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Referencias

Amundsen 2000 {published data only}

Amundsen T, Weber H, Nordal HJ, Magnaes B, Abdelnoor M, Lilleas F. Lumbar spinal stenosis: conservative or surgical management? A prospective 10‐year study. Spine 2000;25(11):1424‐35.

Brown 2012 {published data only}

Brown LL. A double‐blind, randomized, prospective study of epidural steroid injection vs. the mild procedure in patients with symptomatic lumbar spinal stenosis. Pain Practice 2012;12(5):333‐41.

Malmivaara 2007 {published data only}

Malmivaara A, Slatis P, Heliovaara M, Sainio P, Kinnunen H, Kankare J, et al. Finnish Lumbar Spinal Research Group. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial. Spine 2007;32(1):1‐8.
Slätis P, Malmivaara A, Heliövaara M, Sainio P, Herno A, Kankare J, et al. Long‐term results of surgery for lumbar spinal stenosis: a randomised controlled trial. European Spine Journal 2011;20(7):1174‐81.

Weinstein 2008 {published data only}

Birkmeyer NJ, Weinstein JN, Tosteston AN, Tosteston JD, Skinner JS, Lurie JD. Design of the Spine Patients Outcomes Research Trial (SPORT). Spine 2002;27(12):1361‐72.
Radcliff KE, Rihn J, Hilibrand A, Dilorio T, Tosteson T, Lurie JD, et al. Does the duration of symptoms in patients with spinal stenosis and degenerative spondylolisthesis affect outcomes? Analysis of the Spine Outcomes Research Trial. Spine 2011;36(25):2197‐210.
Weinstein JN, Tosteson TD, Lurie JD, Tosteson A, Blood E, Herkowitz H, et al. Surgical versus nonoperative treatment for lumbar spinal stenosis: four‐year results of the Spine Patient Outcomes Research Trial. Spine 2010;35(14):139‐48.
Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, et al. SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. New England Journal of Medicine 2008;358(8):794‐810.

Zucherman 2004 {published data only}

Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, et al. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two‐year follow‐up results. Spine 2005;30(12):1351‐8.
Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, et al. A prospective randomized multi‐center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1‐year results. European Spine Journal 2004;13(1):22‐31.

Athiviraham 2007 {published data only}

Athiviraham A, Yen D. Is spinal stenosis better treated surgically or nonsurgically?. Clinical Orthopaedics & Related Research 2007;458:90‐3.

Atlas 1996 {published data only}

Atlas SJ, Deyo RA, Keller RB, Chapin AM, Patrick DL, Long JM, et al. The Maine Lumbar Spine Study, Part III. 1‐Year outcomes of surgical and nonsurgical management of lumbar spinal stenosis. Spine (Phila Pa 1976) 1996;21(15):1787‐94.
Atlas SJ, Keller RB, Robson D, Deyo RA, Singer DE. Surgical and nonsurgical management of lumbar spinal stenosis: four‐year outcomes from the Maine Lumbar Spine Study. Spine 2000;25(5):556‐62.
Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long‐term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the Maine Lumbar Spine Study. Spine 2005;30(8):936‐43.

Chang 2005 {published data only}

Chang Y, Singer DE, Wu YA, Keller RB, Atlas SJ. The effect of surgical and nonsurgical treatment on longitudinal outcomes of lumbar spinal stenosis over 10 years. Journal of the American Geriatrics Society 2005;53(5):785‐92.

Croft 2012 {published data only}

Croft A. Conservative vs. surgical care of lumbar spinal stenosis. Dynamic Chiropractic 2012;30(5):1‐5.

Hurri 1998 {published data only}

Hurri H, Slatis P, Soini J, Tallroth K, Alaranta H, Laine T, et al. Lumbar spinal stenosis: assessment of long‐term outcome 12 years after operative and conservative treatment. Journal of Spinal Disorders 1998;11(2):110‐5.

Keller 1996 {published data only}

Keller RB, Atlas SJ, Singer DE. The Maine Lumbar Spine Study, part I: background and concepts. Spine 1996;21(15):1769‐76.

Malmivaara 2007a {published data only}

Malmivaara A, Slatis P, Heliovaara M, Sainio P, Kinnunen H, Kankare J, et al. Surgery reduced pain and disability in lumbar spinal stenosis better than nonoperative treatment. Journal of Bone and Joint Surgery [American] 2007;89(8):1872.

Mariconda 2002 {published data only}

Mariconda M1, Fava R, Gatto A, Longo C, Milano C. Unilateral laminectomy for bilateral decompression of lumbar spinal stenosis: a prospective comparative study with conservatively treated patients. Journal of Spinal Disorders and Techniques 2002;15(1):39‐46.

Ohtori 2014 {published data only}

Ohtori S, Yamashita M, Murata Y, Eguchi Y, Aoki Y, Ataka H, et al. Incidence of nocturnal leg cramps in patients with lumbar spinal stenosis before and after conservative and surgical treatment. Yonsei Medical Journal 2014;55(3):779‐84.

Paker 2005 {published data only}

Paker N, Turkmen C, Bugdayci D, Tekdos D, Erbil M. Comparison of conservative and surgical treatment results in lumbar spinal stenosis. Turkish Neurosurgery 2005;15(4):182‐4.

Pearson 2011 {published data only}

Pearson A, Blood E, Lurie J, Abdu W, Sengupta D, Frymoyer JW, et al. Predominant leg pain is associated with better surgical outcomes in degenerative spondylolisthesis and spinal stenosis: results from the Spine Patient Outcomes Research Trial (SPORT). Spine 2011;36(3):219‐29.

