Spine
SPINE Volume 39, Number 13, pp 1044-1054 ©2014, Lippincott Williams & Wilkins
CocHRANE COLLABORATION
Rehabilitation Following Surgery for Lumbar Spinal Stenosis A Cochrane Review Alison H. McGregor, PhD,* Katrin Probyn, MPH,* Suzie Cro, MSc,t Caroline J. Doré, BSc,t A. Kim Burton, PhD,i Federico Balagué, MD,§Tannar Pincus, PhD, "i and Jeremy Fairbank, PhD||
Study Design. A systematic review of randomized controlled trials. Objective. To determine the effects of active rehabilitation on functional outcome after lumbar spinal stenosis surgery when compared with "usual postoperative care." Summary of Background Data. Surgery rates for lumbar spinal stenosis have risen, yet outcomes remain suboptimal. Postoperative rehabilitation has been suggested as a tool to improve postoperative function but, to date, there is limited evidence to support its use. Methods. CENTRAL (The Cochrane Library), the Cochrane Back Review Group Trials Register, MEDLINE, EMBASE, CINAHL, and PEDro electronic databases were searched. Randomized controlled trials comparing the effectiveness of active rehabilitation with usual care in adults with lumbar spinal stenosis who had undergone primary spinal decompression surgery were included. Two authors independently selected studies, assessed the risk of bias, and extracted the data in line with the recommendations of the Cochrane Back Review Croup. Study results were pooled in a meta-analysis when appropriate using functional status as the primary outcome, with secondary outcomes including measures of leg pain, low back pain, and global improvement/general health.The GRADE approach was used to assess the quality of the evidence.
From the 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, United Kingdom; tMedical Research Council Clinical Trials Unit, London, United Kingdom; iSpinal Research Unit, University of Huddersfield, Huddersfield, United Kingdom; §HFR FribourgHôpital Cantonal, Fribourg, Switzerland; I Department of Psychology, Royal Flolloway University of London, Egham, United Kingdom; and jpepartment of Orthopaedic Surgery, Nuffleld Orthopaedic Centre, Oxford, United Kingdom. Acknowledgment date: March 19, 2014. Acceptance date: March 20, 2014. The manuscript submitted does not contain information about medical device(s)/drug(s). No funds were received in support of this work. Relevant financial activities outside the submitted work: consultancy, employment, grants. Address correspondence and reprint requests to Alison FH. McGregor, PhD, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Charing Cross Hospital, London W6 8RF, United Kingdom; E-mail: [email protected] DOI: 10.1097/BRS.0000000000000355 1044
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Results. Our searches yielded 1726 articles, of which 3 studies (N = 373 participants) were suitable for inclusion in meta-analysis. All included studies were deemed to have low risk of bias; no study had unacceptably high dropout rates. There was moderate evidence suggesting that active rehabilitation was more effective than usual care in improving both short- and long-term functional status after surgery. Similar findings were noted for secondary outcomes, including short-term improvement in low back pain and long-term improvement in both low back pain and leg pain. Conclusion. We obtained moderate-quality evidence indicating that postoperative active rehabilitation after decompression surgery for lumbar spinal stenosis is more effective than usual care. Further work is required particularly with respect to the cost-effectiveness of such interventions. Key words: systematic review, Cochrane Back Review Group, postoperative management, meta-analysis, functional outcome. Level of Evidence: 1 Spine 2014;39:1044-1054
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pinal stenosis is a narrowing of the spinal canal leading to pressure on the nerve roots or spinal cord, causing pain, predominantly not only in the leg but also in the back. The causes of spinal stenosis are multifaceted but are associated with degenerative changes to the intervertebral disc, associated vertebrae, and supporting ligamentous structures. The net result is narrowing of either the central or the lateral root canal (or both), leading to pressure on the nerve root and associated pain. However, the Wakayma study suggests a disconnect between stenosis and neurogenic symptoms, with large numbers presenting with radiological evidence of stenosis but no clinical symptoms, although it was noted that the more severe the stenosis the greater the prevalence of symptoms. ' Decompression surgery, which involves a posterior midline incision through the fascia and spinal muscles to obtain access to the compressed nerves, is often performed to relieve this leg pain. Constriction is reduced by removal of any excess bone and thickened ligaments and degenerate disc material and other fibrous tissue. June 2014
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CocHRANE COLLABORATION
Rehabilitation Following Surgery for Lumbar Spinal Stenosis • McGregor et al
Many researchers have note(i a rise in spinal decompression surgical rates in recent times attributing this to the growing elderly population around the world,-"^ with Deyo et af" commenting that spinal stenosis is now the most common indication for spinal surgery in those older than 65 years. Further rises in decompression surgery are, however, predicted in line with the anticipated growth by 59% of the population older than 65 years by 2025. Spinal stenosis does not always require surgery, and there is some evidence that facet joint and epidural injections may be effective in its management,^ but more recent evidence contradicts this.* However, overall, surgery seems to be better than conservative interventions such as injections and rehabilitation.'"' ' This was confirmed by a recent Cochrane review, which noted that good-quality trials into alternative conservative approaches for the management of spinal stenosis were lacking and that further research in this area was urgently required.'- Various surgical techniques are used in decompression surgery, the most common being a decompression laminectomy, whereby the structures compressing the nerve root are removed." When multiple nerve roots are involved, this often necessitates a fusion procedure. The use of spinal fusion is still widely debated, and a range of approaches and techniques and outcomes have been described.''' Decompression is one of the most common types of spinal surgery,'-•'•'' with the US Medicare system reporting that more than 37,500 surgical procedures were performed for this condition in 2007.*^ However, a sizeable proportion of participants do not regain good function after surgery, and the outcome of spinal decompression surgery is not ideal. "Success" rates for decompression surgery vary considerably, with functional improvement ranging between 58% and 69%,^''*''^ participant satisfaction ranging from 15% to 81 %,'•'*'•" and gain in function and pain varying between studies. "*'^' Evidence of trunk muscle dysfunction has been noted in people with back problems,^^ and muscles are known to be damaged by surgery^-; thus, rehabilitation would seem to be a promising approach to improving outcomes. Postoperative care after spinal surgery is variable, with major differences reported between surgeons in the type and intensity of rehabilitation provided and in restrictions imposed and advice offered to participants.^^ Postoperative management may include education,^'* rehabilitation,^"** exercise,^' behavioral graded training,^" neuromuscular training,^' and stabilization training.""^ Evidence is currently insufficient for researchers to determine best clinical practice, although indications suggest that some form of exercise or rehabilitation intervention may be beneficial. This review was, therefore, undertaken to determine whether active rehabilitation programs after primary surgery for lumbar spinal stenosis have an impact on functional outcomes and whether such programs are superior to "usual postoperative care." This article is adapted from the Cochrane review (McGregor et a/").
