2017 Annual Clinical Meeting Hilton San Diego Bayfront San Diego, CA Original Research Poster Abstracts 1. Multidisciplinary Pain Management Program in Japan a. Presenter: Naoto Takahashi, MD., PhD b. First Author: Naoto Takahashi, MD., PhD c. First Author Affiliations: Department of Pain Medicine, Fukushima Medical University School of Medicine d. Co-Author(s): Satoshi Kasahara, MD., PhD., Shoji Yabuki, MD., PhD e. Background: Multidisciplinary pain management is a useful method for the treatment of intractable chronic musculoskeletal pain. There are few facilities in Japan that administer a multidisciplinary pain management program, especially an inpatient program. We are implementing an inpatient multidisciplinary pain management program based on biopsychosocial model guided by the IASP recommendations. f. Objective: To describe our inpatient multidisciplinary pain management program using the biopsychosocial method of self-pain management, and to report preliminary results of the program. g. Methods: Fourteen patients were analyzed. Comparing results before and after the program, the following statistically significant improvement were seen in BPI (p = 0.001), PCS (p=0.003), PDAS (p=0.02), HADS anxiety and depression scale (p=0.004, p=0.03), PSEQ (p=0.0002), EQ5D (p=0.04), 30-sec standing test (muscle endurance)(p=0.02), and 6-minute walking test (physical fitness) (p=0.03). h. Results: Fourteen patients were analyzed. Comparing results before and after the program, the following statistically significant improvement were seen in BPI (p = 0.001), PCS (p=0.003), PDAS (p=0.02), HADS anxiety and depression scale (p=0.004, p=0.03), PSEQ (p=0.0002), EQ5D (p=0.04), 30-sec standing test (muscle endurance)(p=0.02), and 6-minute walking test (physical fitness) (p=0.03). i. Conclusions: We have developed an inpatient pain management program. We may be able to improve the coping mechanisms of our patients for dealing with intractable chronic musculoskeletal pain, and that the program can improve their quality of life and flexibility. The inpatient multidisciplinary pain management program should be indicated for the intractable chronic musculoskeletal pain patients j. References: None. k. Disclosure: None. 2. Interdisciplinary, Self-management Course for Chronic Pain a. Presenter: Joel Kailia b. First Author: Joel Kailia, MD c. First Author Affiliations: UBC d. Co-Author(s): Vincent Zenarosa, MD e. Co-author(s) Affiliations: UBC f. Background: Patients suffering with chronic non-cancer pain (CNCP) experience a diminished quality-of-life, which has been found to be the same as, or worse than, the quality-of life experienced by patients with advanced palliative cancer. Most CNCP care is done in the primary care settings. Pain self-management interventions (SMI) can be done in these settings and are one potential for good pain management.
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2017 Annual Clinical Meeting Hilton San Diego Bayfront San ... · Methods: The use of EST and CET employs complex FM signals and an overidding AM frequency that emphasize chaotic
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2017AnnualClinicalMeetingHiltonSanDiegoBayfront
SanDiego,CAOriginalResearchPosterAbstracts
1. MultidisciplinaryPainManagementPrograminJapan a. Presenter:NaotoTakahashi,MD.,PhDb. FirstAuthor:NaotoTakahashi,MD.,PhDc. FirstAuthorAffiliations:DepartmentofPainMedicine,FukushimaMedicalUniversitySchoolofMedicined. Co-Author(s):SatoshiKasahara,MD.,PhD.,ShojiYabuki,MD.,PhDe. Background:Multidisciplinarypainmanagementisausefulmethodforthetreatmentofintractable
f. Objective:Todescribeourinpatientmultidisciplinarypainmanagementprogramusingthebiopsychosocialmethodofself-painmanagement,andtoreportpreliminaryresultsoftheprogram.
g. Methods:Fourteenpatientswereanalyzed.Comparingresultsbeforeandaftertheprogram,thefollowingstatisticallysignificantimprovementwereseeninBPI(p=0.001),PCS(p=0.003),PDAS(p=0.02),HADSanxietyanddepressionscale(p=0.004,p=0.03),PSEQ(p=0.0002),EQ5D(p=0.04),30-secstandingtest(muscleendurance)(p=0.02),and6-minutewalkingtest(physicalfitness)(p=0.03).
h. Results:Fourteenpatientswereanalyzed.Comparingresultsbeforeandaftertheprogram,thefollowingstatisticallysignificantimprovementwereseeninBPI(p=0.001),PCS(p=0.003),PDAS(p=0.02),HADSanxietyanddepressionscale(p=0.004,p=0.03),PSEQ(p=0.0002),EQ5D(p=0.04),30-secstandingtest(muscleendurance)(p=0.02),and6-minutewalkingtest(physicalfitness)(p=0.03).
i. Conclusions:Wehavedevelopedaninpatientpainmanagementprogram.Wemaybeabletoimprovethecopingmechanismsofourpatientsfordealingwithintractablechronicmusculoskeletalpain,andthattheprogramcanimprovetheirqualityoflifeandflexibility.Theinpatientmultidisciplinarypainmanagementprogramshouldbeindicatedfortheintractablechronicmusculoskeletalpainpatients
j. References:None.k. Disclosure:None.