Tosteson 2011 {published data only}

Tosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, et al. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine 2011;36(24):2061‐8.

Delitto 2015 {published data only}

Delitto A, Piva SR, Moore CG, Fritz JM, Wisniewski SR, Josbeno DA. Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial. Annals of Internal Medicine 2015;162(7):465‐73.

Overdevest 2011 {published data only}

Overdevest GM, Luijsterburg PA, Brand R, Koes BW, Bierma‐Zienstra SM, Eekhof JA, et al. Design of the Verbiest trial: cost‐effectiveness of surgery versus prolonged conservative treatment in patients with lumbar stenosis. BMC Musculoskeletal Disorders 2011;12:57.

Ammendolia 2011

Ammendolia C, Stuber K, deBruin LK, Furlan AD, Kennedy CA, Rampersaud Y, et al. Non‐operative treatment for lumbar spinal stenosis with neurogenic claudication: a systematic review. Spine 2011;10:E609‐16.

Ammendolia 2012

Ammendolia C, Stuber K, de Bruin LK, Furlan AD, Kennedy CA, Rampersaud YR, et al. Nonoperative treatment of lumbar spinal stenosis with neurogenic claudication: a systematic review. Spine (Phila Pa 1976) 2012 May 1;37(10):E609‐16.

Ammendolia 2013

Ammendolia C, Stuber KJ, Rok E, Rampersaud R, Kennedy CA, Pennick V, et al. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database of Systematic Reviews 2013 Aug 30;8:CD010712.

Atlas 2006

Atlas S, Delitto A. Spinal stenosis: surgical versus non surgical treatment. Spinal Stenosis: Surgical versus Non Surgical Treatment. Baltimore, Maryland: Lippincott Williams & Wilkins, 2006; Vol. 443:198‐207.

Benoist 2002

Benoist M. The natural history of lumbar degenerative spinal stenosis. Joint, Bone, Spine 2002;69(50):450‐7.

Binder 2002

Binder DK,  Schmidt MH,  Weinstein PR. Lumbar spinal stenosis. Seminars In Neurology 2002;22(2):157‐66.

Botwin 2007

Botwin K,  Brown LA,  Fishman M,  Rao S. Fluoroscopically guided caudal epidural steroid injections in degenerative lumbar spine stenosis. Pain Physician 2007;10(4):547‐58.

Boutron 2005

Boutron I, Moher D, Tugwell P, Giraudeau B, Poiraudeau S, Nizard R, et al. A checklist to evaluate a report of a non pharmacological trial (CLEAR NPT) was developed using consensus. Journal of Clinical Epidemiology 2005;58:1233‐40.

Carragee 2010

Carragee EJ. The increasing morbidity of elective spinal stenosis surgery: is it necessary?. JAMA 2010;303(13):1309‐10.

Chad 2007

Chad, DA. Lumbar spinal stenosis. Neurologic Clinics 2007;25(2):407‐18.

Ciol 1996

Ciol MA,  Deyo RA,  Howell E,  Kreif S. An assessment of surgery for spinal stenosis: time trends, geographic variations, complications, and reoperations. Journal of the American Geriatrics Society 1996;44(3):185‐90.

Ciricillo 1993

Ciricillo SF, Weinstein PR. Lumbar spinal stenosis. The Western Journal of Medicine 1993;158:171‐7.

Deyo 2006

Deyo RA, Mirza SK. Trends and variations in the use of spine surgery. Clinical Orthopaedics and Related Research  2006;443:139‐46.

Deyo 2010

Deyo RA, Mirza SK, Martin BI. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 2010;303:1259‐65.

Deyo 2011

Deyo RA, Martin BI, Kreuter W, Jarvik JG, Angier H, Mirza SK. Revision surgery following operations for lumbar stenosis. The Journal of Bone and Joint Surgery [American] 2011;93(21):1979‐86.

Deyo 2014

Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, et al. Focus article: report of the NIH Task Force on Research Standards for Chronic Low Back Pain. European Spine Journal 2014;23(10):2028‐45.

Duffy 2014

Duffy S, Misso K, Noake C, Ross J, Stirk L. Supplementary searches of PubMed to improve currency of MEDLINE and MEDLINE In‐Process searches via OvidSP. Kleijnen Systematic Reviews Ltd, York. Poster presented at the UK InterTASC Information Specialists' Sub‐Group (ISSG) Workshop; 9 July 2014; Exeter: UK (2014) (accessed 6.8.14). https://medicine.exeter.ac.uk/media/universityofexeter/medicalschool/research/pentag/documents/Steven_Duffy_ISSG_Exeter_2014_poster_1.pdf.

Fanuele 2000

Fanuele JC, Birkmeyer NJ, Abdu MD, Tosteson TD, Weinstein JN. The impact of spinal problems on the health status of patients: have we underestimated the effect?. Spine 2000;25(12):1509‐14.

Furlan 2009

Furlan AD, Pennick V, Bombardier C, van Tulder M, Editorial BCBRG. 2009 Updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine 2009;34(18):1929‐41.

Haig 2006

Haig AJ,  Tong HC,  Yamakawa KS,  Quint DJ,  Hoff JT,  Chiodo A, et al. Spinal stenosis, back pain, or no symptoms at all? A masked study comparing radiologic and electrodiagnostic diagnoses to the clinical impression. Archives of Physical Medicine and Rehabilitation 2006;7(7):897‐903.

