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Promoting and improving patient safety and health service quality across Alberta.
THE SAFE PRACTICE OF DRY NEEDLING IN ALBERTA
Summary Report
October 2014
TABLE OF CONTENTS
OVERVIEW ......................................................................................................................................... 1 Background .................................................................................................................................. 1 Collection of information .............................................................................................................. 1
INTRODUCTION TO DRY NEEDLING ............................................................................................... 2 FINDINGS ........................................................................................................................................... 4
Adverse outcomes related to dry needling ................................................................................... 4 Clinical presentation of pneumothorax ......................................................................................... 9 Clinical practice issues in dry needling related to pneumothorax ............................................... 10 Identification and management of pneumothorax following needling ......................................... 11 Maintenance of authorization and continuing competence ........................................................ 13
CONCLUSION .................................................................................................................................. 14 APPENDIX ........................................................................................................................................ 16
Appendix I: Presentation of pneumothorax ................................................................................ 17 REFERENCES .................................................................................................................................. 18
OVERVIEW 1
OVERVIEW
Dryneedlingisabroadtermthatreferstoatreatmenttechniquethatusessolidfilamentneedlestopuncturetheskinfortherapeuticpurposes.Itincludesarangeofapproaches,suchasacupuncture,triggerpointdryneedling,intramuscularstimulation,orsimilartreatmentsusedbynumeroushealthcareprofessionals.Approachesdifferintheirrationale,needlingtechniques,andtrainingrequirements.InAlberta,physicians,dentists,surgeons,physiotherapists,occupationaltherapists,chiropractors,nurses,naturopathsaswellasacupuncturistsareauthorizedtopractisedryneedling.
Background
ThisreportisasummaryofareviewconductedbytheHealthQualityCouncilofAlberta(HQCA)inresponsetoarequestbytheCollegeofPhysicalTherapistsofAlberta(College)tocompleteanindependentreviewofadverseoutcomes,specificallypneumothorax,resultingfromdryneedlingpracticesbyphysiotherapistsinAlberta,inordertoimprovethequalityandsafetyofthispractice.WhilethisreviewwasconductedfortheCollege,theHQCA(withpermissionfromtheCollege)issharingthefindingsmorebroadlytoinformqualityandsafetyindryneedlingpracticesforallpractitioners.
Thisreviewidentifiesclinicalpracticeissuesindryneedlingrelatedtopneumothorax,whichisthemostcommonseriousadverseoutcomefollowingdryneedling.Pneumothorax,apotentiallylifethreateningcomplication,isanabnormalcollectionofairinthespacebetweenthelungandthechestwall.Pneumothoraxcanoccurduringdryneedlingifaneedleentersthelungtissue.Becausedryneedlingisaninvasiveprocedurethatpenetratestheskin,itiscriticalthatthepractitionerhasthoroughknowledgeofsurfaceanatomy,theunderlyingstructuresofthethoraxincludinganatomicalanomalies,aswellasknowledgeaboutthemanagementofadverseeventssuchaspneumothorax.
Thetermdryneedlingwillbeusedinthisreporttorefertotreatmentusingsolidfilamentneedles,regardlessoftheapproachorphilosophyofcare.
Collection of information
Informationrelatedtoqualityandpatientsafetyissuesindryneedlingwasgatheredfrom:
Databasesweresearchedforpublishedandgreyliteraturerelatedtodryneedling. Documentsrelatedtothesafepracticeofdryneedlingincludingacupuncture,triggerpointdry
needlingorintramuscularstimulationwereobtainedfromwebsitesofkeynationalandinternationalorganizations.
Documentswereobtainedthroughrecommendationsfromintervieweesorexpertsinthefield.The2013textbook,TriggerPointDryNeedling–AnEvidencedandClinical‐BasedApproach,editedbyexpertsintriggerpointdryneedling,wasalsoreviewed.1
Expertisewassoughtprovincially,nationally,andinternationally.Semi‐structuredinterviewswereconductedwithindividualswhohaveexpertiseindryneedlingpractice,dryneedlingeducation,medicalassessmentandmanagementofpneumothorax,orhealthcareprofessionalpracticeregulation.Authorswhohavepublishedarticlesrelatedtosafetyanddryneedlingwerecontacted.Physicianswhotreatedpatientswithpneumothoraxfollowingdryneedlingwerealsointerviewed.
INTRODUCTION TO DRY NEEDLING 2
INTRODUCTION TO DRY NEEDLING
Dryneedling(DN)includesarangeofapproachesthatdifferintheirrationalefortreatment,needlingtechniques,andtrainingrequirements.However,thereisnostandardizationinterminologyusedtodescribetheseapproachescausingconfusionforbothpractitionersandthepublic.Forexample,dryneedlingcanbeusedeithertodescribethepracticeofahealthcareprofessionalusingtraditionalChineseacupunctureortodescribeahealthcareprofessionalusingatriggerpointapproach,whichisunrelatedtotraditionalChinesemedicine(TCM).Table1outlinessomeofthecommondryneedlingapproachesandterms.
Table 1: Common dry needling approaches
Dryneedlingapproach Definition/focusandsource
Triggerpointdryneedling Myofascialtriggerpointmodel1
Intramuscularmanualtherapy Americantermreferringtomyofascialtriggerpointmodel2
Gunnintramuscularstimulation(IMS)
Radiculopathymodel(UniversityofBritishColumbia)
Superficialdryneedling Acategorizationofaneedlingtechniquethatreferstothetargetdepthoftheneedle.1Definedastheinsertionofneedlesintothesubcutaneoustissuesimmediatelyoverlyingatriggerpoint.3
Deepdryneedling Acategorizationofneedlingthatreferstoinsertionofneedlesintothemuscleandintothetriggerpointtoelicitalocaltwitchresponse.4GunnIMSisanexampleofdeepneedlingtechnique.
