Psychosocial interventions for the management of chronic orofacial pain (Review) Aggarwal VR, Lovell K, Peters S, Javidi H, Joughin A, Goldthorpe J ThisisareprintofaCochranereview,preparedandmaintainedbyTheCochraneCollaborationandpublishedinTheCochraneLibrary 2011,Issue11 http://www.thecochranelibrary.com Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 PLAINLANGUAGESUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Figure1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Figure2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 AUTHORS’CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 CHARACTERISTICSOFSTUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 DATAANDANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Analysis1.1.Comparison1Anypsychosocialinterventionversususualcare,Outcome1Painshortterm(3monthsor less). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Analysis1.2.Comparison1Anypsychosocialinterventionversususualcare,Outcome2Painlongterm(greaterthan3 months). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Analysis1.3.Comparison1Anypsychosocialinterventionversususualcare,Outcome3Musclepalpationpainlongterm (greaterthan3months). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Analysis1.4.Comparison1Anypsychosocialinterventionversususualcare,Outcome4Activityinterference/disability longterm(greaterthan3months). . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Analysis1.5.Comparison1Anypsychosocialinterventionversususualcare,Outcome5Depressionlongterm(greater than3months). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Analysis2.1.Comparison2Habitreversalversuswaitinglistcontrol,Outcome1Painshortterm(lessthan3months). 49 Analysis2.2.Comparison2Habitreversalversuswaitinglistcontrol,Outcome2Lifeinterference. . . . . . . 49 Analysis3.1.Comparison3Cognitivetherapyversusattentionplacebo,Outcome1Painshortterm(3monthsorless). 50 Analysis3.2.Comparison 3Cognitive therapyversusattentionplacebo,Outcome2Painlongterm(greaterthan3 months). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Analysis4.1.Comparison4Hypnosisversusrelaxation,Outcome1Painshortterm. . . . . . . . . . . . 51 Analysis4.2.Comparison4Hypnosisversusrelaxation,Outcome2Depressionshortterm. . . . . . . . . . 51 Analysis4.3.Comparison4Hypnosisversusrelaxation,Outcome3Anxietyshortterm. . . . . . . . . . . 52 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 CONTRIBUTIONSOFAUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 DECLARATIONSOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 INDEXTERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) i Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. [InterventionReview] Psychosocial interventions for the management of chronic orofacial pain VishalRAggarwal1,KarinaLovell2,SarahPeters3,HaniehJavidi1,AmyJoughin1,JoannaGoldthorpe1 1OralHealthUnit,SchoolofDentistry,TheUniversityofManchester,Manchester,UK.2SchoolofNursing,MidwiferyandSocial Work,TheUniversityofManchester,Manchester,UK.3SchoolofPsychologicalSciences,TheUniversityofManchester,Manchester, UK Contactaddress:VishalRAggarwal,OralHealthUnit,NationalPrimaryCareResearchandDevelopmentCentre,SchoolofDentistry, TheUniversityofManchester,HigherCambridgeStreet,Manchester,M156FH,[email protected]. Editorialgroup:CochraneOralHealthGroup. Publicationstatusanddate:New,publishedinIssue11,2011. Reviewcontentassessedasup-to-date: 19September2011. Citation: Aggarwal VR, Lovell K, Peters S, Javidi H, Joughin A, Goldthorpe J. Psychosocial interventions for the man- agement of chronic orofacial pain. Cochrane Database of Systematic Reviews 2011, Issue 11. Art. No.: CD008456. DOI: 10.1002/14651858.CD008456.pub2. Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. ABSTRACT Background Psychosocialfactorshavearoleintheonsetofchronicorofacialpain.However,currentmanagementinvolvesinvasivetherapieslike occlusaladjustmentsandsplintswhichlackanevidencebase. Objectives Todeterminetheefficacyofnon-pharmacologicpsychosocialinterventionsforchronicorofacialpain. Searchmethods Thefollowingelectronicdatabasesweresearched:theCochraneOralHealthGroupTrialsRegister(to25October2010),theCochrane CentralRegisterofControlledTrials(CENTRAL)(TheCochraneLibrary2010,Issue4),MEDLINEviaOVID(1950to25October 2010), EMBASE via OVID (1980 to 25 October 2010) and PsycINFO via OVID (1950 to 25 October 2010). There were no restrictionsregardinglanguageordateofpublication. Selectioncriteria Randomisedcontrolledtrialswhichincludednon-pharmacological psychosocialinterventionsforadultswithchronicorofacialpain comparedwithanyotherformoftreatment(e.g.usualcarelikeintraoralsplints,pharmacologicaltreatmentand/orphysiotherapy). Datacollectionandanalysis Datawereindependentlyextractedinduplicate.Trialauthorswerecontactedfordetailsofrandomisationandlosstofollow-up,and alsotoprovide meansandstandard deviations foroutcome measureswherethesewerenot available.Risk of biaswas assessedand disagreementsbetweenreviewauthorswerediscussedandanotherreviewauthorinvolvedwherenecessary. Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) 1 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Mainresults Seventeentrialswereeligibleforinclusionintothereview.Psychosocialinterventionsimprovedlong-termpainintensity(standardised meandifference(SMD)-0.34,95%confidenceinterval(CI)-0.50to-0.18)anddepression(SMD-0.35,95%CI-0.54to-0.16). However,theriskofbiaswashighforalmostallstudies.Asubgroupanalysisrevealedthatcognitivebehaviouraltherapy(CBT)either aloneorincombinationwithbiofeedbackimprovedlong-termpainintensity,activityinterferenceanddepression.Howeverthestudies pooledhadhighriskofbiasandwerefewinnumber.Thepooledtrialswereallrelatedtotemporomandibulardisorder(TMD). Authors’conclusions Thereisweakevidencetosupporttheuseofpsychosocialinterventionsforchronicorofacialpain.Althoughsignificanteffectswere observedforoutcomemeasureswherepoolingwaspossible,thestudieswerefewinnumberandhadhighriskofbias.However,given thenon-invasive natureofsuchinterventions theyshouldbeusedinpreferencetootherinvasive andirreversibletreatmentswhich alsohavelimitedornoefficacy.Furtherhighqualitytrialsareneededtoexploretheeffectsofpsychosocialinterventionsonchronic orofacialpain. PLAIN LANGUAGE SUMMARY Psychosocialinterventionsforthemanagementofchronicorofacialpain Studiesindicatethatpsychologicalfactorsareassociatedwithchronicpainintheface,mouthorjaws.However,currentmanagement, particularlyindentistry,doesnottargetthesefactors.Thisreviewthereforeexploredwhetherbehaviouralinterventionslikecognitive behaviouraltherapy(CBT),biofeedbackandpostureregulationcomparedwithusualcarecouldimproveoutcomesforpatientswith chronicorofacialpain.Wefoundthatsuchinterventionsimprovedlong-termpainintensity,paininterferencewithdailylifeactivities anddepression.However,thequalityofthestudieswaspoorandtherewerefewstudiesfromwhichwecouldcombineresults.We thereforerecommendfurtherhighqualitytrialsareneededtosupporttheuseofsuchinterventionsforchronicorofacialpain. BACKGROUND andthathasbeenpresentfor3monthsorlonger.Theresultsof thisresearchsupportspreviousfindingsandshowedthatchronic orofacial pain thusdefinedhad distinct characteristics based on paindescriptors,patternsandcomorbiditiesthatdistinguishedit Descriptionofthecondition fromother commonly reported dental pains (Aggarwal 2008a). Thisworknotonlyprovidesevidencethatchronicorofacialpain Therearefourrecognisablesymptomcomplexesofchronicoro- encompassesagroupofdistinctconditions, butalsoshowsthat facial pain that may coexist: temporomandibular disorder (my- chronicorofacialpainco-occurswithotherfrequentlyunexplained