2. Interdisciplinary,Self-managementCourseforChronicPain a. Presenter:JoelKailiab. FirstAuthor:JoelKailia,MDc. FirstAuthorAffiliations:UBCd. Co-Author(s):VincentZenarosa,MDe. Co-author(s)Affiliations:UBCf. Background:Patientssufferingwithchronicnon-cancerpain(CNCP)experienceadiminishedquality-of-life,
g. Objective:Theobjectivesareto(1)createandimplementan8-weekinterdisciplinarycourseforpatientslivingwithchronicpainwiththegoalofeducating,empowering,andsupportingthemand(2)tomakethiscoursefeasible,enjoyable,andreproduciblebothforfurtherstudyandfortransportingtoothercommunities.Wehypothesizethatthis(SMI)coursewillshowimprovedpainscoresforCNCPpatients.
h. Methods:Werecruited8subjectsdiagnosedwithchronicpainfromRISEBCWellnessCentreinNelson,BritishColumbia.Thesubjectsparticipatedinweekly2-hourSMIsessionsfor8-weeks.Thesesessionscoveredavarietyoftopicsincluding:paineducation,mindfulnessbasedstressreduction,cognitivebehavioraltherapy,kinesiology,yogatherapy.Self-reportedquestionnaireswerecompletedandanalyzed.
i. Results:Wedecidedtousethet-testduetothesmallnumberofsubjectsrecruitedforthispilotstudyandtherobustnessofthet-testwithsmallersamplesizes.Quantitativeanalysisshowedthat7outof8subjectsimprovedonthemeaninterferencescoreforpain.Theresultwasstatisticallysignificantatp<0.05.Qualitativefeedbackwaspositiveforallthesubjectswithregardstothecourse.
j. Conclusions:SMIswereeffectiveindecreasingpainseveritybyempoweringthesubjectswithtoolstoovercometheirpain.Subjectsrespondedpositivelytothiseducationalandexercisebasedgroupcourse.SMIswouldbeagreatalternativeforfamilypractitionerstousefortheirchronicnon-cancerpainpatientsasthisislessexpensive,enforcedfasterthanwaitingtobeseenbyapainspecialist'sclinic.
k. References:LynchME.2011.HadjistavropoulosT,MarchildonGP,FinePG,etal.2009.MathewE.,KimE,GoldschneiderK.2014.RobertA.Moore,DSc.2014.BurnsA,DelparteJ,BallantyneE,BoschenK.2013.BourgaultP.LacasseA,ChoinièreM,etal.2015.WilsonM,LavisJ,EllenM.2015.WashingtonDC:InstituteofMedicine,NationalAcademiesPress,2011.
g. Objective:Evaluatethebenefitofaprogramofmultimodalpainmanagementtherapiespriortoanintensivefunctionalrestorationprogram,relativetostandardcare.Identifyprognosticfactors,includingdemographicfactors,psychologicalfactors,andreadinessfactorsthatpredictsuccessfuloutcomesonpainseverityandfunction,followingintensiveinterdisciplinaryfunctionalrestoration.
h. Methods:Acomparativeeffectivenessanalysis,usingaprospectiverandomizedcohortdesign.Participantsrandomizedto3-weeksofFRramp-upcomprisedofeither:StandardCare(SC)(PT,OT,healthpsychology+/-clinicalpharmacology),orComplementaryandIntegrativepaintherapies(chiropractic,acupuncture,yoga+/-massage)inadditiontoSC.Followingthis,bothgroupsparticipatein3weeksFR.
i. Results:Ongoingstudy,inclinicalphase,recruitment>120enrolled.
j. Conclusions:ThereisahighdemandforCIMpaintherapiesandFRamongactivedutyservicemembers.Participationrequireasubstantialcommitmentof90-110hoursoftreatmentoversixweeks,yetdrop-outratesarelow(12%).
k. References:McPhersonF,McGrawL.Treatinggeneralizedanxietydisorderusingcomplementaryandalternativemedicine.AlternativeTherapiesInHealthAndMedicine.2013;19(5):45-50.FlynnDM.Intensivefunctionalrehabilitationforthesoldierandathlete:TheMadiganmedicalcenterexperience.Presentedatthe30thAnnualMeetingoftheAmericanAcademyofPainMedicine.Phoenix,2014.
l. Disclosure:N/Am. Encore:No
4. AnIntegrativePainMedicineTechniquetoReduceOpioidUse a. Presenter:PeterM.Carney,M.D.,F.A.A.NS.b. FirstAuthor:PeterM.Carney,M.D.,F.A.A.NS.c. FirstAuthorAffiliations:CuttingEdgeIntegrativePainCentersd. Co-Author(s):e. Co-author(s)Affiliationsf. Background:Forover5,000yearsthejuiceofthewhitepoppyanditsderivativeshavebeenusedtoreduce
g. Objective:1.TohelpmeetthePresident'sneedforinnovativestrategiesbyadvancingtheAIPM'splanthat:wemustaccelerateaccesstoexisting-aswellasdiscover-newevidence-basedpharmacologic,nonpharmacologicandintegrativechronicpaintreatments.2.Toshowthatanonpharmacologic,integrativetechnique,whichusestheprinciplesofphysicsandiscalledEST/CET,doesreduceopioiduse.(2)
h. Methods:TheuseofESTandCETemployscomplexFMsignalsandanoveriddingAMfrequencythatemphasizechaoticsignalingandself-focusingmechanismstore-establishproperpainsignaling,healnerves,andregeneratenerves.(3)Tworecentarticles,lookingatopioiduseinchronicpainpatients(3)andpatientswithperipheralneuropathy(4)confirmedthatthesetechniquesalsodecreaseopioiduse.
i. Results:16patientswithvariouspainsyndromesreceivedEST/CETwitha67%reductionintheiropioiduse.Eighttotallystoppedopioiduse,2hada50%reduction,3hada33%reductionandanother3hada25%reduction.Fourof14painfulneuropathypatientstookopioidspriortotherapy.Attheirfinalfollow-upvisit3ofthese4hadanaverageopioidreductionof72%(50,65,&100%respectively)
j. Conclusions:Thesestudiesshowedthatpatientswithawidevarietyofpainsyndromesreducedtheiropioidusagebyexploitingtheprinciplesofphysicsratherthanpharmacology.AIPManditssupportinginstitutionshaveagoldenopportunityto"accelerateaccessto...nonpharmacologicandintegrativechronicpaintreatments"byvalidatingtheconceptthatusingphysicswilltransformourtreatmentofpain.
