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Assessment: Use of Epidural Steroid Injections to Treat Radicular Lumbosacral Pain

Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology

Carmel Armon, MD, FAAN, MHS; Charles E. Argoff, MD; Jeffrey Samuels, MD, FAAN; and Misha-Miroslav Backonja, MD

INTRODUCTION

Chronic back pain and its associated disabilities represent an important and increasing health problem. · Theestimatedcostoftreatmentsforspinalpainfor1990wasatleast$13billion,growingby7%peryear. · In1998,individualswithbackpainintheUnitedStateswereestimatedtohaveincurredtotalhealthcareexpendituresof$90.7billion. · Ofthe$90.7billiontotalexpendituresincurredbytheseindividuals,theexpendituresattributabledirectlytobackpaintotaledapproximately$26.3billion, ofwhich42%wereforoffice-basedvisits,18%foroutpatientservices,17%forinpatientcare,15%forprescriptiondrugs,and4%foremergencyroom visits. · MedicarePartBclaimsin1999for40.4millioncoveredindividualswere$49.9millionforlumbarepiduralsteroidinjections,$8.5millionforlumbarfacet orperi-facetjointinjections,and$5.6millionforcervicalorthoracicepiduralsteroidinjections. Lowbackpainmayoccurwithoutorwithradicularfeatures(thelatteroftenreferredtoassciatica).Reportsofepiduralcorticosteroidinjectionstotreatsciatica datebacktothe1950s. · Arecentreview(2004)bytheTechnologyAssessmentCommitteeoftheInstituteofClinicalSystemsImprovement(ICSI)focusedonfluoroscopicallyguided, transforaminal epidural steroid injections in radicular lumbar pain. · Althoughitusedanevidence-basedapproach,theratingsystemisdifferentfromAAN's. · Itconcludedthat,eventhoughresultsbasedonlimiteddataappearedtobepromising,therewasinsufficientevidencetocommentontheefficacyof transforaminal epidural steroid injections in radicular lumbar pain.

ANALYSIS OF EVIDENCE

Efficacy · Thesearchyielded37articles,4ofwhichmetthepredeterminedinclusioncriteria;theyaresummarizedinTable2alongwiththe2articlesidentifiedas beingofthehighestqualityintheICSIreview. · Someofthestudiescombinedsteroidswithalocalanesthetic,usingthelocalanestheticasacontrolornormalsalineasthecontrol,whileothers compared steroids to normal saline. Safety · Themostcommoncomplicationisatransientheadachewhetherornotassociatedwithidentifiableduralpuncture. · Moreseriouscomplicationssummarizedina1996reviewincluded ­ several cases of aseptic meningitis, arachnoiditis, and conus medullaris syndrome, typically after multiple subarachnoid injections ­ 2casesofepiduralabscess,1caseofbacterialmeningitis,and1caseofasepticmeningitis ­ a retroperitoneal hematoma in a patient on anticoagulant therapy ­ transient complications during fluoroscopically guided caudal epidural injections, including insomnia, transient non-positional headaches, increased back pain, facial flushing, vasovagal reactions, nausea, and increased leg pain · Nomajorneurologiccomplications(spinalhematomas)wereencounteredinaseriesof1,035individualswhoreceivedepiduralsteroidinjections whileonantiplatelettherapy. · Minorcomplications(bloodduringneedleplacement)wereencounteredin5.2%,andtransientworseningofsymptomsoremergenceofnewneurologic symptomsformorethan24hoursaftertheinjectionoccurredin4%ofpatientswithmediandurationof3daysandrange1to20days.

RECOMMENDATIONS AND CONCLUSIONS

· Epiduralsteroidinjectionsmayresultinsomeimprovementinradicularlumbosacralpainwhendeterminedbetween2and6weeksfollowingthe injection,comparedtocontroltreatment(Level C,ClassI­IIIevidence).Theaveragemagnitudeofeffectissmall,andthegeneralizabilityofthe observationislimitedbythesmallnumberofstudies,limitedtohighlyselectedpatientpopulations,thefewtechniquesanddosesstudied,andvariable comparison treatments. · Ingeneral,epiduralsteroidinjectionsforradicularlumbosacralpainhaveshownnoimpactonaverageimpairmentoffunction,onneedforsurgery,or onlong-termpainreliefbeyond3months.Theirroutineusefortheseindicationsisnotrecommended(Level B,ClassI­IIIevidence). · Dataonuseofepiduralsteroidinjectionstotreatcervicalradicularpainareinadequatetomakeanyrecommendation(Level U).

