (14.1) 3 (1.34) 3.22 (0.62) 2.27 (0.43) 7 (1.95) 7 (2.47)
ODI, Oswestry Disability Index. a Some participants had leg pain without back pain or back pain without leg pain; others had no leg or back pain but other symptoms.
Others have no back or leg pain but had leg numbness, weakness, burning or tingling. The mean ODI was 51 and the mean walking item of the ODI was 3, suggesting that patients included in this study were severely disabled and had moderate walking limitations. The mean baseline pain score was 7 of 10 for both leg and back and SSS symptom and function scores were 3.22 and 2.27, respectively, suggesting high levels of pain and functional limitations. There were no reported adverse events. Table 2 describes the mean difference in outcome measures after the completion of the 6-week Boot Camp Program. All outcomes demonstrated statistically significant and clinically important improvements.
DISCUSSION This study provides preliminary evidence of the effectiveness of a self-management training program to improve symptoms and function among patients with moderate neurogenic claudication. These findings are supported by previously published guidelines 48 and provide the rationale to conduct future studies to test the Boot Camp Program for Lumbar Stenosis with more rigorous study designs such as a randomized controlled trial (RCT). Developing and testing novel nonsurgical approaches to improve outcomes in neurogenic claudication is important given its increasing prevalence and high morbidity. Neurogenic claudication is a leading cause of pain, disability, and loss of independence in people older than 65 years. With the aging population, the number of people with neurogenic claudication due to DLSS is expected to rise exponentially over the next 20 years. Billions of dollars are spent each year for both surgical and non surgical treatment and these costs are increasing. 10,36 However, what constitutes effective nonsurgical treatment is unknown. A recent Cochrane Review evaluating the effectiveness of nonsurgical treatments for neurogenic claudication 37 identified 4 RCTs of physical therapy. The type of physical therapy used in these trials varied considerably, but one
Outcome (n) ODI (n = 45) ODI walk (n = 44) SSS symptoms (n = 44) SSS function (n = 43) NPS LBP (n = 29) NPS leg (n = 25) SSS treatment satisfaction (n = 43)
6-wk Baseline, Posttreatment, Mean Difference Mean (SD) Mean (SD) (95% CI) P 50.8 (13.9) 35.6 (15.6) 3.39 (1.32) 2.43 (1.58)
15.2 (11.39-18.92) b.0001 0.96 (0.65-1.25) b.0001
3.22 (0.62) 2.48 (0.60)
0.74 (0.55-0.93)
b.0001
2.28 (0.43) 1.87 (0.60)
0.41 (0.26-0.56)
b.0001
7 (2.53)
4 (2.48)
2.07 (1.05-3.09)
.0003
7 (1.79)
5 (2.70)
2.34 (1.15-3.53)
.0004
1.54 (0.50)
CI, confidence interval; LBP, low back pain; NPS, Numeric Pain Score; ODI, Oswestry Disability Index SSS, Swiss Spinal Stenosis Score.
common denominator was exercise. One trial suggested that inpatient physical therapy was better than home exercise in the short term, 38 and in another trial, exercise was better than no treatment in the short term. 39 One trial showed short-term global improvement using a combination of manual therapy, exercise, and unweighted treadmill walking compared with flexion exercises, walking, and sham ultrasound, 28 and another demonstrated no difference in outcomes using a stationary bike compared to unweighted treadmill walking. 22 The authors of this review concluded that the overall evidence for the use of physical therapy was of low or very low quality preventing conclusion to be drawn about its effectiveness. Other systematic reviews evaluating the effectiveness of physical therapy for neurogenic claudication had similar conclusions. 12–14 A systematic review of manual therapy for spinal stenosis concluded there is preliminary evidence for potential benefit, but higher-quality evidence is needed. 40 Similar conclusions were drawn from a review of the literature assessing chiropractic treatment of spinal stenosis. 41 This review could not identify any RCTs evaluating chiropractic treatment of lumbar spinal stenosis. In this preliminary study, the Boot Camp Program for Lumbar Stenosis showed both statistically significant and clinically important improvements in all outcomes. The program is a tailored, structured, and comprehensive program that addresses the structural, 4,42,43 functional, 1,5,6 physiological, 2,44 and psychosocial 45,46 consequences of DLSS. Manual therapy using side posture mobilization/ manipulation and flexion-distraction combined with home flexion exercises aims to improve intersegmental lumbar spine mobility. Core strengthening exercises provide the ability to self-align the spine (reducing the lumbar lordosis) while standing and walking, thereby increasing the crosssectional area of the spinal canals and reducing nerve
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compression. 2 Stationary biking provides the opportunity to improve lower extremity strengthen and overall aerobic capacity without increasing symptoms because sitting and leaning forward increase the cross-sectional area of the spinal canals and reduce nerve compression. 2 A cognitive behavioral approach 16 is used that combines goal setting and positive reinforcement aimed at improving functional status especially walking ability. Neurogenic claudication due to DLSS is a chronic disease, and patients are encouraged to incorporate selfmanagement strategies into their daily routines for life. The self-management strategies are designed to provide patients with the knowledge, skills, tools, and the physical and cognitive capabilities to maximize mobility, functional status, and quality of life. The strengths of this study include the recruitment of consecutive patients with clinical evidence of neurogenic claudication, the use of validated outcome measures, and the large statistically significant and clinically important improvements in all outcomes. Neurogenic claudication is a clinical diagnosis, although most of included patients in this study had also imaging confirmed DLSS.
