Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and

277 Pages·2014·7.34 MB·English

by  Katherine Pohlman

OriginalInvestigation | PhysicalMedicineandRehabilitation
Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical
Care Alone on Pain and Disability Among US Service Members
With Low Back Pain
A Comparative Effectiveness Clinical Trial
ChristineM.Goertz,DC,PhD;CynthiaR.Long,PhD;RobertD.Vining,DC;KatherineA.Pohlman,DC,MS;JoanWalter,JD,PA;IanCoulter,PhD
Abstract KeyPoints
Question Whatistheeffectofadding
IMPORTANCE Itiscriticallyimportanttoevaluatetheeffectofnonpharmacologicaltreatmentson
chiropracticcaretousualmedicalcare
lowbackpainandassociateddisability.
forpatientswithlowbackpain?
OBJECTIVE Todeterminewhethertheadditionofchiropracticcaretousualmedicalcareresultsin Findings Inthiscomparative
betterpainreliefandpain-relatedfunctionwhencomparedwithusualmedicalcarealone. effectivenessclinicaltrialamongactive-
dutyUSmilitarypersonnel,patients
DESIGN,SETTING,ANDPARTICIPANTS A3-sitepragmaticcomparativeeffectivenessclinicaltrial whoreceivedusualmedicalcareplus
usingadaptiveallocationwasconductedfromSeptember28,2012,toFebruary13,2016,at2large chiropracticcarereportedastatistically
militarymedicalcentersinmajormetropolitanareasand1smallerhospitalatamilitarytrainingsite. significantmoderateimprovementin
Eligibleparticipantswereactive-dutyUSservicemembersaged18to50yearswithlowbackpain lowbackpainintensityanddisabilityat
fromamusculoskeletalsource. 6weekscomparedwiththosewho
receivedusualcarealone.
INTERVENTIONS Theinterventionperiodwas6weeks.Usualmedicalcareincludedself-care,
Meaning Thistrialsupportsthe
medications,physicaltherapy,andpainclinicreferral.Chiropracticcareincludedspinalmanipulative
inclusionofchiropracticcareasa
therapyinthelowbackandadjacentregionsandadditionaltherapeuticproceduressuchas
componentofmultidisciplinaryhealth
rehabilitativeexercise,cryotherapy,superficialheat,andothermanualtherapies.
careforlowbackpain,ascurrently
recommendedinexistingguidelines.
MAINOUTCOMESANDMEASURES Coprimaryoutcomeswerelowbackpainintensity(Numerical
RatingScale;scoresrangingfrom0[nolowbackpain]to10[worstpossiblelowbackpain])and
+
disability(RolandMorrisDisabilityQuestionnaire;scoresrangingfrom0-24,withhigherscores InvitedCommentary
indicatinggreaterdisability)at6weeks.Secondaryoutcomesincludedperceivedimprovement, +
Supplementalcontent
satisfaction(NumericalRatingScale;scoresrangingfrom0[notatallsatisfied]to10[extremely
Authoraffiliationsandarticleinformationare
satisfied]),andmedicationuse.Thecoprimaryoutcomesweremodeledwithlinearmixed-effects
listedattheendofthisarticle.
regressionoverbaselineandweeks2,4,6,and12.
RESULTS Ofthe806screenedpatientswhowererecruitedthrougheitherclinicianreferralsorself-
referrals,750wereenrolled(250ateachsite).Themean(SD)participantagewas30.9(8.7)years,
175participants(23.3%)werefemale,and243participants(32.4%)werenonwhite.Statistically
significantsite×time×groupinteractionswerefoundinallmodels.Adjustedmeandifferencesin
scoresatweek6werestatisticallysignificantinfavorofusualmedicalcarepluschiropracticcare
comparedwithusualmedicalcarealoneoverallforlowbackpainintensity(meandifference,−1.1;
95%CI,−1.4to−0.7),disability(meandifference,−2.2;95%CI,−3.1to−1.2),andsatisfaction(mean
difference,2.5;95%CI,2.1to2.8)aswellasateachsite.Adjustedoddratiosatweek6werealso
statisticallysignificantinfavorofusualmedicalcarepluschiropracticcareoverallforperceived
(continued)
OpenAccess.ThisisanopenaccessarticledistributedunderthetermsoftheCC-BYLicense.
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Abstract(continued)
improvement(oddsratio=0.18;95%CI,0.13-0.25)andself-reportedpainmedicationuse(odds
ratio=0.73;95%CI,0.54-0.97).Noseriousrelatedadverseeventswerereported.
CONCLUSIONSANDRELEVANCE Chiropracticcare,whenaddedtousualmedicalcare,resultedin
moderateshort-termimprovementsinlowbackpainintensityanddisabilityinactive-dutymilitary
personnel.Thistrialprovidesadditionalsupportfortheinclusionofchiropracticcareasacomponent
ofmultidisciplinaryhealthcareforlowbackpain,ascurrentlyrecommendedinexistingguidelines.
However,studylimitationsillustratethatfurtherresearchisneededtounderstandlonger-term
outcomesaswellashowpatientheterogeneityandinterventionvariationsaffectpatientresponses
tochiropracticcare.
