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Use of surgery for the management of lumbar spinal stenosis

Practice Points

Andrew J Schoenfeld1 & Christopher M Bono† „„ In the absence of concerning clinical symptoms, surgical treatment and nonoperative management may

be considered viable treatment options for lumbar spinal stenosis. „„ Nonoperative treatment regimens often include a combination of therapies, including physical therapy,

pain medication and/or epidural steroid injections administered transforaminally or interlaminarly. „„ Simple decompression is the surgical intervention for lumbar spinal stenosis most amply supported by

the current literature. „„ Fusion-based surgical interventions are most appropriate for patients with spinal stenosis and

spondylolisthesis, or dynamic instability.

SUMMARY

Lumbar spinal canal stenosis is a clinical condition that often results in symptoms such as radicular pain or neurogenic claudication. In some instances, the clinical manifestations of spinal stenosis can be quite debilitating and the condition is one of the more common reasons for spinal surgical consultation, particularly in those over the age of 65 years. A variety of treatment options are regularly employed in the management of lumbar spinal stenosis, ranging from nonoperative therapies, such as physical therapy and epidural steroid injections, to surgical intervention. Evidence-based recommendations for treatment include an initial trial of conservative management followed by surgical intervention if patient symptoms persist. The surgical intervention for standalone lumbar spinal stenosis that is most supported by the current literature is a simple lumbar decompression. Further investigations need to be conducted in order to characterize the comparative effectiveness of surgery and specific nonoperative treatment algorithms. Lumbar spinal stenosis: the clinical problem & treatment issues Lumbar spinal stenosis is a clinical entity that results from the pathologic narrowing of the spinal canal, most frequently in the setting of lumbar degenerative disease and spondylosis [1–4] . Spinal stenosis represents an end-stage manifestation of

the degenerative process, which begins with intervertebral disc degeneration and desiccation  [2] . With loss of the disc height, an increased bio­ mechanical load is shifted to the facet joints post­ eriorly, ultimately resulting in facet arthro­pathy and infolding or hypertrophy of the ligamentum flavum. A combination of facet spondylosis,

Department of Orthopaedic Surgery, William Beaumont Army Medical Center, Texas Tech University Health Sciences Center, El Paso, TX, USA † Author for correspondence: Department of Orthopedic Surgery, Brigham and Women’s Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA; [email protected] 1

10.2217/PMT.10.16

Pain Manage. (2011) 1(2), 139–145

ISSN 1758-1869

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Management Perspective  Schoenfeld & Bono broad-based degenerative disc bulging and/or ligamentum flavum hypertrophy can all contribute to narrowing of the lumbar spinal canal and neuroforamina [2,4] . The condition was first recognized in the 19th century by Antoine Portal [4] , but modern appreciation of spinal stenosis extends back only 50 years, with the first clinical reports in the work of Verbiest [5,6] . Symptomatic spinal stenosis most commonly arises in the fifth and sixth decades of life, and frequently includes complaints of neuro­genic claudication and/or radicular pain  [1–4] . The annual incidence of lumbar spinal stenosis has been estimated to be in the range of 2–10% of the population [4] ; although numbers are increasing as a result of advances in imaging technology and a healthier population with increased life expectancy [2,7] . The natural history of this condition is not well described and, until recently, most interventions were guided by accepted practice, anecdotal experience and low-level literature‑based evidence [2,4,7,8] . Surgical treatment for spinal stenosis has been utilized since it was first described by Verbiest in 1954 [5] . Between 1980 and 2000, surgical intervention for lumbar spinal stenosis was the fastest growing area in the spinal surgical field [9] and, in the Medicare population, spinal stenosis is now the most common reason for under­going spine surgery [8] . While a number of studies support the clinical effectiveness of surgical decompression for lumbar spinal stenosis, few scientifically rigorous comparisons between surgery and nonoperative management exist. Therefore, questions still remain regarding the long-term efficacy of surgery, the appropriate level of surgical complexity for spinal stenosis and the ultimate cost–effectiveness of treatment. If not surgery, what kind of treatment? The nonoperative management of spinal stenosis has long been informed by individual physician algorithms, experience during residency training, anecdotal evidence, and patient- or physicianbased preferences [1,2,4,7,8] . As the natural history of lumbar spinal stenosis seems to indicate a very low potential for catastrophic neurological compromise or permanent deficit resulting from the condition [10] , it is reasonable to consider nonoperative treatment for as long as a patient desires or their symptomatology permits  [1,2,8] . Most nonoperative interventions are comparatively inexpensive and low risk. However, robust supportive scientific evidence does not exist

