Supervised exercise spinal manipulation and home exercise for chronic文档格式.docx
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Supervised exercise spinal manipulation and home exercise for chronic文档格式.docx
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PURPOSE:
Thepurposeofthisstudywastoassesstherelativeefficacyofsupervisedexercise,
spinalmanipulation,andhomeexerciseforthetreatmentofCLBP.
STUDYDESIGN/SETTING:
Anobserver-blindedandmixed-methodrandomizedclinicaltrial
conductedinauniversityresearchclinicinBloomington,MN,USA.
PATIENTSAMPLE:
Individuals,18to65yearsofage,whohadaprimarycomplaintofmechan-
icalLBPofatleast6-weekdurationwithorwithoutradiatingpaintothelowerextremitywerein-
cludedinthistrial.
OUTCOMEMEASURES:
Patient-ratedoutcomeswerepain,disability,generalhealthstatus,med-
icationuse,globalimprovement,andsatisfaction.Trunkmuscleenduranceandstrengthwereassessed
byblindedexaminers,andqualitativeinterviewswereperformedattheendofthe12-weektreatment
phase.
METHODS:
Thisprospectiverandomizedclinicaltrialexaminedtheshort-(12weeks)andlong-
term(52weeks)relativeefficacyofhigh-dose,supervisedlow-techtrunkexercise,chiropractic
SMT,andashortcourseofhomeexerciseandself-careadviceforthetreatmentofLBPofatleast
6-weekduration.Thestudywasapprovedbylocalinstitutionalreviewboards.
RESULTS:
Atotalof301individualswereincludedinthistrial.Forallthreetreatmentgroups,out-
comesimprovedduringthe12weeksoftreatment.Thosewhoreceivedsupervisedtrunkexercisewere
mostsatisfiedwithcareandexperiencedthegreatestgainsintrunkmuscleenduranceandstrength,but
theydidnotsignificantlydifferfromthosereceivingchiropracticspinalmanipulationorhomeexercise
intermsofpainandotherpatient-ratedindividualoutcomes,inboththeshort-andlong-term.
CONCLUSIONS:
ForCLBP,supervisedexercisewassignificantlybetterthanchiropracticspinal
manipulationandhomeexerciseintermsofsatisfactionwithtreatmentandtrunkmuscleendurance
引言
背景和
目的
2a
科学背景和对试验理由的解释
Theimpactoflowbackpain(LBP)issubstantialwithan
estimatedlifetimeprevalenceofupto80%[1].Moreover,
75%ofbackpainsufferersexperiencelingeringproblems1
yearafteronset[2].IntheUnitedStates,thecostsattribut-
abletoLBPcontinuetoincreaseandarenowestimatedto
exceed$100billionannually[3].ThesocietalcostofLBP
ismorethanfinancial,withmanypatientsdevelopingpsy-
chologicaldistressandillnessbehaviors,whichcanbeas
disablingastheLBPitself[4].
ThereisnoestablishedstandardcareforchronicLBP
(CLBP),butseveralconservativetherapieshavedemon-
stratedbenefit,includingdifferentformsofintensivesup-
ervisedexerciseandspinalmanipulativetherapy(SMT)
[5–9].Lesscostlyandtime-consumingself-careinterven-
tions,suchashomeexercise,havebeenshowntobeeffec-
tiveforacuteandsubacuteLBP;
however,theevidenceto
supporttheiruseforCLBPremainsinconclusive[10].
2b
具体目的或假设
Thepurposeofthisrandomizedclinicaltrialwastoex-
aminetherelativeshort-andlong-termefficacyofhigh-
dose,supervisedlow-techtrunkexerciseandchiropractic
SMTforthetreatmentofLBPofatleast6-weekduration
andtocomparethetwointerventionstoashortcourseof
homeexercise
方法
试验
设计
3a
描述试验设计(诸如平行设计、析因设计)包括受试者分配入各组的比例
Restrictedrandomizationusinga1:
1:
1allocationratiowasappliedusingfourstrata:
withandwithoutradiatingsymptoms,LBP6-to12-weekduration,andLBPmorethan12-weekduration.
3b
试验开始后对试验方法所作的重要改变(如合格受试者的挑选标准),并说明原因
受试
者
4a
受试者的合格标准
Inclusion/exclusioncriteria.
4b
资料收集的场所和地点
ThetrialwasconductedattheWolfe-HarrisCenterforClinical
StudiesattheNorthwesternHealthSciencesUniversityin
Bloomington,MN,USA.
干预
措施
5
详细描述各组干预措施的细节以使他人能够重复,包括它们实际上是在何时、如何实施的
supervisedexercisetherapy
Spinalmanipulativetherapy
Homeexerciseandadvice
结局
指标
6a
完整而确切的说明预先设定的主要和次要结局指标,包括它们是何时、如何测评的
Patient-ratedoutcomeswerepain,disability,generalhealthstatus,med-
icationuse,globalimprovement,andsatisfaction.
Self-reportquestionnaireswerecompletedateachtime
point,independentfromstudyprovidersandinvestigators.
Objectiveoutcomeassessments(includinglumbarrange
ofmotion,strength,andendurance)werecollectedby
ablindedexamineratbaselineandWeek12.Patient-ratedpain,theprimaryoutcome,wasmeasured
onanordinal11-boxscale[16].Thepatientswereasked
toratetheirtypicallevelofbackpainoverthepastweek
ona0to10scale,with0being‘‘nopain’’and10being
‘‘worstpainpossible.’’Secondaryoutcomemeasuresin-
cludedtheModifiedRolandQuestionnaire[17]andthe
36-ItemShortFormHealthSurvey(Version2)[18].The
patientswerealsoaskedtoreportthefrequencyofpain
medicationusefortheirLBPoverthepastweek[19].
