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Percutaneous electrical nerve s/mula/on (PENS) therapy In PENS, one or more individual nerves or dermatomes are s5mulated using needle probes. A single probe with a grounding pad or pairs of fine-gauge needles are inserted into the subcutaneous plane near the targeted nerves or into the affected dermatomes. The needles are connected to a low-voltage pulse generator and an electrical current is then applied. This may generate a sensa5on of paraesthesia and muscle contrac5on (due to alterna5ng low and high frequency s5mula5on). The dura5on of treatment varies but each session of s5mula5on typically lasts between 15-60 minutes. Randomised controlled trials (RCTs) have shown that PENS may be effec5ve in chronic pain condi5ons such as scia5ca, and diabe5c neuropathic pain. Key efficacy outcomes in these trials include reduc5on in pain (allevia5on of localised neuropathic pain, relief of allodynia and hyperpathia, reduc5on in the frequency of sharp shoo5ng pains, reduc5on in the burning sensa5on), and associated func5onal and emo5onal improvements. PENS is generally safe and well tolerated. Reports exist of exacerba5on of pain, bruising and bleeding as immediate adverse events. Theore5cal adverse events include local vascular or nerve damage; pneumothorax; possible interac5on with a cardiac pacemaker if used above the waistline; possible epileptogenic effect if used near the head; and possible adverse effects if used in pregnancy. No published reports exist of any of these theore5cal problems actually arising, however. Neuromodula/on for headache disorders Headache disorders are the most common form of neurological disability on a global basis, and the sixth most common cause of disability worldwide. The cumula5ve life5me incidence of migraine approaches 50 % in females; the 1 year prevalence for cluster headache, for which there is no cumula5ve data, is about 0.1 % of the popula5on; approximately 2% of the popula5on in developed countries have chronic daily headaches. The medical treatment of pa5ents with primary and secondary headache syndromes can be very challenging as serious side effects frequently complicate the course of medical treatments, and some pa5ents prove refractory to numerous and varied medica5ons. The last 10-15 years has seen the expansion of an new branch of headache treatment: neuromodula5on. This group of techniques comprises non-invasive treatments which, by targe5ng the central or peripheral nervous system, aim at modifying pain and other mechanisms involved in headache, and more invasive surgical approaches directed towards structures directly involved in the genesis of specific headache syndromes. The fact that these approaches lack the side effects and drug interac5ons common to medical therapies make them aVrac5ve choices for many pa5ents. The principle of these approaches is to modulate the func5on of neuronal structures that are directly or indirectly involved in detec5on or transmission of painful s5muli, or in the processing of this informa5on in the brain. Neuromodula5on of headache disorders has been achieved by direct modula5on of brain structures involved in the genera5on of aVacks (deep brain s5mula5on of the hypothalamus in cluster headache, for example), modula5on of inhibitory an5nocicep5ve pathways (occipital nerve s5mula5on), modula5on of cor5cal excitability (transcranial magne5c and direct current s5mula5on), and direct inhibitory effects at the level of the peripheral neuron or the spinal cord (TENS). High quality randomised controlled trials are few and far between, however, and further controlled studies to validate, strengthen and disseminate the use of neuromodula5on for headache disorders are needed. In addi5on, new techniques with proven safety and efficacy in other pain disorders, such as PENS therapy, should be trialled in headache disorders. PATIENT # AGE SEX YRS CH YRS CCH # PENS Rx PREVIOUS PREVENTIVE TREATMENTS BEST RESPONSE TO GONB RESPONSE TO 1 st PENS Rx SUBSEQUENT COURSE OUTCOME 1 32 F 13 3 7 VER, TOP, LI, MEL, SVP, MTH, VNS 2-3 wks, itching & localised alopecia 6 wks pain free Up to 3 mths pain free Ongoing PENS therapy & GONB 2 39 M 4 3 2 VER, TOP, LI, MTH, PIZ 3-4 days 4 wks pain free Only 3 days pain free Referred for ONS 3 45 F 22 3 1 VER, TOP N/A Unhelpful N/A