Spinal manipulative therapy for acute low-back pain (Review) Rubinstein SM, Terwee CB, AssendelftWJJ, de BoerMR, van Tulder MW ThisisareprintofaCochranereview,preparedandmaintainedbyTheCochraneCollaborationandpublishedinTheCochraneLibrary 2012,Issue12 http://www.thecochranelibrary.com Spinalmanipulativetherapyforacutelow-backpain(Review) Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 PLAINLANGUAGESUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 SUMMARYOFFINDINGSFORTHEMAINCOMPARISON . . . . . . . . . . . . . . . . . . . 3 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Figure1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Figure2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Figure3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Figure4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Figure5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Figure6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 ADDITIONALSUMMARYOFFINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . 20 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 AUTHORS’CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 CHARACTERISTICSOFSTUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 DATAANDANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 Analysis1.1.Comparison1Spinalmanipulativetherapyversusinertinterventions,Outcome1Pain. . . . . . . 102 Analysis1.2.Comparison1Spinalmanipulativetherapyversusinertinterventions,Outcome2Functionalstatus. . 103 Analysis1.3.Comparison1Spinalmanipulativetherapyversusinertinterventions,Outcome3Recovery. . . . . 104 Analysis2.1.Comparison2SpinalmanipulativetherapyversusshamSMT,Outcome1Pain. . . . . . . . . 105 Analysis2.2.Comparison2SpinalmanipulativetherapyversusshamSMT,Outcome2Functionalstatus. . . . . 105 Analysis3.1.Comparison3Spinalmanipulativetherapyversusallothertherapies,Outcome1Pain. . . . . . . 106 Analysis3.2.Comparison3Spinalmanipulativetherapyversusallothertherapies,Outcome2Functionalstatus. . . 107 Analysis3.3.Comparison3Spinalmanipulativetherapyversusallothertherapies,Outcome3Recovery. . . . . 109 Analysis3.4.Comparison3Spinalmanipulativetherapyversusallothertherapies,Outcome4Return-to-work. . . 110 Analysis4.1.Comparison 4Spinalmanipulativetherapyplusanyinterventionversusthatsameinterventionalone, Outcome1Pain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Analysis4.2.Comparison 4Spinalmanipulativetherapyplusanyinterventionversusthatsameinterventionalone, Outcome2Functionalstatus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Analysis4.3.Comparison 4Spinalmanipulativetherapyplusanyinterventionversusthatsameinterventionalone, Outcome3Recovery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Analysis4.4.Comparison 4Spinalmanipulativetherapyplusanyinterventionversusthatsameinterventionalone, Outcome4Return-to-work. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Analysis5.1.Comparison5Spinalmanipulativetherapy(SMT)versusanotherSMTtechnique,Outcome1Pain. . 116 Analysis5.2.Comparison5Spinalmanipulativetherapy(SMT)versusanotherSMTtechnique,Outcome2Functional status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 Analysis5.3.Comparison5Spinalmanipulativetherapy(SMT)versusanotherSMTtechnique,Outcome3Recovery. 