LIMITATIONS There are several limitations to this study. This was not an experimental or prospective study. Retrospective study limitations include the difficulty to control bias and confounders and the reliance on the accuracy of the records. There was no control group or randomization, and therefore, it is uncertain whether patients would have had similar improved outcomes without the receiving the Boot Camp Program for Lumbar Stenosis. Only patients who had completed the program were included, and therefore, it is possible that patients who were not improving discharged early from the program and only patients who were improving completed the program. There was no blinding of either the practitioner or the patient, and this could have introduced bias. No objective measures of walking capacity or performance were used in this study, although many of the self-report outcomes used are highly correlated with objective walking ability. Only short-term outcomes were measured. Short-term self-report outcomes could have been influenced by the high level of attention provided to the patients during a short period. No long-term follow-up was conducted in this study, and therefore, the improvements in outcomes seen may diminish over time. Future study of the Boot Camp Program for Lumbar Stenosis is needed using more rigorous study designs.
CONCLUSIONS This retrospective study provides preliminary evidence that a multifaceted intervention with an emphasis on
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self-management (Boot Camp Program for Lumbar Stenosis) may improve symptoms and functional status of patients with neurogenic claudication.
FUNDING SOURCES
AND
CONFLICTS
OF INTEREST
This study was funded by the Canadian Chiropractic Research Foundation. No funding sources or conflicts of interest were reported for this study.
CONTRIBUTORSHIP INFORMATION Concept development (provided idea for the research): C.A. Design (planned the methods to generate the results): C.A. Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript): C.A. Data collection/processing (responsible for experiments, patient management, organization, or reporting data): N.C., C.A. Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): N.C., C.A. Literature search (performed the literature search): C.A. Writing (responsible for writing a substantive part of the manuscript): C.A. Critical review (revised manuscript for intellectual content, this does not relate to spelling and grammar checking): C.A.
Practical Applications • The study demonstrates preliminary evidence for the effectiveness of the Boot Camp Program for DLSS. • All outcomes demonstrated both statistical and clinically important improvements at the completion of the program.
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3. Diggle P. Analysis of longitudinal data. In: Press OU, editor. New York: Oxford Statistical Science; 2009. 4. Katz JN, Dalgas M, Stucki G, et al. Degenerative lumbar spinal stenosis: diagnostic value of the history and physical examination. Arthritis Rheum 1995;38:1236-41. 5. Suri P, Rainville J, Kalichman L, Katz JN. Does this older adult with lower extremity pain have the clinical syndrome of lumbar spinal stenosis? JAMA 2010;304:2628-36. 6. Winter CC, Brandes M, Muller C, et al. Walking ability during daily life in patients with osteoarthritis of the knee or the hip and lumbar spinal stenosis: a cross sectional study. BMC Musculoskelet Disord 2010;11:233. 7. Iversen MD, Katz JN. Examination findings and self-reported walking capacity in patients with lumbar spinal stenosis. Phys Ther 2001;81:1296-306. 8. Jonsson B, Annertz M, Sjoberg C, Stromqvist B. A prospective and consecutive study of surgically treated lumbar spinal stenosis. Part I: clinical features related to radiographic findings. Spine (Phila Pa 1976) 1997;22:2932-7. 9. Jansson KA, Nemeth G, Granath F, Jonsson B, Blomqvist P. Health-related quality of life (EQ-5D) before and one year after surgery for lumbar spinal stenosis. J Bone Joint Surg (Br) 2009;91:210-6. 10. Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 2010;303:1259-65. 11. Chen E, Tong KB, Laouri M. Surgical treatment patterns among Medicare beneficiaries newly diagnosed with lumbar spinal stenosis. Spine J 2010;10:588-94. 12. Ammendolia C, Stuber K, de Bruin LK, et al. Nonoperative treatment of lumbar spinal stenosis with neurogenic claudication: a systematic review. Spine (Phila Pa 1976) 2012;37: E609-16. 13. Tran de QH, Duong S, Finlayson RJ. Lumbar spinal stenosis: a brief review of the nonsurgical management. Can J Anaesth 2010;57:694-703. 14. May S, Comer C. Is surgery more effective than non-surgical treatment for spinal stenosis, and which non-surgical treatment is more effective? A systematic review. Physiotherapy 2013;99:12-20. 15. Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Longterm outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the Maine lumbar spine study. Spine (Phila Pa 1976) 2005;30:936-43. 16. Linton SJ, Andersson T. Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain. Spine (Phila Pa 1976) 2000;25:2825-31. 17. Madsen R, Jensen TS, Pope M, Sorensen JS, Bendix T. The effect of body position and axial load on spinal canal morphology: an MRI study of central spinal stenosis. Spine (Phila Pa 1976) 2008;33:61-7. 18. Woby SR, Urmston M, Watson PJ. Self-efficacy mediates the relation between pain-related fear and outcome in chronic low back pain patients. Eur J Pain 2007;11:711-8. 19. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract 2001;4:256-62. 20. Whitman JM, Flynn TW, Fritz JM. Nonsurgical management of patients with lumbar spinal stenosis: a literature review and a case series of three patients managed with physical therapy. Phys Med Rehabil Clin N Am 2003;14:77-101. 21. Bodack MP, Monteiro M. Therapeutic exercise in the treatment of patients with lumbar spinal stenosis. Clin Orthop Relat Res 2001:144-52.