MATERIALS AND METHODS The objective of this systematic review was to determine whether active rehabilitation or specific advice to stay active Spine
has an impact on patient's functional outcome after primary decompression surgery for lumbar spinal stenosis as compared with "usual care," which includes no postoperative intervention or deliberately delivered "therapeutic" advice. Types of Studies Only randomized controlled trials (RCTs) were included in the review. Types of Participants Adults 18 years of age or older who had undergone spinal decompression surgery for central or lateral stenosis at single or multiple levels were included. Stenosis had to be confirmed through imaging and clinical assessment, and the surgery performed had to be primary decompression surgery for stenosis (as distinct from surgery for disc herniation). All surgical decompression procedures, with or without vertebral fusion, were included. Types of Interventions This review examines the delivery of active rehabilitation versus usual care after surgery. Interventions were classified as active rehabilitation or usual care. Postsurgical active rehabilitation interventions included all forms of active rehabilitation treatment that aimed to restore or improve function. This encompasses all forms of group or therapist-led exercise training or stabilization training involving muscle-strengthening exercises and flexibility training, as well as educational materials encouraging activity. Usual care ranged from limited advice provided postoperatively to stay active to a brief general program of exercises with the primary aim of preventing deep vein thrombosis. Types of Outcome Measures Trials were included if they utilized one or more of the standardized outcome measures recommended by the Cochrane Back Review Group. '* These include disease-specific measures of functional and/or disability status (e.g., Oswestry Disability Index, the Roland-Morris Disability Questionnaire) that were considered as primary outcomes and measures of global health (e.g., 36-Item Short Form Health Survey, EuroQol EQ-5D), global improvement measures [e.g., proportion of participants who recovered), pain severity (e.g., visual analogue scale [VAS] score), and work absenteeism that were considered as secondary outcomes. Work absenteeism was poorly or inconsistently reported and, therefore, was not considered in the analysis. Outcomes were considered within 6 months of surgery (short term) and 12 months after surgery (long term). Search Methods for Identification of Studies We searched the following databases from their first issues to March 2013: CENTRAL (The Cochrane Library, most recent issue [March 2013], which includes the CBRG Trials Register; MEDLINE; EMBASE; CINAHL; and PEDro [see Supplemental Digital Content Appendix 1, available at http://links.lww.com/BRS/A867]). In addition, the reference www.spinejournal.com
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COCHRANE COLLABORATION
Rehabilitation Following Surgery for Lumbar Spinal Stenosis • McGregor et al
lists of all relevant articles were screened as well as personal biographies and communications of known experts in the field. DATA COLLECTION A N D ANALYSIS Selection of Studies Two review authors (A.McG. and K.R) independently screened the search results by reading titles and abstracts. Potentially relevant studies were obtained in full text and were independently assessed for inclusion by the same authors. Disagreement was resolved through discussion. A third, fourth, and fifth review authors (A.K.B., J.F., and KB.) adjudicated unresolved disagreements. Authors of individual trials were excluded from any decisions regarding inclusion/exclusion, data extraction, and risk of bias. Data Extraction and Management Basic information was obtained for each study concerning methods (study design, sample size, etc.), participants (selection criteria and diagnoses, age, sex, etc.), type of surgery, intervention, control treatment, and outcome variables, with results recorded onto a separate predeveloped form. Data extraction was performed independently by 2 review authors (K.R and S.C.); inconsistencies were resolved through a third author where necessary.
on the unlogged scale. Ratios are also expressed as percentage differences to aid interpretation of relative differences in original untransformed outcome variables between intervention groups.^*^ The clinical relevance of each included study was independently assessed by the review authors using the approach by Furlan et al.^ We evaluated the statistical importance and the clinical importance of pooled results. Effect sizes were assessed and interpreted using Cohen levels.^^ Unit of Analysis Issues The unit of analysis was the participant. One of the included studies^^ compared 2 treatment groups against 1 usual care group. This raised a unit of analysis problem, as in a metaanalysis, every individual must appear only once in every comparison. So that all individuals and both of the treatment groups could be included, the 2 treatment groups were combined into 1 treatment group (and compared with 1 control group). This is the approach recommended in the Cochrane Handbook." Missing Data In 2 of the articles selected,^**^^ only subgroups were suitable for inclusion in the review; relevant data from these subgroups were not published in the articles but were obtained directly from the authors.
