Review ArticleAn evidence-based clinical guideline for the diagnosis and treatmentof lumbar disc herniation with radiculopathyD.Scott Kreiner,MD a ,*,Steven W.Hwang,MD b ,JohnE.Easa,MD c ,Daniel K.Resnick,MD d ,Jamie L.Baisden,MD e ,Shay Bess,MD f ,Charles H.Cho,MD,MBA g ,Michael J.DePalma,MD h ,Paul Dougherty,II,DC i ,Robert Fernand,MD j ,Gary Ghiselli,MD k ,Amgad S.Hanna,MD l ,Tim Lamer,MD m ,Anthony J.Lisi,DC n ,Daniel J.Mazanec,MD o ,Richard J.Meagher,MD p ,Robert C.Nucci,MD q ,Rakesh D.Patel,MD r ,Jonathan N.Sembrano,MD s ,Anil K.Sharma,MD t ,Jeffrey T.Summers,MD u ,Christopher K.Taleghani,MD v ,William L.Tontz,Jr.,MD w ,John F.Toton,MD xaAhwatukee Sports and Spine,4530E.Muirwood Dr,Suite 110,Phoenix,AZ 85048-7693,USA bDepartment of Neurosurgery,Tufts Medical Center,800Washington St,Boston,MA 02111-1552,USAcThe College of Human Medicine,Michigan State University,12662Riley St,Suite 120,Holland,MI 49424-8023,USAdDepartment Neurosurgery,University of Wisconsin Medical School,K4/834Clinical Science Center,600Highland,Madison,WI 53792-0001,USAeDepartment of Neurosurgery,Medical College of Wisconsin,9200W.Wisconsin Ave.,Milwaukee,WI 53226-3522,USAfRocky Mountain Scoliosis and Spine,2055High St,Suite 130,Denver,CO 80205-5504,USAgBrigham and Women’s Hospital,75Francis St,Boston,MA 02115-6110,USAh2918Calcutt Drive,Midlothian,VA 23113-2681,USA i2000Van Auken Rd,Newark,NY 14513-9221,USA j160Cheyenne Way,Wayne,NJ 07470-4907,USAkDenver Spine,7800E.Orchard Rd,Suite 100,Greenwood Village,CO 80111-2584,USAl9120Bear Claw Way,Madison,WI 53717-2734,USAmMayo Clinic Rochester,2001st St SW,Eisenberg 8G,Rochester,MN 55905-0001,USA nVACT Healthcare System,950Campbell Ave.,Bldg 2,Floor 4,West Haven,CT 06516-2770,USA oCleveland Clinic Spine Institute,9500Euclid Ave.,C21,Cleveland,OH 44195-0001,USAp2152Susquehanna Rd,Abington,PA 19001-4408,USA q6322Gunn Hwy,Tampa,FL 33625-4105,USArUniversity of Michigan,1500E.Medical Center Drive,Ann Arbor,MI 48109-5000,USA sUniversity of Minnesota,2450Riverside Ave.S.,Suite R200,Minneapolis,MN 55454-1450,USAtSpine and Pain Medicine,2Mockingbird Drive,Colts Neck,NJ 07722-2228,USA uNewSouth NeuroSpine,2470Flowood Drive,Flowood,MS 39232-9019,USAvCumberland Brain and Spine,3901Central Pike,Suite 455,Hermitage,TN 37076-3490,USAw3413Mount Ariane Drive,San Diego,CA 92111-3910,USA x4866Hoen Ave.,Santa Rosa,CA 95405-7452,USA Received 7August 2013;accepted 14August 2013AbstractBACKGROUND CONTEXT:The objective of the North American Spine Society’s (NASS)Ev-idence-Based Clinical Guideline for the Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy is to provide evidence-based recommendations to address key clinical questions sur-rounding the diagnosis and treatment of lumbar disc herniation with radiculopathy.The guideline is intended to reflect contemporary treatment concepts for symptomatic lumbar disc herniation with radiculopathy as reflected in the highest quality clinical literature available on this subject as of July 2011.The goals of the guideline recommendations are to assist in delivering optimum efficacious treatment and functional recovery from this spinal disorder.FDA device/drug status:Not applicable.Author disclosures:Listed at the end of this article.*Corresponding author.Ahwatukee Sports and Spine,4530E.Muir-wood Dr.,Suite 110,Phoenix,AZ 85048-7693,USA.Tel.:(480)763-5808.E-mail address :skreiner@ (D.S.Kreiner)1529-9430/$-see front matter Ó2014Elsevier Inc.All rights reserved./10.1016/j.spinee.2013.08.003The Spine Journal 14(2014)180–191PURPOSE:To provide an evidence-based educational tool to assist spine specialists in the diag-nosis and treatment of lumbar disc herniation with radiculopathy.STUDY DESIGN:Systematic review and evidence-based clinical guideline.METHODS:This guideline is a product of the Lumbar Disc Herniation with Radiculopathy WorkGroup of NASS’Evidence-Based Guideline Development Committee.The work group consisted ofmultidisciplinary spine care specialists trained in the principles of evidence-based analysis.A liter-ature search addressing each question and using a specific search protocol was performed onEnglish-language references found in Medline,Embase(Drugs and Pharmacology),and four addi-tional evidence-based databases to identify articles.The relevant literature was then independentlyrated using the NASS-adopted standardized levels of evidence.An evidentiary table was created foreach of the questions.Final recommendations to answer each clinical question were developed viawork group discussion,and grades were assigned to the recommendations using standardizedgrades of recommendation.In the absence of Level I to IV evidence,work group consensus state-ments have been developed using a modified nominal group technique,and these statements areclearly identified as such in the guideline.RESULTS:Twenty-nine