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22. Pua YH, Cai CC, Lim KC. Treadmill walking with body weight support is no more effective than cycling when added to an exercise program for lumbar spinal stenosis: a randomised controlled trial. Aust J Physiother 2007;53:83-9. 23. Ellis RF, Hing WA. Neural mobilization: a systematic review of randomized controlled trials with an analysis of therapeutic efficacy. J Man Manip Ther 2008;16:8-22. 24. Maitland G. Peripheral manipulation. Oxford: ButterworthHeinemann; 1991. 25. McGill S. Low back disorders: evidence-based prevention and rehabilitation. Human Kinetics: Waterloo, Canada; 2007. 26. Murphy DR, Hurwitz EL, Gregory AA, Clary R. A nonsurgical approach to the management of lumbar spinal stenosis: a prospective observational cohort study. BMC Musculoskelet Disord 2006;7:16. 27. Gudavalli MR, Cambron JA, McGregor M, et al. A randomized clinical trial and subgroup analysis to compare flexion-distraction with active exercise for chronic low back pain. Eur Spine J 2006;15:1070-82. 28. Whitman JM, Flynn TW, Childs JD, et al. A comparison between two physical therapy treatment programs for patients with lumbar spinal stenosis: a randomized clinical trial. Spine 2006;31:2541-9. 29. Stucki G, Daltroy L, Liang MH, Lipson SJ, Fossel AH, Katz JN. Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine (Phila Pa 1976) 1996;21:796-803. 30. Pratt RK, Fairbank JC, Virr A. The reliability of the Shuttle Walking Test, the Swiss Spinal Stenosis Questionnaire, the Oxford Spinal Stenosis Score, and the Oswestry Disability Index in the assessment of patients with lumbar spinal stenosis. Spine (Phila Pa 1976) 2002;27:84-91. 31. Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy 1980; 66:271-3. 32. Tomkins CC, Battié MC, Hu R. Construct validity of the physical function scale of the Swiss Spinal Stenosis Questionnaire for the measurement of walking capacity. Spine (Phila Pa 1976) 2007;32:1896-901. 33. Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther 2001;81:776-88. 34. Farrer JT, Young JR, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-58. 35. R Development Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2009 [URL , http://www.R-project.org]. 36. Treatment of degenerative lumbar spinal stenosis. Evidence report/technology assessment no. 32. Agency for Healthcare Research and Quality; 2001 [Vol. Report No.: AHRQ01– E048]. 37. Ammendolia C, Stuber KJ, Rok E, et al. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database Syst Rev 2013;8: CD010712. 38. Koc Z, Ozcakir S, Sivrioglu K, Gurbet A, Kucukoglu S. Effectivness of physical therapy and epidural steroid injections in lumbar spinal stenosis. Spine 2009;34:985-9. 39. Goren A, Yildiz N, Topuz O, Findikoglu G, Ardic F. Efficacy of exercise and ultrasound in patients with lumbar spinal stenosis: a prospective randomized controlled trial. Clin Rehabil 2010;24:623-31. 40. Reiman MP, Harris JY, Cleland JA. Manual therapy interventions for patients with lumbar spinal stenosis: a systematic review. N Z J Physiother 2009;37:17-28.
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41. Stuber K, Sajko S, Kristmanson K. Chiropractic treatment of lumbar spinal stenosis: a review of the literature. J Chiropr Med 2009;8:77-85. 42. Kanno H, Ozawa H, Koizumi Y, et al. Dynamic change of dural sac cross-sectional area in axial loaded magnetic resonance imaging correlates with the severity of clinical symptoms in patients with lumbar spinal canal stenosis. Spine (Phila Pa 1976) 2012;37:207-13. 43. Kalichman L, Cole R, Kim DH, et al. Spinal stenosis prevalence and association with symptoms: the Framingham Study. Spine J 2009;9:545-50. 44. Gempt J, Rothoerl RD, Grams A, Meyer B, Ringel F. Effect of lumbar spinal stenosis and surgical decompression on erectile function. Spine (Phila Pa 1976) 2010;35:E1172-7, http://dx. doi.org/10.1097/BRS.0b013e3181e7d98b.