Risk of Bias Assessment This was determined using the criteria recommended by the Cochrane Back Review Group with the additional criteria, "Other sources of bias."^'*-^'' For each study, each criterion was rated as "low risk," "high risk," or "unclear risk." Studies with a low risk of bias were defined as RCTs that satisfied 6 or more of the low risk of bias criteria and that had no serious flaws.^'* Serious flaws were predefined to include unacceptably high dropout rates [e.g., > 5 0 % at first and subsequent time points); unacceptably unbalanced dropout rates [e.g., 40% greater dropout rate in 1 group); unacceptably low adherence rates (e.g.,
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COCHRANE COLLABORATION Rehabilitation Following Surgery for Lumbar Spinal Stenosis • McGregor et al
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CocHRANF COLLABORATION
Rehabilitation Following Surgery for Lumbar Spinal Stenosis • McGregor et al
In this review, we excluded the study by Abbott et al,"*^ which compared exercise therapy after fusion surgery with cognitive-behavioral therapy because no usual care control arm was included in this study. Nevertheless, it is worth noting that this work suggested that additional improvements could be achieved through the inclusion of psychomotor therapy. Similarly, Christensen et aP^ indicated that simple support provided through a back-cafe group achieved greater improvements in physical function than were attained through regular exercise classes. The intervention was instigated only 3 months after surgery; again, no control arm was included, but study findings do support the inferences of the study by Abbott et aP^ and warrant consideration in the design of future rehabilitation strategies. Clearly, further research is required to consolidate the findings of this current Cochrane review primarily because of the low number of trials eligible for inclusion. Future studies should also include a cost-benefit analysis, because in the present review, such data were available for only 1 of the 3 studies. Other issues highlighted in this review include the timing of the intervention after surgery and, as indicated in the review by Rushton et al.,^^ the content of the rehabilitation package. At the moment, little consensus has been reached on what constitutes an appropriate active rehabilitation program, when it should be delivered, how intense it should be, how long it should be delivered for, or how frequently, and, of course, whether a group format for delivery is preferable. We know that compliance can be an issue for patients'*^'"; thus, future work is needed in this area to explore these issues. This work should factor in the need for clear educational materials and the growing emphasis on self-management strategies. Nielsen et aP^ have suggested that there may be a role for preoperative rehabilitation. It would be useful to look at the care pathway and to view interventions in a more holistic way, rather than simply focusing on the surgical intervention. This would necessitate greater consideration of patient preferences and experiences and the need to tailor care at a more individual level. To summarize, this review has revealed moderate-quality evidence, indicating that postoperative active rehabilitation after decompression surgery for lumbar spinal stenosis is more effective than usual care in improving both short-term and long-term (back-related) functional status. Similar findings were noted for secondary outcomes, including short-term improvement in low back pain and long-term improvement in both low back pain and leg pain.
Key Points Ü Active rehabilitation is more effective than usual care for improving functional status. • Rehabilitation led to improvement in back pain and leg pain although the improvements in leg pain were significant only at 12 months. • Rehabilitation impacted on general health at 6 months only. Spine
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There is moderate-quality evidence to suggest that active rehabilitation can lead to improvements in function and pain.
Acknowledgments The authors thank Teresa Marin, Rachel Couban, and Allison Kelly from the Cochrane Back Review Group for their help. Supplemental digital content is available for this article. Direct URL citation appearing in the printed text is provided in the HTML and PDF version of this article on the journal's web site (www.spinejournal.com).
References 1. Ishimoto Y, Yoshimura N, Muraki S, et al. Associations between radiographie lumbar spinal stenosis and clinical symptoms in the general population: the Wakayama Spine Study. Osteoarthritis Cartilage 2013;21:7S3-8. 2. Deyo RA, Gray DT, Kreuter W, et al. United States trends in lumbar fusion surgery for degenerative conditions. Spine 2005;30: 1441-5. 3. Chou R, Baisden J, Carragee EJ, et al. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine 2009;34:1094-109. 4. Rhee JM, Schaufele M, Abdu WA. Radiculopathy and the herniated lumbar disc. Controversies regarding pathophysiology and management. / Bone Joint Surg 2006;88:2070-80. 5. Stromqvist B, Jonsson B, Fritzell P, et al. The Swedish National Register for lumbar spine surgery: Swedish Society for spinal surgery. Acta Orthopaedica Scandinavica 2001;72:99-106. 6. Deyo RA, Mirza SK, Martin BI, et al. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. / Am Med Assoc 2010;303:1259-65. 7. Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adbesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician 2010;13:91-110. 8. Radcliff K, Kepler C, Hilibrand A, et al. Epidural steroid injections are associated with less improvement in the treatment of lumbar spinal stenosis: a subgroup analysis of the SPORT. Spine 2013;38:279-91. 9. Atlas SJ, Keller RB, Wu YA, et al. Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the Maine lumbar spine study. Spine 2005;30:927-35. 10. Chang Y, Singer DE, Wu YA, et al. The effect of surgical and nonsurgical treatment on longitudinal outcomes of lumbar spinal stenosis over 10 years. / Am Geriatr Soc 2005;53:785-92. 11. Tran de QH, Duong S, Einlayson RJ. Lumbar spinal stenosis: a brief review of the nonsurgical management. Can J Anesth 2010;57: 694-703. 12. Ammendolia C, Stuber KJ, Rok E, et al. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database Syst Rev 2013;8 Art No.:CD010712. doi:10.1002/14651858.CD010712. 13. Genevay S, Atlas SJ. Lumbar spinal stenosis: best practice ÔC research. Clin Rheumatol 20W:,24:2S3-65. 14. Gibson JNA, Waddell G. Surgery for degenerative lumbar spondylosis: an updated Cochrane review. Spine 2005;30:2312-20. 15. Taylor VM, Deyo RA, Cberkin DC, et al. Low back pain hospitalization. Recent United States trends and regional variations. Spine 1994;19:1207-13. 16. Gunzburg R, Szpalski M. The conservative surgical treatment of lumbar spinal stenosis in the elderly. £Mr.Sp¿«e/2003;]2:176-80. 17. Turner JA, Ersek M, Herron L, et al. Surgery for lumbar spinal stenosis. Attempted meta-analysis of the literature. Spine 1992;17:l-8. www.spinejournal.com