k. References:1.Gostinetal."ReframingtheOpioidEpidemicasaNationalEmergency"JAMAonline.August23,20172.OdellRH&SorgnardRE."Anti-InflammatoryEffectsofElectronicSignalTherapy"PAINPHYSICIAN11:2008:P891-9073.CarneyPM,etal."ElectricCellSignalingReducesNeedforOpioids"PAINMEDICINE18:2017:p5694.OdellRH&CarneyPM."RegeneratingNerves"AAPMMEETINGMarch,2017
l. Disclosure:Nonem. Encore:No
5. *DHEADeficiencyinFibromyalgia
a. Presenter:ThomasJ.RomanoMD,PhdFACPFACRDAAPMABIMb. FirstAuthor:ThomasJ.RomanoMD,PhDFACPFACRDAAPMABIMc. FirstAuthorAffiliations:PrivatePracticed. Background:FibromyalgiaFM)isachronic,common,andpainfuldisorderthatcanbedebilitating.Treating
e. Objective:ToobtainserumlevelsofDHEA-sulfatefromFMpatientsanddetermineifDHEAdeficiencyexistsinsuchpatients,and,ifso,howprevalentitis.
f. Methods:108femaleFMpatients,meanage49yrs(range25-68yrs.),wereevaluatedinasolocommunity-basedrheumatologypracticebetween2012and2016.AllfulfilledAmericanCollegeofRheumatology1990and2010FMcriteria.BloodsampleswereobtainedattheinitialvisitandsenttoQuestDiagnostics(Pittsburgh,PA,USA)foranalysis.DHEA-SlevelsinFMpatientswerecomparedtopublishednorms.
g. Results:Ofthe108femaleFMpatientstested,83(77%)hadlow-for-ageDHEA-Slevels.SixpatientshadnodetectableDHEA-S.Thelevelsrangedfrom0to679mcg/dlwith75patientshavinglevelsbelow100mcg/dl.ThemeanDHEA-Slevelwas96.8mcg/dlintheFMpatientscomparedtotheexpectedlevelofapproximately150mcg/dl.
h. Conclusions:AveryhighpercentageoffemaleFMpatientshadDHEAdeficiencywhichcouldaccountforsuchsymptomsasfatigue,lowstamina,anddecreasedlibidooftenseeninsuchpatients.ThissuggeststhatDHEAsupplementationcouldimprovethequalityofli9feformanyFMpatients.
i. References:1.Wolfe,F.etal.Theprevalenceandcharacteristicsoffibromyalgiainthegeneralpopulation.ArthritisRheum1995:38,19-28.2.Bennett,R.DisablingFibromyalgia:AppearanceversusReality.JRheumatol.1993:20,1821-1822.3.Wilke,W.Treatmentof"resistantfibromyalgia".RheumClinicsofNorthAmerica.1995:21,247-260
j. Disclosure:N/Ak. Encore:No.
6. TolerabilityAndAcceptanceOfMicroglialSuppressingAgents a. Presenter:ForestTennantM.D.,Dr.P.H.b. FirstAuthor:K.ScottGuess,PharmD,MSPharm,R.Ph,DAAPMc. FirstAuthorAffiliations:VeractIntractablePainClinicd. Co-Author(s):ForestTennantM.D.,Dr.P.H.e. Co-author(s)Affiliations:VeractIntractablePainClinicf. Background:Neuroinflammationandcentralizationofpainisnowknowntooccurduetomicroglial
g. Objective:Todate,therearenoreportswhethertheseagentswillbetoleratedandacceptedbychronicpainpatientswhoareinpaintreatmentandmaybenefitbyaddingoneormoretoastandardpaintreatmentregimen.
h. Methods:Intractablepainpatientsintreatmentwithavarietyofsymptomatic,neuropathicagentsandopioidswereinitiallygivenoneoftheseagents:(1)acetazolamide(N=11);(2)metformin(N=22);or(3)pentoxifylline(N=19).Startingdosagesofeachdrugwereasfollows:(1)acetazolamide75mgeveryotherday;(2)metformin500mgatbedtime;and(3)pentoxifylline400mgeveryotherday.
i. Results:Eleven(11)patientswhostartedwithacetazolamidehadtheothertwoagentsaddedwithin90daysofitsinitiation.All11tolerated,accepted,anddesiredtocontinueall3agents,astheyperceivedenhancedpaincontrolandfunctionalstability.Patientswhowerestartedonpentoxifyllineormetforminandthenhadtheotheragentsaddedfoundthecombinationstobetolerableandeffective.
j. Conclusions:Allpatientsacceptedtheseagentsatlowstartingdosagesandperceivedthemtobetolerableandeffectiveinreducingpain.Suppressionofmicroglialactivitytoreduceneuroinflammationandenhancepainreliefandneuroregenerationisanewconceptinpainmanagement.Thispilotstudysuggeststhatmicroglialsuppressorsshouldbeaddedtostandardpaintreatmentregimens.
k. References:Nonel. Disclosure:Nonem. Encore:No
7. ElectromagneticEnergyLowersC-ReactiveProteinLevels a. Presenter:ForestTennantM.D.,Dr.P.H.b. FirstAuthor:ForestTennantM.D.,Dr.P.H.c. FirstAuthorAffiliations:VeractIntractablePainClinicd. Co-Author(s):JohnMoffett,PhDe. Co-author(s)Affiliations:RegenesisBiomedcal,Inc.f. Background:Persistentpainfollowinglumbarbacksurgeriesisaproblemoflong-standing.Boththecause
g. Objective:InflammationisgenerallythoughttoplayaroleinPOLBP.Pulsedelectromagneticfieldtherapy(PEMF)isbelievedtoreduceinflammation,butthereisessentiallynodatainhumansubjectstodocumentthisbelief.TheobjectiveofthisstudywastodetermineifPEMFmaylowerserumhigh-sensitivityC-reactiveprotein(hsCRP)levels.