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for most and no evidence-based algorithms in regard to nonoperative management are currently available [2,8] . Nonoperative treatment regimens most commonly include a combination of pain-relieving medications, physical therapy, activity modification, weight reduction, core strengthening and epidural steroid injections [1,2,4,7,8,11] . The physical therapy regimen itself can be quite variegated, with differing degrees of stretching, postural education and pain relief modalities provided at the discretion of the treating physician or physical therapist. No studies have specifically investigated the effectiveness of a singular treatment regimen on the symptoms of spinal stenosis, but the use of nonsteroidal anti-inflammatory medications and physical therapy is supported, based on extrapolations from other research, as well as an appreciation for the underlying pathophysiology of spinal stenosis [1,2,4,8,12] . A recent publication from the Spinal Stenosis Work Group of the North American Spine Society (NASS) maintained that there was insufficient evidence to support any specific physical therapy regimen or intervention, such as spinal manipulation, for the treatment of lumbar spinal stenosis [12] . Epidural steroid injections administered transforaminally or interlaminarly as part of a regimen or as a single administration have been utilized for decades as a standard modality in the nonoperative treatment of spinal stenosis [1,2,4,8,13] . Some studies, such as those of Rosen et al. [14] and Hoogmartens and Morelle [11] , report satisfactory short-term symptom relief from steroid injections but no substantial long-term benefit. In a series of 34 patients with radicular symptoms and radiographically confirmed spinal stenosis, Botwin and Gurber reported continued symptom relief in most patients for a period of up to 12 months following injection [15] . No studies have investigated the disparity between injection regimens, such as single injection versus a series of three injections or multiple series of injections, in the treatment of spinal stenosis. In the only clinical trial to examine the ability of epidural steroid injections to postpone surgery, Riew and colleagues performed a randomized prospective, double-blind trial of betamethasone and bupivacaine compared with bupivacaine alone in a series of 55 patients [16,17] . They reported that the use of betamethasone was effective in helping patients avoid surgery and the benefit was found to persist in 81% of patients at a minimum 5‑year follow-up [17] . However, it should be noted that

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Use of surgery for the management of lumbar spinal stenosis  this trial was performed in patients with radicular pain and not neurogenic claudication, and was not limited to individuals with a diagnosis of spinal stenosis. This is important, as some studies have demonstrated that patients with disc herniation fare better following steroid injections than those with spinal stenosis [18] . Unfortunately, most studies that have focused on comparisons between operative and non­ operative management have not standardized their conservative treatment protocols [19–25] . Furthermore, none have specifically compared a single intervention, such as epidural steroid injection, with surgical treatment. As a result, many questions regarding the long-term efficacy of these interventions remain unanswered. The NASS Spinal Stenosis Work Group maintained that there is adequate level II–III literature supporting the use of epidural steroids for short-term symptomatic relief in patients with spinal stenosis and radicular or claudicant symptomatology [12] . However, the evidence base for multiple injection regimens and the long-term efficacy of steroid injections was graded as weak [12] . What kind of surgery? Traditionally, standalone decompressive procedures have been used to surgically treat spinal stenosis in the absence of instability [2,3,7,8,26–29] . Such decompressive surgeries can include singleor multilevel laminectomy, hemilaminectomy, laminotomy or laminoplasty, which consists of bilateral decompression with a single-sided approach [2,3,8] . In an effort to minimize incision size and limit iatrogenic damage to adjacent muscular and ligamentous structures, some have advocated for microdecompression using an operating microscope and minimally invasive procedures performed using tubular retractors or endoscopy. The common goal of all of these procedures is to decompress the thecal sac and nerve roots in the area of stenotic compression. In a standard open decompression, the lamina, spinous pro­cesses and portions of the arthritic facet joints are removed along with hypertrophic ligamentum flavum. This was the type of surgical intervention initially proposed by Verbiest [5,6] and the one that has been studied most extensively in terms of its ability to relieve the symptoms of spinal stenosis. Several retrospective studies have endorsed the ability of laminectomy to relieve the pre­dominant symptoms and improve functional status in patients with spinal stenosis [6,7,26–29] . In a large retrospective study encompassing 438 patients, Airaksinen