Haig 2010

Haig AJ,  Tomkins CC. Diagnosis and management of lumbar spinal stenosis. JAMA 2010;303(1):71‐2.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. www.cochrane‐handbook.org.

Iversen 2001

Iversen MD, Katz JN. Examination findings and self‐reported walking capacity in patients with lumbar spinal stenosis. Physical Therapy 2001;81(7):1296‐306.

Johnsson 1987

Johnsson KE, Rosén I, Udén A. Neurophysiologic investigation of patients with spinal stenosis. Spine 1987;12(5):483‐7.

Kovacs 2011

Kovacs F, Urrútia G, Alarcón JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine 2011;36(20):E1335–51.

Lurie 2003

Lurie JD,  Birkmeyer NJ,  Weinstein JN. Rates of advanced spinal imaging and spine surgery. Spine 2003;28(6):616‐20.

Negrini 2006

Negrini S, Giovannoni S, Minozzi S, Barneschi G, Bonaiuti D, Bussotti A, et al. Diagnostic therapeutic flow‐charts for low back pain patients: the Italian clinical guidelines. Europa Medicophysica 2006;42(2):151‐70.

Negrini 2010

Negrini S, Zaina F, Romano M, Atanasio S, Fusco C, Trevisan C. Rehabilitation of lumbar spine disorders: an evidence‐based clinical practice approach. In: Frontera WR, Delisa JA, Gans BM, Walsh NE, Robinson LR editor(s). DeLisa’s Physical & Rehabilitation – Principles and Practice. 5th Edition. Baltimore, Maryland: Lippincott Williams & Wilkins, 2010:837‐82.

Porter 1996

Porter RW. Spinal stenosis and neurogenic claudication. Spine 1996;21(17):2046‐52.

Postacchini 1999

Postacchini F. Surgical management of lumbar spinal stenosis. Spine 1999;15(24):1043‐7.

Sobottke 2010

Sobottke R, Röllinghoff M, Siewe J, Schlegel U, Yagdiran A, Spangenberg M, et al. Clinical outcomes and quality of life 1 year after open microsurgical decompression or implantation of an interspinous stand‐alone spacer. Minimally Invasive Neurosurgery 2010;53(4):179‐83.

Stucki 1995

Stucki G, Liang MH, Fossel AH, Katz JN. Relative responsiveness of condition‐specific and generic health status measures in degenerative lumbar spinal stenosis. Journal of Clinical Epidemiology 1995;48(11):1369‐78.

Taylor 1994

Taylor VM,  Deyo RA,  Cherkin DC,  Kreuter W. Low back pain hospitalization. Recent United States trends and regional variations. Spine 1994;19(11):1207‐12; discussion 13.

Tomkins 2009

Tomkins CC, Battié MC, Rogers T, Jiang H, Petersen S. A criterion measure of walking capacity in lumbar spinal stenosis and its comparison with a treadmill protocol. Spine (Phila Pa 1976) 2009;34(22):2444‐9.

Tomkins 2010

Tomkins CC, Dimoff KH, Forman HS, Gordon ES, McPhail J, Wong JR, et al. Physical therapy treatment options for lumbar spinal stenosis. Journal of Back and Musculoskeletal Rehabilitation 2010;23(1):31‐7.

Tomkins‐Lane 2012

Tomkins‐Lane CC, Holz SC, Yamakawa KS, Phalke VV, Quint DJ, Miner J, et al. Predictors of walking performance and walking capacity in people with lumbar spinal stenosis, low back pain, and asymptomatic controls. Archives of Physical Medicine and Rehabilitation 2012;93(4):647‐53.

Tomkins‐Lane 2012b

Tomkins‐Lane CC, Haig AJ. A review of activity monitors as a new technology for objectifying function in lumbar spinal stenosis. Journal of Back and Musculoskeletal Rehabilitation 2012;25(3):177‐85.

Tomkins‐Lane 2015

Tomkins‐Lane CC, Lafave LM, Parnell JA, Rempel J, Moriartey S, Andreas Y, et al. The spinal stenosis pedometer and nutrition lifestyle intervention (SSPANLI): development and pilot. The Spine Journal 2015;15(4):577‐86.

van Tulder 2003

van Tulder M, Furlan A, Bombardier C, Bouter L, Editorial Board Cochrane Back Review Group. Updated method guidelines for systemic reviews in the Cochrane Collaboration Back Review Group. Spine 2003;28(12):1290‐9.

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Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, et al. Surgical versus non surgical treatment for lumbar degenerative spondylolisthesis. New England Journal of Medicine 2007;356(22):2257‐70.

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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. Physical Medicine and Rehabilitation Clinics of North America 2003;14:77‐101.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Amundsen 2000

Methods

Randomised controlled trial

Participants

100 patients with symptomatic lumbar spinal stenosis, 54 men and 46 women whose median age was 59 years (range 16 to 77 years). From these patients, a group S (n = 19) was selected for surgical treatment because of the severity of their symptoms, and a group C (n = 50), with milder pain, was selected for conservative treatment. Remaining patients, group R (n = 31), whose severity of pain left the physician in doubt concerning which treatment to recommend, was randomly assigned to surgical treatment (group RS (n = 13) or conservative treatment (group RC (n = 18)

Inclusion criteria: sciatic pain in the leg(s), with or without pain in the back, together with radiological signs of stenosis and compression of clinically afflicted nerve root(s)