Contemporarymedicalacupuncture
Neurofunctionalmodel(McMasterUniversity)
Traditionalacupuncture
OR
Classicalacupuncture(termusedbyAcupunctureFoundationofCanadaInstitute)
AcupunctureisanancientformofChinesemedicineinvolvingtheinsertionofsolidfiliformneedlesintotheskinatspecificpointsonthebodytoachieveatherapeuticeffect.5
AND
“Acupunctureisasystemofdiagnosisandtreatment.ThediagnosisisbasedonacomprehensiveChinesetheoryofenergybalance.Thetreatmentinvolvesinsertionofsmallsolidneedlesintopreciseanatomicalsitesinthebodytoproducetherapeuticeffects”.6
AnatomicalacupunctureTheapproachtakentodaybywestern‐trainedphysiciansinChinaandmanypartsofthewesternworldwhereonecombinesknowledgeofacupuncturewithwestern‐learnedanatomy,physiology,andpathophysiology.5
Westernmedicalacupuncture
OR
Medicalacupuncture
Therapeuticmodalityinvolvingtheinsertionoffineneedles;itisanadaptationofChineseacupunctureusingcurrentknowledgeofanatomy,physiology,andpathologyandtheprinciplesofevidence‐basedmedicine.7
AND
Amedicaldisciplinehavingacentralcoreofknowledgeembracingtheintegrationofacupuncturefromvarioustraditionsintocontemporarybiomedicalpractice.8
INTRODUCTION TO DRY NEEDLING 3
InAlberta,regulationsrelatedtodryneedlingareprovidedundertwoseparatepiecesoflegislation.IdentifiedregulatedhealthprofessionspracticedryneedlingundertheHealthProfessionsAct(HPA)throughauthorizationfromtheirrespectivecollege.9TheHealthProfessionsAct(HPA)allowsforoverlappingscopesofpracticeamonghealthprofessionsandtherefore,dryneedlingisnotthepurviewofanyonediscipline.Healthprofessionsauthorizedtopracticedryneedlingincludephysicians,dentists,surgeons,physiotherapists,occupationaltherapists,chiropractors,nursesandnaturopaths.Eachprofessionalcollegedeterminestherequisiterequirementsfortheirmemberstobepermittedtopracticeusingdryneedlingtechniquesandthetechniquemustonlybeusedwithinthediscipline’sscopeofpractice.
AcupuncturistsarecurrentlyregulatedundertheAlbertaHealthDisciplinesAct10.AcupuncturistandregisteredacupuncturistareprotectedtitlesreferringtoindividualswhohavestudiedtraditionalChinesemedicineortraditionalChineseacupuncture,havesuccessfullycompletedanationalwrittenandpracticalexamination,andareregisteredwiththeprovincialacupuncturecollegeorlicensingbody.InAlberta,thislicencetopracticeisgrantedbytheCollegeandAssociationofAcupuncturistsofAlberta.ItispossibleforpractitionersinAlbertatohavedualregistrationasitrelatestodryneedling,thatis,toholdregistrationwiththeirhealthprofessions’college,aswellasregistrationasanacupuncturistwiththeCollegeandAssociationofAcupuncturistsofAlberta.
FINDINGS 4
FINDINGS
Adverse outcomes related to dry needling
Thereismuchevidenceintheliteraturethatidentifiesacupunctureasasafetreatmentwhenpractisedbyaproperlytrainedpractitioner.11,12,13,14,15However,authorsagreethatacupuncturedoescarryrisksforseriousadverseoutcomes.TheWorldHealthOrganization’s(WHO)GuidelinesonBasicTrainingandSafetyinAcupuncturepublishedin1999noted,“thereare,inaddition,otherriskswhichmaynotbeforeseenorpreventedbutforwhichtheacupuncturistmustbeprepared”.16
Whiletheliteraturecontainslittleinformationonthesafetyofspecificneedlingtechniques,suchastriggerpointneedlingordeepdryneedling,itisreasonabletoexpectthatthelikelihoodofadverseoutcomeswouldbesimilarforanydryneedlingapproach.Bradychallengedthisassumptionbynotingthat“TrP‐DN[triggerpointdryneedling]differsfromacupunctureinthepointstreatedandthemethodanddepthofneedlestimulationmeaningthatresultsfromacupunctureAE[adverseevents]studiescannotbeextrapolatedandappliedtoTrP‐DN”.17
Since2001,severalEuropeanstudieshavebeenpublisheddemonstratingthenatureandincidenceofadverseoutcomesinacupuncture.TheSurveyofAdverseEventsFollowingAcupunctureStudy(SAFA)byWhiteetalwasthefirstlarge,prospectivestudyonsafetyinacupuncture.18PhysiciansandphysiotherapistsintheUnitedKingdomwhoprovidedacupuncturewererecruitedtoreportadverseeventsovera21‐monthperiod(1998–2000).Acomparablestudy,theYorkAcupunctureSafetyStudy,byMacPhersonetal,wasalsoundertakenin2001withacupuncturistsintheUnitedKingdom.19TwosimilarstudieswereconductedinGermany,onebyMelchartetalin200420andanother,largerstudybyWittetalin2009.21In2013,BradyetalcompletedaprospectivestudyinIrelandonsafetyspecificallyrelatedtotriggerpointdryneedling.17
ThesestudiesaresummarizedbelowinTable2.