h. Methods:Thirty-three(33)POLBPpatientswererandomlyandblindlyassignedtoreceiveshamtreatment(N=13)orPEMFatapulsewidthof38µs(N=11)or42µs(N=9).PEMForshamtreatmentwasadministered2timesadayfor60days.Painscoresweredeterminedevery5days,andhsCRPwasdeterminedatthestartandondays15,30,and60ortreatment.
i. Results:Painscoresdroppedinall3groupsover60days,howeverthegreatestdropwasinthegrouptreatedwithPEMFatapulsewidthof42µs.ThissamegroupsignificantlydroppedtheirmeanhsCRPserumproteinlevelsfrom3.2±2.72to2.7±2.32(P<.05).Theshamand38µspulsewidthgroupsdidnotlowertheirhsCRP.
j. Conclusions:PEMFtherapyhaslongbeenbelievedtoreducepainbyreducinginflammationandincreasingbloodandlymphflow.SincehsCRPsignificantlyloweredinthe42µsgroupofpatients,objectiveevidenceisprovidedthatthisspecificenergeticofPEMFmeaningfullyreducesinflammation.
g. Objective:EarlydiagnosisofAAisessentialasitmayproducesevereconstantpainandprogressive,neurologicimpairments.ThepurposeofthisstudywastodeveloparapidscreeningtooltoidentifybackpainpatientswhomayhaveAA,sothattreatmentmaybeinitiatedtoretardprogressionofthedisease.
h. Methods:Thirty(30)patientswithdocumentedAAbymagneticresonanceimaging(MRI)wereaskedthese5questions:Doyouhaveconstantbackpain?;Doyouhavedifficultystartingofstoppingurination?;Doyouhaveburningonthebottomofyourfeet?;Doyouhaveblurredvisionorringingintheears?;andDoyouhavetostandafteryouhavesatfor10minutes?
i. Results:All30AApatientsansweredyesto4or5ofthequestions.Althoughthescreeningquestionsmayappearunrelated,AAmayentrapneuralconnectionstothebladder,gastrointestinaltract,sexorgans,andlowerextremitiesandimpairspinalfluidflow.
j. Conclusions:Treatmentprotocolshavenowbeendeveloped,sothediagnosisofAAshouldbemadeassoonaspossible.Severe,backpainpatients,particularlythosewithneurologicsymptomsseeminglyunrelatedtothelowerspine,shouldbescreenedforAAsotreatmentcanbeinitiatedinanefforttorestrainprogressionofthisneuroinflammatorydisease.
k. References:None.l. Disclosure:N/Am. Encore:No
9. UndiagnosedEhlers-DanlosSyndromeInChronicPainPatients a. Presenter:ForestTennantM.D.,Dr.P.H.b. FirstAuthor:ForestTennantM.D.,Dr.P.H.c. FirstAuthorAffiliations:VeractIntractablePainClinicd. Co-Author(s):CaronPedersen,FNP-C,DC,BSN,BS-PTandK.ScottGuess,PharmD,MSPharm,R.Ph,
g. Objective:WehavefoundthatsomepatientswhopresentwithmanifestationsofcommonpainfulconditionshaveEhlers-DanlosSyndrome(EDS).Thisconditionisagenetic,connectivetissuediseasethatcanproduce,over-time,abreakdownoftissuestructuresinalmostanyorganofthebody.Severepain,may,therefore,appearinunusualpatternsthatcanmimicanumberofpainfulconditions.
h. Methods:One–hundred-thirty-seven(137)chronicpainpatientsintreatmentwerescreenedforEDSbyquestionsregardingdouble-jointedness,extremityflexibility,bending,andjointdislocation.Ifsomescreeningquestionswereanswered"yes",patientswerefurtherassessedbyaBeightonscoreandthediagnosticcriteriaoftheInternationalConsortiumofEhlers-DanlosSyndromeandRelatedDisorders.
i. Results:All137patientshadbeenreferredforpaintreatmentwithanon-EDSdiagnosisandweretakingmultiplepharmacologicagents.Eleven(11)ofthe137(8.0%)werefoundtohaveundiagnosedEDS.Thereferringpaindiagnoseswere:headandspinepain(3);fibromyalgia(3);adhesivearachnoiditis(2);abdominaladhesions(1);Lymedisease(1),andrheumatoidarthritis(1).
j. Conclusions:EDSisageneralized,geneticconnectivetissuedisorderthatmaydevelopavarietyofverypainful,clinicalmanifestations.Aggressivepaintreatmentincludinghighdose,dailyopioidsmayberequired.AllseverechronicpainpatientsshouldbescreenedforEDS.
g. Objective:Ketamineandoxytocinprovideanalgesiabymechanismsotherthanstimulatingopioidreceptors.Wehavegiventheseagentstomultiplepainpatientsbythenasal,oral,andsublingualroutestofindaneffectivedosageandrouteofadministration.Ourobjectiveherewastodetermineiftheseagents,giveninliquidformbythesublingualroute,maysubstituteforpotentopioids.
h. Methods:Fivechronicpainpatientswhohadusedoxycodone,morphine,hydrocodone,orhydromorphoneforoverayearweretested2to4hoursaftertheirlastoral,opioiddosage.Theyweregivenliquidoxytocin,0.5ml(20units)ofa40unitspermlconcentrationsublinguallyfollowedwithin15minutesby.25to.50ml(12.5to25mg)ofliquidketamineataconcentrationof50mgperml.
i. Results:Within10minutesallfivepatientsreportedvaryingdegreesofpainrelieffromoxytocin.Ketamineenhancedthispainrelief.Twopatientsbecamepainfree.Relieflastedabout4hours.Therewerenosideeffects.
j. Conclusions:Thisinvestigationindicatesthatliquidoxytocinand/orketaminegivensublinguallymaysubstituteforsomepotent,oralopioids.Immediateandfurtherinvestigationofthesenon-opioidagentsisneeded.