Exclusion criteria: bulging or herniated disc, spondylolysis, coxarthrosis, gonarthrosis, arterial insufficiency in the legs, polyneuropathy, concomitant serious disease, previous surgery on the back

Interventions

Surgical procedure: standardised for the purpose of nerve decompression by partial or total laminectomy, medial facetectomy, discectomy and/or removal of osteophytes from the vertebral margins or facet joints. Hypertropic ligamenta flava were removed if necessary. No fusions were performed

Conservative treatment: fitted with an orthosis and transferred to the rehabilitation department for 1 month. No regular physiotherapy was given, except for instruction and "back school"

Outcomes

Outcomes: Visual Analogue Pain Scale, Verbal Rating Scale, Subjective Change (better, worse or unchanged), Work Status, Subjective Physician Rating (excellent, fair, unchanged, worse)

Time points: 6 months, 12 months, 4 years, 10 years

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Block randomisation using tables of random numbers

Allocation concealment (selection bias)

Unclear risk

Details not provided

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of participants not possible for the types of interventions compared

Incomplete outcome data (attrition bias)
All outcomes

High risk

Only completers included

Selective reporting (reporting bias)

High risk

Data not fully reported

Group similarity at baseline (selection bias)

Low risk

Similar characteristics between groups at baseline

Co‐interventions (performance bias)

Low risk

No co‐intervention unbalance

Compliance (performance bias)

High risk

Compliance not monitored for conservative treatment group

Intention‐to‐treat‐analysis

Low risk

ITT performed

Timing of outcome assessments (detection bias)

Low risk

Similar timing for both groups

Other bias

High risk

High dropout rate

Brown 2012

Methods

Double‐blind randomised prospective study

Participants

38 participants were randomly assigned to 2 treatment groups, with 21 included in the mild group and 17 in the ESI group

Inclusion criteria: patients with symptomatic LSS with painful lower limb neurogenic claudication and hypertrophic ligamentum flavum as a contributing factor. All patients were at least 18 years of age, had previously failed conservative therapy and presented with an Oswestry Disability Index (ODI) score > 20. Radiological evidence showed LSS (L3–L5), ligamentum flavum > 2.5 mm confirmed by preoperative MRI or CT, central canal cross‐sectional area £ 100 mm2 and anterior listhesis confirmed at £ 5.0 mm for all patients. All were able to walk at least 10 feet unaided before they were limited by pain

Exclusion criteria: prior surgery at the intended treatment level or previous treatment with epidural steroids. History of recent spinal fracture, disabling back or leg pain from causes other than LSS, fixed spondylolisthesis

> grade 1, disc protrusion or osteophyte formationor excessive facet hypertrophy. Patients with bleeding disorders, current use of anticoagulants or wound healing pathologies deemed to compromise outcomes, such as diabetes, cancer, and severe COPD; and those who had used ASA or NSAID within 5 days of treatment were not eligible
Finally, patients who were pregnant or breastfeeding, unable to lie prone for any reason with anaesthesia support, unable to give informed consent, on Workman’s Compensation or considering litigation associated with back pain were excluded

Interventions

Conservative treatment (epidural steroid treatment): Participants received 80 mg of triamcinolone acetate (40 mg in diabetic patients) mixed with 6 mL of preservative‐free saline injected in divided doses at treated levels. Injections were delivered at the level of pathology with fluoroscopy and radiographic contrast used to document accurate placement of the steroid into the epidural space. In addition, skin anaesthesia and a small incision, followed by trocar placement under fluoroscopy as with the mild procedure, were performed. No bone or tissue was removed, and thus, no decompression procedure was performed. Wounds were dressed and cared for postoperatively identically to those in the mild treatment group. Individuals randomly assigned to mild received no steroid

Surgical treatment: mild lumbar decompression procedure performed. Mild devices are designed to access the interlaminar space from the posterior lumbar spine, enabling removal of small portions of lamina and hypertrophic ligamentum flavum, thereby achieving lumbar decompression. Initially, the mild patient is placed in the prone position for posterior spinal access. Frequently, a bolster is used to open the spinal anatomy for treatment. An epidurogram is performed at the beginning of the procedure for the purpose of identifying the border of the dural and epidural space relative to the ligamentum flavum and interlaminar space. On the basis of these visual landmarks, the mild trocar and portal system is advanced under manual control and is positioned under fluoroscopic guidance. The trocar is then removed, and the 6‐gauge mild portal is secured in place, with the portal stabiliser becoming the percutaneous working port for the procedure. The bone sculpter rongeur is advanced through the secured portal to the laminar bone surface. This device is used to precisely cut and remove very small pieces of bone until access to the ligamentous tissue has been created. The mild tissue sculpter is then placed through the portal and through the laminotomy to excise portions of hypertrophic ligamentum flavum. Progressive tissue cuts are performed to the inferior edge and under the ventral surface of the lamina, under fluoroscopic guidance. The amount of decompression is assessed through visual observation of epidurogram contrast flow, as the flow becomes thicker and straighter. Once the procedure is complete, the mild portal and stabiliser assembly is removed. No implants are left behind, and the site is closed with a sterile adhesive strip. The mild procedure is usually performed with only light sedation and local anaesthetic

Outcomes

Outcomes: Visual Analogue Pain Scale, Oswestry Disability Index, Zurich Claudication Questionnaire

Time points: 6 weeks, 12 weeks

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation determined by the independent statistician in blocks of 4

Allocation concealment (selection bias)