clinical questions were formulated and addressed,and the answers aresummarized in this article.The respective recommendations were graded by strength of the support-ing literature,which was stratified by levels of evidence.CONCLUSIONS:The clinical guideline has been created using the techniques of evidence-basedmedicine and best available evidence to aid practitioners in the care of patients with symptomaticlumbar disc herniation with radiculopathy.The entire guideline document,including the evidentiarytables,suggestions for future research,and all the references,is available electronically on theNASS Web site at /Pages/PracticePolicy/ClinicalCare/ClinicalGuidlines/Default.aspx and will remain updated on a timely schedule.Ó2014Elsevier Inc.All rightsreserved.Keywords:Lumbar disc herniation;Radiculopathy;GuidelineIntroductionIn an attempt to improve and evaluate the knowledge base concerning the diagnosis and treatment of lumbar disc herniation with radiculopathy,the Lumbar Disc Herniation with Radiculopathy Work Group of the North American Spine Society’s(NASS)Evidence-Based Clini-cal Guideline Development Committee developed an evidence-based clinical guideline on this topic.The Insti-tute of Medicine has defined a clinical guideline as ‘‘systematically developed statements to assist practitioner and patient decisions about health care for specific clinical situations’’[1].The application of the principles of evidence-based med-icine(EBM)to guideline development helps to create an ex-plicit linkage between thefinal recommendations in the guideline and the evidence on which these recommendations are based[2].When employing the principles of EBM,the clinical literature is extensively searched to answer specific questions about a disease state or medical condition.The lit-erature that is identified in the search is then rated as to its scientific merit using levels of evidence,determined by spe-cific rule sets that apply to human clinical investigations.The specific questions asked are then answered using studies of the highest possible levels of evidence that have been ob-tained from the searches.As afinal step,the answers to the clinical questions are reformulated as recommendations that are assigned grades of strength related to the best clini-cal evidence available at the time of answering each question.The intent of the grade of recommendation is to in-dicate the strength of the evidence used by the work group in answering the question asked.MethodsFor this clinical guideline,the guideline development process was broken down into11steps.In Step1,guideline participants,trained in the principles of EBM,submitted a list of clinical questions focused on diagnosis and treat-ment of lumbar disc herniation with radiculopathy that the guideline should address.Step2consisted of assigning work group members to a set of clinical questions.Step3con-sisted of each group identifying appropriate search terms and parameters to direct the literature search according to the NASS-instituted Literature Search Protocol.The litera-ture search was then completed in Step4by a medical re-search librarian according to the NASS Literature Search Protocol and stored in a cross-referencing database for future use or reference.The following electronic databases were searched for English-language publications:Medline (PubMed),ACP Journal Club,Cochrane Database of Sys-tematic Reviews,Database of Abstracts of Reviews of Effec-tiveness,Cochrane Central Register of Controlled Trials, Embase(Drugs and Pharmacology),and Web of Science.In Step5,work group members reviewed all the ab-stracts from the literature search.The best research evi-dence available was identified and used to answer the181D.S.Kreiner et al./The Spine Journal14(2014)180–191targeted clinical questions.That is,if adequate Level I, Level II,or Level III studies were available to answer a spe-cific question,the work group was not required to review Level IV or Level V evidence.Members independently de-veloped evidentiary tables summarizing study conclusions, identifying strengths and weaknesses,and assigning levels of evidence in Step6.To systematically control for bias, at least three work group members reviewed each article se-lected and independently assigned a level of evidence as per the NASS levels of evidence table.In Step7,work group members participated in webcasts to update and formulate evidence-based recommendations and incorporate expert opinion when necessary.Expert physician opinion was incorporated only where Level I to IV evidence was insufficient,and the work groups deemed a recommenda-tion was warranted.For transparency in the incorporation of consensus,all consensus-based recommendations in this guideline are clearly stated as such.V oting on guideline rec-ommendations was conducted