119 Analysis6.1.Comparison6SMTversusallcomparisons-forconstructionoffunnelplot,Outcome1Pain-Forfunnel plot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120 Analysis6.2.Comparison6SMTversusallcomparisons-forconstructionoffunnelplot,Outcome2Functionalstatus- Forfunnelplot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122 ADDITIONALTABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 WHAT’SNEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 CONTRIBUTIONSOFAUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 Spinalmanipulativetherapyforacutelow-backpain(Review) i Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. DECLARATIONSOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 DIFFERENCESBETWEENPROTOCOLANDREVIEW . . . . . . . . . . . . . . . . . . . . . 133 INDEXTERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Spinalmanipulativetherapyforacutelow-backpain(Review) ii Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. [InterventionReview] Spinal manipulative therapy for acute low-back pain SidneyMRubinstein1,CarolineBTerwee2,WillemJJAssendelft3,4,MichielRdeBoer5,MauritsWvanTulder5 1Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam,Netherlands.2DepartmentofEpidemiologyandBiostatistics,VUUniversityMedicalCenter,Amsterdam,Netherlands. 3DepartmentofPublicHealthandPrimaryCare,LeidenUniversityMedicalCenter,Leiden,Netherlands.4DepartmentofPrimary andCommunityCare,RadboudUniversityMedicalCenter,Nijmegen,Netherlands.5DepartmentofHealthSciences,FacultyofEarth andLifeSciences,VUUniversity,Amsterdam,Netherlands Contactaddress:SidneyMRubinstein,DepartmentofEpidemiologyandBiostatistics,EMGOInstituteforHealthandCareResearch, VUUniversityMedicalCenter,POBox7057,RoomD518,Amsterdam,1007MB,[email protected]. Editorialgroup:CochraneBackGroup. Publicationstatusanddate:Edited(nochangetoconclusions),publishedinIssue12,2012. Reviewcontentassessedasup-to-date: 4March2012. Citation: RubinsteinSM,TerweeCB,AssendelftWJJ,deBoerMR,vanTulderMW.Spinalmanipulativetherapyforacutelow-back pain.CochraneDatabaseofSystematicReviews2012,Issue9.Art.No.:CD008880.DOI:10.1002/14651858.CD008880.pub2. Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. ABSTRACT Background Manytherapiesexistforthetreatmentoflow-backpainincludingspinalmanipulativetherapy(SMT),whichisaworldwide,extensively practisedintervention.ThisreportisanupdateoftheearlierCochranereview,firstpublishedinJanuary2004withthelastsearchfor studiesuptoJanuary2000. Objectives ToexaminetheeffectsofSMTforacutelow-backpain,whichisdefinedaspainoflessthansixweeksduration. Searchmethods A comprehensive search was conducted on 31 March 2011 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PEDro, and the Index to Chiropractic Literature. Other search strategies were employed for completeness.Nolimitationswereplacedonlanguageorpublicationstatus. Selectioncriteria Randomizedcontrolledtrials(RCTs) whichexaminedtheeffectivenessofspinalmanipulation ormobilization inadultswithacute low-backpainwereincluded.Inaddition,studieswereincludedifthepainwaspredominantlyinthelowerbackbutthestudyallowed mixedpopulations,includingparticipantswithradiationofpainintothebuttocksandlegs.Studieswhichexclusivelyevaluatedsciatica wereexcluded.Nootherrestrictionswereplacedonthesettingnorthetypeofpain.Theprimaryoutcomeswerebackpain,back- painspecificfunctionalstatus,andperceivedrecovery.Secondaryoutcomeswerereturn-to-workandqualityoflife.SMTwasdefined asanyhands-ontherapydirectedtowardsthespine,whichincludesbothmanipulationandmobilization, andincludesstudiesfrom chiropractors,manualtherapists,andosteopaths. Datacollectionandanalysis Two review authors independently conducted the study selection and risk of bias (RoB) assessment. Data extraction was checked bythesecondreviewauthor.Theeffectswereexaminedinthefollowingcomparisons: SMTversus1)inertinterventions, 2)sham SMT,3)otherinterventions,and4)SMTasanadditionaltherapy.Inaddition,weexaminedtheeffectsofdifferentSMTtechniques Spinalmanipulativetherapyforacutelow-backpain(Review) 1 Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. comparedtooneanother.GRADEwasusedtoassessthequalityoftheevidence.Authorswerecontacted,wherepossible,formissing oruncleardata.Outcomeswereevaluatedatthefollowingtimeintervals:short-term(oneweekandonemonth),intermediate(three tosixmonths),andlong-term(12monthsorlonger).Clinicalrelevancewasdefinedas:1)small,meandifference(MD)<10%ofthe scaleorstandardizedmeandifference(SMD)<0.4;2)medium,MD=10%to20%ofthescaleorSMD=0.41to0.7;and3)large, MD>20%ofthescaleorSMD>0.7. Mainresults Weidentified20RCTs(totalnumberofparticipants=2674),12(60%)ofwhichwerenotincludedinthepreviousreview.Sample sizesrangedfrom36to323(median(IQR)=108(61to189)).Intotal,sixtrials(30%ofallincludedstudies)hadalowRoB.Atmost, threeRCTscouldbeidentifiedpercomparison,outcome,andtimeinterval;therefore,theamountofdatashouldnotbeconsidered robust. Ingeneral, for theprimary outcomes, thereislow tovery lowquality evidence suggesting nodifference in effectfor SMT whencompared toinertinterventions, shamSMT, or whenadded toanother intervention. There was varying quality of evidence (fromverylowtomoderate)suggestingnodifferenceineffectforSMTwhencomparedwithotherinterventions,withtheexception oflowqualityevidencefromonetrialdemonstratingasignificantandmoderatelyclinicallyrelevantshort-termeffectofSMTonpain reliefwhencomparedtoinertinterventions, aswellaslowquality evidencedemonstrating asignificant short-termandmoderately clinicallyrelevanteffectofSMTonfunctional statuswhenaddedtoanother intervention. Ingeneral,side-lyingandsupine thrust SMTtechniquesdemonstrateashort-termsignificantdifferencewhencomparedtonon-thrustSMTtechniquesfortheoutcomesof pain,functionalstatus,andrecovery. Authors’conclusions SMTisnomoreeffectiveinparticipantswithacutelow-backpainthaninertinterventions, shamSMT,orwhenaddedtoanother intervention.SMTalsoappearstobenobetterthanotherrecommendedtherapies.Ourevaluationislimitedbythesmallnumberof studiespercomparison,outcome,andtimeinterval.Therefore,futureresearchislikelytohaveanimportantimpactontheseestimates. ThedecisiontoreferpatientsforSMTshouldbebaseduponcosts,preferencesofthepatientsandproviders,andrelativesafetyof SMTcomparedtoothertreatmentoptions.FutureRCTsshouldexaminespecificsubgroupsandincludeaneconomicevaluation. PLAIN LANGUAGE SUMMARY Spinalmanipulativetherapyforacutelow-backpain Low-backpainisacommonanddisablingdisorder,representingagreatburdenbothtotheindividualandsociety.Itoftenresultsin reducedqualityoflife,timelostfromwork,andsubstantialmedicalexpense.Spinalmanipulativetherapy(SMT)iswidelypractised byavarietyofhealthcareprofessionalsworldwideandisacommonchoiceforthetreatmentoflow-backpain.Theeffectivenessofthis formoftherapyforthemanagementofacutelow-backpainis,however,notwithoutdispute. For this review, acute low-back pain was defined as pain lasting less than six weeks. Only cases of low-back pain not caused by a knownunderlyingcondition,forexample,infection,tumour,orfracture,wereincluded.Alsoincludedwerepatientswhosepainwas predominantlyinthelowerbackbutmayalsohaveradiated(spread)intothebuttocksandlegs. SMTisknownasa’hands-on’treatmentdirectedtowardsthespine,whichincludesbothmanipulationandmobilization.Thetherapist