RECOMMENDATIONS FOR FUTURE RESEARCH

· Furtherstudiesoftheefficacyofepiduralsteroidsforradicularlumbosacralpainshouldbewelldesigned,meetingthefollowingcriteria:a)clearcase definition;b)clearmeasuresofoutcomeusingstandardizedtools,withfunctionastheprimarymeasureandclinicallymeaningfulimprovementinpainasa secondarymeasure;c)useofacontrolgroup(placebooractive);d)prospectivedesign;e)randomization;f)double-blindstudydesign,sothatneither patientnorassessorofmeasureofoutcomeknowsthetreatmentarm;ortriple-blind,ifphysicianadministeringtheepiduralsteroidsalsodoesnotknow whattreatmentisadministered;g)adequatepower;andh)adequatestatisticalanalysis. · Studiesofuseofepiduralsteroidstotreatradicularcervicalpainornon-radicularlowbackorcervicalpainshouldalsobedesignedrigorously,meeting similar criteria. · Theprincipalquestionstobeansweredfollow: a. hatisthedegreeofefficacy,expressedintermsofmagnitudeofeffect,durationofeffect,andpercentofpatientswhoachieveclinicallymeaningful W improvement, in comparison to alternative treatments? b. singacontrolleddesign:aretherepredictorsoflackofefficacyorpoorefficacy?Considerstudyingfirstpatientswithoutputativepredictors U of poor efficacy. c. owmanytreatmentsareappropriate,andatwhatintervals? H d.Howfrequentarecomplications,andwhatarethey? · Initially,itwillbenecessarytostandardizesomeofthevariablesreflectedinthequestionsinTable1,suchasaspecifictechnicalapproach,theminimal competency of the treating physician, and utilization of additional therapies. · Subsequently,researchcanbedirectedtoevaluatetheroleofthesevariables.Inparticular,differenttechniqueswillneedtobeassessedusingstandardized methodology.

DESCRIPTION OF PROCESS

Apanelofneurologistsanalyzedtheevidencerelatingtothefollowingquestion,amongothers(Table1):Whatistheevidencetosupportuseofepidural steroid injections in radicular lumbosacral pain to produce pain relief? Efficacy The authors: · ConductedMedlinesearchesinApril2003andFebruary2005usingcombinationsoftheterms"epiduralinjections,"or"epiduralsteroids,""double-blind," and"placebocontrolled,"and"radiculopathy." · SearchedtheCochranedatabaseofsystematicreviewsbutfoundnoreviewontheuseofepiduralsteroidinjectionstotreatradicularpain. · Usedthefollowinginclusioncriteria:1)clearcasedefinition,2)clearmeasureofoutcome(painrelief)usingastandardizedmeasure,3)useofacontrol group(placebooractive),4)randomization,5)atleastdouble-blindstudydesign,sothatneitherpatientnorassessorofmeasureofoutcomewouldknow thetreatmentarm;ortriple-blindifthephysicianinjectingthetreatmentalsodidnotknowwhattreatmentwasadministered;6)prospectivestudydesign, and7)adequatestatisticalanalysis. · Scannedthereferencesofarticlesidentifiedprimarilyandwithinselectreviewarticlesforadditionalarticlesmeetingtheinclusioncriteria;nonewerefound. · Usedthehighestlevelofevidencetomaketheconclusionsandrecommendations. · Consideredarticlesonusingepiduralsteroidsonlytotreatradicularlumbosacralpainsincearticlesonepiduralsteroidtreatmentofradicularcervicalpain did not meet these criteria. Safety · AseparateMedlinesearchwasconductedusingthekeywords"epiduralsteroid"and"complications"toidentifyreportedcomplicationswiththe procedure. · Theauthorssummarizedtheresultsfromselectedarticlesandtheefficacystudiesselectedforinclusion. Table 1. Epidural Steroid Use: Questions for Consideration 1.a. Whoisbeingtreated? Diagnosis for treatment Demographics(age,gender,etc.) Whoshouldbetreated? Whichfactorspredictoutcome(good/bad)? Factorswhichpredictwhoshouldnotbetreated Whatistheexpecteddurationofbenefit? Whatistheappropriatetechnicalapproach? a. Direction of the needle b. Type of needle c. Dose of medication d. Fluoroscopy vs. no fluoroscopy Whatisthecompetencyofthetreater? Istheepiduralinjectionsufficient,orshouldtherebetherapyofanotherkindwithit? a. owdoesitcomparetooraddtoothertreatmentmodalities? H b. Shoulditbecombinedwithothertreatmentmodalities? Canwedifferentiatetreatmentforacute,subacute,chronicpatients,andisthereadifferenceinoutcome? Howisefficacymeasured? a. Whatmeasurementtoolsareusedtomeasureefficacy? b. Whatmeasurementshouldbeusedtomeasureefficacy? c. Howissuccessdefined? Is there evidence for efficacy? Howsafeisthismethodoftreatment?Arethereanyassociatedrisks?