Table 2: European studies of adverse outcomes in acupuncture and dry needling, 2001-2013
Author Locationofstudy Practitionersparticipating Sourceoftreatmentresults
Whiteetal200118 Britain Physicians,physiotherapists Practitioner
MacPhersonetal200119 Britain Acupuncturists Practitioner
Melchartetal200420 Germany Physicians Practitioner
Wittetal200921 Germany Physicians Patient
Bradyetal201317 Ireland Physiotherapists Practitioner
FINDINGS 5
Seriousadverseoutcomesfollowingacupuncturehavebeenwelldocumentedintheliterature;however,manyhavebeenreportedassinglecasestudies.22,23,24,25,26,27,28Whiletheseverifythatadverseeventsdooccur,theydonotidentifysufficientrangeorincidenceofeventstoprovidethebodyofevidenceneededtoalertpractitionerstochangetheirpractice.Similarly,theNationalHealthService(NHS)intheUnitedKingdomgeneratesSignalreportsfromitsNationalReportingandLearningSystemtonotifytheorganizationofrisksidentifiedinreviewofreportedincidents.iInSeptember2011,areportwasissued,RiskofHarmfromAcupunctureTreatmentIncludingPneumothorax,identifying34incidentsofsevereormoderateharmfromacupuncture.29InthereportingperiodfromNovember2003toMarch2011,fiveincidentsofpneumothoraxwerereportedtotheNHS.29Whiletheseincidentswarrantreporting,theNHSreportingsystemfailstocapturethecontextfortheseeventsthatwouldallowidentificationandimplementationofviablesystem‐levelrecommendationsoractionstomitigatetheserisks.TheNationalReportingandLearningSystemattemptstocategorizetherangeofadverseoutcomes(i.e.,moderateorsevere),howeverthereisnodenominatorindicatingthetotalnumberoftreatments,andthusmetrics,suchastherateofadverseoutcomes,cannotbedetermined.Definitionsforthecategorizationofmoderateandseverewerenotprovidedinthe2011reporthowever,intheNationalFrameworkforReportingandLearningfromSeriousIncidents,publishedin2010,severeharmisdefinedasapatientsafetyincidentthatappearstohaveresultedinpermanentharmtooneormorepersonsreceivingNHS‐fundedcare.30
ProspectivesafetystudiesintheUnitedKingdomin2001wereamongthefirsttocaptureseverityandincidencedatarelatedtoacupuncture.TheSAFAstudyintheUnitedKingdomdefinedanadverseeventas“anyill‐effect,nomatterhowsmall,thatisunintendedandnontherapeutic”.18Thescopeofthisdefinitionallowedeventstobecapturedthatmighthavebeenexpectedinthecourseoftreatment,buthavenotherapeuticeffect;forexample,asmallbruisethatdevelopsafteraninjection.Thisisabroaderdefinitionofadverseeventsthanisrecognizedinmuchofthesafetyliterature,whereanadverseeventrelatestounanticipatedharmtoapatient.31Harmrefersto“animpairmentofstructureorfunctionofthebodyand/oranydeleteriouseffectarisingtherefrom”.32Inusingthisbroaderdefinition,theSAFAstudycapturedawiderangeofreportedeventsfrommild–whereresponsesmayhavebeentransientandinothersafetyliteraturewouldnotbecapturedasadverse–toeventsthatrequiredmedicalinterventionandevenhospitalization.18
WhilethefiveEuropeanstudiesidentifiedinTable2werespecificallydesignedtocapturetheincidenceofadverseevents,eachhasdesignlimitationsandvariablereportingformatsthatlimitcomparisonofresults.Wittetalanalyzedpatient‐reportedadverseevents,whiletheremainingfourauthorsusedpractitioner‐reportedevents.21TheSAFAstudybyWhiteetalaskedpractitionerstoreportpatient‐relatedminoradverseeventsineightpredefinedcategoriesandothersignificanteventsonaseparate
iPatientsafetyincidentsaredefinedasanyunintendedorunexpectedincidentwhichcouldhave,ordid,leadtoharmforoneormorepatientsreceivingNHS‐fundedhealthcareSource:NationalFrameworkforReportingandLearningfromSeriousIncidentsRequiringInvestigation.2010.Glossarypg.34
FINDINGS 6
form.18Melchartalsousedpredeterminedcategories,buttheywerenotthesameasthoseusedintheSAFAstudy.20MacPhersonusedstandardizedself‐reportformsbutitisunclearwhetherparticipantsreportedbasedonpredeterminedcategories.19BradymodifiedtheformusedintheSAFAstudyandrevisedthereportingcategories,makingtheminconsistentwithotherstudies.Whilethecommongoalofthesestudieswastofocusonsafety,themethodologyisvariableandthereforeanycomparisonofresultsmustbeviewedwithcaution.17
Withregardtoresearchmethodology,thestudiesdidnotattempttoverifythereliabilityorvalidityoftheresearchtool.Mosthadapilottestofusabilityonly.Melchartnotedthat“therealincidenceofminoradverseeffectsisdifficulttoassessbecauseofdifficultiesinestablishingasimplediscriminativedefinition”.20McDowelletalalsoidentifiedthelackofstandardizationoftermsinreportingnegativeoutcomesintheliteratureandthelimitationsthisplacescomparingtheresearchstudies.33Thislackofclarityindefinitionandthejudgmentinherentinself‐reportedresponsesisalimitationofthesestudies.