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CoLLABORATior
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18. McGregor AH, Hughes SP. The evaluation of the surgical managetnent of nerve root compression in patients with low back pain: part 1: the assessment of outcome. Spine 2002;27:1465-70. 19. Yee A, Adjei N, Do J, et al. Do patient expectations of spinal surgery relate to functional outcome? Clin Orthop Relat Res 2008;466:l 154-61. 20. Yorimitsu E, Chiba K, Toyama Y, et al. Long-term outcomes of standard discectomy for lumbar disc herniation: a follow-up study of more than 10 years. Spine 2001;26:652-7. 21. Hides JA, Stokes MJ, Saide M, et al. Evidence of lumbar multifidus muscle wasting ipsilateral to symptoms in patients with acute/subacute low back pain. Spine 1994;19:165-72. 22. Taylor H, McGregor AH, Medhi-Zadeh S, et al. The impact of selfretaining retractors on the paraspinal muscles during posterior spinal surgery. Spine 2002;27:2758-62. 23. McGregor AH, Dicken B, Jamrozik K. National audit of post-operative management in spinal surgery. BioMed Cent Musculoskeletal Disord 2006;7:47. 24. McGregor AH, Burton AK, Sell P, et al. The development of an evidence-based patient booklet for patients undergoing lumbar discectomy and un-instrumented decompression. Eur Spine J 2007;16:339^6. 25. Erdogmus GB, Resch KL, Sabitzer R, et al. Physiotherapy-based rehabilitation following disc herniation operation: results of a randomized clinical trial. Spine 2007;32:2041-9. 26. McGregor AH, Dore GJ, Morris TP, et al. ISSLS Prize paper: Eunction After Spinal Treatment, Exercise and Rehabilitation (EASTER): a factorial randomised trial to determine whether the functional outcome of spinal surgery can be improved. Spine 201í;36:\7í]—20. 27. Nielsen PR, Andreasen J, Asmussen M, et al. Gosts and quality of life for prehabilitation and early rehabilitation after surgery of the lumbar spine. BioMed Cent Health Serv Res 2008;8:209. 28. Ostelo RW, Gosta LO, Maher GG, et al. Rehabilitation after lumbar disc surgery: an update Gochrane review. Spine 2009;34:1839^8. 29. Kim YS, Park J, Shim JK. Effects of aquatic backward locomotion exercise and progressive resistance exercise on lumbar extension strength in patients who have undergone lumbar diskectomy. Arch Phys Med Rehabil 2010;91:208-14. 30. Ostelo RW, Goossens ME, de Vet HG, et al. Economic evaluation of a behavioral-graded activity program compared to physical therapy for patients following lumbar disc surgery. Spine 2004;29: 615-22. 31. Millisdotter M, Stromqvist B. Early neuromuscular customized training after surgery for lumbar disc herniation: a prospective controlled study. Eur Spine] 2007;16:19-26. 32. Mannion AE, Denzler R, Dvorak J, et a!. A randomised controlled trial of post-operative rehabilitation after surgical decompression of the lumbar spine. £MrSpOTe/2007;16:1101-17. 33. McGregor AH, Probyn K, Gro S, et al. Rehabilitation following surgery for lumbar spinal stenosis. Cochrane Database Syst Rev 2013;12 Art. No.: GD009644. doi:10.1002/14651858.GD009644. pub2. 34. Eurlan AD, Pennick V, Bombardier G, et al. Updated method guidelines for systematic reviews in the Gochrane Back Review Group. S/7¿ne2009;34:1929-41. 35. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1. The Gochrane Gollaboration; 2011. www.cochrane-handbook.org. Updated March 2011. 36. Bland JM, Altman DG. The use of transformation when comparing the two means. Br Mea/1996;312:1153.
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37. Revietv Manager (RevMan) [computer program]. Version 5.1. Gopenhagen, Denmark: The Nordic Cochrane Gentre, The Gochrane GoUaboration; 2011. 38. Pons T, Shipton EA. Multilevel lumbar fusion and postoperative physiotherapy rehabilitation in a patient with persistent pain. Physiother Theory Pract 2011;27:238^5. 39. Sogaard R, Bunger GE, Laurberg I, et al. Gost-effectiveness evaluation of an RGT in rehabilitation after lumbar spinal fusion: a low-cost, behavioural approach is cost-effective over individual exercise therapy. Eur Spine J 2008;17:262-7l. 40. Ganbulat N, Sasani M, Ataker Y, et al. A rehabilitation protocol for patients with lumbar degenerative disk disease treated with lumbar total disk replacement. Arch Phys Med Rehabil 2011;92: 670-6. 41. Jeric Z, Sliepcevic B. Gomparison of the results of early and delayed rehabilitation in patients with surgery for disco-radicular problems in the lumbar spine. [Serbian] Poredba rezultata rane i odlozene rehabilitacije bolesnika operiranih zbog diskoradikularnog konflikta lumbalne kraljesnice. Reumatizam 1991;38:5-6. 42. Mannion AE, Denzler R, Dvorak J, et al. Eive-year outcome of surgical decompression of the lumbar spine without fusion. Eur Spine /2010;19:1883-91. 43. Abbott AD, Tyni-Lenne R, Hedlund R. Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion: a randomized controlled trial. Spine 2010;35:848-57. 44. Brox JI, Sorensen R, Eriis A, et al. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine 2003;28:1913-21. 45. Ghristensen EB, Laurberg I, Bunger GE. Importance of the backcafe concept to rehabilitation after lumbar spinal fusion: a randomized clinical study with a 2-year follow-up. Spine 2003;28: 2561-9. 46. Hagg O, Eritzell P. Re: Brox JI, Sorensen R, Eriis A, et al. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. [Spine 2003;28:1913-21]. Spine 2004;29: 1160-1. 47. Nielsen PR, Jorgensen LD, Dahl B, et al. Prehabilitation and early rehabilitation after spinal surgery: randomized clinical trial. Clin Rehabil 2010;24ú37-48. 48. Wu EY. Influence of rehabilitation education on behavior and lumbar functional exercise in patients following operation for lumbar spinal stenosis. Zhongguo Linchuang Kangfu 2005;9:20-2. 49. Aalto TJ, Leinonen V, Herno A, et al. Postoperative rehabilitation does not improve functional outcome in ltunbar spinal stenosis: a prospective study with 2-year postoperative follow-up. Eur Spine } 2011;20:1331-40. 50. Gopay AG, Glassman SD, Subach BR, et al. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry ÍDisability Index, Medical Outcomes Study questionnaire Short Eorm 36, and pain scales. Spine } 2008;8:968-74. 51. Rushton A, Eveleigh G, Petherick EJ, et al. Physiotherapy rehabilitation following lumbar spinal fusion: a systematic review and meta-analysis of randomised controlled trials. BMJ Open 2012;2:e000829. doi:10.1136/bmjopen-2012-000829. 52. Jobnson RE, Jones GT, Wiles NJ. Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: a randomized controlled trial. Spine 2007;32:1578-85.