using a modification of the nominal group technique in which each work group member independently and anonymously ranked a recommendation on a scale ranging from1(‘‘extremely inappropriate’’)to9 (‘‘extremely appropriate’’)[3].Consensus was obtained when at least80%of work group members ranked the recom-mendation as7,8,or9.When the80%threshold was not at-tained,up to three rounds of discussion and voting were held to resolve disagreements.If disagreements were not resolved after these rounds,no recommendation was adopted.When the recommendations were established,work group members developed guideline content,referencing the literature that supported the recommendations.In Step8,the completed guideline was submitted to the NASS Research Council for review and comment.Revi-sions to recommendations were considered only when sub-stantiated by a preponderance of appropriate levels of evidence.Once evidence-based revisions were incorpo-rated,the guideline was submitted to the NASS Board of Directors for review and approval in Step9.In Step10, the NASS Board–approved guideline was submitted for in-clusion in the National Guidelines Clearinghouse.In Step 11,the guideline recommendations will be reviewed every 3years and the literature base updated by an EBM-trained multidisciplinary team with revisions to the recommenda-tions developed in the same manner as in the original guideline development.ResultsDefinition and natural historyQuestion1:what is the best working definition of lumbar disc herniation with radiculopathy?Localized displacement of disc material beyond the nor-mal margins of the intervertebral disc space resulting in pain,weakness,or numbness in a myotomal or dermatomal distribution.Work Group Consensus StatementQuestion2:what is the natural history of lumbar disc herniation with radiculopathy?In the absence of reliable evidence relating to the natural history of lumbar disc herniation with radiculopathy,it is the work group’s opinion that most patients will improve indepen-dent of treatment.Disc herniations will often shrink/regress over time.Many,but not all,articles have demonstrated a clin-ical improvement with decreased size of disc herniations.Work Group Consensus StatementDiagnosis and imagingQuestion3:what history and physical examinationfind-ings are consistent with the diagnosis of lumbar disc herni-ation with radiculopathy?Manual muscle testing,sensory testing,supine straight leg raise,Lasegue sign,and crossed Lasegue sign are rec-ommended for use in diagnosing lumbar disc herniation with radiculopathy[4–8].Grade of recommendation:AThe supine straight leg raise,compared with the seated straight leg raise,is suggested for use in diagnosing lumbar disc herniation with radiculopathy[7,9].Grade of recommendation:BThere is an insufficient evidence to make a recommenda-tion for or against the use of the cough impulse test,Bell test, hyperextension test,femoral nerve stretch test,slump test, lumbar range of motion,or absence of reflexes in diagnosing lumbar disc herniation with radiculopathy[5,6,8,10–13].Grade of recommendation:I(insufficient evidence)Question4:what are the most appropriate diagnostic tests(including imaging and electrodiagnostics),and when are these tests indicated in the evaluation and treatment of lumbar disc herniation with radiculopathy?There is a relative paucity of high-quality studies on ad-vanced imaging in patients with lumbar disc herniation.It is the opinion of the work group that in patients with history and physical examinationfindings consistent with lumbar disc herniation with radiculopathy,magnetic resonance im-aging(MRI)be considered as the most appropriate nonin-vasive test to confirm the presence of lumbar disc herniation.In patients for whom MRI is either contraindi-cated or inconclusive,computed tomography(CT)or CT myelography is the next most appropriate tests to confirm the presence of lumbar disc herniation.Work Group Consensus StatementIn patients with history and physical examinationfindings consistent with lumbar disc herniation with radiculopathy, MRI is recommended as an appropriate noninvasive test to confirm the presence of lumbar disc herniation[14–16].Grade of recommendation:AIn patients with history and physical examination findings consistent with lumbar disc herniation with radi-culopathy,CT scan,myelography,and/or CT myelography182 D.S.Kreiner et al./The Spine Journal14(2014)180–191are recommended as appropriate tests to confirm the pres-ence of lumbar disc herniation[14,15,17].Grade of recommendation:AElectrodiagnostic studies may have utility in diagnosing nerve root compression although lack the ability to differ-entiate between lumbar disc herniation and other causes of nerve root compression.When the diagnosis of lumbar disc herniation with radiculopathy is suspected,it