Types of adverse outcomes
PeukerandGrönemeyercompiledtheadverseeffectsresultingfromacupunctureidentifiedintheliteratureandgroupedthemintofivebroadcategories.34Thesecategoriesfocusedondelayedormisseddiagnosis,worseningofconditiontreated,vasovagalreactions(e.g.,fainting),infection,andtraumatotissueororgans.Thearticleidentifiestraumaticinjuriesoftissueandorganstoincludecardiactamponadeandpneumothorax,injuriestotheabdominalviscera,injuriestothecentralnervoussystem(spinalcord,spinalnerveroots,orperipheralnerves),andinjuriesrelatedtobloodvessels.Theauthorsnoted,thislistdoesnotreflecttheseverityorimpacttothepatient.34Whileotherliteratureidentifiesmanyoftheadverseoutcomes,nootherliteraturewasfoundtoverifyorvalidatethistypology.
Severity of adverse outcomes
Whiteetalcategorizedrisksassociatedwithacupunctureasmild,significant,orserioususingthefollowingdefinitions:18,35
Mild:Shortduration,reversible,doesnotinconveniencethepatient. Significant:Requiresmedicalinterventionorinterfereswiththepatient’sactivities. Serious:Requireshospitaladmissionwithpotentialpersistentorsignificantdisabilityordeath.
Table3identifiestheadverseoutcomesreportedineachofthefiveprospectivestudiesfromTable2andtheseverityusingthecategorizationdefinedbyWhiteetal.Twoofthefivestudiesreportedseriousadverseoutcomesandbothreportedpneumothoraxasoneoftheseadverseoutcomes.
FINDINGS 7
Table 3: Severity of adverse outcomes reported in five European studies
Prospective study # of treatments Minor Adverse Outcome
Significant Adverse Outcome
Serious Adverse Outcome
White et al 200118 31,822 (treatments) 2135 43 0
MacPherson et al 200119
34,407
(treatments) 10,920 43 0
Melchart et al 200420 760,000 treatments
(97,733 patients)
6,936
(Not categorized)
6
Includes 2 cases of pneumothorax
Witt et all 200921 2.2 million treatments
(229,230 patients) 19,726 patients
*4,963 patients
(Not categorized but included two cases of pneumothorax)
Brady et al 201317 7,629 (treatments) 1463 0 0
Total 3,033,858 treatments 4 cases of pneumothorax
*Author cited 4963 patients experienced adverse effects requiring treatment – page 92
Incidence of adverse outcomes
The nature of acupuncture or dry needling has made it difficult to capture the frequency of adverse outcomes. There are no standard definitions among practitioners to identify an adverse outcome and there is no single reporting mechanism or system to capture event data. From a reporting perspective, self-‐reports have an inherent reporting bias (over-‐ or under-‐ reporting). In some cases, the adverse outcome may take place after the treatment session so it may not be captured at all unless the practitioner is made aware of the diagnosis and medical intervention.
MacPherson and Hammerschlag report that case studies on adverse outcomes in acupuncture “can appear to exaggerate the risks” as they are reported without reference to a measure of incidence.13 The studies undertaken in Europe were the first attempts at quantifying the incidence by using a large sample size and by requiring respondents to report all adverse outcomes that fit the study definition of adverse. This definition included outcomes that were expected but not therapeutic, as well as those that were unexpected.18 Some of the results of these studies are reported in Table 4.
In the 2009 study, Witt et al attempted to quantify the incidence of adverse outcomes using the framework (frequency convention) of the European Commission (developed to identify the side effects of drugs) by using text categories from ‘very common’ to ‘very rare’.21 Pneumothorax was identified in this study as ‘very rare’ which was defined as less than one occurrence in 10,000 treatments.
FINDINGS 8
Table 4: Incidence of reported serious adverse outcomes in five European studies
Prospective study Serious adverse outcomes
Number of serious outcomes/total number of treatments
Rate per 10,000 treatments
Frequency (Using EU Commission Guidelines)
White et al 200118 None reported 0/31,822 -‐
MacPherson et al 200119 None reported 0/34,407 -‐
Melchart et al 200420
Pneumothorax (2) Exacerbation of depression (1) Acute hypertensive crisis (1) Vasovagal reaction (1) Acute asthma attack with angina
and hypertension (1)
6/760,000
Serious events = .08 Very rare
Pneumothorax alone = .03 Very rare
Witt et al 200921
4963 patients reported an adverse event requiring treatment but these were not categorizxed as ‘significant’ or ‘serious’ events. Two patients in this group experienced pneumothorax.
2/2,200,000
(only pneumothorax identified)
Pneumothorax alone = .001 Very rare
Brady et al 201317 None reported 0/7629 -‐
Total 4/3,033,858
Pneumothorax .01 Very rare
FINDINGS 9
Denominator for determining incidence
Focusingonpneumothoraxspecifically,theprobabilityofapatientdevelopingthisconditionispresentonlywhenneedlesareplacedintheneckorthorax.Forthisreason,theincidencedatareportedintheliteraturewouldhaveincreasedvalidityifthestudyresultsconsideredonlytreatmentswherepatientshadneedlesinsertedintheneckorthoraxasadenominator,ratherthancountingallacupuncturetreatments.Byincludingtreatmentswheretheprobabilityofpneumothoraxiszero,becauseneedlesarenotplacednearthehigh‐riskareas,thetrueincidenceofthisadverseoutcomeisdistorted.ThisissueisreflectedbyCummingsinhiscomment:1
Themostfrequentoftheserioustraumaticadverseeffectsispneumothorax,whichisestimated(fromprospectivestudies)tooccurbetween1:200,000(White2004)and1:1,000,000(Wittetal2009)treatmentsessions.Thedrawbackwiththeseestimatesisthattheyincludeallacupuncturesessions,andnotjustthosewheretherehasbeenneedlingoverthethorax.