ofacial face pain); atypical facial pain (atypical facial neuralgia); syndromeslikechronicwidespreadpain,irritablebowelsyndrome atypical odontalgia (phantom tooth pain); and burning mouth andchronicfatigue,andthatitsharescommonpsychosocialfac- (oraldysaesthesia,glossodynia,glossopyrosis).Thesechronicoro- torswiththesesyndromes(Aggarwal2006),andmaythereforebe facial pain conditions have been considered as medically unex- partofawiderspectrumofchronicpaindisorders. plained symptoms affecting the region of the mouth and face (Madland2001;Wessely1999),aspathologicalchangesfailtoex- plaintheassociatedsymptoms.Recentresearchhasalsoshownthat theseconditionssharecommoncharacteristicsandclustertogether into a single group based on theseshared characteristics (Woda Descriptionoftheintervention 2005).Epidemiologicalresearchhastakenthisevidenceforward by ’lumping’ these conditions together and collectivelyterming Psychosocial interventions targeted towards changing thoughts, themaschronicorofacialpain,definedaspainintheface,mouth behaviours and/or feelings that may exacerbate pain symptoms orjawsthathasbeenpresentforadayorlongerinthepastmonth, throughaviciouscycle. Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) 2 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Howtheinterventionmightwork ician assessing them and therefore tends to follow the current biomedicalmodelwhichfocusesonidentifyingunderlyingabnor- Psychosocial interventions may assume two possible models for malpathologyforreportedsymptoms.Patientsarethereforesub- chronicorofacialpain. jectedtomultipletestsandtreatmentsinsearchforsuchacause. 1. Inactivity-wherepersistentphysicalsymptomsofpainlead Pfaffenrath1993showedthatpatientswithatypicalfacialpainhad topatientslearningtoavoidphysicalactivityduetofearof consultedonaverage7.5(range1to20)differentdoctorsperpa- exacerbatingtheircondition.Inturn,thesenegativecognitive tient:91%dentists,80%physicians,66%neurologists,63%ear, andbehaviouralresponsesprolongandintensifysymptoms noseandthroatsurgeons,31%eachorthopaedicsandmaxillofa- (Gheldof2006).Theinterventionwouldtargetthisfear- cialsurgeons,23%psychiatrists,14%neurosurgeonsand6%each avoidancebehaviourtoalleviatesymptomsbyareturntonormal ophthalmologistsanddermatologists(n=30).Thisresultedina functioning.Thismechanismconsiderscentralpainprocessing range of treatmentsvaryingfromsurgery (60%), antidepressant mechanisms. drugs(69%),analgesics(69%),andarangeofphysicaltherapies. 2. Overactivity-emotionalstress(anxiety,depression,anger) Nopatientsconsideredanyformofsurgerytobehelpfuland,in mayincreasepainbyprecipitatingactivityinpsychophysiological many,thepainwasmadeworse.Recentresearchhasalsoexposed systemsthatarealsoactivatedbynoxiouseventsandprovoke this pattern of multiple consultations and lack of agreement in substantialautonomic,visceralandskeletalactivity.The terminologyandmanagementofthesepatients(Aggarwal2008a; interactionsamongthesebiologicalsystemsarewellillustrated Elrasheed2004).Thisimposesahugeburdenonalreadystretched bythe’anxiety-pain-tension’cyclethathasbeenproposedto healthcareresources. accountforsomeformsofchronicpain(Wall1999).This Evidence from systematic reviews has also shown no beneficial viciouscycleisfrequentlyencounteredinchronicorofacialpain effectsoftherapiessuchasirreversibleocclusaladjustments(Koh conditionsliketemporomandibularpaindysfunctionwhereby 2003) and splints (Al-Ani 2004) that are targeted towards the psychosocialfactorslikelifestressandanxietyprovokegrinding correctionofmechanicalfactorswithwhichtemporomandibular ofteethandsustainedcontractionofmusclesoftheface.This jointpain(oneoftheentitiesthatconstitutechronicorofacialpain) producespainwhichprovokesfurtheranxiety,whichinturn is thoughtto be