Low risk

Neither enrolling physician nor participant was aware of the participant's ultimate treatment group

Blinding (performance bias and detection bias)
All outcomes

Low risk

Both groups received skin anaesthesia and a small incision. Wounds were dressed and cared for identically postoperatively. Participants and raters were blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All outcomes reported

Selective reporting (reporting bias)

Low risk

All outcomes reported

Group similarity at baseline (selection bias)

Low risk

Similar characteristics between groups at baseline

Co‐interventions (performance bias)

Low risk

No co‐intervention unbalance

Compliance (performance bias)

Low risk

Similar compliance for both groups

Intention‐to‐treat‐analysis

Unclear risk

ITT performed

Timing of outcome assessments (detection bias)

Unclear risk

Similar timing for both groups

Other bias

Unclear risk

No further details available

Malmivaara 2007

Methods

Randomised controlled trial

Participants

94 participants were randomly assigned to a surgical or non‐operative treatment group: 50 (age 62 ± 9) and 44 participants (63 ± 9), respectively

Inclusion criteria: back pain radiation to lower limbs or buttocks; fatigue or loss of sensation in the lower limbs aggravated by walking; persistent pain without progressive neurological dysfunction; imaging techniques: spinal canal narrowing, sagittal diameter of the dural sac < 10 mm2 or planimetrically assessed cross‐sectional dural area < 75 mm; duration of symptoms and signs > 6 months; clinical signs and symptoms corresponding to segmental radiographic level of stenosis; severity of the disease justifying surgical or non‐operative treatment

Exclusion criteria: severe LSS with intractable pain and progressive neurological dysfunction, suggesting forthcoming surgical treatment; mild LSS, characterised by radiographic narrowing of the lumbar spinal canal, but clinical signs and symptoms feeble enough to exclude surgical intervention; spinal stenosis not caused by degeneration, e.g. congenital spinal stenosis; spondylolysis and spondylolytic spondylolisthesis; previous back operation due to spinal stenosis or instability; lumbar herniated disc diagnosed during last 12 months; another specific spinal disorder, e.g. ankylosing spondylitis, neoplasm or metabolic disease; intermittent claudication due to atherosclerosis; severe osteoarthrosis or arthritis causing dysfunction of the lower limbs; neurological disease causing impaired function of the lower limbs, including diabetic neuropathy; psychiatric disorders; alcoholism

Interventions

Surgical group: segmental decompression and an undercutting facetectomy of the affected area performed. Presence or risk of lumbar instability was, at the surgeon’s discretion, treated by fusion of the lumbar spine, if necessary, augmented by transpedicular instrumentation. Treated individuals also received a brochure and instructions about pain relief and management

Conservative treatment: non‐steroidal anti‐inflammatory drugs prescribed when indicated and individuals referred to physiotherapists. Participants were seen 1 to 3 times by a physiotherapist, in addition to the standard visit at each follow‐up occasion. The physiotherapist gave all participants a printed brochure describing the nature of spinal stenosis, characteristic symptoms and signs of the disease and the principles of activation and physical training
Participants were encouraged to use their back in a normal way. Pain‐relieving body postures were taught to participants as well as basic ergonomics related to lifting and carrying. Individually structured programmes included trunk muscle endurance and stretching‐type exercises. Additional individual physiotherapy consisting of passive treatment methods (such as ultrasound and transcutaneous nerve stimulation) and/or active back exercises was prescribed by a physiatrist to 24% (10 participants) of the non‐operative study group

Outcomes

Outcomes: 11‐point numerical pain scale for leg and back, Oswestry Disability Index, walking ability (distance without a break measured by treadmill), General Health Status (very good, quite good, average, quite poor, very poor)

Time points: 6, 12 and 24 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random blocks of variable size separate for each hospital

Allocation concealment (selection bias)

Unclear risk

Details not provided

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of participants not possible for the types of interventions compared

Incomplete outcome data (attrition bias)
All outcomes

High risk

Analysis performed only for completers

Selective reporting (reporting bias)

Low risk

All outcomes reported

Group similarity at baseline (selection bias)

Unclear risk

Similar characteristics between groups at baseline

Co‐interventions (performance bias)

High risk

Co‐intervention unbalanced in control groups as 24% performed supplementary exercise

Compliance (performance bias)

High risk

Compliance not monitored in the control group

Intention‐to‐treat‐analysis

Low risk

ITT performed

Timing of outcome assessments (detection bias)

Low risk

Similar timing of outcome assessments for both groups

Other bias

Unclear risk

Insufficient details given

Weinstein 2008

Methods

Multi‐centre randomised controlled trial and prospective observational study

Participants

289 participants with a history of neurogenic claudication or radicular leg symptoms ≥ 12 weeks and confirmatory cross‐sectional imaging showing lumbar spinal stenosis at ≥ 1 level were included in the randomly assigned arm. Mean age 65.5 ± 10.5, females 38%. Patients with degenerative spondylolisthesis on instability were excluded. 138 participants were assigned to the surgical group, and 151 to the non‐surgical group

Interventions

The protocol surgery was standard posterior decompressive laminectomy. The non‐surgical protocol consisted of “usual care”, which was recommended to include at least active physical therapy, education or counselling with home exercise instruction and administration of non‐steroidal anti‐inflammatory drugs, if tolerated

Outcomes

Outcomes: SF‐36, Oswestry Disability Index (MODEMS version), Low Back Pain Bothersomeness Scale, Leg Pain Bothersomeness Scale, Stenosis Bothersomeness Index, Self‐Reported Satisfaction