Clinical presentation of pneumothorax
Pneumothoraxisthemostcommonseriousadverseoutcomefollowingdryneedling.Commonlyknownascollapsedlung,pneumothoraxisanabnormalcollectionofairinthespacebetweenthelungandthechestwall.Inasmallnumberofcases,thecollectionofairinthispleuralspacecanincreasetothepointwherethepatientdevelopsatensionpneumothoraxasaircontinuestobuildinthepleuralspaceandobstructsvenousreturntotheheart.Thisisalife‐threateningsituationrequiringimmediatemedicalintervention.36
Individuals,includingthosewithoutunderlyinglungdisease,canexperiencepneumothoraxspontaneouslyorasaresultofdirecttraumatothechest.Commoncausesareblunttrauma,suchasthatfromamotorvehicleaccident,orpunctureofthelungfromaribfracture.Asolidfilamentneedleenteringthelungtissueisalsosufficienttocauseapneumothorax.
Asapointofreference,pneumothoraxisaknowncomplicationofbronchoscopy,amedicalprocedurethatinvolvestheinsertionofascopeintothelungstoexaminetheairwayforabnormalities.Patientsaremonitoredcloselyforpneumothoraxaftertheprocedure,particularlywhentheprocedureincludeslungbiopsy.Thismonitoringcanincludeachestx‐rayorpleuralultrasoundtoidentifyapneumothoraxthatmayhavedeveloped.TheBritishThoracicSociety’s(BTS)guidelinesforradiologicallyguidedlungbiopsyreportsthat“pneumothoraxcomplicatesupto61%ofalllungbiopsies”andidentifiesthattheriskofpneumothoraxisrelatedtotheneedlepassingthroughtheaeratedlung.37Theguidelinesalsostatethat“delayedpneumothoraceshavebeenreportedmorethan24hoursafterbiopsy,despitetheabsenceofpneumothoraxonchestradiographstakenfourhoursafterbiopsy”.37
Clinicalpresentationofpneumothoraxvariesdependingonthetypeofpneumothoraxandtheextentofairinthepleuralspace.Patientsmaydescribeimmediatesymptomsatthetimethepneumothoraxstartstodevelop,orthesymptomsmaybedelayed,asisdescribedinthisexcerpt:“Youngandotherwisehealthypatientscantoleratethemainphysiologicconsequencesofadecreaseinvitalcapacityandpartialpressureofoxygenfairlywell,withminimalchangesinvitalsignsandsymptoms”.36Whileshortnessofbreathisoftenthoughtofasthefirstoronlysymptom,othersymptomsmayinclude
FINDINGS 10
anxiety,coughandchestpainincreasingwithinspiration.The2010BTSguidelinesstatethatthesymptomsofchestpainandshortnessofbreathmaybeminimalorabsent.38
Tensionpneumothoraxischaracterizedbymoreseveresymptoms.“Signsandsymptomsoftensionpneumothoraxareusuallymoreimpressivethanthoseseenwithasimplepneumothorax,andclinicalinterpretationoftheseiscrucialfordiagnosingandtreatingthecondition.Tensionpneumothoraxisclassicallycharacterizedbyhypotensionandhypoxia.”36
Medical management of pneumothorax
Ifapneumothoraxissuspected,thepatientrequiresurgentmedicalassessment.Confirmationbychestx‐rayisoftenusedtodeterminetheextentofthepneumothoraxandtoprovideabaselineforfuturemonitoring.Medicalmanagementisdeterminedbytheclinicalassessmentandmayrangefromconservativemanagementandclosemonitoringasanoutpatienttohospitaladmissionwithinsertionofachesttubetoremovetheairinthepleuralspace.
Clinical practice issues in dry needling related to pneumothorax
Knowledge of anatomy
Dryneedlingisaninvasiveprocedurethatpenetratestheskin,therefore,itiscriticalthatthepractitionerhasathoroughknowledgeofsurfaceanatomy,anatomicalanomalies,andtheunderlyingstructures.Needlinginthethoraxhasinherentrisksspecificallyrelatedtotheproximityofthelungs.PeukerandGrönemeyernotethat:“Pneumothoraxchieflyoccurswhentheneedlesareplacedinaparasternalorsupraclavicularsite;thelatterwithouttakingnoticethatthebordersofthepleuraandlungaresituatedwellabovetheclavicles.Acupuncturetotheparavertebral,infraclavicularandlateralthoracicregionsmayalsocausepneumothorax.”34
McCutcheonandYellanddescribeanomaliesassociatedwiththethoraxthatwouldwarrantcautionwhenneedlinginthisarea:15
Therearethreeareasinthethoraxwithcongenitalanomaliesofrelevancetoacupunctureanddryneedlingregions.Congenitalforaminaeintheinfraspinousfossaofthescapulawithdiametersupto2–5mmhavebeendescribedin0.8–5.4%ofindividuals.Suchforaminahavealsobeendescribedinthesupraspinousfossa.In5–8%ofindividuals,acongenitalforaminaexistsduetoincompleteossificationandfusionofthesternalplateswhichmostcommonlyoccuratthelevelofthefourthintercostalplate.Acongenitalsternalforamenisusuallynotabletobepalpatedduetooverlyingmuscletendonfibresandconnectivetissue.