associated. Epidemiological investigations have producesprolongedmusclespasmattriggerpoints,aswellas alsoshownthatsuchmechanicalfactorsthoughttobeassociated vasoconstriction,ischaemiaandreleaseofpainproducing withchronicorofacialpainrepresentheightenedawarenessofbody substances.Thiswillthenfurtherreducephysicalactivity,and symptomsgenerallyandarenotspecifictochronicorofacialpain consequentlymuscleflexibility,muscletone,strengthand (Aggarwal2008b). physicalendurance.Alltheaboveleadtothecommonlyobserved Thereisalsostrongevidencetoshowthatchronicorofacialpainis physicalsymptomsoftemporomandibularpaindysfunctionsuch associatedwithpsychologicalfactors(Aggarwal2006;Macfarlane aslimitedmouthopeningandthefeelingthatteetharenot 2001; Macfarlane 2002; Macfarlane 2004) and co-occurs with fittingproperly.Fearavoidanceandconsequentdisabilitydueto other medically unexplained symptoms (Aggarwal 2006). Fur- disusehasbeendescribedinotherchronicpainconditions ther,thereisgrowingevidencefromrandomisedcontrolledtrials (Gheldof2006).Psychologicalfactorsalsomodulatepain (Gatchel2006;Turner2006)thatearlybiopsychologicalinterven- responsesandthelimbicsystemthatisresponsibleforemotional tionslikecognitivebehavioural therapy(CBT)andbiofeedback responsesinhibitspainstimuliviadescendingpathways(Wall mechanismscanimproveoutcomeinpatientswithchronicoro- 1999).Analterationofthissystemasencounteredinemotional facialpainconditionsliketemporomandibularpain.Giventhese disturbances(anxiety,depression,anger,etc)willleadtoreduced strongpsychologicalassociationsandlackofassociationswithme- inhibitionviathedescendingpathwaysandthusanincreasein chanicalfactors,theuseofextensiveinvasivetherapyintheman- pain(Wall1999).Psychosocialinterventionshavethepotential agementofchronicorofacialpaindoesnotappeartobejustified. totargetthesenegativethoughts,behavioursand/orfeelingsthat EarlyinterventionwithpsychosocialtherapiessuchasCBTshould mayexacerbatepainsymptomsandthereforeshouldbea beapriorityforinvestigationasithasthepotentialtotargetnega- priorityforinvestigation.Theinterventionwouldtargetthe tivethoughts,behavioursand/orfeelingsthatmayexacerbatepain underlyingstressorresponsibleforoveractivityandinducea symptomsthroughaviciouscycle. returntonormalfunctioning.Thismechanismislikelytowork throughchangesinperipheralnociception. Whyitisimportanttodothisreview OBJECTIVES Although patients with chronic orofacial pain do not have un- derlyingorganicabnormalitiesforreportedsymptoms,theirman- Todeterminetheefficacyofpsychosocialinterventionsintheman- agement tends to be influenced by the background of the clin- agementofchronicorofacialpain. Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) 3 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. METHODS Searchmethodsforidentificationofstudies For the identification of studies included or considered for this review,detailedsearchstrategiesweredevelopedforeachdatabase Criteriaforconsideringstudiesforthisreview searched.Thesewerebasedonthesearchstrategydevelopedfor MEDLINE(OVID)butrevisedappropriatelyforeachdatabase. Thesearchstrategyusedacombinationofcontrolledvocabulary andfreetexttermsandwaslinkedwiththeCochraneHighlySen- Typesofstudies sitiveSearchStrategy(CHSSS)foridentifyingrandomisedtrials Randomisedcontrolledtrials(RCTs)whichincludepsychosocial inMEDLINE:sensitivitymaximisingversion(2009revision)as interventionsforchronicorofacialpaincomparedwithanyother referencedin Chapter6.4.11.1 anddetailedin box6.4.c of the form of treatment such as surgery, usual care, pharmacological CochraneHandbookforSystematicReviewsofInterventionsVersion treatmentand/orwaitinglistcontrols. 