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Management Perspective

and colleagues demonstrated the clinical effectiveness of open lumbar decompression in improving Oswestry Disability Index scores in patients with spinal stenosis at an average of 4 years following surgery [26] . Similarly, a pro­spective study published by Malmivaara et al. reported improved outcomes in terms of leg pain, back pain and disability scores in 50 patients with spinal stenosis treated with lumbar decompression [23] . Most recently, large prospective investigations with extensive follow-up, such as the work of the Maine Lumbar Spine Study [20–22] and the Spine Patient Outcomes Research Trial (SPORT) [24,25] , have provided substantial evidence for the efficacy of lumbar decompression. The Maine Lumbar Spine Study, a prospective cohort study conducted over the course of a 10‑year period, found that surgically treated patients had improvements in leg-related symptoms and functional status that, in many cases, were still evident a decade after surgery [20–22] . Similarly, the 2- and 4‑year results of the SPORT study revealed that surgically treated patients experienced significant improvements in bodily pain, physical function and Oswestry Disability Index scores that were maintained over the course of 4 years [24,25] . While these studies address outcomes for patients treated using standard open laminectomies, the evidence base in support of other decompressive procedures is severely limited. At present, no high-grade comparative trials that contrast outcomes between open laminectomy and decompressive techniques, such as microscopic decompression, laminoplasty or minimally invasive surgery, are available [8,28] . As interest in minimally invasive spine surgery expanded, so too did the concept of placing interspinous process devices capable of increasing the size of the spinal canal without necessitating the removal of bone or ligamentous structures [30,31] . The most popular of these devices, the X‑STOP® (Medtronic, Minneapolis, MN, USA), has been touted as a means to avoid open decompressive procedures, particularly in elderly patients who have medical comorbidities that may preclude general anesthesia or invasive surgery. There is some evidence that these implants are efficacious when compared with nonoperative treatment [12,30,31] , but their long-term results and complications have not been studied, and the device has not been compared with standard surgical decompression in a scientifically appropriate manner [12] . In a recent investigation, open laminectomy was reported to be more effective and less costly than X‑STOP [32] . However, both interventions were

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Management Perspective  Schoenfeld & Bono maintained to be more cost effective than conservative management [32] . The effectiveness of laminectomy compared with nonoperative manage­ment was also maintained, even at 4 years following surgery, with a cost of US$28,256 per quality-adjusted life year (QALY)  [32] . However, the methodology of this study may be open to question and more work must be performed before the true cost–­effectiveness of these procedures can be characterized. In the last decade, the simultaneous performance of lumbar decompression and fusion has gained popularity as a treatment for many degenerative conditions, including spinal stenosis [2,8,9] . The efficacy of performing an arthrodesis in addition to simple decompressive procedures for patients with spinal stenosis, as well as the placement of interbody devices and the use of bone morphogenetic protein has not been completely explored  [2,3,7,8,28] . Fusion-based procedures are most appropriately indicated in situations where spinal stenosis is accompanied by spondylo­listhesis or dynamic instability, or the amount of bone removed in the decompressive surgery is likely to result in iatrogenic instability [2,8,12] . Some clinicians advocate fusion as a means to diminish back pain or prevent future surgery in patients with degenerative spinal stenosis. Others maintain that, in the setting of a collapsed intervertebral disc, minimally invasive interbody procedures are capable of achieving indirect decompression and improving canal dimensions [33] . These claims have not been adequately evaluated in the literature and no study has demonstrated a substantial clinical advantage for the addition of spinal fusion relative to standard decompression in the absence of spinal instability [2,7,8,12,28] . Fusion procedures have been demonstrated to increase the risk of complications, mortality and healthcare-associated costs, particularly in the elderly [9,34,35] . Kuntz et  al. estimated that the performance of spinal fusion, in addition to decompression, cost $56,600 per QALY [36] . The use of instrumentation led to a significant increase in expenditures, reported by these authors to exceed $3 million per QALY [36] . Kalanithi and colleagues maintained that there was a 0.15% mortality rate and 11% complication rate for elective surgical procedures involving lumbar fusion for degenerative conditions [35] . However, these risks were found to increase among the elderly and in those with medical comorbidities [35] . Within the Medicare population, Deyo and colleagues recently documented an increased rate