DISCUSSION

Comparison to the Results of the ICSI Review · Thisevidence-basedreviewfocusingspecificallyonfluoroscopicallyguidedtransforaminalepiduralinjectionsidentifiedtwostudiesitconsideredofhigh quality,whichhadnotbeenidentifiedbytheMedlinesearches. · Onearticlestudiedpainrelief,andweconcurredthatitwasofhighquality(ClassIevidence)withresultsconsistentwithstudiesperformedwithout radiologic guidance. · Thesecondarticleusedavoidanceofsurgeryasitsprimaryoutcomemeasure;however,methodologiclimitationsresultedinalowerratingunderour system(ClassIIIevidence). · Thesecondarticle'sfindingsfavoringefficacy,whileconcordantwiththoseofapreviouslyidentifiedarticle,werediscordantfromthoseofarticlesthat wereratedhigher,thatshowednoimpactonutilizationofsurgery. · Thelackofoverlapbetweenhighqualityarticlesfoundusingthetwosearchstrategiesresultedfromuseofdifferentsearchterms. · TheICSIreviewdidnotretrievearticlesthatdidnotusefluoroscopy,andthehighqualityarticlereportingresultswithtransforaminal,peri-radicular injectionsusingfluoroscopydidnotincorporatethetermswehadusedinouroriginalsearch. Principal Findings, in Clinical Perspective · Withregardstotheprimaryquestionofthisreview,ameliorationofpain,thefindingsofthe4highqualitystudiesareinternallyconsistent,showingthe followingefficacypatterncomparedtoacontrolgroup:noefficacyat24hours;someefficacyat2to6weeks;nodifferenceorreboundworseningat3 monthsand6months;andnodifferenceat1year. · Theseresultssupporttheindividualperceptionofbenefitofepiduralsteroids,expressedintermsofshort-termsymptomaticrelief,apositiveresultinandof itself. · However,theaverageeffectdifference(advantageofsteroidsovercontroltreatment)wassmall,usuallyfallingshortofthevalueproposedasaclinically meaningfulaveragedifference--15mmonthe100mmvisualanaloguepainscale. · Theseresultsareconsistentwiththeresultsofastudycomparing43patientstreatedwithepiduralmethylprednisoloneappliedduringunilaterallumbar discectomywithmatchedhistoricalcontrolsthatshowedreducedneedfornarcoticandnon-narcoticpainmedicationsandmusclerelaxantsduringthe postoperativeperiod,andshorterhospitalstayintreatedpatients(anaverageof2.72daysintreatedpatientsvs4.35daysintheuntreatedpatients). · Reportedcomplicationsofepiduralsteroidinjectionsareusuallyminorandtransient:themostfrequentisatransientheadache. · Reportedmajorcomplicationsarerare(asepticmeningitis,arachnoiditis,bacterialmeningitis,epiduralabscess,andconusmedullarissyndrome),andmay result from subarachnoid, rather than epidural injection. · Theremaybeunderreportingofcomplications,andthereportedsafetytrackrecordofexperiencedpractitionerswithlargevolumesmaynotreflectthe trackrecordofsmallervolumeorlessexperiencedpractitioners. · TheseresultsdonotanswermostoftheotherquestionslistedinTable1. · Withregardstothespecificquestionofavoidanceofsurgery,thedataonfacevalueareconflicting,withthebetterdesignedstudiesshowingnobenefitto epidural steroids. · Thedatadonotpermitinferringifsurgeryisavoidedduetothetreatmenteffectofinjectedsteroids,duetoplaceboeffect,orbecausethetreatment"buys time"foranaturalhistoryofimprovement. · Thedatadonotaddresshowepiduralsteroidinjectionsmightcomparetoothertreatmentmodalitiesandtheroleofpatientandprovidercharacteristics, including temperament and pain tolerance, in selecting among various treatment options. · Therecommendationsgavegreaterweighttothedatafromthebetterdesignedstudies,showingthatepiduralsteroidinjectionsdidnotresultinlesssurgery. · Anuncontrolledstudywithpartialfollow-upoftreatedpatientshasidentifiedfactorsthatpredictpooroutcome:1)greaternumberofprevioustreatments forpain;2)moremedicationstaken;3)painnotnecessarilyincreasedbyactivity;4)painincreasedbycoughing. · Factorsthatpredictnobenefitoneyearaftertreatmentinclude1)paindoesnotinterferewithactivities;2)unemploymentduetopain;3)normalstraightleg raisingtestsbeforetreatment;4)painnotdecreasedbymedication. Limitations · Thisreviewislimitedbyitsinabilitytocomparealltechniquesandalltreatmentapproaches. · Thisreviewdidnotassessissuesoffrequencyofinjectionordosage,anddidnotevaluateoperatorexperience,whichwasimpliedtobehighinallthe published reports. · Thegeneralizabilityofthefindingsislimited. · Thefocusonpainrelief,guidedbythechiefindicationforwhichepiduralsteroidinjectionsareused,isalimitation,comparedtousingimprovementof function as the primary outcome variable.