Time points: 6 weeks, 3 months, 6 months, and 1, 2 and 4 years

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block randomisation with variable clock size stratified according to centre

Allocation concealment (selection bias)

Unclear risk

Details not provided

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of participants not possible because of the types of interventions compared

Incomplete outcome data (attrition bias)
All outcomes

High risk

Large number of cross‐overs made ITT impossible after the first phase

Selective reporting (reporting bias)

Low risk

All outcomes reported

Group similarity at baseline (selection bias)

High risk

Worst pain, function and disability at baseline in surgery group

Co‐interventions (performance bias)

Unclear risk

No co‐intervention unbalance

Compliance (performance bias)

High risk

Compliance not monitored in the control group

Intention‐to‐treat‐analysis

High risk

Large number of cross‐overs made ITT impossible after first phase data from the randomly assigned arm were mixed with those from the observational arm. Data from the randomly assigned arm were presented separately only for the as‐treated protocol

Timing of outcome assessments (detection bias)

Low risk

Similar for both groups

Other bias

Unclear risk

Insufficient details given

Zucherman 2004

Methods

Multi‐centre randomised clinical trial

Participants

Nine centres randomly assigned 200 participants between May of 2000 and July of 2001, in a prospective, controlled trial. Of 200 participants enrolled in this study, 191 were treated: 100 in the X STOP group and 91 in the conservative group. Most of the 9 patients from conservative group who withdrew from the study before receiving their initial epidural injection entered the study with the hope of being randomly assigned to the X STOP group

Inclusion criteria: ≥ 50 years of age with leg, buttock or groin pain, with or without back pain, that could be relieved during flexion; able to sit for 50 minutes without pain and to walk 50 or more feet; completed ≥ 6 months of non‐operative therapy. Stenosis was confirmed by CT or MRI scans at 1 or 2 levels

Primary exclusion criteria: fixed motor deficit, cauda equina syndrome,
significant lumbar instability, previous lumbar surgery, significant peripheral neuropathy or acute denervation secondary
to radiculopathy, scoliotic Cobb angle > 25°, spondylolisthesis > grade 1.0 (on a scale of 1 to 4) at the affected level, sustained pathological fractures or severe osteoporosis, obesity, active infection or systemic disease, Paget’s disease or metastasis to the vertebrae, steroid use for longer than 1 month within 12 months preceding the start of the study

Interventions

Participants enrolled in the X STOP group underwent surgery for implantation of the interspinous implant. Those randomly assigned to the conservative group received ≥ 1 epidural steroid injection and could receive non‐steroidal anti‐inflammatory drugs, analgesics and physical therapy. Physical therapy consisted of back school and modalities such as ice packs, heat packs, massage, stabilisation exercises and pool therapy. Braces, such as abdominal binders and corsets, were permitted, but body jackets and chair‐back braces were not allowed

Outcomes

Outcomes: SF‐36, Zurich Claudication Questionnaire (ZCQ), Oswestry Disabilty Index, Worker's Compensation Claim, radiographic changes

Time points: 6 weeks, 6 months, 1 year

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Block randomisation by surgical centre

Allocation concealment (selection bias)

Low risk

After baseline examination and questionnaires were completed, treating physician phoned the central office, gave participant identification data and received treatment allocation

Blinding (performance bias and detection bias)
All outcomes

High risk

Blinding of participants not possible for the types of interventions compared

Incomplete outcome data (attrition bias)
All outcomes

High risk

Only data from completers used

Selective reporting (reporting bias)

Low risk

All outcomes reported

Group similarity at baseline (selection bias)

Low risk

Similar groups at baseline

Co‐interventions (performance bias)

High risk

Co‐interventions not standardised and not properly described

Compliance (performance bias)

High risk

Compliance not monitored for the control group

Intention‐to‐treat‐analysis

Unclear risk

Not described

Timing of outcome assessments (detection bias)

Unclear risk

Similar timing for both groups

Other bias

Unclear risk

Not clear

Abbreviations:

ASA: acetylsalicylic acid.

COPD: chronic obstructive pulmonary disease.

CT: computed tomography.

ESI: epidural steroid injections

ITT: intention‐to‐treat.

LSS: lumbar spinal stenosis.

MRI: magnetic resonance imaging.

ODI: Oswestry Disability Index.

SF‐36: Short Form 36.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Athiviraham 2007

Not randomly assigned

Atlas 1996

Not randomly assigned

Chang 2005

Not randomly assigned

Croft 2012

Review, not original data

Hurri 1998

Not randomly assigned

Keller 1996

Protocol of a cohort study

Malmivaara 2007a

Commentary, no data

Mariconda 2002

Not randomly assigned

Ohtori 2014

Not randomly assigned

Paker 2005

Not randomly assigned

Pearson 2011

Mixed population including spondylolisthesis

Tosteson 2011

Cost‐effectiveness analysis of mixed population including spondylolisthesis and disc herniation

Characteristics of studies awaiting assessment [ordered by study ID]

Delitto 2015

Methods

Multi‐site randomised controlled trial

Participants

169 participants with lumbar spinal stenosis (LSS) 50 years of age or older. 87 underwent surgery and 82 physical therapy (PT)