TRIALREGISTRATION ClinicalTrials.govIdentifier:NCT01692275
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Introduction
Musculoskeletaldisordersarethesecondleadingcauseofdisabilityworldwide,ledbylowbackpain
(LBP),withanestimatedLBPprevalenceamongUSadultsof20%.1-3Thedirectcostsofbackpain
intheUnitedStatesin2010were$34billion,4withadditionalindirectcostsincludinglostworkplace
productivityestimatedat$200billion.5IntheUSmilitary,LBPisoneofthemostcommonreasons
membersseekmedicalcare6andoneofthemostlikelyconditionstointerruptcombatduty.6,7
CommonmedicaltherapiesforLBP,includingnonsteroidalanti-inflammatorydrugs,opioids,spinal
fusions,andepiduralsteroidinjections,demonstratelimitedeffectiveness8-10;furthermore,manyof
thesetreatmentshaveunacceptablyhighriskprofiles.8,11-14
TheUSopioidcrisis15,16createsanurgentneedtoevaluatecost-effectiveandlow-risk
nonpharmacologicaltreatments.Oneoptionischiropracticcare.Doctorsofchiropracticprovide
conservativecarefocusedondiagnosis,treatment,comanagement,orreferralformusculoskeletal
conditions,includingLBP.17Theprimarytherapeuticprocedureusedbydoctorsofchiropracticis
spinalmanipulativetherapy.18
Theuseofchiropracticcareiscommon,withannualratesamongUSadultsestimatedbetween
8%and14%.19,20Currentguidelinesrecommendtheuseofspinalmanipulativetherapyand/or
chiropracticcareforLBP.21,22Althoughapreviouspilotstudyofchiropracticcareforactive-dutyUS
militarypatientswithacuteLBPshowedpromise,23andchiropracticcareisavailableat66military
healthtreatmentfacilitiesworldwide,24significantgapsinknowledgeremaininmilitarypopulations.
Thesepopulationstendtobeyoungerandmorediverseintermsofraceandethnicitythanthose
includedinprevioustrialsonspinalmanipulation.25Thismultisite,pragmaticclinicaltrialbeginsto
addressthesegapsbyinvestigatingwhetheraddingchiropracticcaretousualmedicalcare(UMC)
improvesoutcomesforpatientswithLBPatmilitarytreatmentfacilities.
Methods
StudyDesign,Setting,andParticipants
Adetailedstudyprotocolwaspreviouslypublished,26andthetrialprotocolisavailablein
Supplement1.Thispragmatic,prospective,multisite,parallel-groupcomparativeeffectiveness
clinicaltrialwithadaptiveallocationwasconductedat2largemilitarymedicalcentersinmajor
metropolitanareas(WalterReedNationalMilitaryMedicalCenter[hereafterreferredtoas“Walter
Reed”],Bethesda,Maryland;andNavalMedicalCenterSanDiego[hereafterreferredtoas“San
Diego”],SanDiego,California)andat1smallerhospitalatamilitarytrainingsite(NavalHospital
Pensacola[hereafterreferredtoas“Pensacola”],Pensacola,Florida).Active-dutyUSmilitary
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participantsaged18to50yearsreportingLBPwereeligible.Lowbackpainofanydurationfroma
nonmusculoskeletalsource,thepresenceofacontraindicationtospinalmanipulativetherapy,recent
spinalfracture,recentspinalsurgery,andadiagnosisofposttraumaticstressdisorderwere
exclusionary.Participantswithradiculopathywereeligibleifafurtherdiagnosticevaluationor
surgicalreferralwasnotnecessary.Participantseitherwerereferredtothestudybyphysicianswho
diagnoseormanageLBPorwereself-referredthroughpostedadvertisements.Physiciansor
IndependentDutyCorpsmenconductedascreeningexaminationtoassesseligibility.Thetrialwas
approvedbyeachsiteandparticipatinginstitution’sinstitutionalreviewboardandwasoverseenby
anindependentdataandsafetymonitoringcommittee.Allparticipantsprovidedwritteninformed
consentandwerenotcompensatedforparticipation.ThestudyfollowedtheConsolidated
StandardsofReportingTrials(CONSORT)reportingguideline.
Allocation
ParticipantswereallocatedinequalproportionstoUMCwithchiropracticcareortoUMCalonefor6
weeks,stratifiedbysite.Thedatacoordinatingcenterprogrammedanadaptivecomputer-
generatedminimizationalgorithmtobalancegroupassignmentonsex,age,LBPduration,andworst
painintensityinthepast24hoursatbaseline.Studypersonnelaccessedthewebapplicationtomake
groupassignments,andfutureallocationswereconcealed.
StudyInterventions
UsualMedicalCare
Inthispragmatictrial,UMCinbothgroupsincludedanycarerecommendedorprescribedby
nonchiropracticmilitaryclinicianstotreatLBP.Optionsincludedself-managementadvice,
pharmacologicpainmanagement,physicaltherapy,orpainclinicreferral.Participantsallocatedto
UMCalonewereaskedtoavoidreceivingchiropracticcarefortheactivecareperiodunlessdirected
bytheirclinician.Inbothgroups,frequencyoftreatmentvisitsandproceduresweredetermined
individuallybasedontheparticipant’sdiagnosisorcondition,responsetocare,andscheduling
availability.
UMCWithChiropracticCare
ParticipantsallocatedtoUMCwithchiropracticcarehadUMCinadditiontoasmanyas12
chiropracticvisitsduringtheactivecareperiod.Theprimarychiropracticprocedurewasspinal
manipulativetherapyinthelowbackandadjacentregions.18Treatmentdecisionsregarding
manipulationtype,location,anddirectionwerebasedonpatientdiagnoses.Otherfactorsincluded
patientpreference,priorresponsetocare,paraspinalmusclehypertonicity,spinaljointhypomobility,
andimagingfindings.Additionaltherapeuticproceduresmayhaveincludedrehabilitativeexercise,
interferentialcurrenttherapy,ultrasoundtherapy,cryotherapy,superficialheat,andothermanual
therapies.