Patient-perceivedglobalimprovementwascollectedusing
a9-pointordinalscale,withresponsechoicesrangingfrom
‘‘nosymptoms(100%improvement)’’to‘‘twiceasbad
(100%worse)’’[20,21].Satisfactionwasmeasuredon
a7-pointscale,with1representing‘‘completelysatisfied,
couldn’tbebetter’’and7‘‘completelydissatisfied,couldn’t
beworse’’
6b
试验开始后对结局指标是否有任何更改,并说明原因
样本量
7a
如何确定样本量
Samplesizedetermination
ThesamplesizewasinformedbypreviousstudiesassessingexerciseandSMTandanexpectationofdetecting
atleastamediumeffectsizedifferenceinpainbetween
groupsinboththeshort-andlong-term[6,9,28].With
a3-groupdesign,apowerof0.80,andanalphalevelof
0.05(two-tailedtest),85individualswereneededpergroup
[29].Toallowforadrop-outrateof15%,werecruitedatotalof300subjects(100pergroup).
7b
必要时,解释中期分析和试验中止原则
随机方法
序列
产生
8a
产生随机分配序列的方法
Beforethetrial,theprojectstatisticiangeneratedarandomizationlistusingrandomlymixedpermutedblocksofdifferentsizes.Theseweresequentiallynumberedandsealedinopaqueenvelopestoconcealallocationfromthestudyteam.
8b
随机方法的类型,任何限定的细节(怎样分区组和各区组样本多少)
分配
隐藏
9
用于执行随机分配序列的机制(如编按序编码的封藏法),描述干预措施分配之前为隐藏序列号所采取的步骤
实施
10
谁产生随机分配序列,谁招募受试者,谁给受试者分配干预措施
盲法
11a
如果实施了盲法,分配干预措施之后对谁设盲(例如受试者、医护提供者、结局评估者),以及盲法是如何实施的
Theactiveinterventionsusedinthistrialmadeblinding
patientsandproviderstotreatmenttypeimpossible.Objectiveoutcomeassessmentwasperformedbyexaminers
maskedtotreatmentallocation.Otheroutcomesweremeasuredwithpatientself-reportquestionnaires,independent
ofproviderandinvestigatorinfluence.
11b
如有必要,描述干预措施的相似之处
统计学方法
12a
用于比较各组主要和次要结局指标的统计学方法
Analysisofcovariance(ANCOVA)wasusedtoanalyze
fordifferencesbetweenthethreegroupsinallpatient-ratedoutcomes(painwastheprimaryoutcome)atWeeks
4,12,26,and52postrandomization.Baselinevalueswere
usedascovariates.Wealsoconductedlinearmixed-model
longitudinalanalyses(whichaccountedforcorrelation
overtimewithinparticipants)usingtheMIXEDprocedure
inSAS9.1(SASInstitute,Cary,NC,USA)[30].Baseline,
Weeks4,and12datawereusedforshort-termanalysis;
thesamedataplusWeeks26and52datawereusedfor
long-termanalysis.Allanalysesusedtheintention-to-treatprinciple.Changescoresfortrunkperformancemeasureswere
calculatedusingendtreatment(Week12)andbaseline
values.Thesewerethenanalyzedforgroupdifferences
withANOVA.Additionally,asecondarymultivariateanalysisofcovariance(MANCOVA),incorporatingallthepatient-rated
outcomes,wasusedasanoveralltestfordifferencesbetweengroupsbothattheendof12weeksoftreatment
andat26-and52-weekfollow-ups[33].Missingdataanalyseswereperformedbyrepeatingtheoriginalanalysesusingimputationofdatamissingatrandom(MIProcedure
SAS9.1)anddatamissingbecauseofattrition.Similartotheshort-termresults,theonlysignificantgroupdifferenceinthelong-termwasforsatisfaction
(p!
.0001),astestedbyunivariateANCOVA,linear
mixed-modellongitudinalanalyses,andtheareaunderthecurveanalyses(seeTables2and3)
12b
附加分析的方法,诸如亚组分析和校正分析
结果
受试者流程
13a
随机分配到各组的受试者例数,接收已知分配治疗的例数,以及纳入主要结局分析的例数
Table4
Gains(changescoresfrombaseline)inbackmuscleenduranceandstrengthandbackrangeofmotionafter12weeksofintervention
13b
随机分组后,各组脱落和被剔除的例数,并说明原因
Onlyfiveparticipantshadvisitsmissingatrandom(fourintheHEAgroupandoneintheSETgroup).Thosewhoattendedallvisitshadslightlylowerpainscoresatbaseline
募集
受试者
14a
招募期和随访时间的长短,并说明具体日期
Evaluationwasconductedduringtwobaselineassess-
mentsandat4,12,26,and52weeksafterrandomization
14b
为什么试验中断或停止
基线
资料
15
用一张表格列出每组受试者的基线数据,包括人口学资料和临床特征
Table1Demographicandbaselineclinicalcharacteristics
纳入
分析例数
16
各组纳入每种分析的受试者数目(分母),以及是否按最初的分组分析
Fig.1.Studyparticipantflowchart
结果和估计值
17a
各组每一项主要和次要结局指标的结果,效应估计值及其精确性(如95%可信区间)
Thegroupdifferencesinpatient-ratedoutcomesatalltimepointswithassociated95%confidenceintervalsareshowninTable3.
17b
对于二分类结局,建议同时提供相对效应值和绝对效应值
辅助
分析
18
所做的其他分析结果,包括亚组分析和校正分析,指出哪些是预先设定的,哪些是新尝
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