k. References:Nonel. Disclosure:Nonem. Encore:No
11. GeneticVariationsinPainPatientsTakingHighDoseOpioids a. Presenter:ForestTennantMD,DrPHb. FirstAuthor:ForestTennantMD,DrPHc. FirstAuthorAffiliations:VeractIntractablePainClinicd. Co-Author(s):RamVairavan,PhDe. Co-author(s)Affiliations:AutoGenomics,Incf. Background:Morethan100millionpeoplesufferfromacuteorchronicpaineveryyearaccordingtothe
g. Objective:Geneticfactorsarebelievedtoplayaroleinopioidprescriptionaddictionaswellwhichagentsareeffectiveforpaincontrol.Thepurposeofthisstudyistoassesstheutilityofamulti-variantgeneticpaneltohelpidentifychronicpainpatientswhorequirehighdoseopioidsorwhomaybeatriskforabuseandaddiction.
h. Methods:Seventyseverechronicpainpatientswhoweretakingover100mgadayofmorphineequivalenceweregeneticallytested.Sixteen(16)singlenucleotidpolymorphismsinvolvedinthebrainrewardpathwaywereanalyzedwithfourcategoriesofgeneticmarkers:(1)ReceptorBindingandActivity;(2)Neurotransmittertransporters;(3)CentralNervousSystem(CNS)Enzymes;(4)CytochromeP450Enzymes.
i. Results:All70patientshadageneticvariationinoneormoredopaminereceptors(DRD1,DRD4,DOR).Only17(30%)hadvariantsinthe3opioidreceptorswhichweretested.Forty-oneof70(58.6%)hadoneormorecytochromeP450defects.Nomarkersexceptthedopaminereceptormarkershadover90%geneticvariation.
j. Conclusions:Itisinterestingthatallpatientshaddefectsintheirdopaminereceptorsystem.Thesefindingsneedtobeinvestigatedinnormalsubjectsandothergroupsofpainpatientswhorequirehighdoseopioidstodetermineifdopaminergicdefectsareanunderlying,geneticcauseofhighdoseopioidrequirements.
c. FirstAuthorAffiliations:EliLillyandCompanyd. Co-Author(s):MarkBangsMD,HimanshuPUpadhyayaMD,RenataMehtaMSce. Co-author(s)Affiliations:Mrs.RenataMehtaisaffiliatedwithFocusClinicalConsultingInc.f. Background:Cymbalta(duloxetinehydrochloride)isaserotonin-norepinephrinereuptakeinhibitor
g. Objective:TheprimaryobjectiveofthisprospectiveobservationalstudyistoestimatetheriskofmajorcongenitalanomaliesamongpregnanciesexposedtoduloxetineduringpregnancyintheU.S..Theenrollmenttargetis484pregnancies.Sincetheplannedenrollmenttargetisnotyetreached,thisreportisbasedona7-yearexperiencewiththeregistry.
h. Methods:ThisisanongoingU.S.-based,voluntary,observational,exposure-registrationandfollow-upstudyofwomentakingduloxetineduringpregnancy.Dataarecollectedatstudyregistration,theendofthesecondtrimester,theoutcomeofpregnancy,and4and12monthspostpartum.Breastfeedingmotherscompleteaquestionnaireat3,6,9,and12monthspostpartum.
i. Results:FromJuly2009toAugust2016,only97prospectivecaseswereenrolled:85withknownpregnancyoutcomes(83livebirths,2spontaneousabortions,and0non-livebirthsorfetaldeaths),4withpendingpregnancyoutcomes,and8losttofollow-up.Reportedoutcomesincluded8prematurebirthsand4birthdefects.Twoinfantsexperiencedsymptomsofneonatalwithdrawalorpoorneonataladaptation.
j. Conclusions:Theregistrysupplementstheongoingmonitoringofduloxetinesafetyduringpregnancy.Theinabilitytocalculateaccuratebirthdefectratesduetotheveryslowenrollmentandsmallnumberofreportedcaseslimitsanyreliableconclusion.Informationregardingtheregistrymaybeobtainedbycalling1-866-814-6975orbyvisitingwww.cymbaltapregnancyregistry.com.
g. Objective:ToobtainRWEonsafetyofTapERvs.widelyprescribedERopioids(oxycodoneER(OxnER)ormorphinesulfateER(MsER))usingIBMTruvenHealthMarketScan®CommercialClaimsandEncountersDatabasedatingfromOctober2010throughMarch2016.
h. Methods:Totalof72,781patientswasobserved.Theadherent(proportionofdayscovered≥0.8)patientswereselectedforcomparisonduring90,180,and365daysofLAOtherapy(Tx).Constipation,nausea/vomitingandheadachewereassessedwithICD9/10codeclaims.ProportionsofpatientsexperiencingAEscommonforopioidswerecompared,inregardtotheirLAOtreatmentanditsduration.
i. Results:ConstipationwasloweronTapERvs.OxnERandMsERon90-dayTx(2.5%vs.3.6%and4.2%,p<0.001each),180-dayTx(4%vs.4.9%,p<0.05,and5.7%,p<0.001)and365-dayTxforTapERvs.MsER(6.5%vs.8.1%,p<0.05).Nausea/vomitingwaslowerforTapERvs.MsER(2.3%vs.3%,p<0.05)during90-dayTx.Meanwhile,headachesweremorefrequentonTapERvs.OxnERandMsER(6%vs.4.7%and5%,p<0.05each).
j. Conclusions:UsingRWE,TapERshowedstatisticallysignificantlylowerratesofconstipationcomparedtoOxnERandMsERduring90-and180-daytherapy,andcomparedtoMsERduringoneyearlongLAOtreatment.Theratesofnausea/vomitingwerestatisticallysignificantlyloweronTapERcomparedtoMsERduring90-dayLAOtherapy,withmorefrequentheadachesreportedforTapERduringthefirst90days.