June 2014
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SPINE Volume 39, Number 13, pp 1044-1054 ©2014, Lippincott Williams & Wilkins
CocHRANE COLLABORATION
Rehabilitation Following Surgery for Lumbar Spinal Stenosis A Cochrane Review Alison H. McGregor, PhD,* Katrin Probyn, MPH,* Suzie Cro, MSc,t Caroline J. Doré, BSc,t A. Kim Burton, PhD,i Federico Balagué, MD,§Tannar Pincus, PhD, "i and Jeremy Fairbank, PhD||
Study Design. A systematic review of randomized controlled trials. Objective. To determine the effects of active rehabilitation on functional outcome after lumbar spinal stenosis surgery when compared with "usual postoperative care." Summary of Background Data. Surgery rates for lumbar spinal stenosis have risen, yet outcomes remain suboptimal. Postoperative rehabilitation has been suggested as a tool to improve postoperative function but, to date, there is limited evidence to support its use. Methods. CENTRAL (The Cochrane Library), the Cochrane Back Review Group Trials Register, MEDLINE, EMBASE, CINAHL, and PEDro electronic databases were searched. Randomized controlled trials comparing the effectiveness of active rehabilitation with usual care in adults with lumbar spinal stenosis who had undergone primary spinal decompression surgery were included. Two authors independently selected studies, assessed the risk of bias, and extracted the data in line with the recommendations of the Cochrane Back Review Croup. Study results were pooled in a meta-analysis when appropriate using functional status as the primary outcome, with secondary outcomes including measures of leg pain, low back pain, and global improvement/general health.The GRADE approach was used to assess the quality of the evidence.
From the 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, United Kingdom; tMedical Research Council Clinical Trials Unit, London, United Kingdom; iSpinal Research Unit, University of Huddersfield, Huddersfield, United Kingdom; §HFR FribourgHôpital Cantonal, Fribourg, Switzerland; I Department of Psychology, Royal Flolloway University of London, Egham, United Kingdom; and jpepartment of Orthopaedic Surgery, Nuffleld Orthopaedic Centre, Oxford, United Kingdom. Acknowledgment date: March 19, 2014. Acceptance date: March 20, 2014. The manuscript submitted does not contain information about medical device(s)/drug(s). No funds were received in support of this work. Relevant financial activities outside the submitted work: consultancy, employment, grants. Address correspondence and reprint requests to Alison FH. McGregor, PhD, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Charing Cross Hospital, London W6 8RF, United Kingdom; E-mail: [email protected] DOI: 10.1097/BRS.0000000000000355 1044
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Results. Our searches yielded 1726 articles, of which 3 studies (N = 373 participants) were suitable for inclusion in meta-analysis. All included studies were deemed to have low risk of bias; no study had unacceptably high dropout rates. There was moderate evidence suggesting that active rehabilitation was more effective than usual care in improving both short- and long-term functional status after surgery. Similar findings were noted for secondary outcomes, including short-term improvement in low back pain and long-term improvement in both low back pain and leg pain. Conclusion. We obtained moderate-quality evidence indicating that postoperative active rehabilitation after decompression surgery for lumbar spinal stenosis is more effective than usual care. Further work is required particularly with respect to the cost-effectiveness of such interventions. Key words: systematic review, Cochrane Back Review Group, postoperative management, meta-analysis, functional outcome. Level of Evidence: 1 Spine 2014;39:1044-1054
S
pinal stenosis is a narrowing of the spinal canal leading to pressure on the nerve roots or spinal cord, causing pain, predominantly not only in the leg but also in the back. The causes of spinal stenosis are multifaceted but are associated with degenerative changes to the intervertebral disc, associated vertebrae, and supporting ligamentous structures. The net result is narrowing of either the central or the lateral root canal (or both), leading to pressure on the nerve root and associated pain. However, the Wakayma study suggests a disconnect between stenosis and neurogenic symptoms, with large numbers presenting with radiological evidence of stenosis but no clinical symptoms, although it was noted that the more severe the stenosis the greater the prevalence of symptoms. ' Decompression surgery, which involves a posterior midline incision through the fascia and spinal muscles to obtain access to the compressed nerves, is often performed to relieve this leg pain. Constriction is reduced by removal of any excess bone and thickened ligaments and degenerate disc material and other fibrous tissue. June 2014
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CocHRANE COLLABORATION
Rehabilitation Following Surgery for Lumbar Spinal Stenosis • McGregor et al
Many researchers have note(i a rise in spinal decompression surgical rates in recent times attributing this to the growing elderly population around the world,-"^ with Deyo et af" commenting that spinal stenosis is now the most common indication for spinal surgery in those older than 65 years. Further rises in decompression surgery are, however, predicted in line with the anticipated growth by 59% of the population older than 65 years by 2025. Spinal stenosis does not always require surgery, and there is some evidence that facet joint and epidural injections may be effective in its management,^ but more recent evidence contradicts this.* However, overall, surgery seems to be better than conservative interventions such as injections and rehabilitation.'"' ' This was confirmed by a recent Cochrane review, which noted that good-quality trials into alternative conservative approaches for the management of spinal stenosis were lacking and that further research in this area was urgently required.'- Various surgical techniques are used in decompression surgery, the most common being a decompression laminectomy, whereby the structures compressing the nerve root are removed." When multiple nerve roots are involved, this often necessitates a fusion procedure. The use of spinal fusion is still widely debated, and a range of approaches and techniques and outcomes have been described.''' Decompression is one of the most common types of spinal surgery,'-•'•'' with the US Medicare system reporting that more than 37,500 surgical procedures were performed for this condition in 2007.*^ However, a sizeable proportion of participants do not regain good function after surgery, and the outcome of spinal decompression surgery is not ideal. "Success" rates for decompression surgery vary considerably, with functional improvement ranging between 58% and 69%,^''*''^ participant satisfaction ranging from 15% to 81 %,'•'*'•" and gain in function and pain varying between studies. "*'^' Evidence of trunk muscle dysfunction has been noted in people with back problems,^^ and muscles are known to be damaged by surgery^-; thus, rehabilitation would seem to be a promising approach to improving outcomes. Postoperative care after spinal surgery is variable, with major differences reported between surgeons in the type and intensity of rehabilitation provided and in restrictions imposed and advice offered to participants.^^ Postoperative management may include education,^'* rehabilitation,^"** exercise,^' behavioral graded training,^" neuromuscular training,^' and stabilization training.""^ Evidence is currently insufficient for researchers to determine best clinical practice, although indications suggest that some form of exercise or rehabilitation intervention may be beneficial. This review was, therefore, undertaken to determine whether active rehabilitation programs after primary surgery for lumbar spinal stenosis have an impact on functional outcomes and whether such programs are superior to "usual postoperative care." This article is adapted from the Cochrane review (McGregor et a/").