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45. Wood DW, Haig AJ, Yamakawa KS. Fear of movement/ (re)injury and activity avoidance in persons with neurogenic versus vascular claudication. Spine J 2012;12:292-300, http:// dx.doi.org/10.1016/j.spinee.2012.02.015 [Epub 2012 Apr 4]. 46. Sinikallio S, Aalto T, Airaksinen O, et al. Depression and associated factors in patients with lumbar spinal stenosis. Disabil Rehabil 2006;28:415-22. 47. Cleland JA, Whitman JM, Houser JL, Wainner RS, Childs JD. Psychometric properties of selected tests in patients with lumbar spinal stenosis. Spine J 2012;12:921-31, http://dx.doi. org/10.1016/j.spinee.2012.05.004 [Epub 2012 Jun 28]. 48. Lawrence DJ, Meeker W, Branson R, et al. Chiropractic management of low back pain and low back-related leg complaints: a literature synthesis. J Manipulative Physiol Ther 2008;31:659-74, http://dx.doi.org/10.1016/j.jmpt.2008.10.007.
ABSTRACT Objective: The purpose of this preliminary study was to assess the effectiveness of a 6-week, nonsurgical, multimodal program that addresses the multifaceted aspects of neurogenic claudication. Methods: In this retrospective study, 2 researchers independently extracted data from the medical records from January 2010 to April 2013 of consecutive eligible patients who had completed the 6-week Boot Camp Program. The program consisted of manual therapy twice per week (eg, soft tissue and neural mobilization, chiropractic spinal manipulation, lumbar flexion-distraction, and muscle stretching), structured home-based exercises, and instruction of self-management strategies. A paired t test was used to compare differences in outcomes from baseline to 6-week follow-up. Outcomes included self-reported pain, disability, walking ability, and treatment satisfaction. Results: A total of 49 patients were enrolled, with a mean age of 70 years. The mean difference in the Oswestry Disability Index was 15.2 (95% confidence interval [CI], 11.39-18.92), and that for the functional and symptoms scales of the Swiss Spinal Stenosis Questionnaire was 0.41 (95% CI, 0.26-0.56) and 0.74 (95% CI, 0.55-0.93), respectively. Numeric pain scores for both leg and back showed statistically significant improvements. Improvements in all outcomes were clinically important. Conclusions: This study showed preliminary evidence for improved outcomes in patients with neurogenic claudication participating in a 6-week nonsurgical multimodal Boot Camp Program. (J Manipulative Physiol Ther 2015;38:188-194) Key Indexing Terms: Spinal Stenosis; Lumbar Vertebrae; Osteoarthritis; Spine; Rehabilitation; Chiropractic; Claudication; Manual Therapy
N
eurogenic claudication is a leading cause of pain, disability, and loss of independence in older adults. 1 It is usually caused by degenerative
a Assistant Professor, Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada. b Associate Scientist, Department of Medicine, Mount Sinai Hospital, Toronto, Canada. c Assistant Professor, Department of Surgery, University of Toronto, Toronto, Canada. d Clinical Resident, Department of Graduate Education and Research, Canadian Memorial Chiropractic College, Toronto, Canada. Submit requests for reprints to: Carlo Ammendolia, DC, PhD, Assistant Professor, 20 Birchcroft Rd, Toronto, Ontario, Canada M9A 2L4. (e-mail: [email protected]). Paper submitted April 10, 2014; in revised form December 21, 2014; accepted December 22, 2014. 0161-4754 Copyright © 2015 by National University of Health Sciences. http://dx.doi.org/10.1016/j.jmpt.2014.12.006
lumbar spinal stenosis (DLSS), which refers to age-related degenerative narrowing of the spinal canals that often lead to compression and ischemia of the spinal nerves (neuroischemia). 2 The clinical syndrome of DLSS is known as neurogenic claudication. This syndrome is characterized by bilateral or unilateral buttock, lower extremity pain, heaviness, numbness, tingling, or weakness, precipitated by walking and standing and 3 relieved by sitting and bending forward. 4,5 Limited walking ability is the dominant functional impairment caused by neurogenic claudication due to DLSS. 4 Those with DLSS have greater walking limitations than individuals with knee or hip osteoarthritis 6 and greater functional limitations than those with congestive heart failure, chronic obstructive lung disease, or systemic lupus erythematosus. 1 Inability to walk among individuals with neurogenic claudication leads to a sedentary lifestyle and a progressive decline in health status. 7–9 The prevalence and economic burden of neurogenic claudication due to DLSS are growing
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exponentially due to the aging population. Although DLSS is the most common reason for spine surgery in individuals older than 65 years, 10 only very few DLSS patients receive surgery. 11 Most individuals with neurogenic claudication due to DLSS receive nonsurgical care. However, what constitutes effective nonsurgical care is unknown. 12–15 Self-management strategies may be a practical and effective means to improve walking ability, functional status, and quality of life in this chronic and often progressive condition. 15 The goal of self management in DLSS is to provide patients with the knowledge, skills, self-confidence, and physical capacity to manage their symptoms and maximize their function on their own. Based on this evidence, a multimodal self-management training program was developed at our institution and is known as the Boot Camp Program for Lumbar Spinal Stenosis; however, the clinical effectiveness of this program is unknown. Therefore, the purpose of this study was to assess the effectiveness of the Boot Camp Program for Lumbar Spinal Stenosis in improving symptoms and functional status among consecutive patients with neurogenic claudication who completed the 6-week program.