Blinding
Itwasnotpossibletoblindtreatingcliniciansorparticipantstotreatmentassignment.However,all
keystudypersonnelanddataanalystswereblinded.
Outcomes
Sociodemographicandclinicalinformationwasobtainedatbaseline.Participantswereclassifiedby
raceandethnicitybasedonself-report.Thesedatawerecollectedtodeterminethegeneralizability
ofstudyfindings,whichisimportantforstudiesofchiropracticcareasprevioustrialshaveincluded
primarilywhiteparticipantsnotofLatinodescent.Usualmedicalcaredataonphysicaltherapyor
specialtyreferralsandprescriptionmedicationsforspine-relatedpainaswellasCurrentProcedural
Terminologycodesdescribingtreatmentsdeliveredbythedoctorofchiropracticwereabstracted
fromtheelectronichealthrecord.
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Primaryoutcomes(eTable1inSupplement2)weremeasuredatbaselineand2,4,6,and12
weeksafterbaselineviaonlineself-reportquestionsthroughanelectronicdatacapturesystem.26
Primaryandsecondaryendpointswereat6and12weeks,respectively.
CoprimaryOutcomes
AverageLBPintensityduringthepriorweekwasassessedbytheNumericalRatingScale(NRS;scores
rangingfrom0[noLBP]to10[worstpossibleLBP]).27-29FunctionaldisabilityrelatedtoLBPwas
assessedbytheRolandMorrisDisabilityQuestionnaire(RMDQ;scoresrangingfrom0-24,with
higherscoresindicatinggreaterdisability).30Primaryanalysescomparedadjustedmeansbetween
groupsattheprimaryandsecondaryendpoints.Asecondaryresponderanalysiscomparedthe
percentageofpatientswithatleast30%improvementfrombaselineateachendpoint.
SecondaryOutcomes
WorstLBPintensityduringthepast24hourswasassessedusingtheNRS.BothersomenessofLBP
symptomsinthepastweekwasmeasuredonascaleof1(notatallbothersome)to5(extremely
bothersome).31Painmedicationusewascollectedbyaskingparticipantshowoftentheytookpain-
relievingmedication(bothprescriptionandover-the-counter)duringthepastweek(0,1-2,3-4,5-6,
or7days).GlobalLBPimprovementwasassessedbyaskingparticipantstoratetheirperceivedLBP
improvementsincebaselineona7-pointscale(0indicatedcompletelygone;6,muchworse).32,33
SatisfactionwithcarewasassessedwithanNRS,withscoresrangingfrom0(notatallsatisfied)to10
(extremelysatisfied).
AdverseEvents
Adverseeventsweredocumentedbyparticipantsviaonlineself-reportquestionsansweredat2,4,
and6weeks,andfromprojectmanagerswhodirectlyqueriedparticipants.
SampleSize
Weanticipatedthatoutcomesmightvarybysiteowingtodifferingpatientpopulations.Therefore,
wecalculatedasamplesizeof106patientspergrouppersitetoprovideadequatepowertodetect
clinicallyimportantbetween-groupdifferences.34ABonferroni-adjustedsignificancelevelof
α=.025accountedforthecoprimaryoutcomevariables,withstandarddeviationsestimatedfrom
ourpilotstudy.Thisprovided92%powertodetectabetween-groupdifferenceofatleast1.2points
ontheNRSand80%powertodetectadifferenceofatleast2.4pointsontheRMDQ35ateachsite.
Weincreasedthesamplesizeto125patientspergroupateachsitetoaccountforanestimatedloss
tofollow-upof15%attheweek6endpoint.
StatisticalAnalysis
ThedataanalysisplanwasprespecifiedandisshowninSupplement1.26Analysesfollowedan
intention-to-treatapproachinwhichallparticipants’datawereanalyzedaccordingtotheiroriginal
treatmentallocation.WeusedSAS/STAT(release9.4;SASInstituteInc)fordataanalyses.All
observeddatawereusedintheanalyses.Regressionmodelsincludedtermsfortime,site,group,and
site×group,time×group,andsite×time×groupinteractions,adjustedforsex,age,painduration,
andworstpainduringthepast24hours.Forallanalyses,ifthesite×time×groupinteractionwas
significantattheα=.05level,resultsfromtheadjustedfinalmodelswerereportedoveralland
bysite.
Thecoprimaryoutcomevariablesweremodeledwithlinearmixed-effectsregressionover
baselineandweeks2,4,6,and12.Bonferroni-correctedP(cid:2).025wasusedtodeterminewhether
between-groupdifferenceswerestatisticallysignificantatweeks6and12.Theresponderanalysesof
thecoprimaryoutcomevariablesweremodeledwithamodifiedPoissonregressionfitthrough
generalizedestimatingequations.
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Twoapproachestosensitivityanalyseswereusedtoexaminepossibleeffectsofmissingdata
onresultsofcoprimaryoutcomevariables.Thefirstassumedthatdataweremissingatrandomand
thesecondwasatipping-pointapproachthatassumeddataweremissingnotatrandom.Multiple
imputationwiththeMarkovchainMonteCarlomethodwasusedforbothmethodstoimpute
missingvaluesforthecoprimaryoutcomevariablesatweeks2,4,6,and12.