MATERIALS AND METHODS The objective of this systematic review was to determine whether active rehabilitation or specific advice to stay active Spine
has an impact on patient's functional outcome after primary decompression surgery for lumbar spinal stenosis as compared with "usual care," which includes no postoperative intervention or deliberately delivered "therapeutic" advice. Types of Studies Only randomized controlled trials (RCTs) were included in the review. Types of Participants Adults 18 years of age or older who had undergone spinal decompression surgery for central or lateral stenosis at single or multiple levels were included. Stenosis had to be confirmed through imaging and clinical assessment, and the surgery performed had to be primary decompression surgery for stenosis (as distinct from surgery for disc herniation). All surgical decompression procedures, with or without vertebral fusion, were included. Types of Interventions This review examines the delivery of active rehabilitation versus usual care after surgery. Interventions were classified as active rehabilitation or usual care. Postsurgical active rehabilitation interventions included all forms of active rehabilitation treatment that aimed to restore or improve function. This encompasses all forms of group or therapist-led exercise training or stabilization training involving muscle-strengthening exercises and flexibility training, as well as educational materials encouraging activity. Usual care ranged from limited advice provided postoperatively to stay active to a brief general program of exercises with the primary aim of preventing deep vein thrombosis. Types of Outcome Measures Trials were included if they utilized one or more of the standardized outcome measures recommended by the Cochrane Back Review Group. '* These include disease-specific measures of functional and/or disability status (e.g., Oswestry Disability Index, the Roland-Morris Disability Questionnaire) that were considered as primary outcomes and measures of global health (e.g., 36-Item Short Form Health Survey, EuroQol EQ-5D), global improvement measures [e.g., proportion of participants who recovered), pain severity (e.g., visual analogue scale [VAS] score), and work absenteeism that were considered as secondary outcomes. Work absenteeism was poorly or inconsistently reported and, therefore, was not considered in the analysis. Outcomes were considered within 6 months of surgery (short term) and 12 months after surgery (long term). Search Methods for Identification of Studies We searched the following databases from their first issues to March 2013: CENTRAL (The Cochrane Library, most recent issue [March 2013], which includes the CBRG Trials Register; MEDLINE; EMBASE; CINAHL; and PEDro [see Supplemental Digital Content Appendix 1, available at http://links.lww.com/BRS/A867]). In addition, the reference www.spinejournal.com
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Rehabilitation Following Surgery for Lumbar Spinal Stenosis • McGregor et al
lists of all relevant articles were screened as well as personal biographies and communications of known experts in the field. DATA COLLECTION A N D ANALYSIS Selection of Studies Two review authors (A.McG. and K.R) independently screened the search results by reading titles and abstracts. Potentially relevant studies were obtained in full text and were independently assessed for inclusion by the same authors. Disagreement was resolved through discussion. A third, fourth, and fifth review authors (A.K.B., J.F., and KB.) adjudicated unresolved disagreements. Authors of individual trials were excluded from any decisions regarding inclusion/exclusion, data extraction, and risk of bias. Data Extraction and Management Basic information was obtained for each study concerning methods (study design, sample size, etc.), participants (selection criteria and diagnoses, age, sex, etc.), type of surgery, intervention, control treatment, and outcome variables, with results recorded onto a separate predeveloped form. Data extraction was performed independently by 2 review authors (K.R and S.C.); inconsistencies were resolved through a third author where necessary.
on the unlogged scale. Ratios are also expressed as percentage differences to aid interpretation of relative differences in original untransformed outcome variables between intervention groups.^*^ The clinical relevance of each included study was independently assessed by the review authors using the approach by Furlan et al.^ We evaluated the statistical importance and the clinical importance of pooled results. Effect sizes were assessed and interpreted using Cohen levels.^^ Unit of Analysis Issues The unit of analysis was the participant. One of the included studies^^ compared 2 treatment groups against 1 usual care group. This raised a unit of analysis problem, as in a metaanalysis, every individual must appear only once in every comparison. So that all individuals and both of the treatment groups could be included, the 2 treatment groups were combined into 1 treatment group (and compared with 1 control group). This is the approach recommended in the Cochrane Handbook." Missing Data In 2 of the articles selected,^**^^ only subgroups were suitable for inclusion in the review; relevant data from these subgroups were not published in the articles but were obtained directly from the authors.