PeukerandGrönemeyersuggestadverseoutcomessuchaspneumothorax“maybereducedbyincreasedawarenessofnormalanatomyandanatomicalvariations”.34Theyalsosuggestthattomitigatethisrisk,effectivetraininginanatomybeapriorityfordryneedlingeducatorsandregulators.Bradyreinforcesthisperspectiveonanatomyknowledge:“Theriskofpneumothoraxissmallifproperconsiderationofpracticalanatomyandapplicationofneedlingtechniquesareemployed.Considerationofpleuralandlunganatomyisessentialandcliniciansshouldremainawareofanatomicallandmarks”.1
Practitionersandeducatorsinterviewedverifiedtheinclusionofanatomyofthethoraxandanatomicallandmarkingindryneedlingcourses.Someidentifiedthevalueofusinganatomylabsparticularlyto
FINDINGS 11
presenthigh‐riskareasanddemonstratetheproximityoftheneedletounderlyingstructures.Itwasdescribedasa“powerfulwaytogetpeopletounderstandhigh‐riskareas”.Somecommentedthatalthoughtheconceptofriskandadverseoutcomesispresentedineducationcourses,studentsarenotfullycomprehendingthatinformation.Onepractitionernoted,“Ididn’trealizethegravityofthesituationatthetimeItookthecourse.”
Needling technique
Boththeliteratureandinformationgatheredfrominterviewswithneedlingexpertspresentsarangeofstrategiestomitigatetherisksofneedlinginthethorax.ThefollowingexampleisexcerptedfromtheIrishSocietyofCharteredPhysiotherapistsdryneedlingguidelines:39
Knowledgeofpleurallunganatomyisessentialforsafedryneedlingprocedurewhentreatinginthethoracicarea[…].Whereappropriate,DN[dryneedling]shouldbeperformedinsuchamannerastoneedleawayfromthepleura/lungincludingtheapexofthelung,intercostalspaceandinfracostalareatoavoidtheriskofpleuralpenetration.Whereable,apincergripshouldbeutilised,forexample,asinthecaseoftheuppertrapezius,orneedlingoverbonetoprotectthelungasinthecaseofthescapulaandribswhenappropriate.Itisimportanttopointoutthatscapulafenestrationispossible,thoughrare,andCharteredPhysiotherapistsshouldbeawarethatanatomicalvariancecanoccur.Againtheriskofapneumothoraxisverysmall(veryrare)ifproperneedlingtechniquesareemployed.
TheAustralianGuidelinesforSafeAcupunctureandDryNeedlingPractice40includesimilartexttotheIrishguidelinesonthetopicofneedlingtechniques:
Thefollowingareusefulpointswhichareclosetovulnerablestructuresandsorequireextracautionandspecifictrainingisrequired.
GB21(trapezius),BL11,LU1andanyotherpointinthethoraxduetotherelativeriskofpneumothorax.Needlinginthisregionshouldbeshallowand/orawayfromlungtissueand/oroverboneorcartilage.
Superiorlythelungfieldextends2‐3cmaboveclavicularline,henceGB21beingmostfrequentpointassociatedwithpneumothorax–(sufficientminimumtrainingisrequiredtoneedlethispoint).39
The2013textbookTriggerPointDryNeedling,AnEvidenceandClinical‐BasedApproachalsodescribesspecificneedlingtechniquesandprecautionsforneedlingeachmuscleinthetrunktoprevent“penetrationofthelung,creatingapneumothorax”.1Theseandotherreferencesdemonstratecommonrecognitionoftherisksofneedlinginthethoraxandthatviablestrategiesexistforthepractitionertomitigatetheserisks.
Identification and management of pneumothorax following needling
Knowledge of signs and symptoms of pneumothorax
McCutcheonandYellanddescribethat“agoodworkingknowledgeoftheclinicalfeaturesofpneumothoraxisvitalto…healthpractitionerspracticingacupunctureordryneedlinginandaroundthethoracicregion”.15Whilepractitionersandeducatorswhowereinterviewedwereveryfamiliarwith
FINDINGS 12
pneumothoraxasanadverseoutcomeofdryneedling,onlyafewcoulddescribethesignsandsymptomsbeyondshortnessofbreath.Similarly,onlyafewmentionedpainasasymptomortheconceptofdelayedonsetofsymptoms.Oneeducatorwhohaddirectexperiencewiththisadverseoutcomestatedthatthereisanassumptionthatdryneedlingstudentsknowhowtoidentifypneumothoraxfromtheirprofessionaltraining,butthisisoftennotthecase.Itwassuggestedthatmoreemphasisisneededonrecognizingthesigns,symptoms,andvariabilityinclinicalpresentationfromthatdescribedinatextbook.Anothereducatorfeltthatdryneedlingstudentsarebeingtaughttheinformationbutthey“arenothearingit”.
WhilepainhasbeenreportedintheEuropeanstudies(Table3)asanadverseoutcomeofdryneedling,itwasmostoftenidentifiedasminor;thatis,transientsymptomsthatdonotinterferewiththepatient’sactivities.Onoccasion,needlingcantemporarilyaggravatetheoriginalpainorcausepost‐treatmentsoreness.1IMSparticularlymaycausepainrelatedtothelocaltwitchresponse(ormusclecramp)elicitedbytheneedleinsertedintothetriggerpoint.Therefore,itiscriticaltobeabletodiscernpainrelatedtotheneedlingprocedurefrompainassociatedwithpenetrationofthepleuraandpossiblepneumothorax.Painassociatedwithpunctureofthepleuraisdescribedasintense,sharp,andradiatingintotheshoulderandneckandoccasionallytothescapula.ThisisdiscussedinDeepdryneedlingoftheshouldermusclesbyC.Bron,J.FranssenandB.Beersma,whonote:“insertionoftheneedlethroughthechestwallandintothelungcanbemorepainfulthandryneedling”.41
Management of adverse outcomes
Allofthepractitionersinterviewedindicatedthatifapneumothoraxwassuspectedfollowingneedling,thepatientwouldrequiremedicalassessmentandpossiblyanx‐ray.Thetimeframeidentifiedtoprovidethatinterventionwasvariable,rangingfromhavingthepatientcomebacktotheclinicforassessmentbythepractitioner,directingthepatienttogotheemergencydepartment,tocalling911foranambulanceandtransfertotheemergencydepartment.Amongthosepractitionerswhoindicatedtheyhadinstructedpatientstocallbacktothecliniciftheyhadconcernsorexperiencedsymptomsthathadbeendescribedtotheminthetreatmentsession,thereviewteamdidnotpursuethestrategiesthatmightbeprovidedtothepatientorthecriteriausedtoselectaparticularstrategytomanagethepatient’ssymptoms.