Continuoussecondaryoutcomevariableswereanalyzedwiththesamelinearmixed-effects
regressionmodelsdescribedearlier(exceptsatisfaction,whichwascollectedthroughweek6),but
P(cid:2).05wasusedtodeterminewhetherbetween-groupdifferencesweresignificant.Pain
medicationuseandperceivedglobalimprovementwereanalyzedoverbaselineandweeks2,4,and
6withaproportionaloddsmodelforordinalcategoricaldatafitthroughgeneralizedestimating
equations.
Results
ParticipantsandTreatmentVisits
Atotalof806patientswerescreenedbetweenSeptember28,2012,andNovember20,2015,with
750(250ateachofthe3sites)allocatedtoreceiveUMCwithchiropracticcare(375participants)or
UMCalone(375participants)(Figure1).DatacollectionwascompletedonFebruary13,2016,and
dataanalysiswasconductedfromMarch7,2016,throughApril30,2016.Demographic
characteristics,inparticularage,race,andLBPchronicity,differedbetweensites(Table1).Overall,
themean(SD)participantagewas30.9(8.7)years,175participants(23.3%)werefemale,and243
participants(32.4%)werenonwhite.Forty-threeparticipants(5.7%)reportedcurrentuseofnarcotic
Figure1.TrialFlowDiagram
806Individuals assessed for eligibility
56Excluded
32Did not meet eligibility criteria
24Declined to participate
750Allocated
375Allocated to UMC 375Allocated to UMC with chiropractic care
273Attended ≥1 visit with UMC clinician 266Attended ≥1 visit with UMC clinician
2Received chiropractic care during 109Did not Dreicde nivoet rUeMceCive UMC
6-wk active care phase
102Did not receive UMC 350Att3e5n0ded ≥1 visit with
doctor of chiropractic
15Did not receive UMC or
chiropractic care
10Received UMC but had no visits with
doctor of chiropractic
319Completed 2-wk assessment (85%) 334Completed 2-wk assessment (89%)
16Lost to follow-up 11Lost to follow-up
3Withdrew from study 3Withdrew from study
302Completed 4-wk assessment (81%) 321Completed 4-wk assessment (86%)
5Lost to follow-up 3Lost to follow-up
2Withdrew from study 1Withdrew from study
340Completed 6-wk assessment (90%) 342Completed 6-wk assessment (91%)
1Lost to follow-up 7Lost to follow-up
4Withdrew from study 2Withdrew from study
316Completed 12-wk assessment (84%) 309Completed 12-wk assessment (82%)
26Lost to follow-up 36Lost to follow-up
2Withdrew from study 3Withdrew from study
375Included in analysis of coprimary outcomes 375Included in analysis of coprimary outcomes
UMCindicatesusualmedicalcare.
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analgesicsand398(53.1%)tooknonsteroidalanti-inflammatorydrugsforbackpain.Amongall
participants,439(58.5%)hadneverbeentreatedwithchiropracticcare.
Therewere102participantsintheUMCgroupwhodidnotvisitaUMCclinician:6atWalter
Reed,2atPensacola,and94atSanDiego.Ofthe273patientswhohadatleast1visittoaUMC
clinician,themean(SD)numberofvisitswas2.6(2.3)atWalterReed,2.3(2.3)atPensacola,and2.7
(2.5)atSanDiego.Therewere109participantsinthegroupreceivingUMCwithchiropracticcare
whodidnotvisitaUMCclinician:11atWalterReedand98atSanDiego.Ofthe266patientswhohad
atleast1visittoaUMCclinician,themean(SD)numberofvisitswas2.6(3.1)atWalterReed,1.6(1.6)
atPensacola,and3.5(3.0)atSanDiego.Ofthe350participantswhohadatleast1chiropracticvisit,
themean(SD)numberofvisitswas4.7(2.5)atWalterReed,5.4(2.6)atPensacola,and2.3(1.4)at
SanDiego.