k. References:1.SantosJ,etal.Tapentadolforchronicmusculoskeletalpaininadults.CochraneDatabaseofSystematicReviews2015.2.BaxterG,etal.AssociationofAdverseEventsandHealthServiceUsageWithTapentadolProlonged-ReleaseTreatmentComparedWithMorphineControlled-Release(Cr)AndOxycodoneCr:AUkPrimaryCareObservationalStudy.ValueHealth.2015.
l. Disclosure:ThisstudywassponsoredbyDepomed,Inc.themanufactureroftapentadolER,throughanunrestrictedgrant.Allauthorswereinvolvedinthestudydesign.VZ,MI,STandNMdidthedataanalyses.VZ,NM,MIandSTanalyzedandinterpretedtheresults.VZacceptsoverallresponsibilityfortheaccuracyofthedata,itsanalysisandthisabstract.
m. Encore:No
14. Useofco-medicationsinchronicpainpatientsonopioids a. Presenter:ZahVladimir,PhDb. FirstAuthor:ZahVladimir,PhDc. FirstAuthorAffiliations:ZRxOutcomesResearchInc.,Toronto,ON,Canada.d. Co-Author(s):MartinaImroMSc.1,NikolayMatveevPhD.1,AnaSikoraMSc.1,MartaSokolowskaPhD.2e. Co-author(s)Affiliations:1.ZRxOutcomesResearchInc.,Toronto,ON,Canada.,2.DepomedInc.,San
g. Objective:ExploringpotentialrateofmisusethroughprescriptionofconcomitantBZDsandBuporBup/NalinpatientsusingexclusivelyoneofLAOs:tapentadolextendedrelease(TapER),oxycodoneER(OxnER)oroxymorphoneER(OxmER),withdataobtainedfromIBMTruvenHealthMarketScan®,July2011-March2016
h. Methods:Patientsadherent(proportionofdayscovered≥0.8)during180-dayLAOtherapywere≥18yearsoldatindexdate(firstprescriptiondateofselectedopioid)andinsuredminimum3monthsbeforetheindexdateandduringLAOtherapy.ChronicpainconditionwasassessedusingICD9/10codes.ProportionofpatientswithadditionalBZDs’fillsorwithBuporBup/NalwascalculatedforeachLAO.
i. Results:Totalof36,479patientswereidentified.SignificantlylesspatientsonTapERhadBZDs’fillsduringLAOtherapy,comparedtopatientsonOxnERandOxmER(40.1%vs.47.5%and46.3%,respectively,p<0.001bothcomparisons).LowerpercentageofpatientsonTapERhadBuporBup/NalfillsduringLAOtherapythanOxnER(0.2%vs.0.3%,p=0.466)andOxmER(0.2%vs.0.6%,p<0.05).
j. Conclusions:TapERpatientshadlowerconcomitantuseofBZDsand/orBuporBup/NalwhencomparedtoOxnERandOxmERduringfirst180daysofchronicpaintherapy.FurtherstudyintotheeffectofconcomitantBZDsand/oropioid-dependencetreatmentutilizationduringLAOtherapyanditsimpactonqualityoflifeofthepatientandtreatmentcostisrecommended.
k. References:1.JermaineD.Jones,ShanthiMogali,SandraD.Comer,Polydrugabuse:Areviewofopioidandbenzodiazepinecombinationuse,DrugandAlcoholDependence,2012.2.AlhoH,SinclairD,VuoriE,HolopainenA.Abuseliabilityofbuprenorphine-naloxonetabletsinuntreatedIVdrugusers.DrugAlcoholDepend.2007.
l. Disclosure:ThisstudywassponsoredbyDepomed,Inc.themanufactureroftapentadolER,throughanunrestrictedgrant.Allauthorswereinvolvedinthestudydesign.VZ,MI,ASandNMdidthedataanalyses.VZ,NM,MIandASanalyzedandinterpretedtheresults.VZacceptsoverallresponsibilityfortheaccuracyofthedata,itsanalysisandthisabstract.
m. Encore:No
15. Economicburdenofchronicpainopioidtherapy
a. Presenter:ZahVladimir,PhD.b. FirstAuthor:ZahVladimir,PhD.c. FirstAuthorAffiliations:ZRxOutcomesResearchInc.,Toronto,ON,Canadad. Co-Author(s):MartinaImroMSc.1,SimonaTatovicMSc.1,AnaSikoraMSc.1,MartaSokolowskaPhD.2e. Co-author(s)Affiliations:1.ZRxOutcomesResearchInc.,Toronto,ON,Canada;2.DepomedInc.San
g. Objective:TocompareHCPMinasubsetofmatchedpatientswithchronicpain(musculoskeletalpain,neuropathicpain,andneoplasm-relatedpain),treatedwithTapERorOxnERforatleast90andupto400days,adherenttoLAOtreatment.PatientswereselectedusingdatafromIBMTruvenHealthMarketScan®CommercialClaimsandEncountersDatabase,fortheperiodofOctober2010throughMarch2016.
h. Methods:Allpatientswere≥18yearsold,continuouslyinsured12monthsbeforeandduringtheLAOtreatmentperiod.PatientswereclassifiedbasedonMedicalPossessionRatio(MPR)andProportionofDayscovered(PDC),withMPR=0.8-1.1andPDC≥0.8.Thepatientswerematchedusingpropensityscore,basedonbaselinevariablesthatsignificantlyimpactHCPMinratioof1:6,TapER:OxnER.
i. Results:Overall2,824TapERwerematchedto16,716OxnERpatients.SignificantlylowerHCPMwasobservedinpatientsonTapERtreatmentvs.OxnER(mean(SD),$2,512(4,218)vs.$3,722(7,612),p<0.001).PatientstreatedwithTapERvs.OxnERhadsignificantlylowerinpatientcostpermonth($502(3,025)vs.$1,091(4,769),p<0.001)andloweremergencyroomcostpermonth($97(348)vs.$141(560),p<0.001).