Ammendolia and Chow Boot Camp for Lumbar Spinal Stenosis
Inclusion criteria: 1) 50 years of age or older 2) clinical evidence of neurogenic claudication due to lumbar spinal stenosis 3) symptoms for more than 3 months 4) Completed both the Boot Camp Program for Lumbar Spinal Stenosis and the pre- and post-treatment outcome measures and questionnaires. Exclusion criteria: 1) Spondylitis, neoplasm, infection or metabolic diseases 2) Radiculopathy due to lumbar disc herniation 3) Psychiatric and/or cognitive disorders 4) Not able to read or comprehend English sufficiently enough to complete self-report
Figure 1. Inclusion and exclusion criteria for medical record selection.
relaxation, and body positioning. 16,17 Reassurance, positive reinforcement, goal setting, and graded activity were provided to reduce pain-related fear, improve self-efficacy, 16,18 and improve function. 19 The emphasis at each session was on maximizing function particularly walking ability. Patients were instructed on how to reduce the lumbar lordosis when standing and walking using the pelvic tilt (body repositioning techniques).
METHODS A retrospective medical record review was conducted of consecutive patients who enrolled in the Boot Camp Program for Lumbar Spinal Stenosis from January 2010 to April 2013 inclusively. Medical records were selected based on the inclusion and exclusion criteria listed in Figure 1.
Protection of Human Subjects The Research Ethics Board at Mount Sinai Hospital in Toronto (MSH REB13-0058-C) gave approval for this study and exempted informed consent. Description of Program. All patients received the following structured 6-week multimodal and self-management training program. The program consisted of one-on-one treatment sessions with one of the authors (C.A.). Each session was approximately 15 to 20 minutes in duration, and the frequency varied from 1 to 3 times per week depending on the severity of the symptoms and travel time to the clinic. The interventions were tailored and directed to the multifaceted aspects of neurogenic claudication, with an emphasis on instructing patients on self-management. The components of the Boot Camp Program for Lumbar Spinal Stenosis were as follows. Education. Patients received instruction on self-management strategies using a cognitive behavioral approach. 16 They received information on the causes of pain and disability due to DLSS, its natural history, and prognosis. They received instruction on how to manage symptoms and maintain daily routines using problem solving, pacing,
Exercises. Patients received instruction on muscle stretching, strengthening, and conditioning exercises directed at improving overall back and lower extremity fitness and facilitating lumbar flexion. 20,21 Tight muscles that promote lumbar extension were progressively stretched, and muscles that promote and control lumbar flexion were strengthened. Muscles stretching exercises included supine knee to chest and knee to opposite stretches, side posture quadriceps stretches, and standing iliopsoas stretches. 21 Core strengthening exercises included supine pelvic tilt and half sit ups, side posture lateral stabilizer exercises, and prone lumbar and gluteal extension exercises. 21 Exercise instruction was provided and reviewed at each session and was part of a progressive structured home exercise program. Patients who had limited walking ability were instructed in a graduated cycling program using a stationary forward leaning bike. A graduated walk program was implemented among patients who were not limited in their walking ability. The aim of cycle or walk program was to improve lower extremity conditioning and overall fitness and was integrated as part of the home exercise program. 22 A written exercise and conditioning program schedule was provided to patients outlining the type, frequency, and intensity of the exercises to be performed. The exercises were performed twice per day at home, with the number, intensity, and frequency of each exercise increasing each week for a period of 6 weeks. Manual Therapy. All patients received manual therapy aimed at improving the flexibility of the lumbar spine and
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facilitating lumbar spine intersegmental flexion. At each session, manual therapy was directed to the lumbar and thoracic spine, pelvis, and lower extremities. Specific techniques included low-amplitude high-velocity manipulation 20; joint, soft tissue, and neural mobilization 20,23–25; lumbar flexion-distraction 23,26,27 ; and manual muscle stretching. 28 The specific and combination of manual therapy techniques and exercises used was determined by the principal investigator (C.A.) based on identified underlying functional impairments. A typical treatment session consisted of, first, providing education, reassurance, and positive reinforcement when improvements are noted. The patient is then positioned prone on a flexion-distraction table (Leander Model 950; Leander Healthcare Technologies, Lawrence, KS) for about 5 minutes, during which time manually assisted mechanical flexion-distraction is performed. 23,27 During mechanical distraction, a push-relax technique 28 is used to progressively stretch the piriformis, gluteus medius, rectus femoris, adductors, and iliopsoas muscles. Side posture mobilization/manipulation 20 is then performed bilaterally with the lumbar spine in a flexed position. This is followed by supine neuromobilization 20,23–25 of the sciatic nerve. A review of the previous exercises is then performed followed by instruction on 2 to 3 new exercises. This routine would be repeated twice per week for 6 weeks, with the intensity and duration of the home exercises schedule increasing each week.