Table1.BaselineCharacteristicsof750Participants
No.(%)
WalterReeda Pensacolaa SanDiegoa Overall
UMCAlone UMC+CC UMCAlone UMC+CC UMCAlone UMC+CC UMCAlone UMC+CC
Characteristic (n=125) (n=125) (n=125) (n=125) (n=125) (n=125) (n=375) (n=375)
Age,mean(SD),y 34.4(8.4) 34.7(8.6) 25.5(7.9) 25.7(7.5) 32.4(7.4) 32.4(7.5) 30.8(8.8) 30.9(8.7)
Male 86(68.8) 85(68.0) 106(84.8) 107(85.6) 95(76.0) 96(76.8) 287(76.5) 288(76.8)
HispanicorLatino 16(12.8) 9(7.2) 29(23.2) 12(9.6) 21(16.8) 31(24.8) 66(17.6) 52(13.9)
Race
Asian 6(4.8) 3(2.4) 3(2.4) 1(0.8) 11(8.8) 6(4.8) 20(5.3) 10(2.7)
BlackorAfricanAmerican 41(32.8) 42(33.6) 17(13.6) 15(12.0) 14(11.2) 20(16.0) 72(19.2) 77(20.5)
White 62(49.6) 62(49.6) 102(81.6) 106(84.8) 88(70.4) 87(69.6) 252(67.2) 255(68.0)
Otherorunspecified 16(12.8) 18(14.4) 2(1.6) 7(5.6) 11(8.8) 17(13.6) 31(8.3) 33(8.8)
LBPduration,mo
<1 42(33.6) 43(34.4) 81(64.8) 80(64.0) 21(16.8) 20(16.0) 144(38.4) 143(38.1)
1-3 14(11.2) 14(11.2) 17(13.6) 17(13.6) 9(7.2) 8(6.4) 40(10.7) 39(10.4)
>3 69(55.2) 68(54.4) 27(21.6) 28(22.4) 95(76.0) 97(77.6) 191(50.9) 193(51.5)
BMI,mean(SD) 27.7(3.9) 27.2(3.7) 26.0(3.3) 25.6(3.5) 26.6(3.5) 26.8(3.6) 26.8(3.6) 26.5(3.7)
Currentsmoker 9(7.2) 5(4.0) 28(22.4) 15(12.0) 27(21.6) 17(13.6) 64(17.1) 37(9.9)
UsedNSAIDsforLBP 82(65.6) 75(60.0) 59(47.2) 58(46.4) 54(43.2) 70(56.0) 195(52.0) 203(54.1)
inpastwk
Usednarcoticanalgesicsfor 9(7.2) 12(9.6) 1(0.8) 4(3.2) 11(8.8) 6(4.8) 21(5.6) 22(5.9)
LBPinpastwk
Neverbeentoadoctorof 70(56.5) 64(51.2) 92(73.6) 84(67.7) 68(54.4) 61(48.8) 230(61.3) 209(55.7)
chiropractic
NRSscoreforaverageLBP 4.3(1.7) 4.4(1.8) 4.7(2.0) 4.4(2.2) 4.8(2.1) 5.0(2.0) 4.6(2.0) 4.6(2.0)
duringpastwk,mean(SD)b
RMDQscorefordisability, 10.3(5.4) 9.7(5.5) 11.0(5.2) 10.5(5.9) 8.9(5.7) 9.3(5.2) 10.1(5.5) 9.8(5.6)
mean(SD)c
Scoreofbothersomenessof 3.6(1.0) 3.5(1.0) 3.8(0.9) 3.7(1.0) 3.5(1.0) 3.5(0.9) 3.7(1.0) 3.6(1.0)
LBP,mean(SD)d
NRSscoreforworstLBPin 5.6(2.4) 5.7(2.0) 6.6(1.9) 6.2(2.1) 5.4(2.4) 5.4(2.1) 5.9(2.3) 5.8(2.1)
past24h,mean(SD)b
ExpectationofUMC+CC, 8.2(1.8) 8.4(1.6) 8.1(1.9) 8.3(1.9) 8.6(1.8) 8.5(1.9) 8.3(1.9) 8.4(1.8)
mean(SD)e
ExpectationofUMCalone, 5.3(2.4) 4.9(2.5) 5.3(2.3) 5.4(2.5) 4.5(2.8) 5.2(3.0) 5.0(2.5) 5.2(2.7)
mean(SD)e
Abbreviations:BMI,bodymassindex(calculatedasweightinkilogramsdividedby bPossiblescoresrangefrom0(noLBP)to10(worstpossibleLBP).
heightinmeterssquared);CC,chiropracticcare;LBP,lowbackpain;NRS,Numerical cPossiblescoresrangefrom0to24,withhigherscoresindicatinggreaterdisability.
RatingScale;NSAIDs,nonsteroidalanti-inflammatorydrugs;RMDQ,RolandMorris
dPossiblescoresrangefrom1(notatallbothersome)to5(extremelybothersome).
DisabilityQuestionnaire;UMC,usualmedicalcare.
eIndicatesparticipant’sexpectationofhelpfulnessoftreatmentforLBP,measuredona
aWalterReedindicatesWalterReedNationalMilitaryMedicalCenter,Bethesda,
scaleof0(nothelpfulatall)to10(extremelyhelpful).
Maryland;PensacolaindicatesNavalHospitalPensacola,Pensacola,Florida;andSan
DiegoindicatesNavalMedicalCenterSanDiego,SanDiego,California.
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PrimaryOutcomes
Wefoundsignificantsite×time×groupinteractionsinallmodels.Adjustedmeandifferences
betweengroupsoverallwereconsistentlyinfavorofUMCwithchiropracticcarecomparedwithUMC
aloneforthecoprimaryoutcomevariablesofLBPintensity(meandifference,−1.1;95%CI,−1.4to
−0.7)anddisability(meandifference,−2.2;95%CI,−3.1to−1.2)atweek6(Table2)aswellasatall3
sites(Figure2).Findingsatweek12weresimilar,butwithaslightlysmallermagnitudeofdifference
(Table2).Resultsofthesensitivityanalysisshowedeffectsinthesamedirectionwithsimilar
magnitudesandstatisticalsignificanceunderbothmissing-at-randomandmissing-not-at-random
approachesforplausibleshiftparametersofthecoprimaryoutcomevariablesatallsites.The
possibleexceptiontothiswasweek6RMDQscoresatPensacola,forwhichatippingpointof2.33
(meandifference,−1.44;95%CI,−2.91to0.03)wasfound;however,weconsideredthistobean
unlikelymeandifferencebetweenparticipantswithandwithoutmissingdata.Relativerisks(RRs)in
theresponderanalysiswerestatisticallysignificantlyinfavorofgreaterbenefitforthegroup
receivingUMCwithchiropracticcarecomparedwiththegroupreceivingUMCaloneoverallatweek
6(LBPintensity:RR=1.43;95%CI,1.23to1.68;disability:RR=1.35;95%CI,1.16to1.56)andweek12
(LBPintensity:RR=1.43;95%CI,1.23to1.68;disability:RR=1.26;95%CI,1.11to1.43)andatSan
Diegoatweeks6and12butnotatWalterReedatweeks6or12oratPensacolaatweek12(Table3).