j. Conclusions:Thisstudyconfirmedchronicpainpopulationpreviousfindingsthatevenamongmatchedchronicpainpatients,beingontapentadolextendedreleaseandoxycodoneextendedreleasetreatment,averagecostofmonthlyTapERtreatmentappearstobeless,accountingfordrug,inpatientandoutpatientcosts.
k. References:GoreM,etal.Theburdenofchroniclowbackpain:clinicalcomorbidities,treatmentpatterns,andhealthcarecostsinusualcaresettings.Spine(PhilaPa1976).2012.ColuzziF,RuggeriM.Clinicalandeconomicevaluationoftapentadolextendedreleaseandoxycodone/naloxoneextendedreleaseincomparisonwithcontrolledreleaseoxycodoneinmusculoskeletalpain.CurrMedResOpin.2014.
l. Disclosure:ThisstudywassponsoredbyDepomed,Inc.themanufactureroftapentadolER,throughanunrestrictedgrant.Allauthorswereinvolvedinthestudydesign.VZ,MI,STandASdidthedataanalyses.VZ,MI,ASandSTanalyzedandinterpretedtheresults.VZacceptsoverallresponsibilityfortheaccuracyofthedata,itsanalysisandthisabstract.
m. Encore:No.
16. TotalHealthcareCostsofOpioidsBasedonChronicPainType a. Presenter:ZahVladimir,PhD.b. FirstAuthor:ZahVladimir,PhD.c. FirstAuthorAffiliations:ZRxOutcomesResearchInc.,Toronto,ON,Canadad. Co-Author(s):MartinaImroMSc.1,SimonaTatovicMSc.1,AnaSikoraMSc.1,MartaSokolowskaPhD.2e. Co-author(s)Affiliations:1.ZRxOutcomesResearchInc.,Toronto,ON,Canada;2.DepomedInc.San
h. Methods:Patientsbeing≥18yearsoldonLAOtreatmentfor90upto400days,withchronicpainassessedwithICD9/10codedoutpatientandinpatientclaims.Allpatientshadcontinuoushealthplanenrollmentforatleast12monthspriortoindexdate(firstprescriptiondateofselectedopioid)andduringanalgesictreatment.TotalHCPMwascomparedacrossLAOtreatmentgroups,basedonchronicpaintype.
i. Results:Totalof72,672patientswereidentified.HCPMforMSweresignificantlylowerforTapERvs.OxnERandMsER(mean(SD)$2,446(4,349)vs.$4,074(8,020)and$3,068(7,305),p<0.001each),aswellasforCPpatients($10,226(16,827)vs.$21,926(20,144)vs.$19,999(17,863),p<0.05each),respectively.InNPpatients,HCPMwerelowerforTapERvs.OxnER($4,048(8,197)vs.$5,555(8,299),p<0.05).
j. Conclusions:Patientssufferingfrompaincausedbycancer,demonstratedsubstantiallyhighertotalhealthcarecostincomparisontopatientswithmusculoskeletalorneuropathicpain,ineachopioidtreatmentgroup,asanticipated.TapentadolERtreatmentappearstobesignificantlylessexpensiveincomparisontooxycodoneERandmorphinesulfateERtreatments,regardlessoftypeofchronicpain.
k. References:None.l. Disclosure:ThisstudywassponsoredbyDepomed,Inc.themanufactureroftapentadolER,throughan
g. Objective:Thisanalysisexaminesthevolume,cost,anddemographicinformationassociatedwithprescriptionsforproductsusedforpain-relatedconditionsthathavenotreceivedformalFDA-approvalorundergoneformalclinicaleffectivenessstudies.Itfocusesonthemostwidelyprescribedproductsclassifiedas“unapproveddrugother,”asnotedbytheFDAOnlineLabelRepository.2
h. Methods:ThisretrospectivecohortanalysisofExpressScripts’pharmacyclaimsdatabase(July1,2016toJune30,2017)identifiedthetop“unapproveddrugother”paidandrejectedclaimsforpatientswhohaveExpressScriptsastheirpharmacybenefitmanager.Profilesofpatientswhoseclaimswererejectedwerefurtheranalyzedtodeterminewhetheralternateprescriptiontherapywasprescribed.
i. Results:In12months,13,402patientswereprescribed22,651prescriptionsforaselectgroupoftopicalproducts;85%ofwhichwererejected.Lidocaine-containingformulationsrepresented97%oftheclaimvolumewithremainingclaimsattributedtotopicalpatchescontainingmentholandcapsaicin.Plansponsorswerebilled$23,781,278,equatingtoanaveragewholesaleprice(AWP)of$1,049.90perclaim.
j. Conclusions:Thisstudydemonstratesthatanumberofproductsclassifiedas“unapproveddrugother”arebeingprescribed,usuallyatamuchhigherpricethanalternativetherapies.FDA-approvedtherapeuticalternativesthatcontainsimilaringredientsareavailableandoffercost-savingsopportunitiestopatientsandplansponsors.
k. References:1.USFDA.UnapprovedPrescriptionDrugs:DrugsMarketedintheUSThatDoNotHaveRequiredFDAApproval.Updated3Jan2017.From:https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htmAccessed30Aug2017.2.USFDA.FDAOnlineLabelRepository.From:https://labels.fda.gov/Accessed30Aug2017.
l. Disclosure:No.m. Encore:No.