reflect higher symptom severity. A change in the mean score of at least 0.1 is considered clinically important. 47 The mean unweighted score was calculated at baseline and at 6-week follow-up. Functional Disability. Functional disability was measured using the Oswestry Disability Index (ODI). 31 The ODI is a reliable and validated measure of back-related disability, where 0 represents no disability and 100 represents the worse possible disability. The walking section (ODI walk) of the ODI was scored and recorded separately. The ODI walk score has been shown to be highly correlated to objective walking distance (r = 0.83). 32 The minimally clinically important difference of the ODI is 8 to 12 percentage points. 33 Leg and Back Pain Intensity While Walking. Leg and back pain intensity while walking was independently measured at baseline and at 6-week follow-up with the 11-point numerical rating scale (NRS). The NRS is a global measure of pain intensity anchored by 2 extremes of pain intensity ranging from 0 (referring to “no pain”) to 10 (referring to “pain as bad as it could be”). Minimally clinically important difference for the NRS is estimated to be 1.5 to 2.0. 34 Treatment Satisfaction. This was measured using the treatment satisfaction scale of the SSS questionnaire. A score of less than 2.5 is considered to be clinically important. 29
DATA ANALYSIS DATA COLLECTION, FOLLOW-UP,
AND
OUTCOMES
Data were extracted from eligible patients' medical records by 2 investigators (C.A. and N.C.) independently. Baseline and 6-week follow-up data were collected. The following patient-centered outcome measures were collected:
Demographic Data and Duration of Symptoms for Both Leg and Back Physical Function. This was measured using the physical performance scale of the Swiss Spinal Stenosis questionnaire (SSS). The SSS is a validated condition-specific measure consisting of 3 scales; a physical performance scale, a symptom severity scale, and a patient satisfaction scale. 29,30 The physical performance scale consists of 5 questions related to walking ability. The raw scores range from 5 to 20 and mean scores from 1 to 4. Higher scores reflect lower physical performance. A change in the mean score of at least 0.1 is considered clinically important. 47 The mean unweighted score was calculated at baseline and at 6-week follow-up. Symptom Severity. This was measured using the symptom severity scale of SSS. The symptom scale consists of 7 questions pertaining to overall severity of pain, pain frequency, back pain and, pain in the leg, numbness, weakness, and balance disturbance. The raw scores range from 7 to 35 and the mean scores from 1 to 5. Higher scores
From the medical records that were selected, descriptive statistics were extracted. Improvements in outcomes were assessed by calculating the change in the mean scores from baseline to 6-week follow-up for each outcome measure. The 95% confidence interval of the mean change was calculated and a 2-sided paired t test with an α of .05 was used to assess the statistical significance of the mean change for each outcome. R Project version 3.0.1 statistical software (2009) was used for the analysis. 35
RESULTS Data were extracted from the medical records of 49 consecutive patients who completed the Boot Camp Program for Lumbar Stenosis from January 2010 to April 2013 and completed outcome questionnaires at baseline and at the 6-week follow-up. Table 1 outlines the characteristics of the included patients. The mean age of the sample was 70 years of age, 65% were female, and the mean duration of symptoms was 11 years for back pain and 8.6 years for leg symptoms. Some medical records had missing data which accounts for the variable number of patients for the different outcomes in the analysis. The relative lower number of patients with numeric pain scores for leg or back pain also reflects the variability in symptoms where some patients have back pain but no leg pain or leg pain but no back pain.