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of so-called complex fusion procedures performed for patients with spinal stenosis [34] . These complex procedures included anterior–posterior interventions, as well as interbody fusions [34] . Deyo et al. reported that the risk of life-threatening complications and rehospitalization, and medical costs were significantly increased among those undergoing complex surgical interventions (including fusionbased procedures) compared with patients undergoing simple decompressions [34] . Deyo et al. [34] , among others [37] , have cautioned that there is a definite personal, as well as societal, cost to the performance of more advanced spinal surgical procedures, and advocate a balanced approach to the selection of spinal interventions, especially in light of the limited literature in support of fusion for stenotic conditions in the absence of instability. The NASS Spinal Stenosis Work Group could not find evidence to support performing decompression and fusion in patients with spinal stenosis and no evidence of instability [12] . Operative versus nonoperative treatment for spinal stenosis: a critical comparison Scientifically rigorous investigations have only recently compared the efficacy of operative and nonoperative interventions for spinal stenosis. Between 1996 and 2005 the Maine Lumbar Spine Study sequentially published three papers prospectively reporting outcomes for patients treated operatively or nonoperatively for spinal sten­osis  [20–22] . The decision for which type of intervention to use was based on patient preference and nonoperative management was not standardized. Over the course of the 10‑year study period, patients who received surgery had consistently better outcomes than those managed conservatively; although the benefit of surgical intervention decreased with time [20–22] . For example, in the first 4 years of the study, individuals receiving surgery had better outcomes in all areas under investigation, including improvement in back pain, predominant symptom relief and overall satisfaction [20,21] . However, at 8–10 years, only leg pain relief and back-related function were substantially different between the operative and nonoperative groups [22] . Time-related degradation of the positive effects of decompressive surgery for lumbar stenosis has previously been highlighted in the work of Katz and colleagues [29] . By contrast, in a prospective randomized trial comparing surgical intervention to nonoperative therapies, Amundsen et al. demonstrated overwhelming benefit for surgery with no time-based

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Use of surgery for the management of lumbar spinal stenosis  clinical deterioration [19] . In this study, 69% of surgical patients were reported to have a good outcome or better at 1‑year postoperatively and this number increased to over 90% at the 4- and 10‑year time points [19] . In comparison, only 33% of the nonoperative group had good outcomes at 1 year, increasing to 47% at 4 years. However, by 10 years, 71% of nonoperative patients were graded as having a good result [19] . The most elegant and often-quoted study on spinal stenosis performed is the SPORT investigation [24,25] . Conducted at 13 medical centers across 11 US states, the SPORT trial was a randomized, prospective study comparing operative and nonoperative treatment for spinal stenosis. The authors applied strict inclusion criteria and only those patients with degenerative lumbar spinal stenosis and no evidence of instability were enrolled in the study. Surgical treatment consisted of stand­alone lumbar decompression, while nonoperative management was at the discretion of the treating physicians and could have consisted of a varying combination of physical therapy, home exercise education and nonsteroidal pain medications. Randomized and observational arms of the study were conducted simultaneously; intent-to-treat and as-treated analyses were performed. Despite a very high rate of crossover in the random­ized arm, surgical treatment still demonstrated superior­ity in terms of reducing bodily pain in the intent-to-treat ana­lysis [24] . In the as-treated ana­lysis, surgery was demonstrated to be superior to nonoperative management for all outcomes that were studied, including bodily pain, physical function and change in the Oswestry Disability Index score [24] . The benefits of surgery were retained in this series throughout the 4‑year follow-up [25] . Conclusion The results of the Maine Lumbar Spine Study and the SPORT investigation have provided valuable insight into the long-term benefit that surgical decompression can provide to properly selected patients. However, there is insufficient evidence to make a recommendation for any one particular intervention as the gold-standard treatment for spinal stenosis [12] , and the ‘right’ intervention for a patient has much to do with that individual’s desires and values, the quality and duration of their symptoms, and what interventions have previously been used. In the absence of red flags, such as saddle anesthesia, bowel or bladder incontinence, and