is the work group’s opinion that cross-sectional imaging be con-sidered the diagnostic test of choice and electrodiagnostic studies should only be used to confirm the presence of co-morbid conditions.Work Group Consensus StatementSomatosensory-evoked potentials are suggested as an adjunct to cross-sectional imaging to confirm the presence of nerve root compression but are not specific to the level of nerve root compression or the diagnosis of lumbar disc her-niation with radiculopathy[18–20].Grade of recommendation:BElectromyography,nerve conduction studies,and F waves are suggested to have limited utility in the diagnosis of lumbar disc herniation with radiculopathy.H reflexes can be helpful in the diagnosis of an S1radiculopathy,although are not specific to the diagnosis of lumbar disc herniation [19,21–24].Grade of recommendation:BThere is an insufficient evidence to make a recommenda-tion for or against the use of motor-evoked potentials or ex-tensor digitorum brevis reflex in the diagnosis of lumbar disc herniation with radiculopathy[24,25].Grade of recommendation:I(insufficient evidence)There is an insufficient evidence to make a recommenda-tion for or against the use of thermal quantitative sensory testing or liquid crystal thermography in the diagnosis of lumbar disc herniation with radiculopathy[26].Grade of recommendation:I(insufficient evidence) Outcome measuresQuestion5:what are the appropriate outcome measures for the treatment of lumbar disc herniation with radiculopathy?The North American Spine Society has a publication entitled Compendium of Outcome Instruments for Assess-ment and Research of Spinal Disorders.To purchase a copy of the compendium,visit https:/// Purchase/ProductDetail.aspx?Product_code568cdd1f4-c4ac-db11-95b2-001143edb1c1.For additional information about the compendium, please contact the NASS Research Department at nassresearch@.Medical/interventional treatmentQuestion6:what is the role of pharmacological treat-ment in the management of lumbar disc herniation with radiculopathy?Tumor necrosis factor alpha inhibitors are not suggested to provide benefit in the treatment of lumbar disc herniation with radiculopathy[27–29].Grade of recommendation:BThere is an insufficient evidence to make a recommenda-tion for or against the use of a single infusion of IV gluco-corticosteroids in the treatment of lumbar disc herniation with radiculopathy[30].Grade of recommendation:I(insufficient evidence)There is an insufficient evidence to make a recommenda-tion for or against the use of5-hydroxytryptamine receptor inhibitors in the treatment of lumbar disc herniation with radiculopathy[31].Grade of recommendation:I(insufficient evidence)There is an insufficient evidence to make a recommenda-tion for or against the use of gabapentin in the treatment of lumbar disc herniation with radiculopathy[32].Grade of recommendation:I(insufficient evidence)There is an insufficient evidence to make a recommenda-tion for or against the use of agmatine sulfate in the treat-ment of lumbar disc herniation with radiculopathy[33].Grade of recommendation:I(insufficient evidence)There is an insufficient evidence to make a recommenda-tion for or against the use of amitriptyline in the treatment of lumbar disc herniation with radiculopathy[34].Grade of recommendation:I(insufficient evidence)Question7:what is the role of physical therapy/exercise in the treatment of lumbar disc herniation with radiculopathy?There is an insufficient evidence to make a recommenda-tion for or against the use of physical therapy/structured ex-ercise programs as stand-alone treatments for lumbar disc herniation with radiculopathy[35,36].Grade of recommendation:I(insufficient evidence)In the absence of reliable evidence,it is the work group’s opinion that a limited course of structured exercise is an op-tion for patients with mild-to-moderate symptoms from lumbar disc herniation with radiculopathy.Work Group Consensus StatementQuestion8:what is the role of spinal manipulation in the treatment of lumbar disc herniation with radiculopathy?Spinal manipulation is an option for symptomatic relief in patients with lumbar disc herniation with radiculopathy [37–39].Grade of recommendation:CThere is an insufficient evidence to make a recommenda-tion for or against the use of spinal manipulation compared with chemonucleolysis in patients with lumbar disc hernia-tion with radiculopathy[38].Grade of recommendation:I(insufficient evidence)Question9:what is the role of traction(manual or me-chanical)in the treatment of lumbar disc herniation with radiculopathy?183D.S.Kreiner et al./The Spine Journal14(2014)180–191There is an insufficient evidence to make a recommenda-tion for or against the use of traction in the treatment of lumbar disc herniation with radiculopathy[40].Grade of