Title:Vertebralaxialdecompression(VAX-D)therapyforchroniclowbackpain- April2001

Agency:MedicareServicesAdvisoryCommittee(MSAC) CommonwealthDepartmentofHealthandAgeing GPOBox9848CanberraACT2601Australia

Reference:MSACApplicationnumber1012. AssessmentreportISSN1443-7120

Aim:

Toassessthesafetyandeffectivenessofvertebralaxialdecompression(VAX-D)therapyandunderwhat

circumstancespublicfundingshouldbesupportedforthisservice.

Conclusionsandresults:

Safety:DetailedevidenceonthesafetyandcomplicationratesoftheVAX-Dtableislacking.

Effectiveness:Forpatientswithradiculopathyorradicularpainassociatedwithaherniated

intervertebraldisc,thereissomeevidencetosuggestthatsurgicaldiscectomyismore effectivethanVAX-Dtherapyatrelievingpainintheshorttomediumterm.No comparisonscanbemadebetweenthesetwotherapiesinthispatientgroupoverthelong term(ie,10years).Forotherpatientgroups(ie,patientswithradiculopathyorradicular painassociatedwithdegeneratedintervertebraldiscs,andpatientswithnon-specificlow backpain)thereisinsufficientevidencetomakeanyconclusionsregardingtherelative effectivenessofVAX-Dtherapy.

Cost-effectiveness:Noevidence-basedconclusionscanbedrawnregardingthecost-effectivenessof VAX-Dtherapyinanypatientgroup.However,itislikelythatdiscectomyismorecost- effectivethanVAX-Dtherapyforthetreatmentofpatientswithradiculopathyor radicular painassociatedwithherniatedintervertebraldiscs.

Recommendations:

AsthereiscurrentlyinsufficientevidencepertainingtotheeffectivenessofVAX-Dtherapy,MSAC

recommendedthatpublicfundingshouldnotbesupportedatthistimeforthisprocedure.

Method:

TheapplicantrequestedthatVAX-Dtherapybesubsidisedforthetreatmentofchroniclowbackpain

resistanttoconservativetreatment.Accordingly,areviewofthemedicalliteraturewaslimitedtoevidenceofsecond-linetreatmentadministeredtopatientswithlowbackpainofatleastthreemonthsduration.Threedistinctpatientgroupswereidentified(seetablebelow),andeachofthesegroupswasassociatedwithaparticulartreatment.Inthisreviewthemostcommonconservativetreatmentfornon-specificlowbackpainwasdefinedasoralanalgesicsornon-steroidalanti-inflammatorydrugs(NSAIDs),withorwithoutphysiotherapy.InadditiontoevaluatingtheevidencepertainingtoVAX-Dtherapyin

eachofthethreepatientgroups,theevaluationincludedareviewofevidencerelatedtoeachofthethree comparatortreatments.

PatientgroupPatientdescriptionMostcommontreatment(Comparator)

1Radiculopathyorradicularpaincausedbyherniatedintervertebraldisc,unresponsivetoconservativetherapy

2Radiculopathyorradicularpaincausedbydegeneratedintervertebraldisc,unresponsivetoconservativetherapy

3Chronicnon-specificlowbackpain,unresponsiveto conservativetherapy

Discectomyormicrodiscectomy

Laminectomy,withorwithoutfusion,orlaminotomy

Ongoingconservativetreatment

Oneprospective,controlledclinicaltrialofVAX-Dtherapywasidentified,whichwasconductedin patientscorrespondingtoPatientGroup1.Thisstudysuffersfromseveralsignificantdesignproblems andwasconductedinarelativelysmallnumberofpatients.Theremainingevidenceisfromquasi- experimentalnon-randomisedstudies,andcase–series,conductedpredominantlyinmixedpatient populations.

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