Risk of Bias Assessment This was determined using the criteria recommended by the Cochrane Back Review Group with the additional criteria, "Other sources of bias."^'*-^'' For each study, each criterion was rated as "low risk," "high risk," or "unclear risk." Studies with a low risk of bias were defined as RCTs that satisfied 6 or more of the low risk of bias criteria and that had no serious flaws.^'* Serious flaws were predefined to include unacceptably high dropout rates [e.g., > 5 0 % at first and subsequent time points); unacceptably unbalanced dropout rates [e.g., 40% greater dropout rate in 1 group); unacceptably low adherence rates (e.g.,
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COCHRANE COLLABORATION Rehabilitation Following Surgery for Lumbar Spinal Stenosis • McGregor et al
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Rehabilitation Following Surgery for Lumbar Spinal Stenosis • McGregor et al
In this review, we excluded the study by Abbott et al,"*^ which compared exercise therapy after fusion surgery with cognitive-behavioral therapy because no usual care control arm was included in this study. Nevertheless, it is worth noting that this work suggested that additional improvements could be achieved through the inclusion of psychomotor therapy. Similarly, Christensen et aP^ indicated that simple support provided through a back-cafe group achieved greater improvements in physical function than were attained through regular exercise classes. The intervention was instigated only 3 months after surgery; again, no control arm was included, but study findings do support the inferences of the study by Abbott et aP^ and warrant consideration in the design of future rehabilitation strategies. Clearly, further research is required to consolidate the findings of this current Cochrane review primarily because of the low number of trials eligible for inclusion. Future studies should also include a cost-benefit analysis, because in the present review, such data were available for only 1 of the 3 studies. Other issues highlighted in this review include the timing of the intervention after surgery and, as indicated in the review by Rushton et al.,^^ the content of the rehabilitation package. At the moment, little consensus has been reached on what constitutes an appropriate active rehabilitation program, when it should be delivered, how intense it should be, how long it should be delivered for, or how frequently, and, of course, whether a group format for delivery is preferable. We know that compliance can be an issue for patients'*^'"; thus, future work is needed in this area to explore these issues. This work should factor in the need for clear educational materials and the growing emphasis on self-management strategies. Nielsen et aP^ have suggested that there may be a role for preoperative rehabilitation. It would be useful to look at the care pathway and to view interventions in a more holistic way, rather than simply focusing on the surgical intervention. This would necessitate greater consideration of patient preferences and experiences and the need to tailor care at a more individual level. To summarize, this review has revealed moderate-quality evidence, indicating that postoperative active rehabilitation after decompression surgery for lumbar spinal stenosis is more effective than usual care in improving both short-term and long-term (back-related) functional status. Similar findings were noted for secondary outcomes, including short-term improvement in low back pain and long-term improvement in both low back pain and leg pain.
Key Points Ü Active rehabilitation is more effective than usual care for improving functional status. • Rehabilitation led to improvement in back pain and leg pain although the improvements in leg pain were significant only at 12 months. • Rehabilitation impacted on general health at 6 months only. Spine
•
There is moderate-quality evidence to suggest that active rehabilitation can lead to improvements in function and pain.
Acknowledgments The authors thank Teresa Marin, Rachel Couban, and Allison Kelly from the Cochrane Back Review Group for their help. Supplemental digital content is available for this article. Direct URL citation appearing in the printed text is provided in the HTML and PDF version of this article on the journal's web site (www.spinejournal.com).
References 1. Ishimoto Y, Yoshimura N, Muraki S, et al. Associations between radiographie lumbar spinal stenosis and clinical symptoms in the general population: the Wakayama Spine Study. Osteoarthritis Cartilage 2013;21:7S3-8. 2. Deyo RA, Gray DT, Kreuter W, et al. United States trends in lumbar fusion surgery for degenerative conditions. Spine 2005;30: 1441-5. 3. Chou R, Baisden J, Carragee EJ, et al. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine 2009;34:1094-109. 4. Rhee JM, Schaufele M, Abdu WA. Radiculopathy and the herniated lumbar disc. Controversies regarding pathophysiology and management. / Bone Joint Surg 2006;88:2070-80. 5. Stromqvist B, Jonsson B, Fritzell P, et al. The Swedish National Register for lumbar spine surgery: Swedish Society for spinal surgery. Acta Orthopaedica Scandinavica 2001;72:99-106. 6. Deyo RA, Mirza SK, Martin BI, et al. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. / Am Med Assoc 2010;303:1259-65. 7. Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adbesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician 2010;13:91-110. 8. Radcliff K, Kepler C, Hilibrand A, et al. Epidural steroid injections are associated with less improvement in the treatment of lumbar spinal stenosis: a subgroup analysis of the SPORT. Spine 2013;38:279-91. 9. Atlas SJ, Keller RB, Wu YA, et al. Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the Maine lumbar spine study. Spine 2005;30:927-35. 10. Chang Y, Singer DE, Wu YA, et al. The effect of surgical and nonsurgical treatment on longitudinal outcomes of lumbar spinal stenosis over 10 years. / Am Geriatr Soc 2005;53:785-92. 11. Tran de QH, Duong S, Einlayson RJ. Lumbar spinal stenosis: a brief review of the nonsurgical management. Can J Anesth 2010;57: 694-703. 12. Ammendolia C, Stuber KJ, Rok E, et al. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database Syst Rev 2013;8 Art No.:CD010712. doi:10.1002/14651858.CD010712. 13. Genevay S, Atlas SJ. Lumbar spinal stenosis: best practice ÔC research. Clin Rheumatol 20W:,24:2S3-65. 14. Gibson JNA, Waddell G. Surgery for degenerative lumbar spondylosis: an updated Cochrane review. Spine 2005;30:2312-20. 15. Taylor VM, Deyo RA, Cberkin DC, et al. Low back pain hospitalization. Recent United States trends and regional variations. Spine 1994;19:1207-13. 16. Gunzburg R, Szpalski M. The conservative surgical treatment of lumbar spinal stenosis in the elderly. £Mr.Sp¿«e/2003;]2:176-80. 17. Turner JA, Ersek M, Herron L, et al. Surgery for lumbar spinal stenosis. Attempted meta-analysis of the literature. Spine 1992;17:l-8. www.spinejournal.com