Informed consent
Patients’informedconsenttoatreatmentthathasinherentriskiscommonlyconsideredanimperativetosafehealthcare.Whenquestionedastohowriskswerepresentedintheirinformedconsentprocess,practitonerswhowereinterviewedpresentedavarietyofresponses.Someindicatedthattheyonlypresentadverseoutcomessuchasvaso‐vagalresponses,butnotpneumothorax.Othersstatedtheydiscussallrisks,includingpneumothorax.Oneexpertstatedthatthepractitionerhastodeterminewhatismaterialforeachpatient,howeverthisexpert’spracticementionspneumothoraxasariskofdryneedlingtoallpatients.Severalpractitionersinterviewedspokeofthebalanceinvolvedindescribingtherisksofthetreatmentintheprocessofprovidinginformedconsent.Whileitwasrecognizedthatpatientsmustbeinformedaboutthoserisks,itwasacknowledgedthatindividualjudgmentwasoftenusedindetermininghowthoseriskswouldbepresented.Theydescribeda‘balance’betweenpotentiallyfrighteningthepatientinpresentingtherangeofpotentialrisksandprovidingassurancethatthetreatmentwouldnotcauseharm.ThissameissueisdescribedbyWhiteetalintheirworktodevelopconsensusabouttheinformationthatshouldbepresentedtopatientsonrisksofacupuncture.42Whilethearticlestatesthatwhatisappropriateinformationisamatterofjudgment,thereisabalance
FINDINGS 13
betweendevelopingatherapeuticrelationshipandensuringthattheethicalandlegalrequirementsforinformedconsentaremet.
Education/training for dry needling
Dryneedlingcoursesforhealthcareprofessionalsareoftenofshorterdurationthanthetrainingrequiredforacupuncturistsbecausethesecoursesbuildontheformaltrainingofeachprofession.Currentlytherearenonationalorinternationalstandardsfordryneedlingeducation/trainingforhealthcareprofessionalsforanydryneedlingapproach.In2011,theAustralianPhysiotherapyCouncilcommissionedtheAcupunctureAccreditationStandardsProject“todevelopanaccreditationstandardtobeusedtoassesswhetheraprogramofstudy,andtheeducationproviderthatprovidestheprogramofstudy,providepersonswhocompletetheprogramofstudywiththeknowledge,skillsandprofessionalattributestopracticeacupuncture”.43Theprojectconcludedthat“theleveloftrainingandeducationvariedconsiderably”andthattherewas“minimalevidenceoftheefficacyofthattraining”.43NosimilarworkhasbeendoneinCanadaalthoughtheAcupunctureFoundationofCanadaInstitute(AFCI),asofSeptember2013,increasedtheirtrainingrequirementsbyintroducinganew200‐hourcoreprogram.44
ThemostrecentIrishGuidelines(2012)39andtheAustralianGuidelines(2013)40bothcite,despitethelackofinternationalstandards,thattherequirementforanytrainingindryneedlingistodevelopcompetencyrequiredforsafepractice.Theydonotidentifyminimumtraininghoursorcontent.
Althoughspecificeducationcurriculawerenotreviewed,thoseinterviewedidentifiedthatthereisinsufficientinformationabouttheprobabilityofadverseoutcomesinthecurrenteducationprograms.Intheirview,thereappearstobemoreemphasisontheriskofinfection,andtheinformationspecifictopneumothoraxisfocusedonthepreventionofpneumothoraxwithmuchlessemphasisonrecognizingthesigns,symptoms,andmanagementofthepatient,shoulditoccur.
Maintenance of authorization and continuing competence
UnderAlberta’sHPAthereisamandatoryrequirementforhealthcareprofessionalstoparticipateincontinuingcompetenceactivitiesidentifiedbytheirprofession.9Currently,forthosewhoareauthorizedtopracticedryneedling,thereisnospecificcontinuingcompetencyrequirementrelatedtodryneedling.
CONCLUSION 14
CONCLUSION
ThisreviewidentifiedfourissuesrelatedtodryneedlingpracticeinAlberta,thatifaddressed,wouldcontributetotheimprovementofthequalityandsafetyofdryneedling.
Information for patients
Theinformationavailabletopatientsandthepublicaboutpotentialadverseoutcomesofdryneedlingishighlyvariable.Examplesweregatheredofprintedmaterialsandonlineinformationaboutdryneedlingintendedforpatientsandthepublic.Thecontentoftheinformationvariedconsiderably,withsomesourcesstatingthatdryneedlingissafeandvirtuallywithoutcomplication,whileothermaterialsdescribedarangeofpossibleadverseoutcomes,includingpneumothorax.Practitionersinterviewedalsoidentifiedvariabilityintheinformationprovidedtotheirpatients.
Incompleteorbiasedinformationontheoutcomesofdryneedlinglimitsthepatient’sabilitytomakeafullyinformeddecisionabouttreatment.Professionalcollegesshouldconsiderhowtheycanbestensurethatpractitionersprovidecomplete,unbiasedandrelevantinformationaboutdryneedlingtopatientsincludingtheprobabilityandseverityofpotentialadverseoutcomes.
