炎性腰痛诊断标准.pdf

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1、SPINE Volume 31,Number 18,pp 211521232006,Lippincott Williams&Wilkins,Inc.A Gold Standard Evaluation of the“Discogenic Pain”Diagnosis as Determined by Provocative DiscographyEugene J.Carragee,MD,Todd Lincoln,MD,Vik Singh Parmar,MD,and Todd Alamin,MDStudy Design.This is a prospective study of the val

2、id-ity of a positive test result in provocative lumbar discog-raphy for the diagnosis of“discogenic pain.”Objective.To investigate the hypothesis that provoc-ative discography by strict criteria accurately identifies alow back pain illness due to a primary disc lesion.Summary and Background Data.Acc

3、ording to theSackett and Haynes criteria for establishing diagnostictest validity,no test without a gold standard externalstandard can be meaningfully applied.Provocative dis-cography as a test for determining“discogenic pain”has,to date,not been compared against a gold standard.Ab-sent a gold stand

4、ard reference,there can be no validityassessment or systematic improvement of test accuracy.This is the first study to apply an external gold standardevaluation of the diagnostic validity of discography in anymanner.Methods.Over a 5-year period using a strict enroll-ment protocol,32 patients with lo

5、w back pain and a pos-itive single-level low-pressure provocative discogram,underwent spinal fusion.Subjects with known patientselection comorbidities were excluded.Generic surgicallimitations/morbidity were controlled by comparison tothe clinical outcomes of a strictly-matched cohort of 34patients

6、having a well-accepted single-level lumbar pa-thology(unstable spondylolisthesis).Treatment successwas compared between groups.Results.In the control-spondylolisthesis group,23 of32 patients(72%)met the highly effective success criteriacompared with 8 of 30 in the presumed discogenic paincohort(27%)

7、.The proportion of patients who met the“minimal acceptable outcome”was 29 of 32(91%)in thespondylolisthesis group and 13 of 30(43%)in the pre-sumed discogenic pain group.Adjusting for surgical mor-bidity and dropout failure,by either criteria of success,the best-case positive predictive value of dis

8、cographywas calculated to be 50%to 60%.Conclusions.Positive discography was not highly pre-dictive in identifying bona fide isolated intradiscal lesionsprimarily causing chronic serious LBP illness in this firststudy comparing discography results to a gold standard.Key words:diagnostic validity,disc

9、ogenic pain,lowback pain,discography,spinal fusion,unstable spon-dylolisthesis,surgical outcome,prospective study.Spine2006;31:21152123Approximately 300,000 spinal fusions are performed intheUnitedStateseachyear.1Themostcontroversialsub-group of these spinal fusions is that performed for sup-posed“d

10、iscogenic pain,”which is primarily diagnosedby provocative discography.In this test,the nucleus of adiscsuspectedofcausingapatientsseverelowbackpain(LBP)illness is injected.If this provocation demonstratesanular disruption and reproduces the patients usualLBP,this is usually considered a positive te

11、st,confirmingthat the disc per se is the cause of the patients LBPillness,independent of any psychosocial or structural co-morbidity.However,the validity of provocative discog-raphy as a diagnostic test in evaluating chronic LBP ill-ness remains unproven.A critical test of validity for any diagnosti

12、c procedureinvolves directly assessing the test results against a goldstandard in a clinically relevant setting(Phase IIII stud-ies by the Sackett and Haynes criteria2).For provocativediscography,despite many proponents,no such studieshave yet been published.Nor have proponents suggesteda reasonable

13、 gold standard against which to test whetherthe results of discography actually identify a clinicallyrelevantlesionprimarilyaccountingforthepatientsLBPillness.3,4Despite a lack of proven diagnostic validity by goldstandard,spinal fusion is often recommended on the ba-sisdiscographydiagnosis.Somehave

14、suggestedusingtheclinical results of fusion as a gold standard in confirmingwhich positive discogram injections were in fact true-positive tests.The primary argument against using clin-ical outcome after successful fusion as a gold standardfor discogenic back pain has been the presence of multi-ple

15、comorbidities,which complicate the outcome of sur-gical ablation of the supposed disc lesion.3It is interesting,however,that the failure of this sur-gery to have a strong clinical effect in discography-positive subjects is rarely attributed to a primary misdi-agnosis.Instead,failures of surgery to a

16、chieve highlyeffective pain relief and functional improvements havebeen attributed to either poor patient selection(i.e.,“pa-tient-specific comorbidities”preventing recovery from abona fide discogenic pain lesion)and/or the trauma ofsurgery(i.e.,“fusion disease”or“surgery-specific mor-bidities”despi

17、te correct diagnosis of the disc lesion).Itfollows,however,if these comorbidities could be con-trolled in a strictly selected cohort of discography test-positive subjects,the clinical results after successful spi-nal fusion should satisfy a gold standard test for theoriginal diagnosis.From the Ortho