SecondaryOutcomes
Overallatweeks6and12,participantsreceivingUMCwithchiropracticcare,comparedwithUMC
alone,reportedsignificantlylowermeanworstLBPintensitywithinthepast24hours(week6:mean
difference,−1.2;95%CI,−1.6to−0.8;week12:meandifference,−1.1;95%CI,−1.6to−0.7)and
symptombothersomeness(week6:meandifference,−0.4;95%CI,−0.6to−0.2;week12:mean
difference,−0.4;95%CI,−0.6to−0.2);thedifferencesateachsitealsowerestatisticallysignificant,
withtheexceptionofbothersomenessatWalterReed(Table2).ParticipantsreceivingUMCwith
chiropracticcarehadsignificantlybetterglobalperceivedimprovementat6weeksatallsites
(overall:oddsratio[OR]=0.18;95%CI,0.13to0.25;WalterReed:OR=0.26;95%CI,0.16to0.42;
Pensacola:OR=0.18;95%CI,0.10to0.33;SanDiego:OR=0.13;95%CI,0.08to0.21).Similarly,
thosereceivingUMCwithchiropracticcarehadsignificantlygreatermeansatisfactionwithcareat6
weeksatallsites(overall:meandifference,2.5;95%CI,2.1to2.8;WalterReed:meandifference,
2.0;95%CI,1.4to2.6;Pensacola:meandifference,2.3;95%CI,1.6to3.0;SanDiego:mean
difference,3.1;95%CI,2.5to3.7).Overall,participantsallocatedtoreceiveUMCwithchiropractic
careself-reportedsignificantlylesspainmedicationusethanthosereceivingUMCaloneatweek6
(OR=0.73;95%CI,0.54to0.97)andweek12(OR=0.76;95%CI,0.58to1.00),butnotatanyof
theindividualsites.
AdditionalTherapeuticProceduresandUMC
Chiropracticcareconsistedofseveraltherapeuticproceduresinadditiontospinalmanipulation
(eTable2inSupplement2).Useofthesetherapiesvariedsubstantiallybysite.ParticipantsatWalter
Reedweremostlikelytoreceivemultipleancillarytherapiesacrosstherangeofoptions,whilemost
inSanDiegoreceivedtherapeuticexerciseforstrengthandflexibility.Usualmedicalcareincluded
physicaltherapyreferralsandprescriptionmedication,withlessvariationacrosssitesthanthatfor
chiropracticcare(eTable3inSupplement2).
AdverseEvents
Threeunrelatedseriousadverseeventswerereported.Therewere62adverseeffectsreported
throughoutthe6-weekactivecarephase:38atWalterReed,16atPensacola,and8atSanDiego.Of
the19adverseeffectsreportedbyparticipantsreceivingUMCalone,3wereduetoprescribed
medications,4wererelatedtoepiduralinjections,and12consistedofmuscleorjointstiffness
attributedtophysicaltherapyorself-carerecommendations.Ofthe43adverseeffectsreportedby
participantsreceivingUMCwithchiropracticcare,38weredescribedasmuscleorjointstiffness
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aTable2.AdjustedWithin-GroupMeansandBetween-GroupDifferencesofMeansinLBPandDisability bbbWalterReedPensacolaSanDiegoOverall UMC+CCvsUMC+CCvsUMC+CCvsUMC+CCvsUMCAlone,UMCAlone,UMCAlone,UMCAlone,Between-GroupBetween-GroupBetween-GroupBetween-GroupWithin-GroupMean(95%CI)Within-GroupMean(95%CI)Within-GroupMean(95%CI)Within-GroupMean(95%CI)DifferenceofDifferenceofDifferenceofDifferenceofMeans(95%CI)UMCAloneUMC+CCUMCAloneUMC+CCUMCAloneUMC+CCUMCAloneUMC+CCMeans(95%CI)Means(95%CI)Means(95%CI)Outcomes PrimaryOutcomes NRSscoreforaverageLBPduringcpastwk 6wk3.93.2−0.73.42.2−1.24.63.3−1.34.02.9−1.1(3.5to4.3)(2.8to3.6)(−1.3to−0.1)(2.9to3.9)(1.7to2.6)(−1.8to−0.6)(4.2to5.1)(2.9to3.7)(−1.9to−0.8)(3.7to4.2)(2.6to3.2)(−1.4to−0.7) 12wk3.63.2−0.42.81.7−1.14.02.9−1.13.52.6−0.9(3.2to4.1)(2.8to3.7)(−1.0to0.2)(2.3to3.3)(1.2to2.2)(−1.8to−0.5)(3.5to4.5)(2.5to3.4)(−1.7to−0.5)(3.2to3.8)(2.3to2.9)(−1.2to−0.5) RMDQscoreforddisability 6wk8.06.2−1.85.23.1−2.18.86.1−2.77.35.2−2.2(6.8to9.2)(5.0to7.4)(−3.4to−0.2)(3.9to6.5)(1.8to4.4)(−3.8to−0.4)(7.6to10.1)(4.9to7.3)(−4.3to−1.1)(6.5to8.1)(4.4to5.9)(−3.1to−1.2) 12wk7.35.8−1.54.42.5−1.97.64.8−2.76.44.4−2.0(6.0to8.5)(4.5to7.0)(−3.2to0.2)(3.0to5.8)(1.1to3.8)(−3.7to−0.2)(6.3to8.8)(3.6to6.1)(−4.4to−1.1)(5.6to7.2)(3.6to5.2)(−3.0to−1.0) SecondaryOutcomes ScoreofbothersomenessofeLBP 6wk3.02.8−0.22.72.1−0.53.22.8−0.53.02.6−0.4(2.8to3.2)(2.6to3.0)(−0.5to0.1)(2.4to2.9)(1.9to2.3)(−0.8to−0.2)(3.0to3.4)(2.6to2.9)(−0.7to−0.2)(2.8to3.1)(2.4to2.7)(−0.6to−0.2) 