18. Singlelevelsonogramguidedlumbarfacetjointinjection a. Presenter:AbrahamT.Rasul,Jr.,MD,FAAPMRb. FirstAuthor:AbrahamT.Rasul,Jr.,MD,FAAPMRc. FirstAuthorAffiliations:NeuroSpineInstituteSierraVistaRegionalMedicalCenterd. Background:Facetjointinjectionsdonewithimagingguidancehadbeenassociatedwithreliefofpain.
e. Objective:Thepurposeofthisstudyistodemonstratethefeasibilityandresultsofdoingsonogramguidedlumbarfacetinjectionsinanofficesetting.
f. Methods:Twohundredfiftythreepatientswithlumbarfacetjointpainwereincludedinthisstudy.Patientswhodidnotgetanyrelieforcouldnottoleratetheoralsteroidreceivedthesinglelevelsonogramguidedlumbarfacetjointinjectiondoneintheoffice.Treatmenteffectivenesswasassessedusingthevisualanaloguescale(VAS),physicalexamination,reductioninuseofpainmedications,
g. Results:Oftheninety-twopatientswhodidnotrespondtoorcouldnottaketheoralsteroids,almosthalf(48.2%)hadsignificantreliefafteronesinglelevelinjectionwhilelessthanhalfofthisgroup(43.6%),notedreliefonlyaftergetting2ormoresubsequentinjections.
h. Conclusions:Sonogramguidedlumbarfacetinjectionsdoneinanofficesettingprovideasafeandviablecostefficienttreatmentoflumbarfacetpain.
i. References:Darrieutort-LafitteC,HamelO,GlemarecJ,MaugarsY,andLeGoffB.Ultrasonographyofthelumbarspine:sonoanatomyandpracticalapplications.JointBoneSpine.2014Mar:81(2):130-6.
g. Objective:Tocharacterizeemotionaldistresssymptoms,includinganxiety,depression,anger,fatigue,andsleepimpairment,endorsedbyasampleofpatientsseekingtreatmentinapainspecialtyclinicforactive-dutymilitary.Toidentifyspecificdimensionsofemotionaldistressmostpredictiveofdisabilityinanactive-dutytreatmentseekingsample.
h. Methods:Thecurrentstudyincludes669activedutyservicemembers,approximately80%male,whopresentedforanevaluationatthePainManagementClinicatNavalMedicalCenterSanDiego.Patientscompletedabatteryofquestionnairesincludingmeasuresofanxiety,depression,anger,fatigue,andsleepimpairment,aswellasmeasuresofpaininterferenceandphysicalandsocialfunctioning.
i. Results:Approximately70%ofpatientsreportedclinicallyelevatedlevelsonatleastoneofthefivesymptomscales,withsleepimpairmentandfatiguebeingthemostcommoncomplaints.Regressionanalysesrevealedthatsleepimpairment,fatigue,anddepressionweresignificantpredictorsofpaininterferenceandphysicalandsocialfunctioningaftercontrollingforreportedaveragepainlevel(ps<.05).
j. Conclusions:Clinicallyelevatedlevelsofemotionaldistressarehighlycommoninactive-dutymilitarymembersseekingtreatmentforpain.Sleepimpairment,fatigue,anddepressionlikelyinfluencepatientfunctioningbeyondreportedpainlevels.Psychosocialandpsychiatricinterventionstargetingsleepimpairment,fatigue,anddepressionmayhelpimprovefunctionaloutcomesinthistreatmentpopulation.
k. References:Lee,H.,Hübscher,M.,Moseley,G.L.,Kamper,S.J.,Traeger,A.C.,Mansell,G.,&McAuley,J.H.(2015).Howdoespainleadtodisability?Asystematicreviewandmeta-analysisofmediationstudiesinpeoplewithbackandneckpain.Pain,156(6),988-997
l. Disclosure:TheviewsexpressedinthisabstractarethoseoftheauthorsanddonotnecessarilyreflecttheofficialpolicyorpositionoftheDepartmentoftheNavy,DepartmentofDefense,ortheU.S.Government.
g. Objective:Conductaseriesofrandomized,controlledclinicalstudiestoassesssymptomclusterincludingpain,stress,depression,fatigue,catastrophizing,andsleepoutcomesafterHRVBinterventionsinchronicpainpatients.ChangesinHRVandoutcomevariableswillbemeasuredpre-posttrainingintervention.
h. Methods:AssesseffectofHRVBonsymptomclusterin3studies:1.Pilot;Veteranswithchronicpain,treatmentasusual(TAU)control;pre-post;singleprimaryendpointofpainandstressratings;2.Phase1;cancersurvivors;TAUcontrol;pre-post;primary,secondaryendpoints;3.Phase1;Veteranswithchronicpain,inactivetreatmentcontrol;4timepoints;primary,secondary,exploratoryendpoints
i. Results:Study1:n=18;Post-HRVBsignificantlylowerthancontrolonalloutcomemeasures(p’s<.05);Study2:n=34;HRVBisfeasible,symptomclusterindicatorsintercorrelated;HRVincreasedbyHRVB;allsymptomclusterindicatorssignificantlydecreased;Study3:n=80;collectingdata;30enrolled;symptomclusterindicatorsincludingcatastrophizingallintercorrelated;groupeffectsnotanalyzedyet
j. Conclusions:Benefitsonsymptomclusteroutcomesshownbyall3studies.HRVBisapromisingintervention.Plannedresearch:(1)NIHRO1,Phase2,singlesite,Veterancancersurvivors;psychoeducationalself-managementcontrol;4timepoints;primary,secondary,exploratoryendpoints(2)NCINCORP,Phase2,multi-site,cancersurvivors.;pre-post;primary,secondary,exploratoryendpoints
k. References:Berry,Metal.2014Non-pharmacologicalinterventionforchronicpaininVeterans:ApilotstudyofheartratevariabilitybiofeedbackGlobalAdvHlthMed3(2),28-33Gharbo,Retal2016HeartRateVariability,ChronicPain,andRehabilitatingtheAutonomicNervousSystemPainPract26,5(17-18)O'Rourke,Metal2017HRVtrainingforsymptomcontrolincancersurvivorsJClinOcol35,15-S10