Continuing competence requirements for dry needling
UndertheHPA,professionalcollegesmustidentifycontinuingcompetencyrequirementsfortheprofession.Whiletheserequirementsareinplaceforgeneralpractice,therearenospecificrequirementsformemberstodemonstratecontinuingcompetencyinspecificareasofpracticesuchasdryneedling.
Someregulatorycollegesinotherprovinceshaveputadditionalstepsinplacetofocusoncontinuingcompetencyindryneedling.Forexample,theCollegeofPhysiotherapistsofManitobastipulatesthatphysiotherapistsaretocontinuedevelopingtheirknowledgeandskillindryneedlingthrougheducationcoursesandconferencesaswellasreviewingrelevantliterature.45Outsideofdryneedlingpractice,anexampleofaprofessionalcollegethathasadoptedreportingrequirementstoensurecurrencyinanauthorizedskillistheAlbertaCollegeofPharmacists.Pharmacistsarerequiredtodeclareactivitiestheyhaveundertakentomaintainboththeirclinicalandtechnicalcompetenceforadministeringinjectionsaspartoftheirannualregistration.Furthermore,“pharmacistswhoareunabletosigntheprofessionaldeclarationbecausetheyhavenotmaintainedthecompetenceandproficiencyorhavenotadministeredinjectionswithinthepastthreeyearsmustre‐qualifyfortheauthorizationtoadministerdrugsbyinjectionbycompletinganaccreditedtrainingprogram”.46Professionalcollegesshouldconsiderspecificrequirementstomaintainauthorizationfordryneedling,includingaprocesstoassessapractitioner’sabilitytorecognizeandmanageadverseoutcomesassociatedwithdryneedling.
Safety-related topics in dry needling education
Educatorsindryneedlingwhowereinterviewednotedthatsafetytopics,suchasadverseoutcomes,werecoveredintheireducationcourses.Theystatedthatwhilepneumothoraxwasidentifiedasanadverseoutcome,limitedemphasiswasplacedonidentificationandmedicalmanagementofpneumothorax.ProfessionalcollegessuchastheCollegeofPhysicalTherapistsofAlbertahaveapracticestandardforrestrictedactivitiesthatrequirespractitionerstohave“aplaninplacetomanageanycriticalorunexpectedeventsincludingadverseeventsassociatedwithrestrictedactivities”.47Professionalcollegesshouldconsiderexpandingtheircriteriatoassessdryneedlingeducation
CONCLUSION 15
programstoincludespecificsafetyinformation,suchasrecognitionandmanagementofanadverseoutcomeandspecificallythosecircumstanceswhenthepatientrequiresmedicalassessment.
Reporting patient-related serious adverse outcomes
Standardizedprocessesforhealthcareprofessionalspracticingdryneedlingshouldbeinplacetoreportpatient‐relatedseriousadverseoutcomesfromdryneedling.Thiswouldsupportbettercollectionofdatatoenablecollegestoupdatestandardsofpracticeandsharethisknowledgeforthepurposeofsafetylearning.SincethereiscurrentlynoprocesstocaptureseriousadverseoutcomesfromdryneedlinginAlberta,orelsewhere,thereisanopportunitytodevelopsuchaprocessforthepurposeofcontinuouslearningandimprovementandultimatelysafercareforpatients.
APPENDIX 16
APPENDIX
APPENDIX I: PRESENTATION OF PNEUMOTHORAX 17
Appendix I: Presentation of pneumothorax
Irish Guidelines
GuidelinesforDryNeedlingPractice(2012),IrishSocietyofCharteredPhysiotherapists(ISCP),Dublin,Ireland.39(p30)
Pneumothorax
Whenneedlingaroundthethoracicregionpatientsshouldbewarnedoftherarepossibilityofapneumothoraxashasbeenoutlinedintheprecautionssectionunderanatomicalconsiderations.Thesymptomsandsignsofapneumothoraxmayinclude:
1. Shortnessofbreathonexertion
2. Chestpain
3. Drycough
4. Decreasedbreathsoundsonauscultation
Thesesymptomsmaynotoccuruntilseveralhoursafterthetreatmentandpatientsneedtobecautionedofthisspeciallyiftheyaregoingtobeexposedtoexerciseandmarkedalterationsinaltitudesuchasflyingorscubadiving.Ifapneumothoraxissuspectedthenthepatientmustbesenturgentlytothenearestaccidentandemergencydepartment(A+E).
Australian Guidelines
GuidelinesforSafeAcupunctureandDryNeedlingPractice(2013),AustralianSocietyofAcupuncturePhysiotherapists.40(p18)
Pneumothorax
Whenneedlingaroundthethoracicregionpatientsshouldbewarnedoftherarepossibilityofapneumothorax.CareshouldbetakenwhenneedlingGB21(uppertrapezius)andanyotherpointsoverthethoracicregionwhichcouldinadvertentlycreateapneumothorax.Wherepossibleangletheneedleawayfromtheunderlyinglungsand/orneedleoverboneorcartilaginoustissue.Practitionersmusthaveattendedadequatetrainingprogramstoneedleinthethoracicregion.Thesymptomsandsignsofapneumothoraxmayincludeshortnessofbreathonexertion,chestpain,drycough,anddecreasedbreathsoundsonauscultation.Suchsymptomswillcommonlyoccurwhenthepatientiswalkingawayfromtheclinic.Thesesymptomsmaynotoccuruntilseveralhoursafterthetreatmentandpatientsneedtobecautionedofthisespeciallyiftheyaregoingtobeexposedtomarkedalterationsinaltitudesuchasflyingorscubadiving.Ifapneumothoraxissuspectedthenthepatientmustbesenturgentlyforanx‐rayandmedicalmanagement.
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