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Supervised exercise spinal manipulation and home exercise for chronic.docx

Supervisedexercisespinalmanipulationandhomeexerciseforchronic

CONSORT清单评价RCT论文

论文

部分

条目

内容

评价

VAS

文题

摘要

文题能识别是随机临床试验

Supervisedexercise,spinalmanipulation,andhomeexercise

forchroniclowbackpain:

arandomizedclinicaltrial

是

结构式摘要，包括试验设计、方法、结果、结论几个部分

BACKGROUNDCONTEXT:

Severalconservativetherapieshavebeenshowntobebeneficialin

thetreatmentofchroniclowbackpain（CLBP）,includingdifferentformsofexerciseandspinal

manipulativetherapy（SMT）.Theefficacyoflesstime-consumingandlesscostlyself-careinterven-

tions,forexample,homeexercise,remainsinconclusiveinCLBPpopulations.

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

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].

具体目的或假设

Thepurposeofthisrandomizedclinicaltrialwastoex-

aminetherelativeshort-andlong-termefficacyofhigh-

dose,supervisedlow-techtrunkexerciseandchiropractic

SMTforthetreatmentofLBPofatleast6-weekduration

andtocomparethetwointerventionstoashortcourseof

homeexercise

方法

试验

设计

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:

1allocationratiowasappliedusingfourstrata:

withandwithoutradiatingsymptoms,LBP6-to12-weekduration,andLBPmorethan12-weekduration.

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

受试者的合格标准

Inclusion/exclusioncriteria.

资料收集的场所和地点

ThetrialwasconductedattheWolfe-HarrisCenterforClinical

StudiesattheNorthwesternHealthSciencesUniversityin

Bloomington,MN,USA.

干预

措施

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

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’’

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

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）.

必要时，解释中期分析和试验中止原则

随机方法

序列

产生

产生随机分配序列的方法

Beforethetrial,theprojectstatisticiangeneratedarandomizationlistusingrandomlymixedpermutedblocksofdifferentsizes.Theseweresequentiallynumberedandsealedinopaqueenvelopestoconcealallocationfromthestudyteam.

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

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

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

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

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

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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