recommendation:I(insufficient evidence)Question10:what is the role of contrast-enhanced,fluoroscopic guidance in the routine performance of epidu-ral steroid injections(ESIs)for the treatment of lumbar disc herniation with radiculopathy?Contrast-enhancedfluoroscopy is recommended to guide ESIs to improve the accuracy of medication delivery [41–44].Grade of recommendation:AQuestion11:what is the role of ESI for the treatment of lumbar disc herniation with radiculopathy?Transforaminal ESI is recommended to provide short-term(2–4weeks)pain relief in a proportion of patients with lumbar disc herniations with radiculopathy[45–47].Grade of recommendation:AInterlaminar ESIs may be considered in the treatment of patients with lumbar disc herniation with radiculopathy [48,49].Grade of recommendation:CThere is an insufficient evidence to make a recommenda-tion for or against the12-month efficacy of transforaminal ESI in the treatment of patients with lumbar disc hernia-tions with radiculopathy[45,50].Grade of recommendation:I(insufficient evidence)Question12:is there an optimal frequency or quantity of injections for the treatment of lumbar disc herniations with radiculopathy?No evidence to address this question.Question13:does the approach(interlaminar,transfor-aminal,caudal)influence the risks or effectiveness of ESIs in the treatment of lumbar disc herniations with radiculopathy?There is an insufficient evidence to make a recommenda-tion for or against the effectiveness of one injection approach over another in the delivery of epidural steroids for patients with lumbar disc herniation with radiculopathy[49,51,52].Grade of recommendation:I(insufficient evidence)Question14:what is the role of interventional spine pro-cedures such as intradiscal electrothermal annuloplasty and percutaneous discectomy(chemical or mechanical)in the treatment of lumbar disc herniation with radiculopathy?There is an insufficient evidence to make a recommenda-tion for or against the use of intradiscal ozone in the treat-ment of patients with lumbar disc herniation with radiculopathy[53].Grade of recommendation:I(insufficient evidence)Endoscopic percutaneous discectomy may be considered for the treatment of lumbar disc herniation with radiculop-athy[54–60].Grade of recommendation:CEndoscopic percutaneous discectomy is suggested for carefully selected patients to reduce early postoperative dis-ability and reduce opioid use compared with open discec-tomy in the treatment of patients with lumbar disc herniation with radiculopathy[57,59,60].Grade of recommendation:BAutomated percutaneous discectomy may be considered for the treatment of lumbar disc herniation with radiculop-athy[61–66].Grade of recommendation:CThere is an insufficient evidence to make a recommenda-tion for or against the use of automated percutaneous dis-cectomy compared with open discectomy in the treatment of patients with lumbar disc herniation with radiculopathy [64].Grade of recommendation:I(insufficient evidence)There is an insufficient evidence to make a recommenda-tion for or against the use of plasma disc decompression/ nucleoplasty in the treatment of patients with lumbar disc herniation with radiculopathy[67,68].Grade of recommendation:I(insufficient evidence)There is an insufficient evidence to make a recommenda-tion for or against the use of plasma disc decompression as compared with transforaminal ESIs in patients with lumbar disc herniation who have previously failed transforaminal ESI therapy[68].Grade of recommendation:I(insufficient evidence)There is an insufficient evidence to make a recommenda-tion for or against the use of intradiscal high-pressure saline injection in the treatment of patients with lumbar disc her-niation with radiculopathy[69].Grade of recommendation:I(insufficient evidence)There is an insufficient evidence to make a recommen-dation for or against the use of percutaneous electrother-mal disc decompression in the treatment of patients with lumbar disc herniation with radiculopathy[70].Grade of recommendation:I(insufficient evidence)Question15:what is the role of ancillary treatments such as bracing,electrical stimulation,acupuncture,and transcutaneous electrical stimulation in the treatment of lumbar disc herniation with radiculopathy?There is an insufficient evidence to make a recommenda-tion for or against the use of ultrasound or low-power laser in the treatment of lumbar disc herniation with radiculop-athy[40].Grade of recommendation:I(insufficient evidence)Question16:what is the likelihood that a patient with lumbar disc herniation with radiculopathy undergoing medical/interventional treatment would have good/excel-lent functional outcomes at short(weeks to6months), medium(6months to2years),and long(O2years) terms?184 D.S.Kreiner et al./The Spine Journal14(2014)180–191。