12wk2.92.8−0.22.41.8−0.52.92.4−0.42.72.3−0.4(2.7to3.1)(2.6to3.0)(−0.5to0.1)(2.1to2.6)(1.6to2.1)(−0.8to−0.2)(2.6to3.1)(2.2to2.6)(−0.7to−0.1)(2.6to2.9)(2.2to2.5)(−0.6to−0.2) NRSscoreforworstcLBPinpast24h 6wk4.53.9−0.73.42.1−1.35.33.6−1.64.43.2−1.2(4.1to5.0)(3.4to4.3)(−1.3to−0.02)(2.9to3.9)(1.6to2.6)(−2.0to−0.7)(4.8to5.7)(3.2to4.1)(−2.3to−1.0)(4.1to4.7)(2.9to3.5)(−1.6to−0.8) 12wk4.43.7−0.83.01.4−1.54.33.2−1.23.92.7−1.1(3.9to4.9)(3.2to4.2)(−1.5to−0.1)(2.4to3.5)(0.9to2.0)(−2.3to−0.8)(3.8to4.8)(2.7to3.7)(−1.9to−0.5)(3.5to4.2)(2.4to3.1)(−1.6to−0.7) bAbbreviations:CC,chiropracticcare;LBP,lowbackpain;NRS,NumericalRatingScale;RMDQ,RolandMorrisWalterReedindicatesWalterReedNationalMilitaryMedicalCenter,Bethesda,Maryland;PensacolaindicatesDisabilityQuestionnaire;UMC,usualmedicalcare.NavalHospitalPensacola,Pensacola,Florida;andSanDiegoindicatesNavalMedicalCenterSanDiego,SanDiego,California.aEstimatedfrommixed-effectsmodelsusingallobserveddata,anunstructuredcovariance,andtermsinthecPossiblescoresrangefrom0(noLBP)to10(worstpossibleLBP).modelfortime(asacategoricalvariable),site,andsite×group,time×group,andsite×time×groupinteractions,adjustedforsex,age,painduration,andworstpainduringthepast24hours.TheBonferronidPossiblescoresrangefrom0to24,withhigherscoresindicatinggreaterdisability.methodwasusedtocontrolforanalyzingthecoprimaryoutcomevariables.Meanbetween-groupdifferencesePossiblescoresrangefrom1(notatallbothersome)to5(extremelybothersome).maybeoffby0.1duetorounding.
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attributedtochiropracticcare(37events)orphysicaltherapy(1event),1wasreportedasindistinct
symptomsfollowinganepiduralinjection,3weredescribedaspain,tingling,orsensitivityinan
extremitywithoutreferencetoaspecifictreatment,and1wasalower-extremityburningsensation
for20minutesfollowingspinalmanipulativetherapy.
Discussion
Thechangesinpatient-reportedpainintensityanddisabilityaswellassatisfactionwithcareandlow
riskofharmsfavoringUMCwithchiropracticcarefoundinthispragmaticclinicaltrialareconsistent
withtheexistingliteratureonspinalmanipulativetherapyinbothmilitary23andcivilian20,36-38
populations.Themagnitudeofmeanbetween-groupdifferencesforbothpain(NRS)anddisability
(RMDQ)areconsistentwithamoderatemagnitudeofeffectasclassifiedbytheAmericanCollegeof
PhysiciansandAmericanPainSocietyguidelines.34,37
Thistrialhasseveralimportantstrengths.Thefirstisitspragmaticdesign.Theadvantagesand
disadvantagesofapragmaticclinicaltrialwhenevaluatingcomplextreatmentapproacheshavebeen
wellargued.39Theseissueswereconsideredbythestudyteampriortoprotocoldevelopmentwithin
thecontextthat(1)placebo-controlledtrialsofspinalmanipulationexist,40,41(2)chiropracticcareis
alreadyintegratedintomorethanhalfofmilitarytreatmentfacilitiesacrosstheUnitedStates,42,43
and(3)spinalmanipulationorchiropracticcareisrecommendedasafirstlineoftreatmentforpain
Figure2.AdjustedMeanLowBackPain(LBP)IntensityandDisabilityOverTimebySite
A LBP intensity, Walter Reed site B LBP disability, Walter Reed site
Adjusted Mean Average LBPIntensity During Past Week 0654321 UUcshusiuarlao mlp mreadecditciiacc lac cla acrraeer ea lwointeh Adjusted Mean Roland MorrisDisability Questionnaire Score 1175220.....505500 UUcshsuiuraaoll pm mraeecddtiiiccca acll ac craaerree a wloitnhe
Baseline 2 4 6 12 Baseline 2 4 6 12
Time, wk Time, wk
C LBP intensity, Pensacola site D LBP disability, Pensacola site
Adjusted Mean Average LBPIntensity During Past Week 0645321 UUcshsuiuraaoll pm mraeecddtiiiccca acll ac craaerree a wloitnhe Adjusted Mean Roland MorrisDisability Questionnaire Score 1175220.....505500 Uchsiuraolp mraecdtiicc acla craerUes wuaitlh m edical care alone Eobstsiemravteedddfarotam,amniuxendst-reufcfetuctrsedmcoodvealrsiaunscineg,aanlldterms
Baseline 2 4 6 12 Baseline 2 4 6 12 inthemodelfortime(asacategoricalvariable),site,
Time, wk Time, wk andsite×group,time×group,and
site×time×groupinteractions,adjustedforsex,age,
E LBP intensity, San Diego site F LBP disability, San Diego site painduration,andworstpainduringthepast24hours.