Ongoing medical treatment 4 49 M 9 9 1 VER, TOP, LI, MEL, DHE, INDO 3-4 days 4 days reduced severity N/A Ongoing medical treatment 5 42 F 2 1 8 VER, TOP, LI, MEL, MTH, INDO Up to 5 wks, but less effec/ve over /me 5 days pain free Up to 2 mths pain free Reverted to episodic CH 6 63 M 7 5 3 VER, TOP 3-4 days 6 wks pain free Up to 3 mths pain free Ongoing PENS therapy 7 33 F 6 6 4 VER, TOP, LI, MEL, MTH, PRG, AMI, INDO, VNS 3-4 days, painful 6 wks pain free 6-8 wks pain free Ongoing PENS therapy & referred for ONS 8 32 F 1 1 2 VER, TOP, LI, INDO Unhelpful 6 mths reduced severity 3 mths pain free Ongoing PENS therapy 9 29 M 12 12 1 VER, TOP, LI 3-4 days 6 mths reduced severity N/A (declined further PENS Rx) Ongoing medical treatment Response to PENS therapy in chronic cluster headache Dr Mark W Weatherall & Mr Dipankar Nandi Departments of Neurology & Neurosurgery, Charing Cross Hospital, Imperial College NHS Healthcare, London, UK PERCUTANEOUS ELECTRICAL NERVE STIMULATION (PENS) THERAPY FOR REFRACTORY PRIMARY HEADACHE DISORDERS Methods Our aim was to demonstrate whether percutaneous electrical nerve s5mula5on (PENS) therapy has a role to play in the management of refractory headache disorders. A retrospec5ve review of the records of 36 pa5ents who have been treated with supraorbital or occipital PENS therapy at our centre between September 2012 and June 2016 was undertaken. Follow-up data was available for 33 pa5ents. Of these, 26 had a primary headache diagnosis, of whom 14 had chronic migraine (CM), 9 had chronic cluster headache (CCH), 2 had new daily persistent headache (with migrainous features), and one had hemicrania con/nua. The secondary headaches comprised occipital neuralgia, cervicogenic headache, and trigeminal neuropathy. Technical details PENS was given using Algotec® disposable 21 gauge PENS therapy probes (50mm ) to the occipital nerve ipsilateral to the pain (or bilaterally in cases of bilateral pain). In some cases supraorbital PENS was tried on a second or subsequent occasion if the pa5ent had failed to respond to occipital s5mula5on. S5mula5on was delivered at 2 Hz/100 Hz, at 3 cycles/ second, between 1.2-2.5 V depending on pa5ent tolerability, for 25-28 minutes. No immediate complica5ons were recorded during s5mula5on, apart from one pa5ent who experienced pain during s5mula5on, and in most cases the trea5ng neurosurgeon (DN) recorded good coverage and radia5on of effect during s5mula5on. Results Six out of the nine pa5ents with CCH improved significantly (see the table below); these pa5ents had previously failed to respond to between two and eight oral preven5ve medica5ons, and had at best experienced temporary benefit from nerve blocks with local anaesthe5c agents. In all pa5ents with CCH, PENS therapy was well tolerated, with no significant adverse events reported. One pa5ent with CCH reverted to the episodic form of the disorder; this improvement has been maintained for more than two years following the cessa5on of therapy. Only three of the pa5ents with CM experienced any no5ceable benefit with PENS therapy; one pa5ent with CM experienced pain during s5mula5on, two pa5ents with CM experienced severe neck pain, and three pa5ents with CM experienced an exacerba5on of their condi5on las5ng days to weeks. These adverse effects are possibly due to the presence of significant allodynia, not improved by PENS therapy. Conclusion PENS therapy shows great poten5al as a rela5vely non-invasive, low-risk, and inexpensive component of the treatment op5ons for refractory primary headache disorders, par5cularly chronic cluster headache. Further trials of the technique in this debilita5ng condi5on are warranted. Acknowledgements The authors are grateful for the assistance of the nursing staff of Ward 10N, Charing Cross Hospital, in delivering PENS therapy to our pa5ents, and to Coral Winslow-Llewellyn and Susan Daniels of Algotec® for their support. CH: cluster headache; CCH: chronic cluster headache; VER: verapamil; TOP: topiramate; LI: lithium; MEL: melatonin; SVP: sodium valproate; MTH: methysergide (no longer available); VNS: vagal nerve s5mula5on (non-invasive); PIZ: pizo5fen; DHE: dihydroergotamine (IV infusion); PRG: pregabalin; AMI: amitriptyline; INDO: indomethacin; GONB: occipital nerve blockade (with Depo Medrone & lidocaine); ONS: occipital nerve s5mula5on.