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Rehabilitation Following Surgery for Lumbar Spinal Stenosis • McGregor et al
18. McGregor AH, Hughes SP. The evaluation of the surgical managetnent of nerve root compression in patients with low back pain: part 1: the assessment of outcome. Spine 2002;27:1465-70. 19. Yee A, Adjei N, Do J, et al. Do patient expectations of spinal surgery relate to functional outcome? Clin Orthop Relat Res 2008;466:l 154-61. 20. Yorimitsu E, Chiba K, Toyama Y, et al. Long-term outcomes of standard discectomy for lumbar disc herniation: a follow-up study of more than 10 years. Spine 2001;26:652-7. 21. Hides JA, Stokes MJ, Saide M, et al. Evidence of lumbar multifidus muscle wasting ipsilateral to symptoms in patients with acute/subacute low back pain. Spine 1994;19:165-72. 22. Taylor H, McGregor AH, Medhi-Zadeh S, et al. The impact of selfretaining retractors on the paraspinal muscles during posterior spinal surgery. Spine 2002;27:2758-62. 23. McGregor AH, Dicken B, Jamrozik K. National audit of post-operative management in spinal surgery. BioMed Cent Musculoskeletal Disord 2006;7:47. 24. McGregor AH, Burton AK, Sell P, et al. The development of an evidence-based patient booklet for patients undergoing lumbar discectomy and un-instrumented decompression. Eur Spine J 2007;16:339^6. 25. Erdogmus GB, Resch KL, Sabitzer R, et al. Physiotherapy-based rehabilitation following disc herniation operation: results of a randomized clinical trial. Spine 2007;32:2041-9. 26. McGregor AH, Dore GJ, Morris TP, et al. ISSLS Prize paper: Eunction After Spinal Treatment, Exercise and Rehabilitation (EASTER): a factorial randomised trial to determine whether the functional outcome of spinal surgery can be improved. Spine 201í;36:\7í]—20. 27. Nielsen PR, Andreasen J, Asmussen M, et al. Gosts and quality of life for prehabilitation and early rehabilitation after surgery of the lumbar spine. BioMed Cent Health Serv Res 2008;8:209. 28. Ostelo RW, Gosta LO, Maher GG, et al. Rehabilitation after lumbar disc surgery: an update Gochrane review. Spine 2009;34:1839^8. 29. Kim YS, Park J, Shim JK. Effects of aquatic backward locomotion exercise and progressive resistance exercise on lumbar extension strength in patients who have undergone lumbar diskectomy. Arch Phys Med Rehabil 2010;91:208-14. 30. Ostelo RW, Goossens ME, de Vet HG, et al. Economic evaluation of a behavioral-graded activity program compared to physical therapy for patients following lumbar disc surgery. Spine 2004;29: 615-22. 31. Millisdotter M, Stromqvist B. Early neuromuscular customized training after surgery for lumbar disc herniation: a prospective controlled study. Eur Spine] 2007;16:19-26. 32. Mannion AE, Denzler R, Dvorak J, et a!. A randomised controlled trial of post-operative rehabilitation after surgical decompression of the lumbar spine. £MrSpOTe/2007;16:1101-17. 33. McGregor AH, Probyn K, Gro S, et al. Rehabilitation following surgery for lumbar spinal stenosis. Cochrane Database Syst Rev 2013;12 Art. No.: GD009644. doi:10.1002/14651858.GD009644. pub2. 34. Eurlan AD, Pennick V, Bombardier G, et al. Updated method guidelines for systematic reviews in the Gochrane Back Review Group. S/7¿ne2009;34:1929-41. 35. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1. The Gochrane Gollaboration; 2011. www.cochrane-handbook.org. Updated March 2011. 36. Bland JM, Altman DG. The use of transformation when comparing the two means. Br Mea/1996;312:1153.
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www.spinejournal.com
37. Revietv Manager (RevMan) [computer program]. Version 5.1. Gopenhagen, Denmark: The Nordic Cochrane Gentre, The Gochrane GoUaboration; 2011. 38. Pons T, Shipton EA. Multilevel lumbar fusion and postoperative physiotherapy rehabilitation in a patient with persistent pain. Physiother Theory Pract 2011;27:238^5. 39. Sogaard R, Bunger GE, Laurberg I, et al. Gost-effectiveness evaluation of an RGT in rehabilitation after lumbar spinal fusion: a low-cost, behavioural approach is cost-effective over individual exercise therapy. Eur Spine J 2008;17:262-7l. 40. Ganbulat N, Sasani M, Ataker Y, et al. A rehabilitation protocol for patients with lumbar degenerative disk disease treated with lumbar total disk replacement. Arch Phys Med Rehabil 2011;92: 670-6. 41. Jeric Z, Sliepcevic B. Gomparison of the results of early and delayed rehabilitation in patients with surgery for disco-radicular problems in the lumbar spine. [Serbian] Poredba rezultata rane i odlozene rehabilitacije bolesnika operiranih zbog diskoradikularnog konflikta lumbalne kraljesnice. Reumatizam 1991;38:5-6. 42. Mannion AE, Denzler R, Dvorak J, et al. Eive-year outcome of surgical decompression of the lumbar spine without fusion. Eur Spine /2010;19:1883-91. 43. Abbott AD, Tyni-Lenne R, Hedlund R. Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion: a randomized controlled trial. Spine 2010;35:848-57. 44. Brox JI, Sorensen R, Eriis A, et al. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine 2003;28:1913-21. 45. Ghristensen EB, Laurberg I, Bunger GE. Importance of the backcafe concept to rehabilitation after lumbar spinal fusion: a randomized clinical study with a 2-year follow-up. Spine 2003;28: 2561-9. 46. Hagg O, Eritzell P. Re: Brox JI, Sorensen R, Eriis A, et al. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. [Spine 2003;28:1913-21]. Spine 2004;29: 1160-1. 47. Nielsen PR, Jorgensen LD, Dahl B, et al. Prehabilitation and early rehabilitation after spinal surgery: randomized clinical trial. Clin Rehabil 2010;24ú37-48. 48. Wu EY. Influence of rehabilitation education on behavior and lumbar functional exercise in patients following operation for lumbar spinal stenosis. Zhongguo Linchuang Kangfu 2005;9:20-2. 49. Aalto TJ, Leinonen V, Herno A, et al. Postoperative rehabilitation does not improve functional outcome in ltunbar spinal stenosis: a prospective study with 2-year postoperative follow-up. Eur Spine } 2011;20:1331-40. 50. Gopay AG, Glassman SD, Subach BR, et al. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry ÍDisability Index, Medical Outcomes Study questionnaire Short Eorm 36, and pain scales. Spine } 2008;8:968-74. 51. Rushton A, Eveleigh G, Petherick EJ, et al. Physiotherapy rehabilitation following lumbar spinal fusion: a systematic review and meta-analysis of randomised controlled trials. BMJ Open 2012;2:e000829. doi:10.1136/bmjopen-2012-000829. 52. Jobnson RE, Jones GT, Wiles NJ. Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: a randomized controlled trial. Spine 2007;32:1578-85.
June 2014
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