CLASSIFICATION OF EVIDENCE

Class I: Prospective,randomized,controlledclinicaltrialwithmaskedoutcomeassessment,inarepresentativepopulation. Thefollowingarerequired: a) primaryoutcome(s)clearlydefined b) exclusion/inclusioncriteriaclearlydefined c) adequateaccountingfordropoutsandcross-overswithnumberssufficientlylowtohaveminimalpotentialforbias d) relevantbaselinecharacteristicsarepresentedandsubstantiallyequivalentamongtreatmentgroupsorthereis appropriate statistical adjustment of differences.

Class II: Prospectivematchedgroupcohortstudyinarepresentativepopulationwithmaskedoutcomeassessmentthatmeetsa-daboveORaRCTina representative population that lacks one criterion a-d. Class III: Allothercontrolledtrials(includingwell-definednaturalhistorycontrolsorpatientsservingasowncontrol(s)inarepresentativepopulation, whereoutcomeisindependentlyassessed,orindependentlyderivedbyobjectiveoutcomemeasurement.* Class IV: Evidencefromuncontrolledstudies,caseseries,casereports,orexpertopinion.

* bjectiveoutcomemeasurement:anoutcomemeasurethatisunlikelytobeaffectedbyanobserver's(patient,treatingphysician,investigator)expectation O orbias(e.g.,bloodtests,administrativeoutcomedata).

1.b. 2. 3. 4.

CLASSIFICATION OF RECOMMENDATIONS

Level A: Level B: Level C: Establishedaseffective,ineffective,orharmfulforthegivenconditioninthespecifiedpopulation.LevelAratingrequiresatleasttwoconsistent Class I studies. Probablyeffective,ineffective,orharmfulforthegivenconditioninthespecifiedpopulation.LevelBratingrequiresatleastoneClassIstudyor atleasttwoconsistentClassIIstudies. Possiblyeffective,ineffective,orharmfulforthegivenconditioninthespecifiedpopulation.LevelCratingrequiresatleastoneClassIIstudyor twoconsistentClassIIIstudies.

5. 6. 7. 8.

Level D: Datainadequateorconflicting;givencurrentknowledge,treatmentisunproven.

CONFLICT OF INTEREST STATEMENT

TheAmericanAcademyofNeurologyiscommittedtoproducingindependent,critical,andtruthfulclinicalpracticeguidelines(CPGs).Significanteffortsare madetominimizethepotentialforconflictsofinteresttoinfluencetherecommendationsofthisCPG.Totheextentpossible,theAANkeepsseparatethose whohaveafinancialstakeinthesuccessorfailureoftheproductsappraisedintheCPGsandthedevelopersoftheguidelines.Conflictofinterestformswere obtainedfromallauthorsandreviewedbyanoversightcommitteepriortoprojectinitiation.AANlimitstheparticipationofauthorswithsubstantialconflicts ofinterest.TheAANforbidscommercialparticipationin,orfundingof,guidelineprojects.DraftsoftheguidelinehavebeenreviewedbyatleastthreeAAN committees,anetworkofneurologists,Neurologypeerreviewers,andrepresentativesfromrelatedfields.

9. 10.

PARTICIPANTS: Therapeutics and Technology Assessment subcommittee members: Yuen T. So, MD, PhD (Co-Chair); Janis Miyasaki, MD, FAAN (Co-Chair); Richard M. Dubinsky, MD, MPH, FAAN; Mark Hallett, MD, FAAN; Cynthia L. Harden, MD; Michael A. Sloan, MD, MS, FAAN; James C. Stevens, MD, FAAN; Fenwick T. Nichols, III, MD; Kenneth J. Mack, MD, PhD; Paul W. O'Connor, MD; Vinay Chaudhry, MD, FAAN; Douglas S. Goodin, MD (ex-officio); Carmel Armon, MD, MHS, FAAN (ex-officio)

DISCLAIMER: This statement is provided as an educational service of the American Academy of Neurology. It is based on an assessment of current scientific and clinical information. It is not intended to include all possible proper methods of care for a particular neurologic problem or all legitimate criteria for choosing to use a specific procedure. Neither is it intended to exclude any reasonable alternative methodologies. The AAN recognizes that specific patient care decisions are the prerogative of the patient and the physician caring for the patient, based on all of the circumstances involved.

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