18、paedic Surgery Division,Stanford School of Medicine,Stanford,CA.Acknowledgment date:October 15,2004.First revision date:April 2,2005.Second revision date:November 2,2005.Third revision date:March 21,2006.Acceptance date:March 22,2006.Thedevice(s)/drug(s)is/areFDA-approvedorapprovedbycorrespond-ing n

19、ational agency for this indication.Institutionalfundswerereceivedinsupportofthiswork.Nobenefitsinany form have been or will be received from a commercial party relateddirectly or indirectly to the subject of this manuscript.Address correspondence and reprint requests to Eugene J.Carragee,MD,Orthopae

20、dic Surgery Division,Stanford School of Medicine,300 PasteurDrive,Room R171,Stanford,CA 94305;E-mail:carrageeleland.stanford.edu2115To control for comorbid factors,direct comparisoncould be made to a surgical cohort,matched for patient-selection comorbid factors,having a well-accepted diag-nostic en

21、tity,for instance,marked radiographic instabil-ity.If both cohorts had been correctly diagnosed andwere to undergo identical surgical procedures(control-ling for surgical morbidities),then outcomes should besimilar and directly comparable.The authors used this experimental model in a PhaseIII-type d

22、iagnostic study2to test the positive predictivevalue(PPV)of discography against a gold standard(sur-gicalsuccess),withcontrolforsurgical-morbidityusingadiagnostically validated single-segment lesion(unstableisthmic spondylolisthesis).If both entities,unstablespondylolisthesis(diagnosed by validated

23、methods)anddiscogenic pain syndrome(diagnosed by discography)are both accurately identified as the local“single level”pain generators responsible for the reported chronic LBPillness,then definitive surgical ablation of these lesionsshould be both highly and equally effective in relievingLBP and rest

24、oring high functional outcomes.The purpose of this investigation is to test the hypoth-esis that positive provocative discography accuratelyidentifies a LBP illness due to a primary discogenic lesionasdeterminedbyclinicalcurewithsuccessfularthrodesisin a best-case clinical setting.Having no other go

25、ld stan-dard,this measure of discography will provide a bestestimate of true-positive primary discogenic disease insubjects with serious LBP illness.Materials and MethodsThis study is designed to address a Sackett and Haynes Diag-nostic Phase III-type question2using a prospective study of thePPV of

26、provocative lumbar discography against a defined goldstandard of surgical outcome.This study was designed in 1996 and enrolled subjectsthrough the end of 2000.In 1996,the senior author discontin-ued recommending fusion surgery for patients with presumed“discogenic pain”if any of the associated comor

27、bidities werefound on evaluation.During the same enrollment period,sub-jects were concomitantly enrolled for unstable spondylolisthe-sis.Subjects were therefore enrolled on a consecutive-case basisand consented to the baseline and follow-up protocols.Thestudy was approved by the Human Subjects Resea

28、rch Commit-tee at Stanford University and followed DHHS guidelines.Once the patients met the inclusion criteria(Table 1),sub-jects with either diagnosis were offered the same operative pro-cedure.The procedure was a two incision 360 single-levelfusion performed in one operative setting.The first sta

29、ge wasan anterior mini-laparotomy(retroperitoneal approach)to ex-pose the affected disc.Following an anterior discectomy,in-cluding the posterior anulus,using an operating microscopeand endplate decortication,a femoral ring allograft and but-tress screw were placed(Synthes,Paoli,CA).Local and allo-g

30、raft bone was packed within and around the structural graft.The second stage involved a posterior single-level intertrans-verse fusion.A small Wiltse exposure was used in each patientwith microscopic dissection to expose the transverse processesand transpedicular screw insertion site as directed by

31、fluoro-scopic imaging.No decompression was performed.Bilateralpedicle screw instrumentation(VAS system,Synthes)and allo-graft bone graft was used in each patient.Comorbidities associated with poor outcomes(Table 2)wereexcludedinbothcohortsduringcomparison.1,511There-fore,comparative analysis of subj

32、ects in this study was re-stricted to those without previous surgery,undergoing single-level surgery alone,and achieving solid fusion by strict criteria.Discography(Presumed Discogenic Pain)Cohort.Thetest study cohort was subjects with low-pressure-positive lum-bar discography and no other structura

33、l spinal,pelvic,or hippathology.Consecutive patients with single-level positive dis-cography injections who failed conservative therapy and re-quested a surgical alternative were considered for inclusion inthe study.Table 1.Inclusion and Additional Exclusion CriteriaDiscography cohortInclusion crite

34、riaFailed conservative therapyChronic low back pain without radicular painCurrent pain episode?6 mo and?24 mo durationPositive discogram at operative levelNormal discogram at adjacent levelsWorking full time prior to onset pain episode and no more than12 mo work loss during episodeExclusion criteria

35、Table 2 exclusionsDisc extrusion or sequestered herniationSymptomatic spinal stenosisSpinal deformityInflammatory,infectious,or neoplastic disease of the spine,pelvis,or hipPositive response to facet or sacroiliac joint blockUnstable spondylolisthesis cohortInclusion criteriaFailed conservative ther

36、apyChronic low back pain with/without sciaticaGrade I or II isthmic spondylolisthesis at L5S1 or L4L5Radiologic instability*Working full time prior to onset pain episode and no more than12 mo work loss during episodeExclusion criteriaTable 2 exclusionsDisc extrusion or sequestered herniation with po

37、sitive straight legraise signL4S1 motor weakness greater than trace levelAdditional spinal deformityInflammatory,infectious,or neoplastic disease of the spine,pelvis,or hip*A?4-mm translation and/or?22 change of angulation on flexion-extensionlateral radiographs.Table 2.Exclusionary Patient-Specific

38、 Risks Factors forPoor OutcomePatient specific factorsCompensation claims(Workers Compensation or personal injury)Abnormal psychometric examination*Additional chronic pain processes(e.g.,chronic migraine,fibromyalgia,etc.)Additional occupational disabilitiesProlonged disability for LBP(?12 mo)Surger

39、y specific factorsPrior lumbar surgeryMultilevel surgeryPseudarthrosis*Measured by the DRAM method.2116SpineVolume 31Number 182006The discography protocol was based on the protocol ofWalsh et al but included only low pressure positive injec-tions.12,13A positive test was defined as pain of?6/10,at a

40、pressure of?20 psi above opening pressure with a central discinjection,and a demonstrable anular fissure with dye to orthrough the posterior outer anulus.In the current study,the adja-cent disc or discs must have both a normal morphologic dye pat-tern and a pain level?2/10 on pressurization to 100 p

41、si.EligiblesubjectswithLBPwithoutradicularsymptomswereenrolled if meeting inclusion and exclusion criteria listed inTables 1 and 2.Additional exclusion criteria in this cohortincluded the aforementioned primary patient specific and sur-gery specific comorbidities,as well as the presence of a discext

42、rusion or sequestered herniation,symptomatic spinal steno-sis,spinal deformity,spondylolysis or spondylolisthesis,in-flammatory,infectiousorneoplasticdiseaseofthespine,pelvis,or hip.Patients with a positive response to facet or sacroiliacjoint anesthetic blockage were also excluded.Unstable Spondylo

43、listhesis Cohort.The control cohort for“surgical comorbidity”was patients with LBP with radio-graphically confirmed,unstable Grade I or II isthmic spon-dylolisthesis with or without sciatica.Consecutive patientswho were diagnosed with unstable spondylolisthesis,havingfailed conservative care and req

44、uesting consideration for sur-gery options,were similarly evaluated.Eligible subjects reported chronic LBP with or withoutsciatica had demonstrated Grade I or II isthmic spondylolis-thesis of either the L5S1 or L4L5 anatomic segments,andradiologic segmental instability defined by?4 mm transla-tion a

45、nd/or?22 of angulation as seen on standing flexion-extension or upright/recumbent lateral radiographs.Thesefindings on flexion-extension radiography are very unusualin asymptomatic and even symptomatic isthmic spondylolis-thesis and the presence of posterior column deficiency(isth-mic defects)and sl

46、ip would satisfy common definitions ofinstability.1416Spondylolisthesis patients seen in our clinic were offeredsurgery in many cases irrespective of the presence or absence ofassociated patient-specific outcome comorbidities.However,the spondylolisthesis control subjects to the discography co-hort

47、were recruited as a matched subgroup from the generalspondylolisthesis group,identified as being without patient-selection comorbidities as in the discography group(Tables 1,2).Exclusion criteria included disc extrusion or herniation,symptomatic spinal stenosis,spinal deformity(other thanspondylolys

48、is/listhesis),inflammatory,infectious,or neoplasticdisease of the back,spine,or pelvis.All patients either hadnormal MRI for cephalad discs(Grade I or II degenerative discdisease based on MRI17)or negative discograms based on lackof pain on injection and lack of anular fissuring seen on disco-gram r

49、adiographs.Baseline Data.Preoperative baseline measures were collectedon for all patients including:the visual analog scale(VAS)fortheseverityofbackandlegpain;AAOSModemsinstrument,18Oswestry Disability Index(ODI),19and underwent psycho-metric testing using the Fear Avoidance Behavior Question-naire(

50、FABQ P),20Modified Zung depressive index,and themodified somatic perception questionnaire(MSPQ)scores.10Each patient also recorded a history of pain medication usage,preoperative symptom duration,and the amount of preopera-tive work loss on a standard questionnaire.During the preoperative evaluation