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Ammendolia and Chow Boot Camp for Lumbar Spinal Stenosis
Table 1. Baseline Characteristics
Table 2. Mean Difference in Outcomes From Baseline
Baseline Characteristics
n
Means (SD) or %
Age (y) Female sex (%) Duration of back symptoms (y) Duration of leg symptoms (y) ODI ODI—walking item Swiss Spinal Stenosis Symptoms Score Swiss Spinal Stenosis Function Score Numeric Pain Score—leg a Numeric Pain Score—low back a
49 49 46 45 47 46 44 44 35 38
70 (8.6) 65 11 (13.6) 8.6 (12) 51 (14.1) 3 (1.34) 3.22 (0.62) 2.27 (0.43) 7 (1.95) 7 (2.47)
ODI, Oswestry Disability Index. a Some participants had leg pain without back pain or back pain without leg pain; others had no leg or back pain but other symptoms.
Others have no back or leg pain but had leg numbness, weakness, burning or tingling. The mean ODI was 51 and the mean walking item of the ODI was 3, suggesting that patients included in this study were severely disabled and had moderate walking limitations. The mean baseline pain score was 7 of 10 for both leg and back and SSS symptom and function scores were 3.22 and 2.27, respectively, suggesting high levels of pain and functional limitations. There were no reported adverse events. Table 2 describes the mean difference in outcome measures after the completion of the 6-week Boot Camp Program. All outcomes demonstrated statistically significant and clinically important improvements.
DISCUSSION This study provides preliminary evidence of the effectiveness of a self-management training program to improve symptoms and function among patients with moderate neurogenic claudication. These findings are supported by previously published guidelines 48 and provide the rationale to conduct future studies to test the Boot Camp Program for Lumbar Stenosis with more rigorous study designs such as a randomized controlled trial (RCT). Developing and testing novel nonsurgical approaches to improve outcomes in neurogenic claudication is important given its increasing prevalence and high morbidity. Neurogenic claudication is a leading cause of pain, disability, and loss of independence in people older than 65 years. With the aging population, the number of people with neurogenic claudication due to DLSS is expected to rise exponentially over the next 20 years. Billions of dollars are spent each year for both surgical and non surgical treatment and these costs are increasing. 10,36 However, what constitutes effective nonsurgical treatment is unknown. A recent Cochrane Review evaluating the effectiveness of nonsurgical treatments for neurogenic claudication 37 identified 4 RCTs of physical therapy. The type of physical therapy used in these trials varied considerably, but one
Outcome (n) ODI (n = 45) ODI walk (n = 44) SSS symptoms (n = 44) SSS function (n = 43) NPS LBP (n = 29) NPS leg (n = 25) SSS treatment satisfaction (n = 43)
6-wk Baseline, Posttreatment, Mean Difference Mean (SD) Mean (SD) (95% CI) P 50.8 (13.9) 35.6 (15.6) 3.39 (1.32) 2.43 (1.58)
15.2 (11.39-18.92) b.0001 0.96 (0.65-1.25) b.0001
3.22 (0.62) 2.48 (0.60)
0.74 (0.55-0.93)
b.0001
2.28 (0.43) 1.87 (0.60)
0.41 (0.26-0.56)
b.0001
7 (2.53)
4 (2.48)
2.07 (1.05-3.09)
.0003
7 (1.79)
5 (2.70)
2.34 (1.15-3.53)
.0004
1.54 (0.50)
CI, confidence interval; LBP, low back pain; NPS, Numeric Pain Score; ODI, Oswestry Disability Index SSS, Swiss Spinal Stenosis Score.
common denominator was exercise. One trial suggested that inpatient physical therapy was better than home exercise in the short term, 38 and in another trial, exercise was better than no treatment in the short term. 39 One trial showed short-term global improvement using a combination of manual therapy, exercise, and unweighted treadmill walking compared with flexion exercises, walking, and sham ultrasound, 28 and another demonstrated no difference in outcomes using a stationary bike compared to unweighted treadmill walking. 22 The authors of this review concluded that the overall evidence for the use of physical therapy was of low or very low quality preventing conclusion to be drawn about its effectiveness. Other systematic reviews evaluating the effectiveness of physical therapy for neurogenic claudication had similar conclusions. 12–14 A systematic review of manual therapy for spinal stenosis concluded there is preliminary evidence for potential benefit, but higher-quality evidence is needed. 40 Similar conclusions were drawn from a review of the literature assessing chiropractic treatment of spinal stenosis. 41 This review could not identify any RCTs evaluating chiropractic treatment of lumbar spinal stenosis. In this preliminary study, the Boot Camp Program for Lumbar Stenosis showed both statistically significant and clinically important improvements in all outcomes. The program is a tailored, structured, and comprehensive program that addresses the structural, 4,42,43 functional, 1,5,6 physiological, 2,44 and psychosocial 45,46 consequences of DLSS. Manual therapy using side posture mobilization/ manipulation and flexion-distraction combined with home flexion exercises aims to improve intersegmental lumbar spine mobility. Core strengthening exercises provide the ability to self-align the spine (reducing the lumbar lordosis) while standing and walking, thereby increasing the crosssectional area of the spinal canals and reducing nerve
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compression. 2 Stationary biking provides the opportunity to improve lower extremity strengthen and overall aerobic capacity without increasing symptoms because sitting and leaning forward increase the cross-sectional area of the spinal canals and reduce nerve compression. 2 A cognitive behavioral approach 16 is used that combines goal setting and positive reinforcement aimed at improving functional status especially walking ability. Neurogenic claudication due to DLSS is a chronic disease, and patients are encouraged to incorporate selfmanagement strategies into their daily routines for life. The self-management strategies are designed to provide patients with the knowledge, skills, tools, and the physical and cognitive capabilities to maximize mobility, functional status, and quality of life. The strengths of this study include the recruitment of consecutive patients with clinical evidence of neurogenic claudication, the use of validated outcome measures, and the large statistically significant and clinically important improvements in all outcomes. Neurogenic claudication is a clinical diagnosis, although most of included patients in this study had also imaging confirmed DLSS.