Adjusted Mean Average LBPIntensity During Past Week 0654321 UcUhssiuuraoalpl mrmaecedtdiiccic acala lcr aecraer ew aitlho ne Adjusted Mean Roland MorrisDisability Questionnaire Score 1120752.....050505 UUcshsuiuraaollp mmraeecddtiiiccc aaclla crcaearree w ailtohn e LafLRfdMPrrsoBieooosiswlnPlammieats-bnsabra00iserdlcaeyil-toca[Md2yMnklt4a)eboo.pe,diyrWndawLrtfdiiBiasnuichtiPlacnDehtin]aleciNhCtsttrteeoaiiueRgosnbnm1ehnsiN0teleaieiettadrl[ryryvwd,isicdaBnQciaosloudeualrHrritRsbeceihotnaisaslespgttittpisiieononytdisshdtngwasaWein,SiclabaMpacPasliatreleraatiielnoneerLsygr(srsB(salewRsagPccscenroe]osoe)edreel;raead;kdet,sseNwbrrraayaantsntigohgineninaggl
Baseline 2 4 6 12 Baseline 2 4 6 12 Pensacola,Florida;andSanDiegoindicatesNaval
Time, wk Time, wk MedicalCenterSanDiego,SanDiego,California.
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UMC+CCvsResponders,%UMCAlone,RR(95%CI)UMC+CC 57.51.77(51.2-64.6)(1.46-2.14) 60.91.43(54.5-68.1)(1.23-1.68) 62.61.35(56.6-69.3)(1.16-1.56) 69.91.26(63.6-76.7)(1.11-1.43) a,Maryland;PensacolaindicatesMedicalCenterSanDiego,San
Overall UMC+CCvsWithin-GroupUMCAlone,RRUMCAlone(95%CI) 2.8532.5(1.85-4.38)(27.3-38.8) 1.6242.5(1.20-2.18)(36.7-49.2) 1.6346.6(1.20-2.22)(40.9-53.0) 1.5355.5(1.18-1.99)(49.4-62.2) alMilitaryMedicalCenter,Bethesdda;andSanDiegoindicatesNaval
aTable3.Within-GroupPercentageofRespondersandBetween-GroupRRsforPrimaryOutcomes bbbWalterReedPensacolaSanDiego UMC+CCvsUMC+CCvsWithin-GroupResponders,%Within-GroupResponders,%Within-GroupResponders,%UMCAlone,RRUMCAlone,RRUMCAloneUMC+CCUMCAloneUMC+CCUMCAloneUMC+CC(95%CI)(95%CI)Scale NRSforaverageLBPduringpastwk 6wk38.049.11.2946.169.11.5019.756.0(29.9-48.3)(40.5-59.5)(0.96-1.73)(37.4-56.8)(59.3-80.5)(1.20-1.88)(13.2-29.3)(46.0-68.2) 12wk37.148.51.3152.873.41.3939.263.5(28.9-47.5)(39.9-59.0)(0.97-1.78)(43.4-64.1)(63.5-84.8)(1.14-1.70)(30.1-51.1)(53.1-75.9) RMDQfordisability 6wk43.853.71.2363.076.61.2236.659.7(35.4-54.1)(45.0-64.1)(0.94-1.60)(53.9-73.6)(67.5-86.9)(1.03-1.43)(28.0-47.7)(49.9-71.4) 12wk50.459.21.1871.779.51.1147.272.4(41.6-61.0)(50.2-69.9)(0.92-1.50)(62.4-82.4)(70.5-89.7)(0.96-1.28)(37.6-59.3)(62.1-84.4) bAbbreviations:CC,chiropracticcare;LBP,lowbackpain;NRS,NumericalRatingScale;RMDQ,RolandMorrisWalterReedindicatesWalterReedNationDisabilityQuestionnaire;RR,relativerisk;UMC,usualmedicalcare.NavalHospitalPensacola,Pensacola,FloriDiego,California.aResponderisdefinedasatleast30%improvementfrombaseline.EstimatedfrommodifiedPoissonregressiongeneralizedestimatingequationmodelswithtermsinthemodelfortime(asacategoricalvariable),group,site,andsite×group,time×group,andsite×time×groupinteractions,adjustedforsex,age,painduration,andworstpainduringthepast24hours.
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