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Management Perspective

progressive neurological deterioration, surgical intervention and nonoperative therapies, such as nonsteroidal pain medications and epidural steroid injections, are viable treatment options. In the absence of spondylolisthesis, dynamic instability or concerns regarding the potential for an unstable spine following laminectomy, standalone lumbar decompression is the surgical intervention most consistently supported by the literature. Ideally, management options, as well as risks and benefits in light of the current state of the literature, should be presented to the patient as part of an office consultation and an informed decision can then be made on an individualized basis with regard to the optimal course of treatment. Future perspective Although our scientific understanding regarding the effectiveness of certain treatments for spinal stenosis has substantially improved in the last decade, there is still much that remains to be determined. Specifically, optimal non­operative treatment regimens, the long-term efficacy of epidural steroid injections, benefits of steroid injections versus surgery, and the role of fusion with decompression remain poorly understood at present. Hopefully within the next few years more comparative research will become available, capable of identifying patients who might benefit from specific treatment regimens. In addition, future research may also be able to highlight the long-term benefits of minimally invasive procedures, such as X‑STOP, lumbar laminoplasty or minimally invasive decompressions, in the treatment of patients with lumbar spinal stenosis. Disclosure AJ Schoenfeld is an employee of the US Federal Government and the US Army. The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or reflecting the views of the William Beaumont Army Medical Center, the Department of Defense or the US Government.

Financial & competing interests disclosure AJ Schoenfeld is an employee of the US Federal Government and the US Army. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

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Management Perspective  Schoenfeld & Bono Bibliography

14

Papers of special note have been highlighted as: of interest of considerable interest n

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n

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23 Malmivaara A, Slätis P, Heliövaara M et al.;

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n

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The 4‑year results of the as-treated ana­lysis of patients in the Spine Patient Outcomes Research Trial (SPORT) for lumbar spinal stenosis.

25 Weinstein JN, Tosteson TD, Lurie JD et al.;

SPORT Investigators: Surgical versus nonsurgical therapy for lumbar spinal stenosis. N. Engl. J. Med. 358, 794–810 (2008). n

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30 Kuchta J, Sobottke R, Eysel P, Simons P:

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Nandakumar A, Clark NA, Peehal JP, Bilolikar N, Wardlaw D, Smith FW: The increase in dural sac area is maintained at 2 years after X‑STOP implantation for the treatment of spinal stenosis with no significant alteration in lumbar spine range of movement. Spine J. 10, 762–768 (2010).

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direct and indirect decompression with XLIF. In: Extreme Lateral Interbody Fusion (XLIF). Goodrich JA, Volcan IJ (Eds). Quality Medical Publishing Inc., St Louis, MO, USA, 61–74 (2008).

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Goodman DC, Jarvik JG: Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 303, 1259–1265 (2010). n

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n

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Management Perspective

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Pope MH, Katz JN: Cost–effectiveness of fusion with and without instrumentation for patients with degenerative spondylolisthesis and spinal stenosis. Spine 25, 1132–1139 (2000). 37 Carragee EJ: The increasing morbidity of

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Use of surgery for the management of lumbar spinal stenosis.

Summary Lumbar spinal canal stenosis is a clinical condition that often results in symptoms such as radicular pain or neurogenic claudication. In some...
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