appliesmanualmobilizationbypassivelymovingthespinaljointswithinthepatient’srangeofmotionusingslow,passivemovements, beginningwithasmallrangeandgraduallyincreasingtoalargerrangeofmotion.Manipulationisapassivetechniquewherebythe therapistappliesaspecificallydirectedmanualimpulse,orthrust,toajointatorneartheendofthepassive(orphysiological)rangeof motion.Thisisoftenaccompaniedbyanaudible‘crack’. In this review, a total of 20 randomized controlled trials (RCTs) (representing 2674 participants) assessing the effects of SMT in patientswithacutelow-backpainwereidentified.Treatmentwasdeliveredbyavarietyofpractitioners,includingchiropractors,manual therapists,andosteopaths.Approximatelyone-thirdofthetrialswereconsideredtobeofhighmethodologicalquality,meaningthese studiesprovidedahighlevelofconfidenceintheoutcomeofSMT. Overall,wefoundgenerallylowtoverylowqualityevidencesuggesting thatSMTisnomoreeffectiveinthetreatmentofpatients withacutelow-backpainthaninertinterventions,sham(orfake)SMT,orwhenaddedtoanothertreatmentsuchasstandardmedical care.SMTalsoappearstobenomoreeffectivethanotherrecommendedtherapies.SMTappearstobesafewhencomparedtoother treatmentoptionsbutotherconsiderationsincludecostsofcare. Spinalmanipulativetherapyforacutelow-backpain(Review) 2 Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. e- e- e- el el el y-r y-r y-r all all all c c c ni ni ni cli cli cli Comments Small,notvanteffect. Small,notvanteffect. Small,notvanteffect. e c n e d vi e e h t 1 Qualityof(GRADE) ⊕⊕(cid:13)(cid:13),12low ⊕⊕⊕(cid:13)moderate ⊕⊕(cid:13)(cid:13),23low n] o anati nts pl pa N[Ex Particies) dies) dies) dy) O ofudi 3stu 6stu 1stu S No(st 38(3 60(3 24(1 I R A P M ct e O eff C ain ative%CI) IN ackp Rel(95 SUMMARYOFFINDINGSFORTHEMA Spinalmanipulativetherapycomparedtootherinterventionsforacutelow-b Patientorpopulation:Patientswithacutelow-backpainSettings:PrimaryortertiarycareIntervention:SpinalmanipulativetherapyComparison:Otherinterventions(e.g.physiotherapy,exercise,backschool) OutcomesIllustrativecomparativerisks*(95%CI) AssumedriskCorrespondingrisk OtherinterventionsSpinalmanipulativetherapy PainatoneweekThemeanpainatoneThemeanpainatone0(nopain)to10(worseweekrangedacrosscon-weekintheinterventiontrolgroupsfromgroupswaspain)2.6to3.5points0.1higher(0.5lowerto0.7higher) PainatonemonthThemeanpainatoneThemeanpainatone0(nopain)to10(worsemonthrangedacrossmonthintheinterventionpain)controlgroupsfromgroupswas0.5to2.3points0.2lower(0.5lowerto0.2higher) FunctionalstatusatoneThemeanfunctionalsta-Themeanfunctionalsta-weektusatoneweekinthetusatoneweekinthein-RolandMorrisDisabil-controlgroupswasterventiongroupswas7.2points0.1standarddeviationsityQuestionnaire.Scalehigherfrom:0(nodysfunction)to24(worsefunction)(0.2lowerto0.3higher) Spinalmanipulativetherapyforacutelow-backpain(Review) 3 Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Small,notclinically-rel-evanteffect.BasedonpooledSMD:-0.11(-0.426to0.05). Small,notclinically-rele-vanteffect. Total578participants.NoseriousadverseeventswereobservedintheSMTgroup stothedifferentlevelsof d n o p s e orr c and ate. ⊕⊕⊕(cid:13)1moderate ⊕⊕(cid:13)(cid:13),15low wasfulfilled eestimate.getheestim m than 681(3studies) 117(2studies) 2studies swerefulfilled(foreach,oneite⊕ estimateofeffectandmaychangeestimateofeffectandislikelytoch FunctionalstatusatoneThemeanfunctionalsta-Themeanfunctionalsta-monthtusatonemonthinthetusatonemonthinthecontrolgroupswasinterventiongroupswasRolandMorrisDisabil-4.1points0.5pointslowerityQuestionnaire.Scale(1.2lowerto0.2higher)from:0(nodysfunction)to24(worsefunction) RecoveryatonemonthStudypopulationRR1.06(0.94to1.21)87per10092per100(81to100) SeriousadverseeventsStudypopulationNotestimable CI:RR:⊕⊕Confidenceinterval;Riskratio;=thesesymbolsindicatehowmanyoftheitem(cid:13)(cid:13)evidence) GRADEWorkingGroupgradesofevidenceHighquality:Furtherresearchisveryunlikelytochangeourconfidenceintheestimateofeffect.Moderatequality:FurtherresearchislikelytohaveanimportantimpactonourconfidenceintheLowquality:FurtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheVerylowquality:Weareveryuncertainabouttheestimate. 