LIMITATIONS There are several limitations to this study. This was not an experimental or prospective study. Retrospective study limitations include the difficulty to control bias and confounders and the reliance on the accuracy of the records. There was no control group or randomization, and therefore, it is uncertain whether patients would have had similar improved outcomes without the receiving the Boot Camp Program for Lumbar Stenosis. Only patients who had completed the program were included, and therefore, it is possible that patients who were not improving discharged early from the program and only patients who were improving completed the program. There was no blinding of either the practitioner or the patient, and this could have introduced bias. No objective measures of walking capacity or performance were used in this study, although many of the self-report outcomes used are highly correlated with objective walking ability. Only short-term outcomes were measured. Short-term self-report outcomes could have been influenced by the high level of attention provided to the patients during a short period. No long-term follow-up was conducted in this study, and therefore, the improvements in outcomes seen may diminish over time. Future study of the Boot Camp Program for Lumbar Stenosis is needed using more rigorous study designs.
CONCLUSIONS This retrospective study provides preliminary evidence that a multifaceted intervention with an emphasis on
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self-management (Boot Camp Program for Lumbar Stenosis) may improve symptoms and functional status of patients with neurogenic claudication.
FUNDING SOURCES
AND
CONFLICTS
OF INTEREST
This study was funded by the Canadian Chiropractic Research Foundation. No funding sources or conflicts of interest were reported for this study.
CONTRIBUTORSHIP INFORMATION Concept development (provided idea for the research): C.A. Design (planned the methods to generate the results): C.A. Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript): C.A. Data collection/processing (responsible for experiments, patient management, organization, or reporting data): N.C., C.A. Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): N.C., C.A. Literature search (performed the literature search): C.A. Writing (responsible for writing a substantive part of the manuscript): C.A. Critical review (revised manuscript for intellectual content, this does not relate to spelling and grammar checking): C.A.
Practical Applications • The study demonstrates preliminary evidence for the effectiveness of the Boot Camp Program for DLSS. • All outcomes demonstrated both statistical and clinically important improvements at the completion of the program.
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41. Stuber K, Sajko S, Kristmanson K. Chiropractic treatment of lumbar spinal stenosis: a review of the literature. J Chiropr Med 2009;8:77-85. 42. Kanno H, Ozawa H, Koizumi Y, et al. Dynamic change of dural sac cross-sectional area in axial loaded magnetic resonance imaging correlates with the severity of clinical symptoms in patients with lumbar spinal canal stenosis. Spine (Phila Pa 1976) 2012;37:207-13. 43. Kalichman L, Cole R, Kim DH, et al. Spinal stenosis prevalence and association with symptoms: the Framingham Study. Spine J 2009;9:545-50. 44. Gempt J, Rothoerl RD, Grams A, Meyer B, Ringel F. Effect of lumbar spinal stenosis and surgical decompression on erectile function. Spine (Phila Pa 1976) 2010;35:E1172-7, http://dx. doi.org/10.1097/BRS.0b013e3181e7d98b.
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45. Wood DW, Haig AJ, Yamakawa KS. Fear of movement/ (re)injury and activity avoidance in persons with neurogenic versus vascular claudication. Spine J 2012;12:292-300, http:// dx.doi.org/10.1016/j.spinee.2012.02.015 [Epub 2012 Apr 4]. 46. Sinikallio S, Aalto T, Airaksinen O, et al. Depression and associated factors in patients with lumbar spinal stenosis. Disabil Rehabil 2006;28:415-22. 47. Cleland JA, Whitman JM, Houser JL, Wainner RS, Childs JD. Psychometric properties of selected tests in patients with lumbar spinal stenosis. Spine J 2012;12:921-31, http://dx.doi. org/10.1016/j.spinee.2012.05.004 [Epub 2012 Jun 28]. 48. Lawrence DJ, Meeker W, Branson R, et al. Chiropractic management of low back pain and low back-related leg complaints: a literature synthesis. J Manipulative Physiol Ther 2008;31:659-74, http://dx.doi.org/10.1016/j.jmpt.2008.10.007.