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Page 1: PERCUTANEOUS ELECTRICAL NERVE STIMULATION (PENS) … · PENS was given using Algotec® disposable 21 gauge PENS therapy probes (50mm ) to the occipital nerve ipsilateral to the pain

Percutaneouselectricalnerves/mula/on(PENS)therapy

InPENS,oneormoreindividualnervesordermatomesares5mulatedusingneedleprobes.Asingleprobewithagroundingpadorpairsoffine-gaugeneedlesareinsertedintothesubcutaneousplanenearthetargetednervesorintotheaffecteddermatomes.Theneedlesareconnectedtoalow-voltagepulsegeneratorandanelectricalcurrentisthenapplied.Thismaygenerateasensa5onofparaesthesiaandmusclecontrac5on(duetoalterna5nglowandhighfrequencys5mula5on).Thedura5onoftreatmentvariesbuteachsessionofs5mula5ontypicallylastsbetween15-60minutes.

Randomisedcontrolledtrials(RCTs)haveshownthatPENSmaybeeffec5veinchronicpaincondi5onssuchasscia5ca,anddiabe5cneuropathicpain.Keyefficacyoutcomesinthesetrialsincludereduc5oninpain(allevia5onoflocalisedneuropathicpain,reliefofallodyniaandhyperpathia,reduc5oninthefrequencyofsharpshoo5ngpains,reduc5onintheburningsensa5on),andassociatedfunc5onalandemo5onalimprovements.

PENSisgenerallysafeandwelltolerated.Reportsexistofexacerba5onofpain,bruisingandbleedingasimmediateadverseevents.Theore5caladverseeventsincludelocalvascularornervedamage;pneumothorax;possibleinterac5onwithacardiacpacemakerifusedabovethewaistline;possibleepileptogeniceffectifusednearthehead;andpossibleadverseeffectsifusedinpregnancy.Nopublishedreportsexistofanyofthesetheore5calproblemsactuallyarising,however.

Neuromodula/onforheadachedisorders

Headachedisordersarethemostcommonformofneurologicaldisabilityonaglobalbasis,andthesixthmostcommoncauseofdisabilityworldwide.Thecumula5velife5meincidenceofmigraineapproaches50%infemales;the1yearprevalenceforclusterheadache,forwhichthereisnocumula5vedata,isabout0.1%ofthepopula5on;approximately2%ofthepopula5onindevelopedcountrieshavechronicdailyheadaches.Themedicaltreatmentofpa5entswithprimaryandsecondaryheadachesyndromescanbeverychallengingasserioussideeffectsfrequentlycomplicatethecourseofmedicaltreatments,andsomepa5entsproverefractorytonumerousandvariedmedica5ons.

Thelast10-15yearshasseentheexpansionofannewbranchofheadachetreatment:neuromodula5on.Thisgroupoftechniquescomprisesnon-invasivetreatmentswhich,bytarge5ngthecentralorperipheralnervoussystem,aimatmodifyingpainandothermechanismsinvolvedinheadache,andmoreinvasivesurgicalapproachesdirectedtowardsstructuresdirectlyinvolvedinthegenesisofspecificheadachesyndromes.Thefactthattheseapproacheslackthesideeffectsanddruginterac5onscommontomedicaltherapiesmakethemaVrac5vechoicesformanypa5ents.

Theprincipleoftheseapproachesistomodulatethefunc5onofneuronalstructuresthataredirectlyorindirectlyinvolvedindetec5onortransmissionofpainfuls5muli,orintheprocessingofthisinforma5oninthebrain.Neuromodula5onofheadachedisordershasbeenachievedbydirectmodula5onofbrainstructuresinvolvedinthegenera5onofaVacks(deepbrains5mula5onofthehypothalamusinclusterheadache,forexample),modula5onofinhibitoryan5nocicep5vepathways(occipitalnerves5mula5on),modula5onofcor5calexcitability(transcranialmagne5canddirectcurrents5mula5on),anddirectinhibitoryeffectsattheleveloftheperipheralneuronorthespinalcord(TENS).Highqualityrandomisedcontrolledtrialsarefewandfarbetween,however,andfurthercontrolledstudiestovalidate,strengthenanddisseminatetheuseofneuromodula5onforheadachedisordersareneeded.Inaddi5on,newtechniqueswithprovensafetyandefficacyinotherpaindisorders,suchasPENStherapy,shouldbetrialledinheadachedisorders.

PATIENT# AGE SEX YRSCH YRSCCH #PENSRxPREVIOUSPREVENTIVETREATMENTS BESTRESPONSETOGONB RESPONSETO1stPENSRx SUBSEQUENTCOURSE OUTCOME

1 32 F 13 3 7 VER,TOP,LI,MEL,SVP,MTH,VNS 2-3wks,itching&localisedalopecia 6wkspainfree Upto3mthspainfree OngoingPENStherapy&GONB

2 39 M 4 3 2 VER,TOP,LI,MTH,PIZ 3-4days 4wkspainfree Only3dayspainfree ReferredforONS

3 45 F 22 3 1 VER,TOP N/A Unhelpful N/A Ongoingmedicaltreatment

4 49 M 9 9 1 VER,TOP,LI,MEL,DHE,INDO 3-4days 4daysreducedseverity N/A Ongoingmedicaltreatment

5 42 F 2 1 8 VER,TOP,LI,MEL,MTH,INDO Upto5wks,butlesseffec/veover/me 5dayspainfree Upto2mthspainfree RevertedtoepisodicCH