5.1.0(updatedMarch2011)(Higgins2011).DetailsoftheMED- LINE search are providedin Appendix1. Thesearchesof EM- BASEandPsycINFOwerelinkedtotheCochraneOralHealth Typesofparticipants GroupfiltersforidentifyingRCTs. Therewerenorestrictionsregardinglanguage. Adultsover18yearsofagewithchronicorofacialpaindefinedas thosediagnosedwiththefollowingconditions:temporomandibu- lar disorders (TMDs), atypical facial pain, atypical odontalgia, Electronicsearches burningmouthsyndrome.Othertermsusedtodescribethesecon- Thefollowingelectronicdatabasesweresearched. ditionswillalsobeincludedinthesearchstrategye.g.myofacial • CochraneOralHealthGroup’sTrialsRegister(to25 pain,myofascialpainrelatedtothefacialregion,craniomandibu- October2010)(seeAppendix2). lar/oromandibular dysfunction, mandibular stresssyndrome,fa- • TheCochraneCentralRegisterofControlledTrials cialarthromyalgia,masticatorymuscledisorder,masticatorymyal- (CENTRAL)(TheCochraneLibrary,2010,Issue4) gia,temporomandibularjointsyndrome,stomatodynia. (seeAppendix3). • MEDLINEviaOVID(1950to25October2010) (seeAppendix1). Typesofinterventions • EMBASEviaOVID(1980to25October2010) Psychosocial interventions targeted towards changing thoughts, (seeAppendix4). behaviours and/or feelings that may exacerbate pain symptoms • PsycINFOviaOVID(1950to25October2010) throughaviciouscycle. (seeAppendix5). Searchingotherresources Typesofoutcomemeasures Thereferencelistsofalleligibletrialswerecheckedforadditional studies. Where these had not already been searched as part of the Cochrane Journal Handsearching Programme, the journals Primaryoutcomes werehandsearchedbythereviewauthorsifelectroniccopieswere 1. Painintensity(shortand/orlongterm)measuredusinga notavailable.Thesearchattemptedtoidentifyallrelevantstudies visualanaloguescaleoravalidatedcategoricalscale. irrespectiveoflanguage.Translatedcopiesofnon-Englishpapers 2. Painseverity-impact(activityinterference,functionand/or were obtained. The principal review author is a member of the distress)scoresmeasuredusingvalidatedscales(e.g.briefpain International Association for Studies on Pain (IASP) Orofacial inventory,multidimensionalpaininventory,hospitalanxietyand Pain SpecialInterest Groupand contacted key membersof this depressionscale). grouptoascertainwhethertheyknewofanyunpublishedmaterial. 3. Satisfactionwithpainrelief. 4. Qualityoflife. Datacollectionandanalysis Secondaryoutcomes 1. Serviceuse-numberofconsultationstoclinicians. Selectionofstudies Compliancewiththeinterventionwasalsotoberecordedwhere Thetitleandabstracts ofarticlesandreportsresultingfromthe reported. searchstrategywerescreenedindependentlyandinduplicateby Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) 4 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. tworeviewauthors.Fullreportswereobtainedwheretrialsmetthe • Randomsequencegeneration(selectionbias). inclusioncriteriaorwhereacleardecisioncouldnotbemadefrom • Allocationconcealment(selectionbias). thetitleorabstract. Disagreements wereresolvedby discussion. • Blindingofparticipants/caregivers(wherefeasible)and Studiesrejectedatthisorsubsequentstageswererecordedinthe outcomeassessors(performancebiasanddetectionbias). ’Characteristicsofexcludedstudies’tablealongwithreasonsfor • Incompleteoutcomedata(attritionbias). exclusion. • Selectivereporting(attritionbias). • Otherbias. Dataextractionandmanagement Eachdomaininthetoolincludesoneormorespecificentriesin Datawasextracted,independentlyandinduplicate,usingapre- a‘Riskofbias’table.Withineachentry,thefirstpartofthetool viously prepared data extraction form which included thechar- describes what was reported to have happened in the study, in acteristicsoftrialparticipants,interventions,controlgroupsand sufficientdetailtosupportajudgementabouttheriskofbias.The outcomes. Characteristics of included and excluded studies are secondpartofthetoolassignsajudgementrelatingtotheriskof presentedintheirrespectivetables(seeCharacteristicsofincluded