Interventions

Surgical decompression vs physical therapy

Outcomes

Mean improvement in physical function for surgery and PT groups was 22.4 (95% confidence interval (CI) 16.9 to 27.9) and 19.2 (95% CI 13.6 to 24.8), respectively Intention‐to‐treat analyses revealed no differences between groups (24‐month difference 0.9, 95% CI ‐7.9 to 9.6). Sensitivity analyses using causal‐effects methods to account for the high proportion of cross‐overs from PT to surgery (57%) showed no significant differences in physical function between groups

Notes

Characteristics of ongoing studies [ordered by study ID]

Overdevest 2011

Trial name or title

Verbiest

Methods

Multi‐centre randomised controlled trial

Participants

Patients (> 50 years of age) with ≥ 3 months of complaints of neurogenic intermittent claudication and considering surgical treatment are eligible for inclusion

Interventions

Prolonged conservative treatment vs surgery

Outcomes

Primary

  • Zurich Claudication Questionnaire

  • Shuttle walking test

Secondary

  • Demographic data

  • Neurological/clinical investigations

  • Modified Roland Disabilty Questionnaire

  • Visual analogue scale (VAS) for pain in back and leg

  • Perceived recovery

  • Short Form (SF)‐36/30

  • Societal costs and utilities (European Organization for Research and Treatment of Cancer core quality of life questionnaire (EuroQol‐5D), visual analogue scale)

  • Complications

  • Reoperation incidence

  • Operative data

  • Imaging findings

  • Participant's, neurologist’s, neurosurgeon’s, general practitioner's (GP’s) preferences at baseline

  • Timed‐up and go test

  • Short physical performance battery (SPPB)

  • MicroFET (Force Evaluating and Testing)

  • Grip strength

  • Accelerometry

Starting date

N/A

Contact information

Notes

NTR2216

Data and analyses

Open in table viewer
Comparison 1. Decompression ± fusion vs usual conservative care for Oswestry Disability Index

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Oswestry Disability Index Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Decompression ± fusion vs usual conservative care for Oswestry Disability Index, Outcome 1 Oswestry Disability Index.

Comparison 1 Decompression ± fusion vs usual conservative care for Oswestry Disability Index, Outcome 1 Oswestry Disability Index.

1.1 6 months

2

349

Mean Difference (IV, Random, 95% CI)

‐3.66 [‐10.12, 2.80]

1.2 1 year

2

340

Mean Difference (IV, Random, 95% CI)

‐6.17 [‐15.02, 2.67]

1.3 2 years

2

315

Mean Difference (IV, Random, 95% CI)

‐4.43 [‐7.91, ‐0.96]

2 Pain Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.2

Comparison 1 Decompression ± fusion vs usual conservative care for Oswestry Disability Index, Outcome 2 Pain.

Comparison 1 Decompression ± fusion vs usual conservative care for Oswestry Disability Index, Outcome 2 Pain.

2.1 3 months

1

31

Risk Ratio (M‐H, Fixed, 95% CI)

1.38 [0.22, 8.59]

2.2 4 years

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

7.5 [1.00, 56.48]

2.3 10 years

1

29

Risk Ratio (M‐H, Fixed, 95% CI)

4.09 [0.95, 17.58]

Open in table viewer
Comparison 2. Epidural steroid injection vs decompression with or without fusion

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Oswestry Disability Index Show forest plot

1

38

Mean Difference (IV, Fixed, 95% CI)

5.7 [0.57, 10.83]

Analysis 2.1

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 1 Oswestry Disability Index.

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 1 Oswestry Disability Index.

1.1 6 weeks

1

38

Mean Difference (IV, Fixed, 95% CI)

5.7 [0.57, 10.83]

2 Visual Analogue Scale Show forest plot

1

38

Mean Difference (IV, Fixed, 95% CI)

2.4 [1.92, 2.88]

Analysis 2.2

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 2 Visual Analogue Scale.

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 2 Visual Analogue Scale.

2.1 6 weeks

1

38

Mean Difference (IV, Fixed, 95% CI)

2.4 [1.92, 2.88]

3 Zurich Claudication Questionnaire Show forest plot

1

38

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐0.77, ‐0.43]

Analysis 2.3

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 3 Zurich Claudication Questionnaire.

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 3 Zurich Claudication Questionnaire.

3.1 6 weeks

1

38

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐0.77, ‐0.43]

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Forest plot of comparison: 1 Decompression ± fusion vs usual non‐operative care for Oswestry Disability Index, outcome: 1.1 Oswestry Disability Index [%].
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Decompression ± fusion vs usual non‐operative care for Oswestry Disability Index, outcome: 1.1 Oswestry Disability Index [%].

Forest plot of comparison: 1 Decompression ± fusion versus usual non‐operative care for adverse events.
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 Decompression ± fusion versus usual non‐operative care for adverse events.

Comparison 1 Decompression ± fusion vs usual conservative care for Oswestry Disability Index, Outcome 1 Oswestry Disability Index.
Figuras y tablas -
Analysis 1.1

Comparison 1 Decompression ± fusion vs usual conservative care for Oswestry Disability Index, Outcome 1 Oswestry Disability Index.

Comparison 1 Decompression ± fusion vs usual conservative care for Oswestry Disability Index, Outcome 2 Pain.
Figuras y tablas -
Analysis 1.2

Comparison 1 Decompression ± fusion vs usual conservative care for Oswestry Disability Index, Outcome 2 Pain.

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 1 Oswestry Disability Index.
Figuras y tablas -
Analysis 2.1

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 1 Oswestry Disability Index.

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 2 Visual Analogue Scale.
Figuras y tablas -
Analysis 2.2

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 2 Visual Analogue Scale.