6 63 M 7 5 3 VER,TOP 3-4days 6wkspainfree Upto3mthspainfree OngoingPENStherapy

7 33 F 6 6 4 VER,TOP,LI,MEL,MTH,PRG,AMI,INDO,VNS 3-4days,painful 6wkspainfree 6-8wkspainfree OngoingPENStherapy&referredforONS

8 32 F 1 1 2 VER,TOP,LI,INDO Unhelpful 6mthsreducedseverity 3mthspainfree OngoingPENStherapy

9 29 M 12 12 1 VER,TOP,LI 3-4days 6mthsreducedseverity N/A(declinedfurtherPENSRx) Ongoingmedicaltreatment

ResponsetoPENStherapyinchronicclusterheadache

DrMarkWWeatherall&MrDipankarNandiDepartmentsofNeurology&Neurosurgery,CharingCrossHospital,ImperialCollegeNHSHealthcare,London,UK

PERCUTANEOUSELECTRICALNERVESTIMULATION(PENS)THERAPYFOR

REFRACTORYPRIMARYHEADACHEDISORDERS

MethodsOuraimwastodemonstratewhetherpercutaneouselectricalnerves5mula5on(PENS)therapyhasaroletoplayinthemanagementofrefractoryheadachedisorders.Aretrospec5vereviewoftherecordsof36pa5entswhohavebeentreatedwithsupraorbitaloroccipitalPENStherapyatourcentrebetweenSeptember2012andJune2016wasundertaken.Follow-updatawasavailablefor33pa5ents.Ofthese,26hadaprimaryheadachediagnosis,ofwhom14hadchronicmigraine(CM),9hadchronicclusterheadache(CCH),2hadnewdailypersistentheadache(withmigrainousfeatures),andonehadhemicraniacon/nua.Thesecondaryheadachescomprisedoccipitalneuralgia,cervicogenicheadache,andtrigeminalneuropathy.

Technicaldetails

PENSwasgivenusingAlgotec®disposable21gaugePENStherapyprobes(50mm)totheoccipitalnerveipsilateraltothepain(orbilaterallyincasesofbilateralpain).InsomecasessupraorbitalPENSwastriedonasecondorsubsequentoccasionifthepa5enthadfailedtorespondtooccipitals5mula5on.S5mula5onwasdeliveredat2Hz/100Hz,at3cycles/second,between1.2-2.5Vdependingonpa5enttolerability,for25-28minutes.Noimmediatecomplica5onswererecordeddurings5mula5on,apartfromonepa5entwhoexperiencedpaindurings5mula5on,andinmostcasesthetrea5ngneurosurgeon(DN)recordedgoodcoverageandradia5onofeffectdurings5mula5on.

Results

Sixoutoftheninepa5entswithCCHimprovedsignificantly(seethetablebelow);thesepa5entshadpreviouslyfailedtorespondtobetweentwoandeightoralpreven5vemedica5ons,andhadatbestexperiencedtemporarybenefitfromnerveblockswithlocalanaesthe5cagents.Inallpa5entswithCCH,PENStherapywaswelltolerated,withnosignificantadverseeventsreported.Onepa5entwithCCHrevertedtotheepisodicformofthedisorder;thisimprovementhasbeenmaintainedformorethantwoyearsfollowingthecessa5onoftherapy.Onlythreeofthepa5entswithCMexperiencedanyno5ceablebenefitwithPENStherapy;onepa5entwithCMexperiencedpaindurings5mula5on,twopa5entswithCMexperiencedsevereneckpain,andthreepa5entswithCMexperiencedanexacerba5onoftheircondi5onlas5ngdaystoweeks.Theseadverseeffectsarepossiblyduetothepresenceofsignificantallodynia,notimprovedbyPENStherapy.

Conclusion

PENStherapyshowsgreatpoten5alasarela5velynon-invasive,low-risk,andinexpensivecomponentofthetreatmentop5onsforrefractoryprimaryheadachedisorders,par5cularlychronicclusterheadache.Furthertrialsofthetechniqueinthisdebilita5ngcondi5onarewarranted.

Acknowledgements

TheauthorsaregratefulfortheassistanceofthenursingstaffofWard10N,CharingCrossHospital,indeliveringPENStherapytoourpa5ents,andtoCoralWinslow-LlewellynandSusanDanielsofAlgotec®fortheirsupport.

CH:clusterheadache;CCH:chronicclusterheadache;VER:verapamil;TOP:topiramate;LI:lithium;MEL:melatonin;SVP:sodiumvalproate;MTH:methysergide(nolongeravailable);VNS:vagalnerves5mula5on(non-invasive);PIZ:pizo5fen;DHE:dihydroergotamine(IVinfusion);PRG:pregabalin;AMI:amitriptyline;INDO:indomethacin;GONB:occipitalnerveblockade(withDepoMedrone&lidocaine);ONS:occipitalnerves5mula5on.

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