biasforthatentry.Thisisachievedbyassigning ajudgementof studiesandCharacteristicsofexcludedstudies).Anydifferences ‘Lowrisk’ofbias,‘Highrisk’ofbias,or‘Unclearrisk’ofbias. wereresolvedbydiscussion.Priortodataextractiontheformwas Aftertakingintoaccounttheadditionalinformationprovidedby pilotedusing threestudies andallreview authors extracting the the authors of the trials, studies weregraded into the following dataparticipatedinthepilotingsothattheywereclearaboutthe categories. extractionprocess.Theformwasmodifiedforeaseofusefollow- • Lowriskofbias:lowriskofbiasforallkeydomains. ingthepilotextractions. • Unclearriskofbias:unclearriskofbiasforoneormorekey domains. • Highriskofbias:highriskofbiasforoneormorekey Assessmentofriskofbiasinincludedstudies domains. Theassessmentofriskofbiasintheincludedtrialswasundertaken independentlyandinduplicateaspartofthedataextractionpro- A risk of bias table was completed for each included study (see cess,asdescribedabove,andinaccordancewiththeapproachde- Characteristicsofincludedstudies).Resultsarepresentedgraph- scribedinChapter8oftheCochraneHandbook(Higgins2011). icallybystudy(Figure1)andbydomainoverallstudies(Figure Thisisatwo-parttooladdressingsixspecificdomainsasfollows. 2). Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) 5 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Figure1. Riskofbiassummary:reviewauthors’judgementsabouteachriskofbiasitemforeachincluded study. Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) 6 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Figure2. Riskofbiasgraph:reviewauthors’judgementsabouteachriskofbiasitempresentedas percentagesacrossallincludedstudies. Assessmentofreportingbiases Measuresoftreatmenteffect Thestrengthandgeneralisabilityoftheevidencewasassessedby For dichotomous outcomes, treatment effectswere expressed as taking into account issues around publication bias and internal risk ratios with 95% confidence intervals whilst for continuous andexternalvalidity. outcomes mean differenceswith 95% confidence intervalswere used. All analyses were performed using RevMan 5 software ( RevMan2011). Datasynthesis Meta-analyseswasonlycarriedoutiftrialswereofsimilarcom- parisonsreportingthesameoutcomemeasures.Estimatesofeffect werecombinedusingarandom-effectsmodelifthreeormoretri- Dealingwithmissingdata alswereavailableforanalysis,otherwisethefixed-effectmodelwas Trialauthorswerecontactedtoretrievemissingdatawhereneces- tobeused.Riskratioswerecombinedfordichotomousoutcomes, sary. and mean differences for continuous outcomes or standardised Theanalysesgenerallyincludedonlytheavailabledata(ignoring mean differences where the same outcome was measured using missingdata),howevermethodsforestimatingmissingstandard differentscales. deviationsinChapter7.7.3oftheCochraneHandbook(Higgins 2011)weretobe usedifrequired. Noimputations or statistical methodstoallowformissingdatawereused. Subgroupanalysisandinvestigationofheterogeneity Subgroupanalysiswasintendedonthetypeofchronicorofacial pain investigated. However, all studies included were based on TMDpainandthiswasthereforenotpossible. Assessmentofheterogeneity Clinicalheterogeneitywasassessedbyexaminingtheparticipants, Sensitivityanalysis interventions and outcome measures included inthe trials. Sta- tisticalheterogeneitywasassessedbymeansofCochran’stestfor Wewereunabletoundertakethisduetoinsufficientdata.Data heterogeneityandquantifiedbytheI2statistic. permitting,wewouldhaveusedsensitivityanalysestoexaminethe Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) 7 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. effect of allocation concealment, intention-to-treat analysis and long-term changes. Therefore, based on the information avail- blindoutcomeassessmentontheoverallestimatesofeffect. able