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 3 Zurich Claudication Questionnaire.
Figuras y tablas -
Analysis 2.3

Comparison 2 Epidural steroid injection vs decompression with or without fusion, Outcome 3 Zurich Claudication Questionnaire.

Decompression ±fusion vs usual conservative care for Oswestry Disabilty Index and Visual Analogue Pain Scale (VAS) for lumbar spinal stenosis

Patient or population: lumbar spinal stenosis

Intervention: decompression ± fusion

Comparison: usual conservative care

Outcomes

Relative effect
(95% CI)

Outcome means

Number of participants
(studies)

Quality of the evidence
(GRADE)

Oswestry Disability Index ‐ 6 months

(0 to 100%)

(MD ‐3.66%, 95% CI ‐10.12 to 2.80)

Decompression range: 20.7 to 28.1

Usual conservative care range: 28.3 to 29.0

349 (2)

⊕⊕⊝⊝
Low

Oswestry Disability Index ‐ 1 year

(0 to 100%)

(MD ‐6.17%, 95% CI ‐15.02 to 2.67)

Decompression range: 18.9 to 27.8

Usual conservative care range: 30.0 to 30.2

340 (2)

⊕⊕⊝⊝
Low

Oswestry Disability Index ‐ 2 years

(0 to 100%)

(MD ‐4.43%, 95% CI ‐7.91 to ‐0.96)

Decompression range: 21.2 to 26.3

Usual conservative care range: 29 to 29.8

315 (2)

⊕⊕⊝⊝
Low

Pain ‐ 3 months

(0 to 10)

(RR 1.38, 95% CI 0.22 to 8.59)

Decompression: 5.45

Usual conservative care: 2.81

31 (1)

⊕⊕⊝⊝
Low

Pain ‐ 4 years

(0 to 10)

(RR 7.50, 95% CI 1.00 to 56.48)

Decompression: 5.05

Usual conservative care: 2.72

30 (1)

⊕⊕⊝⊝
Low

Pain ‐ 10 years

(0 to 10)

(RR 4.09, 95% CI 0.95 to 17.58)

Decompression: 4.87

Usual conservative care: 2.74

29 (1)

⊕⊕⊝⊝
Low

CI: confidence interval; MD: mean difference; RR: risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

Studies failed on 3 of 5 GRADE factors, including:

  • bias: All but 1 study had high bias risk;

  • design: All but 1 study were not blinded; and

  • imprecision: Only 1 study presented compete outcome data.

Figuras y tablas -

Epidural steroid injection vs mild decompression ±fusion for lumbar spinal stenosis

Patient or population: lumbar spinal stenosis

Intervention: epidural steroid injection

Comparison: decompression ± fusion

Outcomes

Relative effect
(95% CI)

Outcome means

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Oswestry Disability Index ‐ 6 weeks

(MD 5.70, 95% CI 0.57 to 10.83)

Epidural injection: 34.8

Mild decompression: 27.4

38 (1)

⊕⊕⊝⊝
Low

Visual Analogue Scale (VAS) ‐ 6 weeks

(MD 2.40, 95% CI 1.92 to 2.88)

Epidural injection: 6.3

Mild decompression: 3.8

38 (1)

⊕⊕⊝⊝
Low

Zurich Claudication Questionnaire ‐ 6 weeks

(MD ‐0.60, 95% CI ‐0.77 to ‐0.43)

Epidural injection: 2.8

Mild decompression: 2.2

38 (1)

⊕⊕⊝⊝
Low

CI: confidence interval; MD: mean difference
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

Although this study had low risk of bias, this was the only study examined. Further research is very likely to have an impact on our confidence

Figuras y tablas -
Comparison 1. Decompression ± fusion vs usual conservative care for Oswestry Disability Index

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Oswestry Disability Index Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 6 months

2

349

Mean Difference (IV, Random, 95% CI)

‐3.66 [‐10.12, 2.80]

1.2 1 year

2

340

Mean Difference (IV, Random, 95% CI)

‐6.17 [‐15.02, 2.67]

1.3 2 years

2

315

Mean Difference (IV, Random, 95% CI)

‐4.43 [‐7.91, ‐0.96]

2 Pain Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 3 months

1

31

Risk Ratio (M‐H, Fixed, 95% CI)

1.38 [0.22, 8.59]

2.2 4 years

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

7.5 [1.00, 56.48]

2.3 10 years

1

29

Risk Ratio (M‐H, Fixed, 95% CI)

4.09 [0.95, 17.58]

Figuras y tablas -
Comparison 1. Decompression ± fusion vs usual conservative care for Oswestry Disability Index
Comparison 2. Epidural steroid injection vs decompression with or without fusion

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Oswestry Disability Index Show forest plot

1

38

Mean Difference (IV, Fixed, 95% CI)

5.7 [0.57, 10.83]

1.1 6 weeks

1

38

Mean Difference (IV, Fixed, 95% CI)

5.7 [0.57, 10.83]

2 Visual Analogue Scale Show forest plot

1

38

Mean Difference (IV, Fixed, 95% CI)

2.4 [1.92, 2.88]

2.1 6 weeks

1

38

Mean Difference (IV, Fixed, 95% CI)

2.4 [1.92, 2.88]

3 Zurich Claudication Questionnaire Show forest plot

1

38

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐0.77, ‐0.43]

3.1 6 weeks

1

38

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐0.77, ‐0.43]

Figuras y tablas -
Comparison 2. Epidural steroid injection vs decompression with or without fusion