1HighRoB2N<400subjects.3Onlyonestudyreportedtheoutcome;therefore,dataareinconsistentandimprecise.4RMDQbaseduponCherkin1998.5N<300events. Spinalmanipulativetherapyforacutelow-backpain(Review) 4 Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. BACKGROUND Descriptionoftheintervention Low-backpainisacommonanddisablingdisorderinwesternsoci- Inthisreview,SMTisconsideredtobeanyhands-ontreatment etywhichrepresentsagreatsocietalandfinancialburden(Dagenais that includes manipulation, mobilization, or both, directed to- 2008).Therefore,adequatetreatmentoflow-backpainisanim- wards the spine. Mobilizations use low-grade velocity, small or portantissueforpatients,clinicians,andhealthcarepolicymakers. largeamplitudepassivemovementtechniqueswithinthepatient’s Onewidelyusedinterventionforlow-backpainisspinalmanipu- joint range of motion and control. Manipulation, on the other lativetherapy(SMT),whichhasbeenexaminedinnumerousran- hand,usesahighvelocityimpulseorthrustappliedtoasynovial domizedcontrolledtrials(RCTs).Thesetrialshavebeensumma- joint over a short amplitude at or near the end of the passive rizedinrecentsystematicreviews(Bronfort2004a;Cherkin2003; or physiologicrange ofmotion, whichisoftenaccompanied by Brown2007)thathaveformedthebasisforrecommendationsin anaudible ’crack’(Sandoz1969).Thecrackingsoundiscaused clinicalguidelines(Chou2007;vanTulder2006).However,these by cavitation of the joint, which is a termused to describe the recommendations are largely based on an earlier version of this formationandactivityofbubbleswithinthefluid(Evans2002; Cochranereview(Assendelft2004),whichreportedthatSMTwas Unsworth 1971).Variouspractitioners, including chiropractors, superioronlytoshamtherapyortherapiesjudgedtobeineffective manualtherapists(physiotherapiststrainedinmanipulativetech- orevenharmful,andconcludedthattherewasnoevidencethat niques),orthomanualtherapists(medicaldoctorstrainedinma- SMT is superior to other standard treatments for patients with nipulation),orosteopathsusethisintervention.However,thefo- acutelow-backpain.Theeffectsizes,however,weresmallandar- cusofthetreatment,education,diagnosticproceduresused,treat- guablynotclinicallyrelevant.Furthermore,theseestimateswere mentobjectives,techniques,aswellasthephilosophyofthevari- basedmainlyonsmallstudieswithahighriskofbias. ousprofessionsdiffer,oftenconsiderably.Forexample,thefocus SMTis deliveredbyvarious professional groups, including chi- oforthomanualtherapyisoncorrectingabnormalpositionsofthe ropractors,manualtherapists,andosteopaths,andisincludedin skeletonandestablishing symmetryinthespine through mobi- manynationalguidelinesforthemanagementofacutelow-back lization. Manual therapyfocusesoncorrectingfunctional disor- pain(Koes2001;vanTulder2004).Theserecommendationsvary ders of the musculoskeletal system through predominantly pas- however.Inmostguidelines,SMTisconsideredtobeatherapeu- sivemobilization andsometimesusing high-velocitylow-ampli- ticoptionintheacutephaseofalow-backpainepisode.TheUSA, tude(HVLA)techniques.Chiropractors,ontheotherhand,focus UK,NewZealand,andDanishguidelinesconsiderSMTauseful oncorrectingdisordersoftheneuromusculoskeletalsystembyus- treatment,whereastheDutch, Australian, andIsraeliguidelines ingpredominantlyHVLAmanipulativetechniques(vandeVeen donotrecommendSMTfortheacutephase(vanTulder2006). 2005). ThisreportisanupdateofthepreviousCochranereviewandfol- lowsthemostrecentguidelinesdevelopedbyTheCochraneCol- laborationingeneral(Higgins2011)andbytheCochraneBack Howtheinterventionmightwork Review Group (Furlan 2009) in particular. The current review Many hypotheses exist regarding the mechanism of action for wassplitintotwopartsaccordingtodurationofthecomplaint, spinal manipulation and mobilization (Bronfort 2008; Khalsa namelyacuteandchroniclow-backpain.Thereviewonchronic 2006;Pickar2002),whichtosomeextentisduetothedifference low-backpainhassincebeenpublished(Rubinstein2011).The inopinionsbetweenthevariousprofessionalgroups.Somehave presentreviewfocusesontheeffectivenessofSMTforacutelow- postulatedthatmobilizationandmanipulationshouldbeassessed backpain(Rubinstein2010)andfollowsthesamemethodology asseparateentitiesgiventheirtheoreticallydifferentmechanisms asthereviewforchroniclow-backpain. of action (Evans 2002).The modesof action mightbe roughly dividedintomechanicalandneurophysiologic.Themechanistic approach suggests that SMT acts on a manipulable lesion (of- Descriptionofthecondition ten calledthe functional spinal lesion or subluxation) and pro- Low-backpainisdefinedaspainanddiscomfortthatislocalised posesthatforcestoreduceinternalmechanicalstressesresultinre- belowthecostalmarginandabovetheinferiorglutealfolds,with ducedsymptoms(Triano2001).Theneurophysiologicapproach or without referred leg pain. Acute low-back pain is defined as suggests that SMT impacts the primary afferent neurons from thedurationofanepisodepersistingfornolongerthansixweeks. paraspinal tissues, the motor control system, and pain process- Thiscondition isconsideredtobetypicallyself-limiting,witha ing(Pickar2002).Inconclusion,itwouldappearthattheactual recoveryrateof90%withinsixweeksoftheinitialepisode,while mechanismremainsdebatable(Evans2002;Khalsa2006). 2%to7%developchroniclow-backpain(vanTulder2006).Non- specificlow-back pain isoperationally definedaslow-back pain notattributedtoarecognisable, specificpathology(forexample Whyitisimportanttodothisreview infection,tumor,orfracture). Spinalmanipulativetherapyforacutelow-backpain(Review) 5 Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. SMTisaworldwide,extensivelypractisedintervention;however, Exclusioncriteria itseffectivenessforacutelow-backpainisnotwithoutdispute.Al- Participantswith: thoughnumeroussystematicreviewshaveexaminedtheeffective- • post-partumlow-backpainorpelvicpainduetopregnancy, nessofSMTforlow-backpain(Airaksinen2006;Chou2007), • painnotrelatedtothelow-back,e.g.coccydynia, veryfewhaveconductedameta-analysis,especiallyforacutelow- • post-operativestudiesorparticipantswith’failed-back backpain.ThepreviousCochranereview(Assendelft2004)last syndrome’; searchedfor studiesupto January 2000. NumerousRCTs have beenidentifiedsincethen.Inaddition,themethodologyforcon- orstudieswhich: ducting systematic reviews, including the criteria for evaluating • examined’maintenancecare’orprevention, theriskofbiasandtheGRADEsystemforevaluatingthestrength • exclusivelyexaminedspecificpathologies,including of the evidence, have been substantially revised; therefore, this sciatica.Ofnote:Studiesofsciaticawereexcludedbecauseitisa updateisthoughttoshedamorereliableoverviewonthisissue prognosticfactorassociatedwithworsepain,disability,orboth (Higgins2011). (Bronfort2004;Bouter1998),especiallywithSMT(Axen2005; Malmqvist2008).Itisthoughttorepresentapathologydifferent thannon-specificlow-backpain. Typesofinterventions OBJECTIVES Theobjective of thisreviewwas toexamine theeffectivenessof SMT on primary (that is pain, functional status, and recovery) Experimentalintervention andsecondaryoutcomes(thatisreturn-to-work,qualityoflife)as Theexperimentalinterventionsexaminedinthisreviewincluded comparedtoinertinterventions, sham,andallothertreatments both spinal manipulation andmobilization of thespine. Unless foradultswithacutelow-backpain.Theeffectswereexaminedfor otherwiseindicated,SMTreferstobothmodesof’hands-on’treat- short-term(closesttoonemonth),intermediate(closesttothree mentofthespine. tosixmonths),andlong-termfollow-up(closestto12months). Typesofcomparisons Studieswereincludedforconsideration ifthestudydesignused METHODS indicatedthattheobserveddifferenceswereduetotheuniquecon- tributionofSMT.Thisexcludesstudieswithamulti-modaltreat- mentasoneoftheinterventions(forexamplestandardphysician Criteriaforconsideringstudiesforthisreview care+spinalmanipulation+exercisetherapy)andeitheradiffer- enttypeofinterventionoronlyoneinterventionfromthemulti- modaltherapyasthecomparison(forexamplestandardphysician care alone) since this would make itimpossible todecipher the Typesofstudies actualeffectofSMT. Allrandomized controlledtrials(RCTs) wereincludedwith the Comparison therapies were combined into the following main exceptionofthosethatusedinappropriaterandomizationproce- clusters: dures(forexamplealternateallocation,birthdates).Inaddition, 1)SMTversusinertinterventions; studieswithfollow-upoflessthanonedaywereexcluded. 2)SMTversusshamSMT; 3)SMTversusallothertherapies; 4)SMTplusanyinterventionversusthatsameinterventionalone Typesofparticipants (i.e.SMTasanadjuncttherapy); 5) SMT versus another SMT technique (e.g. side-lying thrust SMTversusnon-thrustside-lyingtechnique,supinethrustSMT Inclusioncriteria versusside-lyingthrustSMT). • Adultparticipants(>18yearsofage)withameanduration Inertinterventionsincludedetuneddiathermyanddetunedultra- oflow-backpain<sixweeks sound.ShamSMTwasdefinedasanymanipulationormobiliza- • Participantswithorwithoutradiatingpain tiontechniquethatwasostensiblyindistinguishableforthepatient fromthetruetechnique,meaningthepatientdidnotknowifhe Nolimitswereplacedonthesetting(thatiswhetherfromprimary, orshewasreceivingthereal’(oractivecomponent)ortheplacebo secondary,ortertiarycare). or’fake’therapy.ShamSMTwasconsideredacceptableifthiswas Spinalmanipulativetherapyforacutelow-backpain(Review) 6 Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. queriedamongtheparticipantspost-treatmentandtheblinding Searchingotherresources appearedtobesuccessful. Wealsoscreenedthereferencelistsofallincludedstudiesand(sys- tematic)reviewspertinenttothistopic.Wereviewedgreylitera- turethatisavailableelectronicallyfromclinicaltrialsregistersand Typesofoutcomemeasures thewebsitesrecommendedbytheChiropracticLibraryCollabo- Onlypatient-reportedoutcomemeasureswereevaluated.Physio- ration.WesearchedforregisteredtrialsintheUSClinicalTrials logicalmeasures,suchasspinalflexibilityordegreesachievedwith databaseandtheWorldHealthOrganizationInternationalClin- astraightlegraisetest(thatisLasegue’stest),werenotconsidered icalTrialsRegistryPlatform(ICTRP).Selectedresearchersfamil- clinically-relevantoutcomesandwerenotincludedintheanalyses. iarwiththisliteraturewerealsoapproachedinordertoconfirm whetherourselectionofstudieswascomplete. Primaryoutcomes • Pain,measuredbyavisualanalogueorotherpainscale(e.g. visualanaloguescale(VAS),numericalratingscale(NRS), Datacollectionandanalysis McGillpainscore) Two review authors(SMR, CBT)independently conducted the • Back-painspecificfunctionalstatus,measuredbyaback- selection of studies and performed the risk of bias assessment. painspecificscale(e.g.Roland-MorrisDisabilityQuestionnaire Bothqualitativeandquantitativedatawereextractedbyonereview (RMDQ),OswestryDisabilityIndex(ODI)) authorandcheckedforaccuracyagainsttheoriginalpaperbythe • Globalimprovementorperceivedrecovery,measuredbyan second review author. All disagreements were resolved through ordinalordichotomousscale(definedasthenumberofpatients consensusanditwasnotnecessarytoconsultathirdreviewauthor reportedtoberecoveredornearlyrecovered) (MWvT). Secondaryoutcomes Selectionofstudies • Perceivedhealthstatusorqualityoflife(e.g.subscalefrom Wescreenedtitlesandabstractsfromthesearchresults.Potentially theSF-36,theEuroQolthermometer) relevantstudieswereobtainedinfulltextandindependentlyas- • Return-to-work sessedforinclusion.Disagreementswereresolvedthroughdiscus- sion.Onlyfullpaperswereevaluated.Abstractsandproceedings fromcongressesoranyother’greyliterature’wereexcluded.No Searchmethodsforidentificationofstudies languagerestrictionswereimposed. Dataextractionandmanagement Electronicsearches Astandardizedformwasusedtoextractthequalitativedata.The RCTs and systematic reviews were identified by electronically followingwereextracted:studycharacteristics(forexamplecoun- searchingthefollowingdatabases(searchdate:31March2011). trywherethestudywasconducted,recruitmentmodality,sourceof The search was limited to studies published since 2000. Stud- funding,riskofbias),patientcharacteristics(forexamplenumber ies published prior to this date were included in the previous ofparticipants,age,gender),descriptionoftheexperimentaland Cochrane review and were also considered for inclusion in this control interventions, duration of follow-up, typesof outcomes updatedreview. assessed, and theauthors’ resultsandconclusions. Datarelating • CochraneCentralRegisterofControlledTrials totheprimaryoutcomeswereassessedforinclusioninthemeta- (CENTRAL)(Appendix1). analyses.Datawerenotextractedfromthosestudiesthoughtto • MEDLINE(Appendix2). • EMBASE(Appendix3). haveafatalflaw,whichwasdefinedas:1)adrop-outrategreater • CINAHL(Appendix4). than50%atthefirstandsubsequentfollow-upmeasurements;or 2) statistically and clinically-relevant, important baseline differ- • PEDro. encesforoneormoreprimaryoutcomes(thatispain,functional • IndextoChiropracticLiterature. status)indicatingunsuccessfulrandomization. Finalvaluescores The search strategy developed by the Cochrane Back Group wereusedforthemeta-analysesonly,meaningdatawereestimated wasfollowedusingfreetextwordsandmedicalsubjectheadings when change scores were presented. Outcomes were assessed at (MeSH).Thesearchwasconductedbyaclinicallibrarianwithex- oneweekaswellasatone,threeand12monthsandwerecate- perienceinsearchingforarticlesforsystematicreviews.Thesearch gorizedaccording tothetimeclosesttotheseintervals.Insome wasupdatedonJuly18,2012. casesoutcomedatawerenotavailableforthethreemonthinterval Spinalmanipulativetherapyforacutelow-backpain(Review) 7 Copyright©2012TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
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