from the included trials, psychological interventions were groupedintothefollowing:cognitivebehaviouraltherapy(CBT) alone,biofeedbackalone,combinationofCBTandbiofeedback andphysicalself-regulationwhichwasusedbyonetrial(Carlson 2001).Outcomemeasuresincludedshort-term(3monthsorless) RESULTS and long-term (more than 3 months) pain intensity and long- termmeasuresformusclepalpationpain,activityinterferenceand Descriptionofstudies depression. See:Characteristicsofincludedstudies;Characteristicsofexcluded studies. Detaileddescriptionsofthestudiesareinthe’Characteristicsof Excludedstudies includedstudies’and’Characteristicsofexcludedstudies’tables. From the 38 manuscripts identified for detailed extraction, 15 studieswereexcludedastheywerenotrandomisedcontrolledtrials orhadthewrongdiseasedefinitionand/orpatientgroup. Resultsofthesearch Theinitialsearchstrategyyielded525referenceswhichwereas- sessedblindandindependentlybytworeviewauthors,andbased on the abstracts and titles these were reduced to 38 relevant Riskofbiasinincludedstudies manuscripts.Mainreasonsforexclusionwerethatalargepropor- tionofstudieswerenottrialsandotherswerenotonchronicoro- RiskofbiasplotsaredisplayedinFigure1andFigure2;theformer facialpain. showingtheoverallriskofbiasandthelatterindividualplotsfor All the 38 manuscripts identified were data extracted by the eachstudy. leadauthor.Dataextractionwasduplicatedbysharingblindand independently between the other review authors. Twenty-three manuscriptswererelevantforinclusionandrepresented17studies Allocation (sixpaperswerefollow-upstudiesofthesametrial). Thiswasreportedby onlyone study (Turner 2006)andoverall theriskofbiasinthisareawasthereforehigh. Includedstudies Of the 17 included trials, 15 were on temporomandibular dis- orders(TMDs) and two trials investigated burning mouth syn- Blinding drome. Twelve of the TMD trials included comparable control It is notable that due to the nature of the intervention, blind- groupsthathadusualtreatmentwhichinvolvedconservativetreat- ing was difficultwhere the intervention and controls were con- ment composed of education, counselling and an intraoral flat cerned.However,itwaspossibleforoutcomeassessmentandfor planeappliance.However,thetrialsonburningmouthsyndrome thepurposesofthisreviewweevaluatedwhetherincludedstudies usedanattentionplaceboandplacebopillsascontrols(Bergdahl hadblindedoutcomemeasurement.Thiswaspoorwithonlyfour 1995;Miziara2009)whilsttheTownsend2001andTurk1993 oftheincludedstudies(Carlson2001;Dworkin1994;Dworkin studiesusedwaitinglistcontrols.AsTurk1993hadanintraoral 2002b;Turner2006)adequatelyreportingblindingforassessing appliancecomparison,thiswasusedasausualtreatmentcompar- outcomemeasures. isonandthisstudyincludedinthemaincomparison. However, of the 12 studies eligible for pooling, Dworkin’s two studies(Dworkin2002a;Dworkin2002b)andKomiyama’sstudy Incompleteoutcomedata (Komiyama 1999) displayed results graphically and we did not havemeansandstandarddeviations(SDs)topoolthesestudies. Onlysevenofthe17trialsincludedreportedonmissingoutcome Trial authors were contacted to obtain data but only provided dataandwereassessedasbeingatlowriskofbiasforthisdomain. meanswithnoSDsordidnotrespond.Thesethreestudiescould thereforenotbeincludedinthemeta-analysis.Overall,therefore, nineTMDtrialswereeligibleforpooling.Evenwithinthesenine Selectivereporting studies, there was much heterogeneity whereby studies did not usethesameintervention,didnotmeasuresimilaroutcomesand Nineofthe17includedtrialswereassessedasbeingatlowriskof somereportedonlyshort-termchangeswhilstothersreportedonly biasforselectivereporting. Psychosocialinterventionsforthemanagementofchronicorofacialpain(Review) 8 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Description: