February 23, 2018c.ymcdn.com/sites/ 2 of 4 2. We recommend the use of non-particulate steroid (dexamethasone) as a first-line injection for transforaminal epidural steroid injections

Spine Intervention Society (SIS)(Formerly International Spine Intervention Society)

120 E. Ogden Avenue, Suite 202 Hinsdale, IL 60521 630.203.2252SpineIntervention.org

February23,2018 DivisionofWorkers’Compensation viaEmailto:[email protected],CA94142Re:AdoptionofACOEMGuidelinesonLowBackDisordersToWhomItMayConcern:TheSpineInterventionSociety(SIS),amulti-specialtyassociationofover2,800physiciansdedicatedtothedevelopmentandpromotionofthehigheststandardsforthepracticeofinterventionalproceduresinthediagnosisandtreatmentofspinepain,wouldliketotakethisopportunitytocommentonyouradoptionoftheACOEMguidelinesaddressinglowbackdisorders.TheSociety’smembershipincludesmanyofthecliniciansandacademicianswhosepublishedliteratureprovidestheseminalreferencesuponwhichthepracticeofevidence-informedinterventionalspinecareisbased.Ourorganizationhasastrongrecordofworkingtoeliminatefraudulent,unproven,andinappropriateprocedures.Atthesametime,weareequallycommittedtoassuringthatappropriate,effective,andresponsibletreatmentsarepreservedsothatpatientsdonothavetosufferorundergomoreinvasiveandoftenunnecessarysurgicalprocedures.Whileweofferseveralspecificcommentstoassistinensuringappropriateaccesstointerventionalpainproceduresforappropriatelyselectedpatients,wearealsoattachingcoveragepolicyrecommendationsonepiduralsteroidinjections(ESI),facetjointinterventions,andsacroiliacjoint(SIJ)injections.ThesecoveragepolicyrecommendationsweredevelopedbytheNorthAmericanSpineSocietyandhavebeenendorsedbySIS.Thecoveragepolicyrecommendationswereestablishedasaresultofamultidisciplinary,collaborativeeffortofhealthcareleadersandexpertsinspinecare,utilizingthebestavailableevidence,whiletakingintoaccountreasonablestandardpracticesintheUnitedStates.Weofferthefollowingrecommendationsforchangestobeconsidered:LumbarEpiduralSteroidInjections1. WedisagreeincludingonthelistofindicationspainhavingbeentreatedwithNSAIDs

priortoconsideringanESI.TherearemanypatientswhoareintoleranttoNSAIDsandaclearmedicalconsensusregardingtherisksassociatedwithNSAIDs.Forthisreason,webelieveatrialofNSAIDsshouldnotberequiredpriortoanESI.

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2. Werecommendtheuseofnon-particulatesteroid(dexamethasone)asafirst-lineinjectionfortransforaminalepiduralsteroidinjections.Thiswouldbeconsistentwiththeestablishedsafetyguidelines(1).

3. WealsodisagreewiththerecommendationagainsttheuseofESIsforspinalstenosis.WhileweagreeaboutthelimitedutilityofESIsintreatingaxialbackpainforthemajorityofpatientswithstenosis,evidencedoessupporttheeffectivenessofESIsinthetreatmentofradicularpainandneurogenicclaudicationwhichcanbothresultfromspinalstenosis(2-4).

FacetInterventionsWithregardtothesectionondiagnosticandtherapeuticfacetjointprocedures,weareinstrongdisagreementwiththecurrentguidelines.Thereisextensivehighqualityevidenceregardingtheuseofmedialbranchblocksandradiofrequencyneurotomyfortheevaluationandtreatmentoflumbarspinepainasitarisesfromthefacetjoints.Weareincludingasummaryofextensiveliteraturetothiseffect(attached)andwishtohighlighttwoimportantstudiesforyourreference(5,6).Webelievethecurrentguidelinesreflectasignificantmisunderstandingofthecurrentliteratureandrequestthattheevidencebecarefullyreviewedtoensurepatientshaveaccesstoinvaluabletreatmentfortheirfacet-mediatedpain.SacroiliacInterventionsWithregardtothesectiononsacroiliacjointinterventions,wearealsoinstrongdisagreementwiththeindicationsstatingthatsacroiliacjointinterventionsshouldonlybeusedinpatientswithaknowncauseofsacroiliitis,whichisdescribedasprovenrheumatologicinflammatoryarthritisinvolvingthesacroiliacjoints.Thisistoonarrowanindicationandonceagainisnotconsistentwiththeavailableliterature(7-9).Whileweagreethatthemainindicationfortheseproceduresissacroiliitis,wedisagreethatthisonlyoccursinknownrheumatologicconditions.Thiscancertainlyoccurasaresultoftrauma.Wehopethatthisinformation,aswellasanydialogueandcollaborationbetweentheCaliforniaDivisionofWorkers’CompensationandtheSpineInterventionSociety,willleadtotheestablishmentofreasonablecoveragepoliciesthatwilleliminateinappropriateutilizationwhilepreservingaccessinappropriatelyselectedpatients.Weofferourongoinginputandexpertiseinthismatter.Ifwemayansweranyquestionsorprovideanyassistance,pleasefeelfreetocontactBelindaDuszynski,SeniorDirectorofPolicyandPracticeatbduszynski@SpineIntervention.org.Sincerely,

TimothyMaus,MDPresidentSpineInterventionSociety

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Attachments:

NorthAmericanSpineSociety.CoveragePolicyRecommendations:LumbarEpiduralInjections.2014.

NorthAmericanSpineSociety.CoveragePolicyRecommendations:FacetJointInterventions.2016.

NorthAmericanSpineSociety.CoveragePolicyRecommendations:SacroiliacJointInjections.2015.

MultisocietyLetterofSupportandComprehensiveEvidenceReviewonLumbarMedialBranchRadiofrequencyNeurotomy.February2018.

References:

1. RathmellJP,BenzonHT,DreyfussP,HuntoonM,WallaceM,BakerR,etal.Safeguardstopreventneurologiccomplicationsafterepiduralsteroidinjections:consensusopinionsfromamultidisciplinaryworkinggroupandnationalorganizations.Anesthesiology.2015;122(5):974-84.

2. MacVicarJ,KingW,LandersMH,BogdukN.Theeffectivenessoflumbartransforaminalinjectionofsteroids:acomprehensivereviewwithsystematicanalysisofthepublisheddata.PainMed.2013;14(1):14-28.

3. SharmaAK,VorobeychikY,WassermanR,JamesonJ,MoradianM,DuszynskiB,etal.TheEffectivenessandRisksofFluoroscopicallyGuidedLumbarInterlaminarEpiduralSteroidInjections:ASystematicReviewwithComprehensiveAnalysisofthePublishedData.PainMed.2017;18(2):239-51.

4. VorobeychikY,SharmaA,SmithCC,MillerDC,StojanovicMP,LobelSM,etal.TheEffectivenessandRisksofNon-Image-GuidedLumbarInterlaminarEpiduralSteroidInjections:ASystematicReviewwithComprehensiveAnalysisofthePublishedData.PainMed.2016;17(12):2185-202.

5. DreyfussP,HalbrookB,PauzaK,JoshiA,McLartyJ,BogdukN.Efficacyandvalidityofradiofrequencyneurotomyforchroniclumbarzygapophysialjointpain.Spine(PhilaPa1976).2000;25(10):1270-7.

6. MacVicarJ,BorowczykJM,MacVicarAM,LoughnanBM,BogdukN.LumbarmedialbranchradiofrequencyneurotomyinNewZealand.Painmedicine(Malden,Mass).2013;14(5):639-45.

7. KennedyDJ,EngelA,KreinerDS,NampiaparampilD,DuszynskiB,MacVicarJ.FluoroscopicallyGuidedDiagnosticandTherapeuticIntra-ArticularSacroiliacJointInjections:ASystematicReview.PainMed.2015;16(8):1500-18.

8. KingW,AhmedSU,BaisdenJ,PatelN,KennedyDJ,MacVicarJ,etal.Diagnosisandtreatmentofposteriorsacroiliaccomplexpain:asystematicreviewwithcomprehensiveanalysisofthepublisheddata.PainMed.2015;16(2):257-65.

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9. MacVicarJ,KreinerDS,DuszynskiB,KennedyDJ.AppropriateUseCriteriaforFluoroscopicallyGuidedDiagnosticandTherapeuticSacroiliacInterventions:ResultsfromtheSpineInterventionSocietyConvenedMultispecialtyCollaborative.PainMed.2017;18(11):2081-95.

| NASS Coverage Policy Recommendations 05/2014

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NASS coverage recommendations should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physician and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. The coverage recommendations do not represent a “standard of care,” nor are they intended as a fixed treatment protocol. It is anticipated that there will be patients who will require less or more treatment than the average. It is also acknowledged that in atypical cases, treatment falling outside these criteria will sometimes be necessary. This document should not be seen as prescribing the type, frequency or duration of intervention. Treatment and accompanying payment should be based on this information in addition to an individual patient’s needs as well as the doctor’s professional judgment and experience. This document is designed to function as a guide and should not be used as the sole reason for denial of treatment and services. It is not intended to supersede applicable ethical standards or provisions of law. This is not a legal document.

© 2014-17 North American Spine Society. All rights reserved.

NASS COVERAGE POLICY RECOMMENDATIONS

North American Spine Society 7075 Veterans Blvd. Burr Ridge, IL 60527

DEFINING APPROPRIATECOVERAGE POSITIONS

CervicalArtificial DiscReplacement

TASKFORCE

LumbarEpidural Injections

Endorsed by:

NASS Coverage Policy Recommendations

NASS Coverage Committee

North American Spine SocietyCoverage Policy Recommendations

Copyright © 2014-2017 North American Spine Society7075 Veterans BoulevardBurr Ridge, IL 60527 USA

(630) 230-3600www.spine.org

ISBN 1-929988-44-3

This coverage recommendation is proprietary information owned by NASS. NASS members and other lawful purchasers of this document are authorized to use this recommendation for personal use only. Distribution beyond the member or purchasers own personal use is expressly forbidden, absent written consent from NASS.


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IntroductionNorth American Spine Society (NASS) coverage policy recommendations are intended to assist payers and members by proactively defining appropriate coverage positions. Historically, NASS has provided comment on payer coverage policy upon request. However, in considering coverage policies received by the organization, NASS believes proactively examining medical evidence and recommending credible and reasonable positions may be to the benefit of both payers and members in helping achieve consensus on coverage before it becomes a matter of controversy. This coverage recommendation reflects the best available data as of 3/20/2013; information and data available after 3/20/2013 is thus not reflected in this recommendation and may warrant deviations from this recommendation, if appropriate.

MethodologyThe coverage policies put forth by NASS use an evidence-based approach to spinal care when possible. In the absence of strict evidence-based criteria, policies reflect the multidisciplinary and non-conflicted experience and expertise of the authors in order to reflect reasonable standard practice indications in the United States.

NASS Coverage Policy Methodology

Background InformationLumbar epidural steroid injections can be performed via an interlaminar or caudal approach or a transforaminal approach that in-cludes the use of fluoroscopic or CT-guidance, which is bundled into the procedure. Fluoroscopic-guidance is not bundled into the procedure and can be billed separately when performed with an interlaminar epidural steroid injection. Interlaminar and transforam-inal epidural steroid injections using ultrasound guidance are not recommended for coverage by NASS.

Scope and Clinical Indications Therapeutic lumbar epidural steroid injections (ESIs) are indicated for the following diagnoses with qualifying criteria, when appro-priate.

1. Lumbar radicular pain in which the following criteria are met:a. the pain is severe enough to cause some degree of functional deficitb. failure of at least four weeks of noninvasive care (see below*)c. imaging demonstrating a correlative region of nerve impingement

2. Neurogenic claudication in which the following criteria are met:a. the pain is severe enough to cause some degree of functional deficitb. failure of at least four weeks of noninvasive care (see below*)c. imaging demonstrating a correlative region of nerve impingement

3. Low back pain without lower extremities symptoms ONLY in the following clinical scenarios:a. High-level athletes during a competitive seasonb. Pregnant women with intractable low back pain unresponsive to other treatments

*It is known that the majority of back and radicular pain will improve over 4 weeks. It is therefore reasonable to recommend failure of four weeks of non-surgical, noninvasive care. Appropriate nonsurgical, noninjection treatments should be considered along with a rationale for interventional treatment. Exceptions to waiting 4 weeks can exist but should be carefully documented and should be reviewed on a case-by-case basis. These include, but are not limited to:

1. At least moderate pain with significant functional loss at work and/or home2. Severe pain unresponsive to outpatient medical management 3. Inability to tolerate non-surgical, non-injection care due to co-existing medical condition(s) (e.g. cardiac disease)4. Prior successful ESI for the same condition

Diagnostic selective nerve root blocks (DSNRBs) use a small amount of anesthetic via a transforaminal approach to anesthetize a specific spinal nerve and share the same CPT codes as therapeutic transforaminal ESIs. DSNRBs are used to evaluate a patient’s ana-tomical level and/or source of radicular pain and are often used in surgical planning and decision-making. Post-injection assessment

Lumbar Epidural Injections

https://www.spine.org/Portals/0/Documents/PolicyPractice/CoverageRecommendations/CoveragePolicyMethodology.pdf

https://www.spine.org/Portals/0/Documents/PolicyPractice/CoverageRecommendations/CoveragePolicyMethodology.pdf

NASS Coverage Policy Recommendations | 05/2014

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of the percentage of pain relief and/or change in visual or numerical analog score (VAS/NAS) must be documented.

Contraindications to Lumbar Epidural Injections and DSNRBsLumbar ESIs and DSNRBs are NOT indicated in cases that do not fulfill the above criteria. Of note, lumbar epidural steroid injections are not indicated in the following scenarios:

1. Cancer:a. New onset low back pain with a history of cancer, multiple risk factors for cancer, or strong clinical suspicion for cancer

in the absence of advanced imaging studies (to rule out local cancer involvement)b. Epidural injections may be considered if cancer is ruled-out or if the patient’s pain is felt to be unrelated to their cancer

AND they meet one of the above criteria lists (Items 1, 2, or 3)2. Infection:

a. New onset of low back pain with fever in the absence of advanced imaging studies (to rule out local infection)b. History of active intravenous drug usec. History of recent or ongoing systemic bacterial or fungal infectiond. Immunosuppression

3. Cauda equina syndromea. New onset urinary retention, fecal incontinence, or saddle anesthesiab. Rapidly progressing (or other) neurological deficits

4. Axial Low Back Pain without lower extremity symptoms5. Co-existing medical conditions that would preclude the safe performance of the injection or be a contraindication to the in-

tervention (eg, bleeding disorder, presence of an epidural mass, or central nerve system (CNS) disorders† such as transverse myelitis or other demyelinating disorder)

†Note that if a CNS process is present, but the pain or neurologic deficit is clearly unrelated, an ESI may still be indicated if the patient meets one of the above criteria lists (Items 1, 2, or 3)

Procedural Requirements, Utilization, and Restrictions:Lumbar epidural steroid injections, regardless of approach or indication, are subject to the following requirements and restrictions:

1. Contrast enhanced fluoroscopy or CT guidance.a. for transforaminal ESIs, live contrast-enhanced fluoroscopy or digital subtraction angiography is preferred, though

contrast-enhanced CT guidance may be performed with the understanding that this form of visualization might not detect intravascular flow leading to potential complications, especially if particulate steroids are used.

b. exceptions to the use of contrast are considered in patients who have a significant history and/or are at high risk for an adverse event if contrast material is used (eg, contrast allergy).

i. in these cases, physicians should consider using a test-dose injection prior to injecting any particulate steroids and/or use only non-particulate steroid solutions.

ii. the reasons for not using contrast should be documented in the procedure report. 2. Injections are performed independently based on the patients’ symptoms and response to prior injections and approach (if

performed). There is no role for a routine “series of 3” ESIs.3. If a prior lumbar ESI provided no relief, a second ESI is allowed following reassessment of the patient, injection technique and/

or medication used.4. No more than 3 lumbar ESIs and/or DSNRBs may be performed in a 6 month time period.5. No more than 6 lumbar ESIs and/or DSNRBs may be performed in a 12 month time period regardless of the number of levels

involved.6. Films that adequately document final needle position and injectate flow must be retained and made available upon request.7. No more than 2 transforaminal injections may be performed at a single setting (eg, single level bilaterally or two levels)8. For caudal or lumbar interlaminar injections, only one per session may be performed and NOT in conjunction with a transfo-

raminal injection.9. For each session, no more than 80 mg of triamcinolone, 80 mg of methylprednisolone, 12 mg of betamethasone, 15 mg of

dexamethasone or equivalent corticosteroid dosing should be used.



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10. Given the recent RCT evidence1-2 for the therapeutic equivalency of dexamethasone to particulate steroid, particulate-free ste-roid, such as dexamethasone, should be used as the first line drug in all transforaminal ESIs. Particulate steroid should be used only after failure of particulate-free steroid and with appropriate patient counseling and safeguards, such as digital subtraction imaging.

11. Local anesthesia is usually sufficient for a majority of lumbar ESIs though on occasion minimal to moderate conscious sedation is an appropriate option

12. If monitored anesthesia care is utilized, the need for such sedation should be clearly documented in the medical records.

RationaleLumbar epidural steroid injections are one the most commonly performed injection procedures in the treatment of spine-related pain. The Coverage Policy (also known as the “Policy”) put forth by the North American Spine Society utilizes an evidence-based approach to spinal care when possible. In the absence of strict evidence-based criteria, the Policy utilizes the multidisciplinary and nonconflicted experience and expertise of the task force in order to reflect reasonable standard practice indications in the United States.

For lumbar radicular pain, the rationale for coverage is based on high-level evidence and what most practitioners would consider to be accepted practice patterns. Lumbar radicular pain may be caused by a myriad of pathologic conditions including, but not limited to lumbar disc herniation, lumbar stenosis (central or foraminal), lumbar spondylolisthesis, postoperative perineural fibrosis, or failed low back surgery syndrome. Multiple randomized-controlled trials have demonstrated that ESIs are effective in the treatment lumbar radiculitis caused by disc herniation.2-10 There is sufficient literature to suggest that at least a trial of ESI’s for radicular pain caused by conditions other than disc herniation is appropriate prior to considering surgical intervention.11-19

For neurogenic claudication, the rationale for coverage is based on what most practitioners would consider to be accepted practice patterns. Neurogenic claudication is caused by spinal stenosis, either degenerative or isthmic. There is literature to suggest that ESIs are effective in reducing pain in this patient population12, 20, 21 though this treatment seems to be less effective in this group than in pa-tients with herniated discs.22,23 In addition, there is data that shows that the injection of epidural steroid is equivalent to epidural local anesthetic.17, 24-28 It should be noted that epidural injection of local anesthetic has been clearly demonstrated to be more effective than a placebo.29 Based on these data, it is felt that a trial of epidural injections is reasonable prior to the consideration of surgical interven-tion for neurogenic claudication associated with lumbar spinal stenosis.

For selected cases of LBP, the rationale for coverage is based on what most practitioners would consider to be accepted practice pat-terns. While epidural injections are not typically considered an effective treatment for isolated, non-specific low back pain, they can be helpful in certain circumstances as described above. It is acknowledged that there is a paucity of data on this topic. In the absence of quality data, this coverage recommendation is guided by what appears to be reasonable and accepted practice patterns.

The rationale for the procedural requirements, utilization and restrictions is based on what most practitioners would consider to be accepted practice patterns. In addition, there are a number of reports of complications associated with epidural injections30-35 that have occurred primarily as a result of intravascular injection. The use of live, contrast-enhanced fluoroscopy, digital subtraction, and the use of nonparticulate steroids minimizes these risks.

As the potential risks with ESIs are both local from the procedure itself and systemic from the medications injected (specifically steroids), it is reasonable to place limits on the number of injections that should be administered in a given time. Currently, there are no data to support performing a predetermined “series” of injections. The determination to perform more than one injection should be based on the patient’s response to the prior injection, the approach/location it was administered, the patient’s symptoms, the medica-tions used, and the imaging findings. This evaluation needs to be done via a face-to-face encounter and the reasons for repeating the injection clearly documented.

References1. Kennedy DJ, Plastaras C, Casey E, et al. Comparative effectiveness of lumbar transforaminal epidural steroid injections with particulate versus

nonparticulate corticosteroids for lumbar radicular pain due to intervertebral disc herniation: a prospective, randomized double-blind trial. Pain Med. 2014 Apr;15(4)548-55.

2. El-Yahchouchi C, Wald J, Brault J, et al. Lumbar transforaminal epidural steroid injections: does immediate post-procedure pain response predict longer term effectiveness? Pain Med. 2014 Jun;15(6):921-8.


http://www.ncbi.nlm.nih.gov/pubmed/24393129






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3. Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med. 2010;11:1149-68.

4. Ng L, Chaudhary N, Sell P. The efficacy of corticosteroids in periradicular infiltration for chronic radicular pain: a randomized, double-blind, con-trolled trial. Spine. 2005;30:857-62.

5. Riew KD, Yin Y, Gilula L, et al. The effect of nerve-root injections on the need for operative treatment of lumbar radicular pain. A prospective, randomized, controlled, double-blind study. J Bone Joint Surg Am. 2000;82-A:1589-93.

6. Karppinen J, Malmivaara A, Kurunlahti M, et al. Periradicular infiltration for sciatica: a randomized controlled trial. Spine. 2001;26:1059-67.7. Tafazal S, Ng L, Chaudhary N, Sell P. Corticosteroids in peri-radicular infiltration for radicular pain: a randomised double blind controlled trial.

One year results and subgroup analysis. Eur Spine J. 2009;18:1220-5. 8. Vad VB, Bhat AL, Lutz GE, Cammisa F. Transforaminal epidural steroid injections in lumbosacral radiculopathy: a prospective randomized study.

Spine. 2002;27:11-6.9. Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. A randomized, controlled, double-blind trial of fluoroscopic caudal epidur-

al injections in the treatment of lumbar disc herniation and radiculitis. Spine. 2011;36:1897-905.10. Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing

chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial. Pain Physician. 2010;13:343-55. 11. Arden NK, Price C, Reading I, et al. A multicentre randomized controlled trial of epidural corticosteroid injections for sciatica: the WEST study.

Rheumatology. 2005;44:1399-406. 12. Botwin K, Brown LA, Fishman M, Rao S. Fluoroscopically guided caudal epidural steroid injections in degenerative lumbar spine stenosis. Pain

Physician. 2007;10:547-58. 13. Buchner M, Zeifang F, Brocai DR, Schiltenwolf M. Epidural corticosteroid injection in the conservative management of sciatica. Clini Orthop Relat

Res. 2000:149-56.14. Bush K, Hillier S. A controlled study of caudal epidural injections of triamcinolone plus procaine for the management of intractable sciatica.

Spine. 1991;16:572-5.15. Iversen T, Solberg TK, Romner B, et al. Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded,

randomised controlled trial. BMJ. 2011;343:d5278.16. Klenerman L, Greenwood R, Davenport HT, White DC, Peskett S. Lumbar epidural injections in the treatment of sciatica. Br J Rheumatol.

1984;23:35-8.17. Manchikanti L, Cash KA, McManus CD, Pampati V, Singh V, Benyamin R. The preliminary results of a comparative effectiveness evaluation of ad-

hesiolysis and caudal epidural injections in managing chronic low back pain secondary to spinal stenosis: a randomized, equivalence controlled trial. Pain Physician. 2009;12:E341-54.

18. Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. A comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing lumbar post surgery syndrome: a randomized, equivalence controlled trial. Pain Physician. 2009;12:E355-68.

19. Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain physician 2010;13:509-21.

20. Koc Z, Ozcakir S, Sivrioglu K, Gurbet A, Kucukoglu S. Effectiveness of physical therapy and epidural steroid injections in lumbar spinal stenosis. Spine. 2009;34:985-9.

21. Lee JW, Myung JS, Park KW, et al. Fluoroscopically guided caudal epidural steroid injection for management of degenerative lumbar spinal ste-nosis: short-term and long-term results. Skeletal radiology 2010;39:691-9.

22. Radcliff K, Kepler C, Hilibrand A, et al. Epidural steroid injections are associated with less improvement in patients with lumbar spinal stenosis: a subgroup analysis of the Spine Patient Outcomes Research Trial. Spine 2013;38:279-91.

23. Rivest C, Katz JN, Ferrante FM, Jamison RN. Effects of epidural steroid injection on pain due to lumbar spinal stenosis or herniated disks: a pro-spective study. Arthritis Care Res. 1998;11:291-7.

24. Fukusaki M, Kobayashi I, Hara T, Sumikawa K. Symptoms of spinal stenosis do not improve after epidural steroid injection. Clin J Pain. 1998;14:148-51.

25. Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. Lumbar interlaminar epidural injections in central spinal stenosis: pre-liminary results of a randomized, double-blind, active control trial. Pain Physician. 2012;15:51-63.

26. Manchikanti L, Cash KA, McManus CD, Pampati V, Abdi S. Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 4--Spinal stenosis. Pain Physician. 2008;11:833-48.

27. Manchikanti L, Cash KA, McManus CD, Pampati V, Fellows B. Fluoroscopic caudal epidural injections with or without steroids in managing pain of lumbar spinal stenosis: one-year results of randomized, double-blind, active-controlled trial. J Spinal Disord Tech. 2012;25:226-34.

28. Manchikanti L, Cash KA, McManus CD, Pampati V, Fellows B. Results of 2-year follow-up of a randomized, double-blind, controlled trial of fluo-roscopic caudal epidural injections in central spinal stenosis. Pain Physician. 2012;15:371-84.

29. Bicket MC, Gupta A, Brown CH, Cohen SP. Epidural injections for spinal pain: a systematic review and meta-analysis evaluating the “control” injections in randomized controlled trials. Anesthesiology. 2013;119(4):907-31.

30. Dere K, Akbas M, Bicerer E, Ozkan S, Dagli G. A complication during caudal steroid injection. J Back Musculoskeletal Rehabil. 2009;22:227-9.31. Houten JK, Errico TJ. Paraplegia after lumbosacral nerve root block: report of three cases. Spine J. 2002;2:70-5.32. Huntoon MA, Martin DP. Paralysis after transforaminal epidural injection and previous spinal surgery. Reg Anesth Pain Med. 2004;29:494-5.









http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2899508/






http://www.painphysicianjournal.com/linkout_vw.php?issn=1533-3159&vol=13&page=343


http://rheumatology.oxfordjournals.org/content/44/11/1399.long

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http://www.painphysicianjournal.com/linkout_vw.php?issn=1533-3159&vol=13&page=E279





















http://www.dovepress.com/fluoroscopic-caudal-epidural-injections-in-managing-chronic-axial-low--peer-reviewed-article-JPR

http://www.dovepress.com/fluoroscopic-caudal-epidural-injections-in-managing-chronic-axial-low--peer-reviewed-article-JPR









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33. Karaman H, Kavak GO, Tufek A, Yldrm ZB. The complications of transforaminal lumbar epidural steroid injections. Spine 2011;36:E819-24.34. Kennedy DJ, Dreyfuss P, Aprill CN, Bogduk N. Paraplegia following image-guided transforaminal lumbar spine epidural steroid injection: two case

reports. Pain medicine (Malden, Mass) 2009;10:1389-94.35. Thefenne L, Dubecq C, Zing E, et al. A rare case of paraplegia complicating a lumbar epidural infiltration. Ann Phys Rehabil Med. 2010;53:575-83.

AuthorsNASS Coverage CommitteeChair: Christopher Bono, MDMembers:Jamie Baisden, MDRay Baker, MDAshok Biyani, MD

Maxwell Boakye, MDCharles Cho, MD, MBAMichael DePalma, MDDonald Dietze, MDJohn Easa, MDGary Ghiselli, MDJohn Glaser, MDJames Harrop, MD

Anthony Lapinsky, MDDarren Lebl, MDPaul Matz, MDDavid O’Brien, MDAlpesh Patel, MD, FACSMitchell Reiter, MDCharles Reitman, MDLee Riley, MD

Alok Sharan, MDJeffrey Summers, MDWilliam Tontz, MDJohn Toton, MD, JDScott Tromanhauser, MD, MBAEeric Truumees, MDAllen Villavincencio, MDMichael Zindrick, MD

Financial StatementThese Coverage Recommendations were developed in their entirety by the North American Spine Society (NASS). All participating authors have disclosed potential conflicts of interest consistent with NASS’ disclosure policy.

Author DisclosuresBono, Christopher: Royalties: Wolters Kluwer (B); Consulting: Harvard Clinical Research Institute (Financial), United Health Care (B);

Board of Directors: North American Spine Society (Nonfinancial) Other Office: JAAOS (B), The Spine Journal (Nonfinancial) Baisden, Jamie: Nothing to Disclose.Biyani, Ashok: Royalties: Globus Medical (E), custom spine (C); Consulting: K2M (B)Boakye, Maxwell: Nothing to Disclose.Cho, Charles: Nothing to Disclose.DePalma, Michael: Consulting: Vertiflex, Inc (Financial); Trips/Travel: Medtronic (Financial); Board of Directors: International Spine

Intervention Society (Financial), Virginia Spine Research Institute, Inc (Financial); Scientific Advisory Board: Medtronic; Kimber-ly Clark (Financial); Other Office: Secretary, International Spine Intervention Society (Financial); Research Support (Investigator Salary): Relievant (B), SI Bone (B), Mesoblast, Inc (B); Research Support (Staff/Materials): Relievant (B), Mesoblast (B), SI Bone (B); Relationships Outside the One Year Requirement: AOI Medical (Upcoming Committee Meeting [Clinical Guidlelines), Stryker Interventional Spine (B), St. Jude Medical (NASS Annual Meeting, Consulting), Stryker Biotech (NASS Annual Meeting), ATRM (NASS Annual Meeting)

Dietze, Donald: Stock Ownership: Globus Medical Consulting: Globus Medical (Financial); Other: DePuy Spine (B)Easa, John: Stock Ownership: Janus Biotherapeutics Ghiselli, Gary: Private Investments: DiFusion; Consulting: Biomet (C); Speaking and/or teaching arrangements: Medacta (B); Scientific

Advisory Board: DiFusion (Nonfinancial)Glaser, John A.: Trips/Travel: Depuy Synthes Spine (Nonfinancial, Trip expenses, A); Grants: SI Bone (D, Research grant funding, Paid

directly to institution/employer).Harrop, James: Consulting: Depuy Spine (B); Board of Directors: Jefferson Medical College Physician Board (Nonfinancial); Scientific

Advisory Board: Axiomed (Nonfinancial); Other Office: Bioventus (B ), Penn Neurologic Society (Nonfinancial); Research Support (Staff/Materials): NACTN (E); Grants: AO Spine/ NREF (F)

Lapinsky, Anthony: Royalties: RTI formerly Pioneer (B); Consulting: Orthofix (Financial)Lebl, Darren: Nothing to Disclose. Matz, Paul: Speaking and/or teaching arrangements: AO Spine North America (B); Trips/Travel: NASS (A)O’Brien, David: Speaking and/or teaching arrangements: NASS (B); Trips/Travel: ISIS & AAPMR (B); Other Office: ISIS & AAPMR (Non-

financial)Patel, Alpesh: Royalties: Amedica (B); Stock Ownership: Amedica, Cytonics, Nocimed Vital5; Consulting: Amedica (B), Stryker (B),

Biomet (Financial), Depuy (B); Board of Directors: Lumbar Spine Research Society (Nonfinancial), Cervical Spine Research Society (Nonfinancial), Indo-American Spine Alliance (Nonfinancial); Fellowship Support: OREF (D), Omega (B); Other: Amedica (Finan-cial)

Reiter, Mitchell: Private Investments: CreOsso





http://www.sciencedirect.com/science/article/pii/S1877065710002071



8



Reitman, Charles: Trips/Travel: NASS - BOD (Financial), AAOS - Evidence Based Committee (Financial); Scientific Advisory Board: Clinical Orthopedics And Related Research - Deputy Editor (B)

Riley, Lee: Stock Ownership: Spinal kinetics; Speaking and/or teaching arrangements: AOSNA (B); Trips/Travel: DePuy Spine (B); Board of Directors: Lifenet Health (C); Other Office: CSRS (A); Grants: DePuy Spine (B)

Sharan, Alok: Consulting: Paradigm Spine (B); Speaking and/or teaching arrangements: Synthes Spine (B)Summers, Jeffrey: Stock Ownership: MedWorx ; Private Investments: Morris Innovative (2000 Shares); Board of Directors: Internation-

al Spine Intervention Society (ISIS) (Nonfinancial)Tontz, William: Stock Ownership: Phygen; Consulting: Medtronic (C); Speaking and/or teaching arrangements: SpineArt (B); Trips/

Travel: Medtronic (B); Scientific Advisory Board: Medtronic (Financial)Toton, John: Nothing to Disclose.Tromanhauser, Scott: Stock Ownership: Soteira, Inc.; Speaking and/or teaching arrangements: DePuy Synthes Spine, Inc. (B); Other

Office: Best Doctors Occupational Health Institute (E)Truumees, Eeric: Royalties: Stryker Spine (C); Stock Ownership: Doctor’s Research Group (D); Board of Directors: North American Spine

Society (Nonfinancial); Other Office: AAOS Communications Cabinet (Financial); Research Support (Investigator Salary): Reliev-ant (B) Globus (B); Other: Stryker Biotech (Nonfinancial)

Villavincencio, Allen: Stock Ownership: Lanx; Board of Directors: Junstin Parker Neurological Institute (Nonfinancial); Other Office: Boulder Neurosurgical Associates, LLC (Nonfinancial); Research Support (Investigator Salary): Profibrix, Medtronic (F)

Zindrick, Michael: Royalties: OrthoFix (C), Biomet (B); Stock Ownership: VTI; Scientific Advisory Board: Orthofix

Comments Comments regarding the coverage recommendations may be submitted to [email protected] and will be considered in develop-ment of future revisions of the work.

Disclosure KeyDirect or indirect remuneration: royalties, stock ownership, private invest-ments, consulting, speaking and/or teaching arrangements, trips/travel. Position held in a company: board of directors, scientific advisory board, other office. Support from sponsors: endowments, research–investigator salary, research–staff and/or materials, grants, fellowship support. Other

Degree of support: Level A. $100 to $1000 Level F. $100,001 to $500,000Level B. $1,001 to $10,000 Level G. $500,001 to $1MLevel C. $10,001 to $25,000 Level H. $1,000,001 to $2.5MLevel D. $25,001 to $50,000 Level I. greater than $2.5MLevel E. $50,001 to $100,000



9



NASS Coverage Recommendations Methodology

Topic Selection: Coverage Recommendations topic lists are developed and approved by the Coverage Committee. Topics include both therapeutic and diagnostic procedures and treatments as well as nonoperative, interventional, and surgical procedures and treatments. The breadth of the topics attempts to represent all facets of spinal care. Topics are selected based on frequency of use in spine care and will attempt to represent the full breadth of procedures, diagnostics, and interventions.

Author Assignment: The Coverage Committee members rank their preferences (1, 2, or 3) for topic assignment. The Chair matches topics to the members’ preferences as much as possible. Active consideration is given to avoiding conflicts of interest, whether financial or otherwise, be-tween members and the topics assigned. All authors disclose any conflicts of interest in accordance with the NASS disclosure policy.

Background Data Review: For each topic, authors coordinate a literature search with the help of a research librarian/NASS staff member.

A literature search using PubMed, EMBASE, Web of Science and Cochrane is performed using search terms identified by the author specific to the topic assigned. Searches are limited to systematic reviews, meta-analyses, clinical guidelines, and most importantly, randomized controlled trials. The search produces a list of abstracts to be sent to the author for review and selection of appropriate ar-ticles for full review. Selected articles are then be sent to the Coverage Committee Chair for the approval to reduce any potential bias. The National Guidelines Clearinghouse is also be searched by NASS staff for appropriate clinical guidelines. Note that only full text, peer-reviewed articles published in English are eligible for review. Abstracts and non-published reports are not eligible for review.

In addition, NASS staff identify and retrieve any previously issued coverage policy on the topic, either by a private or public insurance provider.

Data Analysis: The medical literature is analyzed with preference given to the highest quality literature available. Funding and other potential sources of bias are taken into consideration, as is consistency of the literature reviewed. In the absence of high-level data, coverage recom-mendations reflect the multi-disciplinary experience and expertise of the committee members in order to present reasonable standard practice indications in the United States.

Coverage Recommendations Formulation: When trials, guidelines, or systematic reviews are available, the coverage recommendations should reflect the published data as much as possible. However, given the complexities of clinical care and the limitations of the medical literature in many circumstances, addi-tional consideration is given to specific clinical scenarios and the currently available treatment options for those scenarios, including the potential risks and benefits of the alternative treatment options, prior to establishing a coverage decision. In summary, final deter-minations are made upon an evidence-based review of the existing data, an understanding of clinical care, and the NASS mission.

Individual coverage recommendations follow a standard format document approval: Once formulated, the coverage recommendations are reviewed and revised by the Coverage Committee Chair incorporating any new data if available since the document is developedand with modifications for format. The document is then sent to the senior reviewers of the Coverage Committee and subject-matter experts from the NASS’ Payor Policy Review Committee (PPRC) for review and comment. After review at this level, final modifications are made and author is advised. The proposed coverage document is sent to the NASS Executive Committee of the board directors for review and final approval before publication. The proposed coverage document is published on NASS’ website with a 30-day public comment period. At the end of the public comment period, comments are reviewed and considered by the NASS Coverage Commit-tee. Where appropriate, the Committee makes edits and then publish the final document on NASS website.


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NASS Resources

Clinical GuidelinesDiagnosis and Treatment of Adult Isthmic Spondylolisthesis

Diagnosis and Treatment of Degenerative Spondylolisthesis (Revised 2014)

Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy

Antibiotic Prophylaxis in Spine Surgery (Revised 2013)

Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis (Revised 2011)

Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders

Antithrombotic Therapies in Spine Surgery

Appropriate Use CriteriaCervical Fusion

Coding FAQs (NASS Member Resource Only)

Patient Education Brochures (Complete Catalog)

https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/AdultIsthmicSpondylolisthesis.pdf

https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/Spondylolisthesis.pdf

https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/LumbarDiscHerniation.pdf

https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/AntibioticProphylaxis.pdf

https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf

https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/CervicalRadiculopathy.pdf

https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/AntithromboticTherapies.pdf

https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/CervicalFusionAUC.pdf

https://www.spine.org/Login/tabid/262/Default.aspx?returnurl=https%3a%2f%2fwww.spine.org%2fDefault.aspx%3fTabID%3d392

http://www.knowyourback.org/Pages/Brochures/Default.aspx


North American Spine Society7075 Veterans BoulevardBurr Ridge, IL 60527(630) 230-3600

North American Spine Society 7075 Veterans Blvd. Burr Ridge, IL 60527spine.org


Cervical Fusion

COMMITTEE


Facet Joint Interventions

Endorsed by:


NASS Coverage Committee




ISBN 1-929988-48-6

Authorized Use: This coverage recommendation is proprietary information owned by NASS. NASS members and other lawful purchasers of this document are authorized to use this recommendation for personal use only. Distribution beyond the member or purchasers own personal use is expressly forbidden, absent written consent from NASS.


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MethodologyThe coverage policies put forth by NASS use an evidence-based approach to spinal care when possible. In the absence of strict evi-dence-based criteria, policies reflect the multidisciplinary and nonconflicted experience and expertise of the authors in order to reflect reasonable standard practice indications in the United States.


Background InformationPublished, peer-reviewed studies have established prevalence estimates for cervical and lumbar facet joint pain in chronic neck (CNP) and low back pain (CLBP) subjects, respectively. Lumbar facet joint pain occurs in 15-32% of CLBP patients1-3 with patients over age 55 years most commonly affected.1,2 In the lumbar spine, L5-S1 is the level most commonly responsible for pain followed by L4-5.1,2,4,5 Cervical facet joint pain occurs in 55-69% of CNP patients6-10 and increases after whiplash injuries.6 In the cervical spine, C2-3 has been found to be the level most commonly responsible for upper neck and headache pain while low neck pain has been found to asso-ciated more often with C5-6.6 In most cases, a single joint is the source of symptoms.7 The prevalence of thoracic facet involvement in chronic thoracic pain has been estimated to be as high as 48%.11

Facet Joint Interventions: Diagnostic and TherapeuticScope and Clinical IndicationsInjections involving the zygapophysial joints (Z-joints) can be indicated for diagnostic or therapeutic purposes. Therapeutic injections typically involve administration of corticosteroids, with or without local anesthetics, while diagnostic injections use anesthetic alone. This document will cover the diagnostic uses and therapeutic uses of intraarticular Z-joint injections and of diagnostic medial branch blocks.

The pain referral patterns of the cervical Z-joints are described and can include pain in the neck, and/or the head, and/or the periscap-ular and shoulder region.12 The pain referral patterns of the lumbar Z-joints are similarly described and can include pain in the back, gluteal area and leg.13,14 For patients with such pain, the procedures covered in this report may be considered when ALL of the following criteria are met:

1. The patient’s pain is severe enough to cause some degree of functional deficit.2. Failure of at least 4 weeks of noninvasive care (see below*).3. There is no other significant pathology that could explain the source of the patient’s pain, such as fracture, tumor, infection or

significant extraspinal lesion.4. Pain is predominantly axial, within the locations described above, and not associated with radiculopathy or myelopathy.5. Clinical assessment implicates the Z-joint as the putative source of pain.

* It is known that the majority of back and neck pain will improve over 4 weeks. It is therefore reasonable to recommend failure of 4 weeks of nonsurgical, noninvasive care. Appropriate nonsurgical, noninjection treatments should be considered along with a rationale for interventional treatment. Exceptions to waiting 4 weeks can exist but should be carefully documented and should be reviewed on a case-by-case basis. These include but are not limited to:

a. At least moderate pain with significant functional loss at work and/or home.b. Severe pain unresponsive to outpatient medical management.


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c. Inability to tolerate nonsurgical, noninjection care due to coexisting medical condition(s) (eg, cardiac disease).d. Prior successful injections for the same condition.e. The presence of a facet synovial cyst causing nerve root compression with moderate-severe radicular pain and associ-

ated functional limitations.

Of note, any and all cervical spine injections should be performed with some form of image guidance (eg, fluoroscopy or CT).

Intervention 1: Diagnostic Medial Branch BlocksZygapophysial joint medial branch blocks (MBBs) are a validated means to diagnose Z-joint related pain15, which can include pain in the back, neck, and/or the head and/or the periscapular and shoulder region. Notably, this also includes the third occipital nerve since it innervates the C2-C3 Z-joint. Medial branch blocks, properly conducted, will anesthetize the target Z-joint(s), including the intraarticular surfaces, the joint capsule and the adjacent tissues including the paravertebral muscle supplied by the medial branch of the cervical dorsal ramus. The primary utility of MBBs is to determine the suitability of the patient for a radiofrequency neurotomy of painful segmental levels identified by the diagnostic MBBs, in order to achieve long-term management of the patient’s pain.

When diagnostic MBBs are performed, the following criteria apply:

1. Dual blocks, performed in the same location(s) on 2 separate occasions, are necessary to confirm the diagnosis due to the unacceptably high false positive rate of single diagnostic anesthetic injections in the spine.

2. A second confirmatory injection is indicated only if the first injections produces ≥80% relief of the primary (index) pain and the onset and minimum duration of relief is consistent with the agent employed. This confirmatory block confirms the tested joint as the source if the index pain is reduced by > 80%.

3. A second injection may also be performed at a different or additional level if the pain is believed to be arising from a different joint (and the pain relief from the initial block was <80%).

Intervention 2: Therapeutic Medial Branch BlocksTherapeutic MBBs are performed in the same manner as diagnostic MBBs, but the therapeutic blocks are intended to achieve long-term management of the patient’s pain.

While MBBs are valid and reliable diagnostic procedures, current evidence does not support their use as a therapeutic intervention. Currently published research shows that the number of therapeutic MBB injections required in a single year (4-5) exceeds the number of therapeutic injections recommended for routine use elsewhere in this report, and no benefits are observed when adding corticoste-roids or other potentially therapeutic medications to traditional anesthetic MBBs. Therefore, therapeutic MBBs are not recommended in the treatment of back or neck pain.

Intervention 3: Diagnostic Intraarticular Zygapophysial Joint InjectionsUnlike MBBs, intraarticular (IA) Z-joint injections have not be validated as a means to diagnose Z-joint related pain and should generally not be used in lieu of MBBs for the diagnosis of suspected Z-joint pain. IA anesthetic injections are capable of blocking only the articular joint surfaces and interior joint capsule. There have been no studies that have compared the diagnostic effectiveness of intraarticular Z-joint injections versus MBBs.

IA Z-joint blocks should not be used as a diagnostic test unless MBBs cannot be performed due to specific documented anatomic restrictions. For example, in the case of the occipitoatlantal and atlantoaxial joints, there is no medial branch or other innervation available to block reliably, so IA injections are the only means of arriving at a potential diagnosis of pain from these joints.

If diagnostic IA Z-joint injections are performed, the following criteria apply:

1. Dual IA injections are necessary to confirm the diagnose pain due to the unacceptably high false positive rate of single diag-nostic injections in the spine.

2. A second confirmatory injection is indicated only if the first injections produces ≥80% relief of the primary (index) pain and the onset and minimum duration of relief is consistent with the agent employed.


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Intervention 4: Therapeutic Intraarticular Zygapophysial Joint InjectionsThere is some evidence in the current medical literature of clinical efficacy of IA Z-joint injection techniques in the treatment of chronic low back pain, chronic neck pain and/or its associated headaches, periscapular and shoulder pain. There are 3 published RCTs along with multiple cohort studies demonstrating short to mid-term relief of pain following intraarticular steroid injections, though when compared with RFA, RFA offers longer term relief in patients with chronic pain.16-18 Long-term outcomes have not been reported in adequately designed studies. Thus, utility has not been well established in the medical literature. As a result, the use of therapeutic IA Z-joint injections is an empiric practice, related to past experience and extrapolation of the presumed benefits of steroid injections from their use in other synovial joints.

• Therapeutic IA injections should be repeated no more than three times annually and only if the initial injection results in signif-icant pain relief (> 50%) for at least 3 months.

There is a unique subset of patients that suffer from lumbar radicular pain due to facet joint pathology. In these cases, facet synovial cysts may cause nerve root compression or irritation with associated radicular pain similar to other neuro-compressive lesions. A number of interventional treatments for symptomatic Z-joint cysts has been described including intraarticular aspiration,19-21 injec-tion,16-18, 20-22 rupture23, 24 and direct cyst puncture.25,26 Each of these treatments require direct access into the Z-joint under fluoroscopic or CT guidance. In addition, it is appropriate and indicated to perform a transforaminal epidural steroid injection (one or two level) in combination with the above techniques to treat the associated radiculitis. These are distinct and separate procedures used to treat two separate and distinct but associated pathologies and diagnoses.

For the treatment of Z-joint synovial cysts with Z-joint aspiration/injection/rupture or direct puncture, the following criteria apply:

• The procedure should not be repeated more than two times on the same joint annually and only if the initial procedure results in significant pain relief (> 50%) for at least three months.

Intervention 5: Therapeutic Medial Branch Radiofrequency NeurotomyTherapeutic medial branch RFN is a validated treatment for Z-joint pain. Long-term follow-up demonstrates that treatment effects are durable and reproducible if symptoms return.27, 28 Success rates for initial treatment are high when patients are selected based on dual confirmatory diagnostic MBB. If symptoms return, repeat treatment shares an equally high success rate if response to the prior RFN lasted at least three months.29

If therapeutic medial branch RFN is performed, the following criteria apply:

1. RFN is offered to patients only if dual diagnostic MBB injections each produce ≥ 80% relief of the primary (index) pain and the onset and minimum duration of relief is consistent with the agent employed.

2. RFN should be performed using a 20-gauge or larger needle with ≥ 10 mm active tip in lumbar spine and at least 5 mm active tip in the cervical spine. Heating must be performed to at least 80 degrees Celsius for 90 seconds in the lumbar and cervical spine.29-33 Repositioning and multiple lesions may be required to achieve appropriate denervation.

3. The patient should have pain that has been present for at least 3 months despite other treatments.4. RFN should be performed at the same level no more than twice annually and only if the initial radiofrequency lesion results in

significant pain relief (> 50%) for at least 6 months. In those situations, a repeat procedure in that year is appropriate.

RationaleThe proposed policy utilizes an evidence-based approach to care, where such evidence exists. In the absence of strict evidence-based criteria, the policy utilizes the multidisciplinary and non-conflicted experience and expertise of the committee in order to reflect rea-sonable standard practice indications in the United States.

Image guidance is considered mandatory for successful needle placement for both IA and MBBs. The vast majority of studies have used fluoroscopy during needle placement. Ultrasound is experiencing increasing popularity in the cervical spine due to the proximity of the target structures to the skin and thus the ability to visualize these structures; however, at the time of this publication, the use of ultrasound to perform any of these procedures is considered experimental, and NASS does not recommend coverage at this time. CT


6




guidance has also been used to direct needle placement, particularly for intraarticular injections.

Medial Branch BlocksAs described in Intervention 1, there are no valid historical physical exam findings, imaging studies or tissue examinations that can identify the cervical facets joints as the source of a patient’s neck pain, headaches or shoulder girdle pain. The rationale for using diagnostic cervical MBBs is that pain relief during the anesthetic nerve block provides prima facie evidence that the patient’s pain is caused by structures innervated by the target nerves.34-40 In addition to determining the possible cause of the patient’s pain, positive responses to diagnostic MBBs are an indication for a medial branch radiofrequency neurotomy. The effectiveness and long-term durability cervical medial branch radiofrequency neurotomy has been studied by multiple authors and is discussed elsewhere in this coverage document.

Since there is evidence of a significant false positive rate for diagnostic cervical medial branch blocks,41, 42 dual confirmatory (or “com-parative”) blocks with local anesthetics of different expected durations of effect, administered on two separate occasions, are recom-mended to decrease the rate of false positive results. However, the increased specificity afforded by comparative blocks comes at the cost of decreased sensitivity , meaning that the number of false negative patients will increase, meaning some will be disqualified from potentially effective treatment.35,43

While the rate of false positives is lower with dual blocks, some have suggested that this practice is neither necessary nor cost ef-fective.44 However, the study used to make this argument used provocation discography to identify false positives, when provocation discography is controversial specifically for its potential to produce false positive results.45 Placebo controls have also been advo-cated to further improve the specificity of MBBs.46 The decision to use placebo controls is felt by some to depend on whether or not absolute diagnostic certainty was critical, such as in the performance of an initial placebo controlled trial of treatment efficacy, in a medicolegal context or if surgery is contemplated based on the results of the testing.36 Still, no studies have used cervical IA or medial branch blocks to predict surgical outcomes. Thus, the primary indication for diagnostic cervical MBBs is to determine the suitability of the patient for a radiofrequency neurotomy of the painful segmental level(s) identified by the diagnostic MBBs, in order to achieve long-term management of the patient’s pain.

In Intervention 2, the rationale behind therapeutic MBBs is that that compression or inflammation of the medial branch nerve may be responsible for Z-joint related pain or that injections of anesthetic and other potentially therapeutic substances may cause local nerve or central nervous system changes in pain transmission. However, these suggested mechanisms have never been demonstrated empirically. Prospective randomized studies of therapeutic MBBs compared the standard anesthetic MBBs with blocks combining anesthetics and corticosteroids, showing no differences between groups in terms of pain relief, function, or number of required injection treat-ments.47,48 In these studies, patients in each group received an average of 4-5 injections per year for diagnosis and treatment. Therapeutic cervical medial branch blocks showed short-term relief in an initial small case series published in 1986.49 Since then, nearly all research on therapeutic MBBs has come from a single center and includes a prospective case series and publications from a randomized controlled trial.50, 51 The outcomes documented in these studies involve patients who received between 4-5 injections in the first year of the trial. The repeated treatments were performed at various unspecified intervals, without reporting their timing relative to outcomes collection. Thus, it is impossible to determine the true duration of treatment effect. Furthermore, the publications from the randomized trail reveal no additional benefits when other potentially therapeutic medications, such as corticosteroids, are added to traditional anesthetic MBBs. There are no studies that have compared the effectiveness of therapeutic MBBs injections with medial branch radiofrequency neurotomy, a treatment known to provide effective long-term management of cervical Z-joint pain. Only one study has compared therapeutic MBBs to any other treatment, and this was in the lumbar spine. In this prospective, blinded, randomized trial patients were treated with the same combination of corticosteroids and anesthetics with MBBs vs. IA Z-joint injec-tions.18 Statistically significant and clinically relevant improvements were observed in IA Z-joint injection group relative to the thera-peutic MBB group.

Intraarticular InjectionsAs detailed in Item 3, cervical IA Z-joint injections have not been validated for diagnostic use. Thus, their false positive rate is not known. Lacking validity, they have limited utility in the diagnosis of Z-joint pain.52 There have been no studies that compare the ef-


7




fectiveness of IA Z-joint injections vs. MBBs in the cervical spine. The use of diagnostic IA injections is thus reserved for those cases where MBBs are not anatomically possible, as is the case with occipitoatlantal and atlantoaxial joints.

In Item 4, the use of therapeutic IA Z-joint injections is placed into context. Corticosteroid injections for painful joint conditions out-side the spine are a common practice, yet evidence is relatively lacking for these therapeutic joint injections – both within and outside the spine. Therefore, policy regarding the recommended indications and frequency of IA Z-joint injections is largely based on limited case series and anecdotes.53-57 Results of existing studies are conflicting. In controlled trials, benefits relative to other treatments are observed in some, but others fail to show significant short- or long-term benefits.58 The negative trial, however, studied only patients with chronic pain following a whiplash injury, so it is unknown if similar results will occur when treating acute pain or pain related to inflammatory joint conditions. Accordingly, reviews addressing the treatment of chronic neck pain have found little or no evidence to support the use of therapeutic IA Z-joint injections in the management of chronic neck pain.59-61

Cysts can arise from the facet joints, primarily in the lumbar spine, causing both mechanical and biochemical irritation of the adjacent nerves. These cysts most commonly arise from the L4-5 Z- joints19-21, 23, 24, 26 and typically can be histologically divided into synovial and ganglion cysts.62,63 Ganglion cysts, the less common of the two, lack a synovial lining, are typically multiloculated and do not commu-nicate with the adjacent Z- joint.62 Synovial cysts, which represent about 75% of Z-joint cysts,62 have a synovial lining and commu-nicate with the Z-joint, making them amenable to fluoroscopic visualization and rupture though needle entry into the Z-joint. Z-joint injection and cyst rupture is performed to treat not only the Z-joint arthropathy and associated pain but also is performed to rupture the associated facet cyst, thereby decompressing the nerve root in an attempt to avoid the need for a more invasive, open surgical decompression.

The use of intraarticular injections for aspiration, steroid injection and rupture of synovial cysts arising from the lumbar facet joints is well described.19-24, 26, 64-67 These procedures are typically accompanied by transforaminal epidural steroid injections20, 21, 67, 68 to treat the radicular pain component. However, the use of these procedures does not produce universally excellent results, and the cysts return about half of the time,21-24, 26 necessitating the need for surgical consideration. For this reason, it is recommended that the procedure not be repeated more than once and only if the first procedure produced satisfactory results.

Medial Branch Radiofrequency NeurotomyThe facet joints are dually innervated by medial branches emanating from the dorsal rami at the two adjacent levels in the cervical spine69 and superior levels in the lumbar spine.70-72 Surgical investigation has revealed intraarticular nerve endings as well as neu-rotransmitters associated with inflammation and pain,73-75 and animal studies have revealed the presence of mechanoreceptors.76 Joint provocation by intraarticular injection and capsule distension has produced clinically significant pain in asymptomatic individuals.14

When cervical medical branch RFN is performed using appropriate anatomic technique and when the patients are selected based on response to dual confirmatory diagnostic MBB, there is consistent evidence of the treatment’s effectiveness in reducing pain and dis-ability caused by cervical Z-joint pain.15,27 The most recent systematic review included eight primary studies.27 This systematic review found that a majority of patients, selected based on response to confirmatory MBB, were pain free at 6 months, with a number needed to treat of 2.

In the lumbar spine, an observational study of anatomically accurate RFA demonstrated that 80% of patients experienced at least 60% pain relief, and 60% of patients obtained at least 80% pain relief lasting 12 months after RFA.4 One randomized controlled trial employed a technique in which the RFA probes were positioned perpendicular to the medial branches. This is contrary to existing procedural recommendations as presumably only a short length of the nerve is lesioned using this approach. Indeed, the pain relief re-ported in the treatment arm was appreciable compared to the sham group, but as could be expected a diminishing number of patients had relief beyond 6 weeks after RFA.77 A randomized, controlled study of anatomically correct RFA in 40 patients revealed statistically significant improvement in back pain as well as functional outcome measures at 6 months.78 No serious adverse events or complica-tions were reported in these trials when motor stimulation is performed prior to ablation and the patients remained awake.79

When medial branch RFN is performed using appropriate anatomic technique and when the patients are selected based on response to dual confirmatory diagnostic MBB, there is consistent evidence of the treatment’s effectiveness in reducing pain and disability caused by Z-joint pain.15, 27


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There is no literature addressing the use of IA injections for thoracic pain, and literature for the use of MBB or RFA for persistent pain in the thoracic spine is limited to lower level evidence from retrospective studies and case series.80-83 Empirically, studies have demon-strated that the thoracic facets are also innervated by medial branches, though the anatomical course of these nerves is more unpre-dictable and varies by the given anatomical level within the thoracic spine.84 Literature exists demonstrating efficacy of thoracic MBB and RFN, though this is limited to retrospective studies with relatively small study populations. However, there is no medical literature that suggests any other effective alternative therapy for this patient population. As such, we feel clinicians should weigh the risks and benefits of pursuing these interventions versus other palliative care in patients with thoracic spine pain who otherwise appear to have very limited remaining treatment options.

Another recent systematic reviews investigated the durability of the response and effectiveness of repeat RFA treatment in the cer-vical spine and lumbar spine.28 This review found durable treatment effects, averaging nine months in patients treated in the cervical spine. It also showed that benefits were reproducible with repeat treatment, provided that response to the prior RFN was at least 3 months. Thus, medial branch RFN is indicated in patients with a diagnosis of Z-joint pain based on response to dual diagnostic MBB injections. Repeat treatment is indicated in patients who experience a return of symptoms following at least three months’ relief from a previous RFN.

References1. Schwarzer AC, Wang SC, Bogduk N, McNaught PJ, Laurent R. Prevalence and clinical features of lumbar zygapophysial joint pain: a study in an

Australian population with chronic low back pain. Ann Rheum Dis. 1995;54:100-6. 2. DePalma MJ, Ketchum JM, Saullo T. What is the source of chronic low back pain and does age play a role? Pain Med. 2011;12:224-33. 3. Manchikanti L, Manchikanti KN, Cash KA, Singh V, Giordano J. Age-related prevalence of facet-joint involvement in chronic neck and low back

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and lumbar regions. BMC Musculoskel Disord. 2004;5:15. 10. Speldewinde GC, Bashford GM, Davidson IR. Diagnostic cervical zygapophyseal joint blocks for chronic cervical pain. Medical J Aust.

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286. 34. Barnsley L, Bogduk N. Medial branch blocks are specific for the diagnosis of cervical zygapophyseal joint pain. Regional Anesth. 1993;18:343-50.35. Bogduk N. International Spinal Injection Society guidelines for the performance of spinal injection procedures. Part 1: Zygapophysial joint blocks.

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surgery. 1995;36:732-9.39. Veizi E MA. Medial branch blocks and facet joint injections as predictors of successful radiofrequency ablation. Tech Reg Anesth Pain Manage.

2011;15:33-8.40. Zakaria D. Facet joint injection as a diagnostic and therapeutic tool for spinal pain: a review of clinical and cost effectiveness. Technology Report

Canadian Agency for Drugs and Technologies in Health. 2007:77.41. Barnsley L, Lord S, Wallis B, Bogduk N. False-positive rates of cervical zygapophysial joint blocks. Clin J Pain. 1993;9:124-30.42. Lord SM, Barnsley L, Bogduk N. The utility of comparative local anesthetic blocks versus placebo-controlled blocks for the diagnosis of cervical

zygapophysial joint pain. Clin J Pain. 1995;11:208-13.43. Schwarzer AC, Aprill CN, Derby R, Fortin J, Kine G, Bogduk N. The false-positive rate of uncontrolled diagnostic blocks of the lumbar zygapoph-

ysial joints. Pain. 1994;58:195-200.44. Cohen SP, Larkin TM, Chang AS, Stojanovic MP. The causes of false-positive medial branch (facet joint) blocks in soldiers and retirees. Mil Med.

2004;169:781-6.45. Carragee EJ, Alamin TF, Carragee JM. Low-pressure positive Discography in subjects asymptomatic of significant low back pain illness. Spine.

2006;31:505-9.46. Hildebrandt J. AA. Percutaneous nerve block of the cervical facets - A relatively new method in the treatment of chronic headache and neck pain.

Pathological-anatomical studies and clinical practice. Manual Med. 1986;2:48-52.47. Manchikanti L, Singh V, Falco FJ, Cash KA, Fellows B. Comparative outcomes of a 2-year follow-up of cervical medial branch blocks in manage-

ment of chronic neck pain: a randomized, double-blind controlled trial. Pain Physician. 2010;13:437-50. 48. Manchikanti L, Singh V, Falco FJ, Cash KM, Fellows B. Cervical medial branch blocks for chronic cervical facet joint pain: a randomized, dou-

ble-blind, controlled trial with one-year follow-up. Spine. 2008;33:1813-20.49. Manchikanti L, Manchikanti KN, Damron KS, Pampati V. Effectiveness of cervical medial branch blocks in chronic neck pain: a prospective out-

come study. Pain Physician. 2004;7:195-201. 50. Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain

Physician. 2007;10:229-53. 51. Manchikanti L, Damron K, Cash K, Manchukonda R, Pampati V. Therapeutic cervical medial branch blocks in managing chronic neck pain: a

preliminary report of a randomized, double-blind, controlled trial: clinical trial NCT0033272. Pain Physician. 2006;9:333-46. 52. Bogduk N. Diagnostic procedures in chronic pain. In: Wilson PR WPJ, Hawthornthwaite JA, Jensen TS, ed. Clinical Pain Management: Chronic

Pain. 2008:145-68.53. Dory MA. Arthrography of the cervical facet joints. Radiology. 1983;148:379-82.

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54. Dussault RG, Nicolet VM. Cervical facet joint arthrography. J Can Assoc Radiol. 1985;36:79-80.55. Hove B, Gyldensted C. Cervical analgesic facet joint arthrography. Neuroradiology. 1990;32:456-9.56. Roy DF, Fleury J, Fontaine SB, Dussault RG. Clinical evaluation of cervical facet joint infiltration. Can Assoc Radiol J. 1988;39:118-20.57. Wedel DJ. Cervical facet arthrography. Reg Anesth. 1985;10:7-11.58. Barnsley L, Lord SM, Wallis BJ, Bogduk N. Lack of effect of intraarticular corticosteroids for chronic pain in the cervical zygapophyseal joints. N

Engl J Med. 1994;330:1047-50. 59. Bogduk NMB. Management of Acute and Chronic Neck Pain. An Evidence-Based Approach. Amsterdam: Elsevier; 2006.60. Boswell MV, Colson JD, Spillane WF. Therapeutic facet joint interventions in chronic spinal pain: a systematic review of effectiveness and com-

plications. Pain Physician. 2005;8:101-14. 61. Spitzer WOL FE, Dupuis M. Scientific approach to the assessment and management of activity-related spinal disorders: a monograph for clini-

cians. Report of Quebec Task Force on Spinal Disorders. Spine. 1987; 12:S1-S59.62. Wilby MJ, Fraser RD, Vernon-Roberts B, Moore RJ. The prevalence and pathogenesis of synovial cysts within the ligamentum flavum in patients

with lumbar spinal stenosis and radiculopathy. Spine. 2009; 34:2518-24. 63. DePalma MJ. Driving the lane: a clearer view of facet joint cyst intervention. Spine J. 2009;9:921-3.64. Hong Y, O'Grady T, Carlsson C, Casey J, Clements D. Percutaneous aspiration of lumbar facet synovial cyst. Anesthesiology. 1995;82:1061-2. 65. Imai K, Nakamura K, Inokuchi K, Oda H. Aspiration of intraspinal synovial cyst: recurrence after temporal improvement. Arch Orthop Trauma

Surg. 1998;118:103-5.66. Ortiz AO, Tekchandani L. Improved outcomes with direct percutaneous CT guided lumbar synovial cyst treatment: advanced approaches and

techniques. J Neurointerv Surg. 2014;6:790-4.67. Rauchwerger JJ, Candido KD, Zoarski GH. Technical and imaging report: fluoroscopic guidance for diagnosis and treatment of lumbar synovial

cyst. Pain Practice. 2011;11:180-4.68. Hsu KY, Zucherman JF, Shea WJ, Jeffrey RA. Lumbar intraspinal synovial and ganglion cysts (facet cysts). Ten-year experience in evaluation and

treatment. Spine. 1995;20:80-9. 69. Stabler A, Eck J, Penning R, et al. Cervical spine: postmortem assessment of accident injuries--comparison of radiographic, MR imaging, anatom-

ic, and pathologic findings. Radiology. 2001;221:340-6. 70. Bogduk N, Wilson AS, Tynan W. The human lumbar dorsal rami. J Anat. 1982;134:383-97. 71. Bradley KC. The anatomy of backache. Aust N Z J Surg. 1974;44:227-32.72. Lewin T, Moffett B, Vidik A. The morphology of the lumbar synovial interveertebral joints. Acta Morphol Neerl Scand. 1962;4:299-319.73. Ashton IK, Ashton BA, Gibson SJ, Polak JM, Jaffray DC, Eisenstein SM. Morphological basis for back pain: the demonstration of nerve fibers and

neuropeptides in the lumbar facet joint capsule but not in ligamentum flavum. J Orthop Res. 1992;10:72-8.74. Beaman DN, Graziano GP, Glover RA, Wojtys EM, Chang V. Substance P innervation of lumbar spine facet joints. Spine. 1993;18:1044-9.75. Giles LG, Harvey AR. Immunohistochemical demonstration of nociceptors in the capsule and synovial folds of human zygapophyseal joints. Br J

Rheumatol. 1987;26:362-4.76. Avramov AI, Cavanaugh JM, Ozaktay CA, Getchell TV, King AI. The effects of controlled mechanical loading on group-II, III, and IV afferent units

from the lumbar facet joint and surrounding tissue. An in vitro study. J Bone Joint Surg Am. 1992;74:1464-71.77. Bogduk N, Macintosh J, Marsland A. Technical limitations to the efficacy of radiofrequency neurotomy for spinal pain. Neurosurgery. 1987;20:529-

35.78. Nath S, Nath CA, Pettersson K. Percutaneous lumbar zygapophysial (Facet) joint neurotomy using radiofrequency current, in the management

of chronic low back pain: a randomized double-blind trial. Spine. 2008;33:1291-7; discussion 8.79. Falco FJ, Irwin L, Zhu J. Lumbar spine injection and interventional procedures in the management of low back pain. Clin Occup Environ Med.

2006;5:655-702, vii-viii.80. Tzaan WC, Tasker RR. Percutaneous radiofrequency facet rhizotomy—experience with 118 procedures and reappraisal of its value. Can J Neurol

Sci. 2000;27:125-130.81. Stolker RJ, Vervest AC, Groen GJ. Percutaneous facet denervation in chronic thoracic spinal pain. Acta Neurochir (Wien). 1993;122(1-2):82-90.82. Kim D. Bipolar intra-articular radiofrequency thermocoagulation of the thoracic facet joints: a case series of a new technique. The Korean Journal

of Pain. 2014; 27(1):43-48. 83. Wilson PR. Thoracic facet syndrome: a clinical entity? Pain. 1987;4(Suppl):S87.84. Dreyfuss P, Tibiletti C, Dreyer S, et al. Thoracic zygapophyseal joint pain: a review and description of an intra-articular block technique. Pain

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AuthorsNASS Coverage CommitteeCo-Chairs: John Glaser, MD & Scott Kreiner, MDMembers:Jamie Baisden, MDRay Baker, MDMaxwell Boakye, MDR.S. Cowan, MDMichael DePalma, MDDonald Dietze, MD

John Easa, MDGary Ghiselli, MDJames Harrop, MDTimothy Holt, MDScott Horn, DOD.J. Kennedy, MDAnthony Lapinsky, MD

Darren Lebl, MDPaul Matz, MDE. Kano Mayer, MDDavid O’Brien, MDAlpesh Patel, MD, FACSMitchell Reiter, MDCharles Reitman, MD

Timothy Sanford, MDAlex Seldomridge, MD, MBAAlok Sharan, MDMatthew Smuck, MDJeffrey Summers, MDWilliam Tontz, MDScott Tromanhauser, MD, MBA


Author DisclosuresBaisden, Jamie L.: Nothing to disclose.Baker, Ray M.: Private Investments: Nocimed (1%), Laurimed (<1%), Consulting: UnitedHealthcare (B), Mesoblast (C); Board of

Directors: SIS (Immediate Past President of the International Spine Intervention Society); Scientific Advisory Board: Veritas Health (B); Relationships Outside the One Year Requirement: Relievant MedSystems (<1%, dissolved 2012).

Boakye, Maxwell: Nothing to disclose.Cowan, R. S.: Consulting: LDR (B); Research Support - Investigator Salary: LDR (B); Relationships Outside the One-Year Require-

ment: LDR (Speaking and/or Teaching Arrangement, A, dissolved 2010).DePalma, Michael J.: Consulting: VertiFlex, Inc. (Amount not disclosed, Paid directly to institution/employer); Trips/Travel:

Medtronic (Travel expenses); Board of Directors: SIS (Travel expenses, Paid directly to institution/employer), Virginia Spine Research Institute, Inc. (President and Director of Research, Paid directly to institution/employer); Scientific Advisory Board: Medtronic (Amount not disclosed), Halyard (Amount not disclosed, Paid directly to institution/employer); Research Support (Investigator Salary): Relievant (B, Paid directly to institution/employer), SI-Bone (B, Paid directly to institution/employer), Mesoblast, Inc. (B, Paid directly to institution/employer), VertiFlex (B, Paid directly to institution/employer); Research Support (Staff/Materials): Relievant (B, Paid directly to institution/employer), Mesoblast (B, Paid directly to institution/employer), SI-Bone (B, Paid directly to institution/employer), VertiFlex (B, Paid directly to institution/employer); Relationships Outside the One Year Requirement: AOI Medical (A, dissolved 2010), Stryker Interventional Spine (B, dissolved 2010), St. Jude Medical (Amount not disclosed, dissolved 2010), Kyphon/Medtronic (B, dissolved 2008), Stryker Biotech (A, dissolved 2011). ATRM (A, dissolved 2011).

Dietze, Donald: Stock Ownership: Globus Medical (<1%, Paid directly to institution/employer); Consulting: Medtronic (None, Paid directly to institution/employer), Precision Spine (None), Spinal Frontier (None).

Easa, John E.: Stock Ownership: Janus Biotherapeutics (3%, Paid directly to institution/employer).Ghiselli, Gary: Private Investments: DiFusion (9%); Consulting: New Era Orthopedics (B).Glaser, John A.: Nothing to disclose.Harrop, James S.: Royalties: Jaypee Publishing (A); Consulting: DePuy Spine (C, Paid directly to institution/employer); Board of Di-

rectors: Jefferson Medical College Physician Board (None); Scientific Advisory Board: Bioventus (B, Medical Advisory Board); Other Office: Bioventus (B), Asterias (B, Data Monitoring Safety Board); Grants: AO Spine (E, Paid directly to institution/em-ployer); Fellowship Support: NREF (E, Paid directly to institution/employer); Other: Teijin (B, Data safety monitoring board).

Holt, Timothy A.: Speaking and/or teaching arrangements: SI-Bone (E, Paid directly to institution/employer); Trips/Travel: SI-Bone (B).

Horn, Scott I.: Speaking and/or Teaching Arrangements: North American Spine Society (Travel expenses), AAPMR (Travel ex-penses), SIS (Travel expenses); Board of Directors: Spine Intervention Society (Health Policy Chair); Other Office: SIS (CPT Advisor).

Kennedy, D.J.: Speaking and/or Teaching Arrangements: Spine Intervention Society (Travel expenses); Trips/Travel: AAPM&R (Travel expenses), Spine Intervention Society (A); Board of Directors: AAPM&R (Board of Directors – Member At Large), Spine


12




intervention Society (Treasurer), Association of Academic Physiatrists (Board of Directors - Chair of Membership Committee).Kreiner, Scott: Stock Ownership: LDR Holdings (1%); Speaking and/or Teaching Arrangements: North American Spine Society

(Travel expenses.); Trips/Travel: ISIS (Travel expenses).Lapinsky, Anthony S.: Nothing to disclose.Lebl, Darren R.: Speaking and/or Teaching Arrangements: Medtronic (B); Scientific Advisory Board: K2M MIS Advisory Team (B).Matz, Paul G.: Speaking and/or teaching arrangements: AO Spine North America (B).Mayer, E. Kano A.: Speaking and/or Teaching Arrangements: North American Spine Society (Travel expenses); Trips/Travel: North

American Spine Society (B); Research Support - Staff and/or Materials: SI-Bone (B, Paid directly to institution/employer).O'Brien, David R.: Stock Ownership: OrthoCarolina (<1%), Transformant Healthcare Solutions (<1%), Arrowlytics (<1%); Trips/

Travel: North American Spine Society (B); Board of Directors: North American Spine Society (Health Policy Council Director); Speaking and/or Teaching Arrangements: SIS (Travel expenses).

Patel, Alpesh A.: Royalties: Amedica (B); Stock Ownership: Amedica (<1%), Cytonics (<1), Nocimed (<1), Vital5 (<1); Consulting: Amedica (None), Stryker (None), Biomet (C), DePuy Synthes Spine (B); Board of Directors: Cervical Spine Research Society (None); Fellowship Support: OREF (A), Omega (B); Other: Amedica (Private investment, <1%).

Reiter, Mitchell F.: Private Investments: CreOsso (4%).Reitman, Charles A.: Trips/Travel: North American Spine Society (Travel expenses); Board of Directors: North American Spine

Society (Research Council Director); Scientific Advisory Board: Clinical Orthopedics and Related Research (B, Deputy Editor, Paid directly to institution/employer).

Sanford, Timothy: Nothing to disclose.Seldomridge, Alex: Nothing to disclose.Sharan, Alok D.: Consulting: Paradigm Spine (B); Other: Jaypee Brothers (A).Smuck, Matthew: Stock Ownership: NuSpine (1%), BlueJay Mobile-Health (1%); Private Investments: Vivametrica/Sikoya (20%,

Founding partner); Trips/Travel: SIS (B), North American Spine Society (B); Board of Directors: Vivametrica/Sikoya (None), SIS (None), North American Spine Society (None); Scientific Advisory Board: NuSpine (Stock options), Lumo Body Tech (Stock options), BlueJay Mobile-Health (Stock options); Other Office: The Spine Journal (Deputy Editor), SIS (Board of Directors), North American Spine Society (Board of Directors); Other: Expert witness - State Farm (F), Expert witness - Kaiser Permanente (C); Relationships Outside the One-Year Requirement: Cytonics, Inc. (Research Support: Staff and/or Materials, F, dissolved in 2011).

Summers, Jeffrey T.: Stock Ownership: NEVRO (1%); Board of Directors: First Choice Insurance (Representative for Pain Manage-ment), SIS (Board Member and Past President, Travel expenses).

Tontz, William L.: Device or Biologic Distributorship (Physician-Owned Distributorship): Aliphatic (A, Paid directly to institution/employer); Stock Ownership: Phygen (<1%, Paid directly to institution/employer); Consulting: Medtronic (B, Paid directly to institution/employer); Speaking and/or Teaching Arrangements: SpineArt (A); Trips/Travel: Stryker (B); Scientific Advisory Board: Medtronic (Consulting Disclosed Above).

Tromanhauser, Scott G.: Stock Ownership: Soteira, Inc. (1%); Consulting: Boston Biomedical Associates (B); Board of Directors: New England Baptist Hospital (Ex Officio member of the Board of Trustees); Other Office: Controlled Risk Insurance Company (Board-level committee member, provided with travel and lodging expenses for annual meetings only).

Truumees, Eeric: Royalties: Stryker Spine (B); Board of Directors: North American Spine Society (Administration and Development Council Director); Other Office: AAOS Communications Cabinet (Incoming Editor-in-Chief of AAOS Now, AAOS Communi-cations Cabinet member, Travel expenses, Monthly stipend.); Research Support - Investigator Salary: Relievant (B, Paid directly to institution/employer); Relationships Outside the One-Year Requirement: Research Support - Staff and/or Materials: Globus (B, Paid directly to institution/employer, Dissolved 2013).

CommentsComments regarding the coverage recommendations may be submitted to [email protected] and will be considered in development of future revisions of the work.










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North American Spine Society 7075 Veterans Blvd. Burr Ridge, IL 60527


CervicalArtificial DiscReplacement

TASKFORCE

SacroiliacJointInjections

Endorsed by:

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This coverage recommendation is proprietary information owned by NASS. NASS members and other lawful purchasers of this document are authorized to use this recommendation for personal use only. Distribution beyond the member or purchasers own personal use is expressly forbidden, absent written consent from NASS.


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MethodologyThe coverage policies put forth by NASS use an evidence-based approach to spinal care when possible. In the absence of strict evidence-based criteria, policies reflect the multidisciplinary and non-conflicted experience and expertise of the authors in order to reflect reasonable standard practice indications in the United States.


Scope and Clinical Indications Management of chronic low back pain is a significant contributor to the national health care budget. When using comparative anes-thetic blocks with a high degree of pain relief, the prevalence of sacroiliac joint pain likely ranges from 20% to 30% in patients with suspected SIJ pain based on history and physical examination.1-5 Sacroiliac (SI) joint injections have been used to diagnose and treat pain from this structure. Lateral branch blocks and radiofrequency ablation have similarly been used to diagnose and treat pain from the SI joint or from the posterior sacroiliac complex.

Pain from the SI joint may arise from a variety of disorders but most commonly is thought to be from degenerative or inflammatory arthritis. Certain conditions can increase the prevalence of SI joint pain, these include prior lumbar fusion6-9, older patient age10-12 and history of trauma.10,13

There is a known high false positive rate, at around 20% with SI joint injections.1,2,14,15 In order to increase the likelihood of the presence of this condition in patients whom an injection is considered, physical examination can be helpful. The literature has not demonstrated a single physical exam maneuver with a likelihood ratio greater than 1.3 for predicting a positive response to intra-articular anesthet-ic.2,16,17 However, other studies15,18,19 have reported that responses to at least three exam maneuvers (FABER, thigh thrust, Gaenslen’s, distraction, sacral thrust, and compression) were predictive of a positive response with a reported sensitivity of 78%.Clinical Criteria for the Procedure

Item 1: Diagnostic SI joint injectionsIntraarticular SI joint injections are indicated to aid in the diagnostic work-up of low back pain when ALL of the listed criteria are met. Of note, any and all SIJ injections should be performed with some form of radiographic image guidance (eg, fluoroscopic, CT-guided). Further, volume of injectate should be limited to 2 mL20-24, the inclusion of steroid with local anesthetic is not inappropriate. A diag-nosis of SI joint pain is confirmed with at least 75% reduction of pain for the expected duration of the anesthetic used on 2 separate occasions.

1. Patient’s report of nonradicular, typically unilateral pain that is caudal to the lumbar spine (L5 vertebrae), localized over the posterior SIJ, and consistent with SIJ pain

2. A thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin’s point, ie, at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (eg, greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist.

3. Positive response to a cluster of three provocative tests (eg, thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test). Note that the thrust tests is not recommended in pregnant patients or those with connective tissue disorders.

Sacroiliac Joint Injections


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Item 2: Therapeutic SI joint injectionsIntraarticular SI joint injections of corticosteroid with or without local anesthetic are indicated for the treatment of low back pain when all of the listed criteria are met:

1. Patient’s report of nonradicular, typically unilateral pain that is caudal to the lumbar spine (L5 vertebrae), localized over the posterior SIJ, and consistent with SIJ pain.

2. A thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin’s point, ie, at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (eg, greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist.

3. Positive response to a cluster of three provocative tests (eg, thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test). Note that the thrust tests is not recommended in pregnant patients or those with connective tissue disorders.

4. SIJ pain has been confirmed with diagnostic SIJ injections.

RationaleItem 1:Image Guidance: Some form of image guidance is considered requisite for performing SI joint injections. In 2003, Hansen25, in an observational study, showed that blind needle placement for sacroiliac joint injection was successful in only 12% of patients. He subsequently recommended image guidance. Rosenberg et al26, in a prospective, double-blind study, showed intra-articular injections in only 22% of patients when no image guidance was used. Though multiple ultrasound-guided sacroiliac joint injection systems are available, Simopoulos et al27 found no systematic evaluations of ultrasound for SI joint injections. In most recent systematic reviews of SI joint interventions, fluoroscopic or CT guidance has been considered an inclusion criteria.25,27-29

Physical Exam Findings: The utility of physical exam findings in the diagnosis of SI joint pain has been well-studied. In a systemic review by Szadek, meta-analysis of five individual provocation tests, compression, distraction, thigh thrust, Gaenslen’s test, and Patrick’s sign were evaluated.30 Analysis showed that positive thigh thrust test or compression tests are likely to have SI joint pain. Also, threshold of three positive tests had good diagnostic validity for SI joint pain. Joint injection with varying degree of pain relief (as low as 50%) was the gold standard. In contrast, Dreyfuss reviewed 20 physical examination tests, including thigh thrust, Gaenslen’s, Patrick’s, sacral thrust, and compression.17 This group showed that no single test or combination of tests was sufficiently useful in diagnosing sacroiliac joint pain. Of note, SI joint injection with high level of pain relief (>90%) was used as the gold standard. Three studies15,18,19 have reported that responses to at least three exam maneuvers (FABER, thigh thrust, Gaenslen’s, distraction, sacral thrust, and compression) were predictive of a positive response with a reported sensitivity of 78%. Finally, a review by Hancock found that single manual tests for SI joint pain were uninformative, although combinations of test were helpful.31 Based on these available data, it seems reasonable to require documentation of at least three positive provocative physical examination maneuvers prior to consider-ation of a diagnostic or therapeutic injection.

Requirement of Radiographic Findings: Hansen reviewed the databases of EMBASE, MEDLINE and Cochrane reviews.32 This group concluded that MRI can detect abnormalities of the cartilaginous sacroiliac joint, early spondyloarthropathy, and inflammatory and destructive changes of the SI joint. Similar to literature about the lack of correlation between disc degeneration and back pain, this group found that radiological SI findings have not been found to be an accurate indicator of symptoms. Interestingly, Hancock, in a review of Medline, EMBASE, and CINAHL, found a positive bone scan may increase the probability of the SIJ being the source of pain, though a negative scan does not reduce the probability.31 In a more detailed analysis, Blum showed that MRI was more sensitive and specific than scintigraphy or radiography for sacroilitis.33 Simopoulos concluded that MRI appears to be useful for early sacroiliitis and to follow patients with spondyloarthropathy.27 Thus, imaging is considered be helpful in identifying patients who might benefit from further evaluations such as a diagnostic injection, though the absence of abnormalities on imaging does not negate the appropriate-ness of performing the procedure.

Utility of Diagnostic Injections: There have been 7 studies using controlled blocks to diagnose SI joint pain. Increasing the percentage of pain relief required for a positive block also decreases the reported prevalence of SIJ pain. Differences mainly arose when relaxing criteria from >75% to >50% pain relief (Table 1).



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Single diagnostic injections have been used in multiple studies3,11,14,16,17,22,23,34-40. When comparing controlled blocks with single diagnostic injections, the known false positive rate of injections is clearly demonstrated. Studies utilizing single blocks report rates of 29-63%, while studies utilizing dual blocks report rates between 10-33% (with only one study showing higher rates at 45%). For this reason, dual diagnostic blocks, with at least a 75% reduction in pain, are needed to confirm the diagnosis of SI joint pain.

Item 2: Therapeutic SI joint injections: The utility of therapeutic SI joint injections has been well-studied. Hansen (2012) in a systematic re-view for therapy of SI joint pain found limited (or poor) evidence for intra-articular steroid injection and limited (or poor) evidence for peri-articular injection of local anesthetic and steroid or botulinum toxin.25 Hawkins (2009), in a retrospective audit of 155 patients, showed 77% of patients with short-term pain relief after one injection.41 Of those who showed pain relief, approximately 1/3 remained improved after one injection, and 2/3 remained improved after one or 2 injections. Of those who received 2 or more injections, the duration of relief averaged 9.3 months. Liliang (2009), in a prospective case series of sacroiliac joint pain determined by dual blocks, showed 66.7% patients with pain relief of more than 6 weeks.5 All patients required a second injection, which then had a mean dura-tion of pain relief of 36.8 weeks. Interestingly, the 33.3% with a positive diagnostic injection but less than 6 weeks of pain relief had pain reduction mean of 4.4 weeks.

Luukkainen demonstrated in a non-blinded, randomized single injection study a significant decrease in VAS and pain index at four weeks in patients with peri-articular methyl-prednisolone acetate and lidocaine injection compared to sodium chloride and lidocaine injection.42 Borowsky showed in a retrospective review of two case series that injection of steroids in the SI joint and the posterior in-ter-osseous ligament and S1-3 lateral branches improved short-term (3 months) clinical outcomes when compared to sacroiliac joint alone, although both were suboptimal (12.5% vs. 31.25%).34 McKenzie-Brown in a systematic review that included spondyloarthopa-thy concluded that evidence for intra-articular sacroiliac joint injections was moderate for short-term relief and limited for long-term relief.28

Based on these data, it seems reasonable to offer coverage of therapeutic SI joint injections in those cases that fulfill the listed criteria. It is acknowledged that there will likely not be high quality data to support the predictive value of each of these criteria. However, con-sidering the available evidence discussed above in Item 1, it seems reasonable to apply these criteria to therapeutic SI joint injections.

Table 1

Percentage Positive 95% CI ReferencesSelection Based on Controlled Local Anesthetic BlocksAt least 80% relief 10% 0-23% Manchikanti 2001At least 75% relief 19% 9-29% Maigne 1996At least 50% relief 45% 32-58% Van Der Wurff 2006Selection Based on Controlled Injections of Local Anesthetic and SteroidAt least 80% relief 33% 20-46% Laslett 2005At least 75% relief 26% 19-33% Liliang 2009

33% 26-40% Liliang 2011At least 50% relief 27% 20-34% Irwin 2007

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2001; 4: 308-16. 2. Maigne JY, Aivaliklis A, Pfefer F. Results of sacroiliac joint double block and value of sacroiliac pain provocation tests in 54 patients with low back

pain. Spine. 1996; 21: 1889-92.3. Maigne JY, Boulahdour H, Chatellier G. Value of quantitative radionuclide bone scanning in the diagnosis of sacroiliac joint syndrome in 32 pa-

tients with low back pain. Eur Spine J. 1998;7:328-31. 4. Laslett M, McDonald B, Tropp H, Aprill CN, Oberg B. Agreement between diagnoses reached by clinical examination and available reference










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treatment of sacroiliac joint dysfunction without spondyloarthropathy. Spine. 2009; 34: 896-900.6. Liliang PC, Lu K, Liang CL, Tsai YD, Wang KW, Chen HJ. Sacroiliac joint pain after lumbar and lumbosacral fusion: Findings using dual sacroiliac

joint blocks. Pain Med. 2011; 12: 565-70.7. DePalma MJ, Ketchum JM, Saullo TR. Etiology of chronic low back pain in patients having undergone lumbar fusion. Pain Med. 2011 May;12:732-9.8. Maigne JY, Planchon CA. Sacroiliac joint pain after lumbar fusion. A study with anesthetic blocks. Eur Spine J. 2005 Sep;14(7):654-8. 9. Katz V, Schofferman J, Reynolds J. The sacroiliac joint: A potential cause of pain after lumbar fusion to the sacrum. J Spinal Disord Tech. 2003

Feb; 16: 96-9.10. DePalma MJ, Ketchum JM, Saullo T. What is the source of chronic low back pain and does age play a role? Pain Med. 2011 Feb;12(2): 224-33.11. DePalma MJ, Ketchum JM, Saullo TR. Multivariable analyses of the relationships between age, gender, and body mass index and the source of

chronic low back pain. Pain Medicine. 2012; 13: 498-506.12. Laplante BL, Ketchum JM, Saullo TR, DePalma MJ. Multivariable analysis of the relationship between pain referral patterns and the source of

chronic low back pain. Pain Physician. 2012 Mar-Apr;15(2):171-8. 13. Weksler N, Velan GJ, Semionov M, et al. The role of sacroiliac joint dysfunction in the genesis of low back pain: the obvious is not always right.

Arch Orthop Trauma Surg. 2007 Dec;127(10):885-8.14. Chou LH, Slipman CW, Bhagia SM, et al. Inciting events initiating injection-proven sacroiliac joint syndrome. Pain Med. 2004 Mar;5(1):26-32.15. Laslett M, Young SB, Aprill CN, McDonald B. Diagnosing painful sacroiliac joints: A validity study of a McKenzie evaluation and sacroiliac prov-

ocation tests. Aust J Physiother. 2003;49(2):89-97. 16. Schwarzer AC, Aprill CN, Bogduk N. The sacroiliac joint in chronic low back pain. Spine. 1995; 20: 31-7.17. Dreyfuss P, Michaelsen M, Pauza K, McLarty J, Bogduk N. The value of medical history and physical examination in diagnosing sacroiliac joint

pain. Spine. 1996; 21: 2594-602.18. Laslett M, Aprill CN, McDonald B, Young SB. Diagnosis of sacroiliac joint pain: Validity of individual provocation tests and composites of tests.

Man Ther. 2005 Aug;10(3):207-18.19. Van Der Wurff P, Buijs EJ, Groen GJ. Intensity mapping of pain referral areas in sacroiliac joint pain patients. J Manipulative Physiol Ther. 2006

Mar-Apr;29(3):190-5.20. Dreyfuss P, Henning T, Malladi N, Goldstein B, Bogduk N. The ability of multi-site, multi-depth sacral lateral branch blocks to anesthetize the

sacroiliac joint complex. Pain Med. 2009;10(4):679-88.21. Dreyfuss P, Snyder BD, Park K, Willard F, Carreiro J, Bogduk N. The ability of single site, single depth sacral lateral branch blocks to anesthetize

the sacroiliac joint complex. Pain Med. 2008 Oct;9(7):844-50.22. Fortin JD, Aprill CN, Ponthieux B, Pier J, Derby Jr R. Sacroiliac joint: Pain referral maps upon applying a new injection/arthrography technique.

Part II: Clinical evaluation. Spine. 1994; 19: 1483-9.23. Fortin JD, Dwyer AP, West S, Pier J. Sacroiliac joint: Pain referral maps upon applying a new injection/arthrography technique. Part I: Asymptom-

atic volunteers. Spine. 1994; 19: 1475-82.24. Fortin JD, Tolchin RB. Sacroiliac arthrograms and post-arthrography computerized tomography. Pain Physician. 2003 Jul;6(3):287-90. 25. Hansen HC. Is fluoroscopy necessary for sacroiliac joint injections? Pain Physician. 2003 Apr;6(2):155-8. 26. Rosenberg JM, Quint TJ, de Rosayro AM. Computerized tomographic localization of clinically-guided sacroiliac joint injections. Clinical J Pain.

2000 Mar;16(1):18-21.27. Simopoulos TT, Manchikanti L, Singh V, et al. A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions. Pain

Physician. 2012 May-Jun;15(3):E305-E44. 28. McKenzie-Brown AM, Shah RV, Sehgal N, Everett CR. A systematic review of sacroiliac joint interventions. Pain Physician. 2005 Jan;8(1):115-25. 29. Rupert MP, Lee M, Manchikanti L, Datta S, Cohen SP. Evaluation of sacroiliac joint interventions: a systematic appraisal of the literature. Pain

Physician. 2009 Mar-Apr;12(2):399-418. 30. Szadek KM, van der Wurff P, van Tulder MW, Zuurmond WW, Perez RS. Diagnostic validity of criteria for sacroiliac joint pain: a systematic re-

view. J Pain. 2009 Apr;10(4):354-68.31. Hancock MJ, Maher CG, Latimer J, et al. Systematic review of tests to identify the disc, SIJ or facet joint as the source of low back pain. Eur Spine

J. 2007; 16: 1539-50. 32. Hansen HC, McKenzie-Brown AM, Cohen SP, Swicegood JR, Colson JD, Manchikanti L. Sacroiliac joint interventions: a systematic review. Pain

Physician. 2007; 10: 165-84. 33. Blum U, Buitrago-Tellez C, Mundinger A, et al. Magnetic resonance imaging (MRI) for detection of active sacroiliitis--a prospective study com-

paring conventional radiography, scintigraphy, and contrast enhanced MRI. J Rheumatol. 1996 Dec;23(12):2107-15.34. Borowsky CD, Fagen G. Sources of sacroiliac region pain: Insights gained from a study comparing standard intra-articular injection with a tech-

nique combining intra- and peri-articular injection. Arch Phys Med Rehabil. 2008 Nov;89(11):2048-56.35. Chakraverty R, Dias R. Audit of conservative management of chronic low back pain in a secondary care setting - Part I: Facet joint and sacroiliac

joint interventions. Acupunct Med. 2004 Dec;22(4):207-13. 36. Cohen SP, Hameed H, Kurihara C, et al. The effect of sedation on the accuracy and treatment outcomes for diagnostic injections: a randomized,

controlled, crossover study. Pain Med. 2014 Apr;15(4): 588-602.




































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37. Slipman CW, Sterenfeld EB, Chou LH, Herzog R, Vresilovic E. The value of radionuclide imaging in the diagnosis of sacroiliac joint syndrome. Spine. 1996; 21: 2251-4.

38. Slipman CW, Sterenfeld EB, Chou LH, Herzog R, Vresilovic E. The predictive value of provocative sacroiliac joint stress maneuvers in the diagnosis of sacroiliac joint syndrome. Arch Phys Med Rehabil. 1998 Mar;79(3):288-92.

39. Stanford G, Burnham RS. Is it useful to repeat sacroiliac joint provocative tests post-block? Pain Med. 2010 Dec;11(12):1774-6.40. Young S, Aprill C, Laslett M. Correlation of clinical examination characteristics with three sources of chronic low back pain. Spine J. 2003 Nov-

Dec;3(6):460-5.41. Hawkins J, Schofferman J. Serial therapeutic sacroiliac joint injections: a practice audit. Pain Med. 2009 Jul-Aug;10(5):850-3.42. Luukkainen RK, Wennerstrand PV, Kautiainen HH, Sanila MT, Asikainen EL. Efficacy of periarticular corticosteroid treatment of the sacroiliac

joint in non-spondylarthropathic patients with chronic low back pain in the region of the sacroiliac joint. Clin Exp Rheumatol. 2002 Jan-Feb;20(1): 52-4.

AuthorsNASS Coverage CommitteeCo-Chairs: John Glaser, MDScott Kreiner, MDMembers:Jamie Baisden, MD, FACSRay Baker, MDAshok Biyani, MD


Author DisclosuresBaisden, Jamie L.: Nothing to Disclose.Baker, Ray M.: Stock Ownership: Relievant (<1%); Private Investments: Nocimed (1.78%), Laurimed (<1%); Consulting: Medtronic (B),

UnitedHealthcare (B), Mesoblast (B); Board of Directors: ISIS (Immediate Past President); Scientific Advisory Board: Collaborative Spine Research Foundation (Board Member), Spine-Health.com (B).

Biyani, Ashok: Royalties: Globus Medical (E), Custom Spine (C); Consulting: K2M (B).Boakye, Maxwell: Nothing to Disclose.Cho, Charles: Board of Directors: North American Spine Society (Evidence Compilation and Analysis Chair, Travel expenses); Other

Office: American Society of Neuroradiology (Finance Management Committee Co-Chair).Cowan, R.S.: Relationships Outside the One Year Requirement: LDR (A, dissolved 2010).DePalma, Michael J.: Consulting: VertiFlex, Inc. (Amount not disclosed, Paid directly to institution/employer); Trips/Travel: Medtronic

(Travel expenses); Board of Directors: ISIS (Travel expenses, Paid directly to institution/employer), Virginia Spine Research Insti-tute, Inc. (Amount not disclosed, President and Director of Research, Paid directly to institution/employer); Scientific Advisory Board: Medtronic (Amount not disclosed), Halyard (Amount not disclosed, Paid directly to institution/employer); Research Sup-port (Investigator Salary): Relievant (B, Paid directly to institution/employer), SI-Bone (B, Paid directly to institution/employer), Mesoblast, Inc. (B, Paid directly to institution/employer), VertiFlex (B, Paid directly to institution/employer); Research Support (Staff/Materials): Relievant (B, Paid directly to institution/employer), Mesoblast (B, Paid directly to institution/employer), SI-Bone (B, Paid directly to institution/employer), VertiFlex (B, Paid directly to institution/employer); Relationships Outside the One Year Requirement: AOI Medical (None, dissolved 2010), Stryker Interventional Spine (B, dissolved 2010), St. Jude Medical (Amount not disclosed, dissolved 2010), Stryker Biotech (None, dissolved 2011). ATRM (None, dissolved 2011).

Dietze, Donald D.: Stock Ownership: Globus Medical (<1%, Paid directly to institution/employer); Consulting: Globus Medical (None, Paid directly to institution/employer).

Donelson, Ronald G.: Stock Ownership: Integrated Mechanical Care (4%); Consulting: The McKenzie Institute International (B); Other Office: Integrated Mechanical Care (Medical Director).

Easa, John E.: Stock Ownership: Janus Biotherapeutics (3%, Paid directly to institution/employer).

Maxwell Boakye, MD Charles Cho, MD, MBAR.S. Cowan, MDMichael DePalma, MDDonald Dietze, MDRonald Donelson, MD, MSJohn Easa, MDGary Ghiselli, MD

James Harrop, MDTimothy Holt, MDScott Horn, DOAnthony Lapinski, MDDarren Lebl, MDPaul Matz, MDDavid O'Brien, MDAlpesh Patel, MD, FACS

Mitchell Reiter, MDCharles Reitman, MDAlok Sharan, MDJeffrey Summers, MDWilliam Tontz, MDScott Tromanhauser, MD, MBAEeric Truumees, MD














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Ghiselli, Gary: Private Investments: Difusion (9%); Consulting: Biomet (B); Scientific Advisory Board: Difusion (Stock options).Glaser, John A.: Grants: SI-Bone (D, Paid directly to institution/employer).Harrop, James S.: Consulting: DePuy Synthes Spine (C, Paid directly to institution/employer); Board of Directors: Jefferson Medical Col-

lege Physician Board (None); Scientific Advisory Board: AxioMed (Medical Advisory Board); Other Office: Bioventus (B), Asterias Biotherapeutics (B, Data Monitoring Safety Board); Other: Teijin (B, Data Safety Monitoring Board).

Holt, Timothy A.: Speaking and/or teaching arrangements: SI-Bone (E, Paid directly to institution/employer); Trips/Travel: SI-Bone (B).Horn, Scott: Speaking and/or teaching arrangements: North American Spine Society (Travel expenses), AAPMR (Travel expenses), ISIS

(Travel expenses); Other Office: ISIS (Travel expenses, CPT Advisor).Kreiner, Scott: Stock Ownership: LDR (<1%); Speaking and/or teaching arrangements: North American Spine Society (Travel expenses);

Trips/Travel: ISIS (Travel Expenses).Lapinsky, Anthony S.: Royalties: RTI Surgical (B); Consulting: Orthofix (Amount not disclosed).Lebl, Darren R.: Consulting: Medtronic (B); Scientific Advisory Board: K2M MI Advisory Board (Travel expenses).Matz, Paul G.: Speaking and/or teaching arrangements: AO Spine North America (B); Trips/Travel: North American Spine Society (A).O'Brien Jr., David R.: Speaking and/or teaching arrangements: North American Spine Society (B, Travel expenses); Trips/Travel: ISIS

(Travel expenses), AAPMR (Travel expenses); Board of Directors: North American Spine Society (Health Policy Council Director); Other Office: ISIS (Socioeconomic Council Vice-Chair), AAPMR (NC CAC Representative).

Patel, Alpesh A.: Royalties: Amedica (B); Stock Ownership: Amedica (<1%), Cytonics (<1%), Nocimed (<1%), Vital5 (<1%); Consulting: Amedica (B), Stryker (None), Biomet (B ), DePuy Synthes Spine (B); Board of Directors: Cervical Spine Research Society (None); Fellowship Support: OREF (D), Omega (B); Other: Amedica (<1%).

Reiter, Mitchell F.: Private Investments: CreOsso (4%).Reitman, Charles A.: Trips/Travel: North American Spine Society (Travel expenses); Board of Directors: North American Spine Society

(Research Council Director); Scientific Advisory Board: Clinical Orthopedics and Related Research (B, Deputy Editor, Paid directly to institution/employer).

Sharan, Alok D.: Other: Jaypee Brothers (A).Summers, Jeffrey T.: Stock Ownership: Medworx (15%); Private Investments: Morris Innovative (<1%); Board of Directors: First Choice

Insurance (None), ISIS (President, Travel expenses).Tontz, William L.: Stock Ownership: Phygen (<1%, Paid directly to institution/employer); Consulting: Medtronic (C, Paid directly to in-

stitution/employer); Speaking and/or teaching arrangements: SpineArt (B); Trips/Travel: Medtronic (B); Scientific Advisory Board: Medtronic (consulting disclosed).

Tromanhauser, Scott G.: Stock Ownership: Soteira, Inc. (<1%).Truumees, Eeric: Royalties: Stryker (C); Stock Ownership: Doctor's Research Group (<1%); Board of Directors: North American Spine So-

ciety (Administration and Development Council Director); Other Office: AAOS Communications Cabinet (Incoming Editor-in-Chief of AAOS Now, AAOS Communications Cabinet Member, Travel expenses); Research Support - Investigator Salary: Relevant (B, Paid directly to institution/employer); Research Support - Staff and/or Materials: Globus (B, Paid directly to institution/employer); Relationships Outside the One-Year Requirement: IP Evolutions (Private Investment, dissolved 2012), Stryker Biotech (Paid directly to institution/employer, dissolved 2004).

CommentsComments regarding the coverage recommendations may be submitted to [email protected] and will be considered in development of future revisions of the work.





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Methodology | NASS Coverage Policy Recommendations

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NASS Resources























February23,2018DivisionofWorkers’Compensation viaEmailto:[email protected],CA94142Re:MultisocietySupportforCoverageofRadiofrequencyNeurotomyToWhomItMayConcern:Theundersignedmedicalspecialtysocieties,comprisingphysicianswhoutilizeand/orperforminterventionalspineprocedurestoaccuratelydiagnoseandtreatpatientssufferingfromspinepathologies,wouldliketotakethisopportunitytoexpressourstrongsupportforcoverageoflumbarmedialbranch(facet)thermalradiofrequencyneurotomy(RFneurotomy)andprovideadetailedexplanationforwhyyoushouldtoo.Oursocietieshaveastrongrecordofworkingtoeliminatefraudulent,unproven,andinappropriateprocedures.Atthesametime,weareequallycommittedtoassuringthatappropriate,effective,andresponsibletreatmentsarepreservedsothatpatientsdonothavetosuffer,orundergomoreinvasivesurgicalprocedures,unnecessarily.PayersareconcernedabouttheincreasingcostoffacetRFneurotomyanditsassociateddiagnosticmedialbranchblocks;andjustifiablyso.Inseekingtolimitcosts,however,itisimportanttoidentifytherootoftheproblem.Therootoftheproblemliesnotintheprocedures,butratherintheirinappropriateapplication.LiteratureassessingmedialbranchblocksandfacetRFneurotomyshowshowtheseprocedurescanbeperformedinadisciplined,responsiblemanner,inordertoachievedesirableoutcomesthatareclinically,socially,andeconomicallyworthwhile1,2.Surelysignificantreliefofpain,withgreaterrestorationoffunctionandreturntowork,aswellasdecreasedutilizationofotherhealthcareresourcesisanoutcomethatyoudonotwanttodenypatients.ThoseoutcomescanbeachievedbytheresponsibleapplicationoffacetRFneurotomy.Inordertoaddressthetrueproblemoftheinappropriateapplicationoftheseprocedures,thefollowingrequirementsshouldbeapplied:

§ Atleast80%reliefofindexpainfrommedialbranchblocksshouldberecognizedasapretextforfurtherinvestigation.

§ Lessthan80%reliefofindexpainshouldberegardedasnon-positive;andfurthermedialbranchblocksatthoselevelsshouldnotbepursued.

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§ Atleast80%reliefofindexpainfollowingcomparativeorplacebo-controlledblocksshouldbecometheonlyindicationforfacetRFneurotomy.

Byadoptingsuchmeasures,payerswillgreatlyreducetheburdenofcostbyeliminatingunproductiveproceduresfromtheportfolio,whilepreserving,respecting,andsupportingconscientiouspracticeforthosepatientswhocanbenefitfromtheseprocedures.SUMMARYOFRECOMMENDATIONSRelativetothepracticeoffacetRFneurotomy,weencouragespayersto:

1. Recognizeasvalidonlythoseproceduresperformedinaccordancewithtechniquesthathavebeenvalidated.Optimalresultshavebeenachievedonlywhenthosetechniqueshavebeenused.ResultsfromthetechniquesdescribedintheSISguidelinesincludecompletereliefofbackpainaccompaniedbyrestorationoffunction,returntowork,andnoneedforfurtherhealthcare.

2. AdopttheSISguidelines3asthestandardfortheperformanceofmedialbranchblocksandfacet RF neurotomy.

Furthermore,werecommendthatpayersregardasinvestigationalanyothertechniquesforfacetRFneurotomy,oranyotherbasisfortheselectionofpatientsfortreatmentbyfacetRFneurotomy.Bysuchmeasurespayerscanmakeavailabletosufferingpatientsthebeststandardofcarecurrentlyavailable,andavoidcontinuingtosubsidizepracticesoflesserstandardwithsubstantiallypooreroutcomes.DISCUSSIONRecentlypublishedsystematicreviewsandtechnologyassessments4,5poorlyservetheneedsofthepayersorpatients.Whilesuchreportsadheretothecommonrequirementsofsystematicreviews,theirdepictionoftheevidenceisflawedduetolackofinsightintothedetails–notofthedatapublished–butofthepracticesinherentintheproceduresbeingassessed.Informalterms,thereportssufferfromlackofcontentexpertise.Imaginethatthetopicwas“theeffectivenessofantibioticsforcough”.Cough,similartolowbackpain,ismerelyasymptomrepresentingavarietyofdiseases.Inthecaseofcoughthiscouldinclude:viralpneumonia,asthma,gastroesophagealrefluxdisease,heartfailure,andevenbacterialpneumonia.Withoutproperpatientselectionandstratificationonemaybetemptedtosayantibioticsarenoteffectiveforallpatientssufferingfromacough.Thiswouldclearlybeadisservicetothosewithbacterialpneumonia.Inadditiontothelackofspecificityinthediagnosis,thisanalogyisalsosimilarinthatlikespineinterventionsnotallantibioticsarethesame.Thereareavarietyofantibiotictypeswithdifferingefficacies

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androutesofadministration.Thecombinationofthesedifferenttreatmentstargetedatdifferentdiseasesleadstotheunfortunatemisinterpretationofaneffectivetreatmentforaselectgroupofpatientsasineffective.Armedwithsuchinformation,areviewwouldnotpoolalldataanddiseasesindiscriminately,whilesimultaneouslynotdistinguishingtheeffectivenessoforalantibioticsandintravenousantibiotics,full-strengthantibiotics,orevendilutedantibiotics.Yet,inthecaseoffacetRFneurotomythisiswhathasbeendoneinhighprofilestudiesandsystematicreviews.TheliteratureonfacetRFneurotomymustbemeticulouslystratified.Thatstratificationcanbeappliedineachofthreedomains:selection,technique,andoutcome(Figure1).

FIGURE1

Technique

OutcomeSelection

Figure1.AgraphicrepresentationofastructureforthestratificationofliteratureonfacetRFneurotomy.

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TECHNIQUEForavarietyofreasons,practitioners–whetherthoseinclinicalpracticeorthosewhopublish–usedifferenttechniques,yetcalltheirprocedurebythesamename.Thereasonsinclude:

§ continuingtouseoldertechniquesthatarenotonlyoutofdate,butwhichhavebeendisproven6-8;

§ preferringtechniquesaccordingtotheirinventororcountryoforigin,suchastheDutchtechniqueortheAustraliantechnique6-8;

§ usingpersonaladaptationsorshortcutsinordertosavetime,becausethepublishedtechniqueislabor-intensiveandtime-consuming,andnotproportionatelyreimbursed;

§ usingsmallerelectrodesbecausephysiciansaremorecomfortableusingthem.Correcttechniqueisnotdefinedbyarbitrary,personalchoice;norisitdefinedbyrandomizedcontrolledtrials.Correcttechniqueisdefinedbystudiesinbasicscience.ForfacetRFneurotomytohavefacevaliditytheelectrodemustbeaccuratelyplacedsuchthatthelesionthatitproducesoptimallycapturesthetargetnerve.Iftheelectrodeisnotplacednearthenerve,thevalidityofthetechniquelapses.Somewhatcontentiousiswhetherelectrodescanbeplacedperpendiculartothecourseofthetargetnerveorparalleltoit.Inbothinstances,theelectrodemaybesufficientlyclosetothenerveinordertocaptureit,butbasicsciencestudiesindicatethatperpendicularplacementsmayfailtocapturetheentirediameterofthenerve,andthatparallelplacementsaremorelikelybothtocaptureafullthicknessofthenerveandasubstantiallengthofthenerve1,9,10,11.Therefore,theorientationoftheelectrodeislikelytobepivotaltoclinicaloutcome.Perpendicularplacementscouldbesuccessful,butarelikelytohavelowersuccessratesandshorterdurationsofeffect,whereasparallelplacementsaremorelikelytohavegreatersuccessratesforlongerperiods.This,indeed,isborneoutintheliterature(see:OUTCOMES).Inlightofthesetechnicalprecepts,theliteraturecanbestratifiedaccordingtofacevalidityofthetechniqueused(Table1).Theoriginaltechniquefor“facetdenervation”describedbyShealywasseriouslyflawed1,12.Electrodeswereplacednowherewithinreachofthetargetnerve.Thereforetheprocedurewastantamounttoashamprocedure.Studiesthatusedthisdisproventechniqueare,therefore,notrepresentativeofacorrecttechnique.Theclinicaldatathattheyprovidemightbeofusetoshowwhatmeageroutcomesareobtainedwhenflawedtechniquesareused,buttheyareinadmissibleasevidenceoftheeffectivenessorefficacyoffacetRFneurotomywhencorrectlyperformed.InadmissibleforthisreasonisthestudyofGallagher,whichexplicitlystatedthatitusedtheShealytechnique13.Similarly,thestudyofLeclaireetal14usedatechniquethatwasa

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modifiedversionoftheShealytechnique.Therefore,thatstudyalsolapsesasprovidingvaliddataontheefficacyoffacetRFneurotomyifcorrectlyperformed.Indeed,Leclaireetalacknowledgedthisflawinsurgicalanatomy,andeffectivelyretractedtheirresults15.ThestudyofvanWijketal16illustratedthetechniqueused.Itispatentlyinaccurateaspointedoutbyalettertotheeditor.17Notonlywereelectrodesplacedperpendiculartothetargetnerve,butmanyplacementsweretoofarawayfromthenerveforthelesionmadebythesmallelectrodesusedtobeabletocapturethenervereliablyandadequately.Thatcontrolledtrial,therefore,pittedoneshamprocedureagainstanother,thusitisnotsurprisingthatnostatisticallysignificantdifferenceinoutcomewasfound.

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TABLE1

OrientationofElectrode

PlacementofElectrodeinRelationtoTargetNerve

WithinReach OutofReach

Parallel Valid Dreyfuss25

MacVicar26Gofeld27Burnham28Speldewinde29Schofferman30Rambaransingh31Nath32Tekin33Lakemeier34

Perpendicular Questionable Inadmissible Tzaan18

Civelek19Son20Chakraverty21Kroll22vanKleef23Juch24

Gallagher13Leclaire14vanWijk16

Table1.ThestratificationofstudiesoflumbarfacetRFneurotomyaccordingtowhetherthetechniqueusedplacedtheelectrodewithinreachofthetargetnerve,andwhetherthe

electrodewasplacedperpendicularorparalleltothenerve.Theotherstudiesthatusedperpendicularplacements18-24eitherillustratedtheirprocedureordescribedtheirtechniqueinsufficientdetailtocreditthattheirelectrodeswereplacedwithinrangeofthetargetnerve.However,theperpendicularplacement,aswellastheuseofsmall-gaugeelectrodes,constitutesariskofbiasagainstgoodoutcomes,becausethetargetnervesmayhavebeenincompletelycoagulated–resultinginalowerthanoptimalsuccessrate–orinsufficientlycoagulated–resultingindurationofrelieflessthanthedurationachievablebyothertechniques.Therefore,theclinicaloutcomesofthesestudiesneedtobeinterpretedcarefullyandwithinsight.

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Inthe2017studybyJuchetal24,theauthorsdidnotadequatelydescribeorprovideimagestoillustrateplacementrelativetothetargetnerve.Theyusedsmall-gaugeelectrodesanddidnotmentionparallelelectrodeplacement,increasingtheoddsofincompleteorunaccomplishedfacetRFneurotomy.Inthecaseofonestudythatusedperpendicularplacement23andwhichwasalsoacontrolledtrial,thetechnicallimitationmayaffectthesuccessrateanddurabilityofoutcome,butitdoesnotaffecttestingthetechniqueagainstplacebo,becausethesameplacementwasusedineacharm.Ninestudiesusedwhatappearstobecorrecttechnique:placementoftheelectrodeparalleltothetargetnerve25-34.Ofthese,someprovideevidenceofoutcomes25-29;othersprovidedataonrepeattreatment26,29-31;twoarecontrolledtrials32,33;andonewasacomparisonstudy34.Inlightofthisstratificationofstudiesbyfacevalidityoftechniqueused,certaincorrectionsapplytotheconclusionsofthereportspublishedtodateonfacetRFneurotomy.RFNeurotomyversusShamNeurotomy:EfficacyintheLumbarSpineThestudiesofGallagher1994,Leclaire2001,andvanWijk2005donotqualifyasprovidingevidenceofefficacybecausethetechniquesusedfortheactivearmlackedfacevalidity.13,14,16CensoringthesestudiesleavesonlythoseofNath2008,Tekin2007,andvanKleef1999eligibletoprovideevidence.32-34ThestudyofNath2008showedadifferenceinfavoroffacetRFneurotomythatwasnotsignificantforthereliefofbackpainatsixmonths,butwhichwassignificantforreliefoflegpain,globalperceivedeffect,andconsumptionofanalgesics.32Forthereliefofbackpain,thegroupdataofvanKleef1999showedadifferenceinfavorofRFneurotomythatwasnotsignificantstatistically,butsurvivalanalysisshowedastatisticallysignificantgreatersuccessratefromthreemonthstooneyearafterfacetRFneurotomy.34Tekin2007showedstatisticallysignificantdifferencesinfavorofactiveRFneurotomyatsixmonthsandatoneyear,forgroupscoresforbackpain,andfordisability,withasignificantlygreaterproportionofpatientsreportinganexcellentoutcome.33Nostudyprovideddatathatcontradictedthesuperiorityofactivetreatmentovershamtreatment.

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OUTCOMESTheoutcomesoffacetRFneurotomycanbequantifiedinseveraldomains:

• successrate:theproportionofpatientswhoachieveasuccessfuloutcome;• degreeofreliefthatconstitutesasuccess;• durationofthatrelief;• corroborationofreliefbyimprovementsincriticaldomainssuchasrestorationof

function,returntowork,anduseofotherhealthcare.Tovariousextents,thesecriteriahavebeensatisfiedinvariousstudies.Reviewerscanchoosewhichoutcomestheyconsidertobeworthwhile,orsatisfactory.TheparadigmoffacetRFneurotomyisthatifpatientsobtainatleast80%reliefoftheirindexpainfollowingcontrolleddiagnosticblocksofoneormoremedialbranches,thensimilarreliefshouldbeobtainedifthosenervesaresuccessfullycoagulated.TwostudieshaveprovidedbenchmarksfortheoptimaloutcomesoffacetRFneurotomy.Eachusedoptimaltechnique,asdiscussedabove.Thefirstreported,inessence,that80%ofpatientscouldexpectatleast60%reliefoftheirbackpainat12months,andthat60%couldexpectatleast80%relief25.Thesecondstudyreportedtheoutcomesfromtwoneighboringpractices,inwhich58%(44-72%)or53%(40-66%)ofpatientsrespectivelyachievedcompletereliefofpain,accompaniedbyrestorationofactivitiesofdailyliving,returntoworkifapplicable,andnoneedforfurtherhealthcarefortheirbackpain26.Theresultsofthesetwostudiesarestatisticallycompatiblewithoneanother,andindicatewhatcanbeachievedbyfacetRFneurotomyifperformedcorrectly,andinappropriatelyselectedpatients.InbothinstancesthetechniqueusedforfacetRFneurotomywasthatrecommendedbytheSpineInterventionSociety1,andpatientswereselectedusingcomparativelocalanestheticblocks2.Asuccessrateof55%maynotseemimpressive,butiscompensatedbythedefinitionofsuccess:completereliefofpain,restorationoffunction,andnootherhealthcare.Themodestsuccessrate,however,ismathematicallyconsistentwiththevicissitudesofdiagnosticblocks(see:DIAGNOSIS).Becausetheprevalenceoflumbarfacetjointpainislow,therateoffalse-positivediagnosesishigh,evenifcontrolledblocksareused.Otherstudiesthathaveusedcorrecttechniquehavereportedlesseroutcomes,suchas39%28or35%27ofpatientsachievingatleast50%reliefofpainatsixmonths.Ineachcase,however,patientswereselectedfortreatmentusingdiagnosticblocksinamannerlessrigorousthaninthebenchmarkstudies.

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DIAGNOSISItisnotpossibletodiagnosefacetjointpainbyphysicalexaminationorbymedicalimaging.Diagnosticblocksaretheonlymeansofestablishingadiagnosis,andprovidinganindicationfortreatmentbyfacetRFneurotomy.Theacmeofdiagnosticblocksareplacebo-controlledtripleblocks35-37.Theseinvolvefirstadministeringanactiveagent,inordertofindprimafacieifanesthetizingthetargetnervesrelievesthepatient’spain.Inordertotesttheresponse,thepatientsubsequentlyundergoesrepeatblocks,underdouble-blindconditions,inwhichaplaceboandanactiveagentarerandomlyadministered.Apositiveresponseisoneinwhichpainisnotrelievedwhentheplaceboisused,butisrelievedeachtimethattheactiveagentisused,andforadurationconcordantwiththeexpecteddurationofactionoftheagentused.Althoughplacebo-controlled,tripleblockshavebeenusedinresearchstudies38,theyareregardedbymanyastooconsumingofresourcestobepracticalinconventionalpractice.Meanwhile,payersappeartobeaversetofundingtripleblocksonthegroundsthattheyareexpensive.Interestingly,however,tripleblocksarecost-effectiveinjurisdictionssuchasthoseinAustraliaandNewZealand,wherethereimbursementforfacetRFneurotomysubstantiallyexceedsthatofadiagnosticblock39.Asuitablealternativetoplacebo-controlled,tripleblocksiscomparativelocalanestheticblocks.Theseinvolveadministering,onadouble-blindbasisinrandomorder,eitheralong-actingorashort-actinglocalanestheticagent.Apositiveresponseisoneinwhichthepatientobtainsatleast80%reliefoftheindexpainoneachoccasion.Aconcordantpositiveresponseisoneinwhichthedurationofreliefisconcordantwiththeexpecteddurationofactionofeachoftheagentsused.Adiscordantresponseisoneinwhichoneoftheagents,usuallylidocaine,hasalongerthanexpecteddurationofeffect35-37,40.Whencomparedwithplacebo-controlledblocks,comparativelocalanestheticblocksareareasonablyexpedientclinicaltool.Concordantresponseshaveasensitivityof54%andaspecificityof88%,generatingapositivelikelihoodratioof4.535,41.Discordantresponseshaveasensitivityof100%buttheirspecificitylapsesto65%,generatingapositivelikelihoodratioof2.9.Althoughnumericallydifferent,likelihoodratiosof2.9and4.5makelittleappreciabledifferencetoclinicalpractice.Discordantresponsesandconcordantresponsesprovideeffectivelythesamediagnosticconfidence(post-testlikelihood).However,diagnosticconfidenceiscriticallydependentontheprevalenceoftheconditionbeingdiagnosed(Figure2).Foraconditionwithahighprevalence,e.g.60%,thediagnosticconfidenceforadiscordantresponseis81%andthatforaconcordantresponseis87%.However,forconditionswithaprevalencebelow30%,diagnosticconfidenceplummets35,37(Figure2).

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FIGURE2

Figure2.Agraphoftherelationshipbetweendiagnosticconfidence,i.e.post-test

probability,andtheprevalenceoftheconditionbeingdiagnosed,foreitherdiscordantorconcordantpositiveresponsestocomparativelocalanestheticblocks.

Singlediagnosticblocks,eveniftheyprovidecompleterelief,arenotadependablediagnostictool,fortheyhaveanunacceptablyhighfalse-positiverate.Variously,thefalse-positiveratehasbeenmeasuredasbetween25%and45%40-47.Suchhighvaluesgenerateuncertaintyastowhetherapositiveresponseistrueornot.Thepracticalutilityofcomparativelocalanestheticblocks,andtheirlimitations,canbeillustratedinthefollowingfigures.Figure3showsthediagnosticconfidenceaftersingleblocks,comparativeblocks,andplacebo-controlledblocks,forconditionsofdifferentprevalence.Afterasinglepositiveblock,thediagnosticconfidenceisbarelygreaterthantheprevalenceofthecondition.Diagnosticconfidenceincreasesmarkedlyifcomparativeblocksarepositive,withlittledifferencebetweentheconfidencegeneratedbydiscordantorconcordantresponses.However,throughout,diagnosticconfidenceisaffectedbyprevalence.Onlyforcommonconditionsisdiagnosticconfidencehigh.

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FIGURE3

Figure3.Agraphoftherelationshipsbetweendiagnosticconfidenceandprevalenceafterpositiveresponsestonoblocks,onediagnosticblock,comparativeblocks,andplacebo-controlledblocks.Thepairsoffiguresabovecomparativeblocksaretheconfidenceafter

discordantandconcordantresponses,respectively.Figure4showsthenumbersofpatientswhowouldundergofacetRFneurotomydependingoniftheindicationwasresponsetonoblocks,asingleblock,comparativeblocks,orplacebo-controlledblocks.Thegraphshowsthatifnoblocksareused,allpatientsundergotreatment.Thosenumbersreducelittleifsingleblocksarethesoleindicationfortreatment.Substantialreductionsoccurinthenumberofpatientsbeingtreatedifcomparativeblocksareapplied,withthosereductionsbeinggreaterthelessprevalenttheconditionbeingdiagnosed.Thisfigureunderscorestheutilityofmakingadiagnosisusingcomparativeblocks.Itprotectssubstantialnumbersofpatientsfromundergoingunnecessaryandfutiletreatment.

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FIGURE4

Figure4.AgraphshowingthenumbersofpatientswhowouldundergofacetRFneurotomyiftheindicationwasapositiveresponsetonoblocks,onediagnosticblock,comparativeblocks,orplacebo-controlledblocks.Thepairsoffiguresabovecomparativeblocksarethenumbersofpatientsforwhomdiscordantandconcordantresponses,

respectively,wouldbetheindicationfortreatment.Figure5completesthesequence.Itshowsthatthesuccessratesoftreatmentincreasesubstantiallyifcomparativeblocks(orplacebo-controlledblocks)areused.Thosesuccessratesaregreaterinproportiontotheprevalenceoftheconditiondiagnosedandtreated.Conversely,successratesareadverselylowiftheprevalenceislow.TheseprincipleshavesignificantimplicationsfortheuseofcomparativelocalanestheticblocksforselectingpatientsfortreatmentbyfacetRFneurotomy.

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FIGURE5

Figure5.AgraphoftherelationshipsbetweenprevalenceandtheexpectedsuccessratesoffacetRFneurotomyiftheindicationfortreatmentisapositiveresponsestonoblocks,onediagnosticblock,comparativeblocks,orplacebo-controlledblocks.Thepairsoffiguresabovecomparativeblocksarethesuccessratesafterdiscordantandconcordantresponses,

respectively.InbothofthebenchmarkstudiesoflumbarfacetRFneurotomy25,26thesingularindicationwasapositiveresponsetocomparativelocalanestheticblocks.Theearlierstudyusedarelaxedcriterionof80%relief25,whereasthelaterstudyrequiredcompleterelief26.Bothstudiesachievedthebestresultsheretoforereportedintheliterature.Theearlierstudyreported60%ofpatientsmaintainingatleast80%relieffor12months25.Thelaterstudyreportedcompletereliefofpainin55%ofpatients,accompaniedbyrestorationoffunction,returntowork,andnoneedforotherhealthcare,foramediandurationof15monthspertreatment26.Inisolation,asuccessrateof55%or60%maynotseemimpressive.However,thisfigurearisesintwocontexts.Thefirstisthatitappliestocompletereliefofpain.Thesecondisthatnootherinterventionofanykind,foranyformofbackpain,provideseithersuchsuccessorsuchasuccessrate.

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Thereasonforthemodestsuccessrateliesinthevicissitudesofcomparativeblocksforconditionsoflowprevalence(Figure3).Theprevalenceoflumbarfacetjointpain,basedoncompletereliefofpain,isnotknown,butitappearstobelow6,8.Foraprevalenceof30%,Figure3indicatesthatthediagnosticconfidenceofcomparativeblocksisonlyabout65%,andFigure5indicatesthatthesuccessrateoflumbarfacetRFneurotomyshouldbeoftheorderof60%.Greaterdiagnosticconfidenceandgreatersuccessratescannotbeachievedunlesstheprevalenceoflumbarfacetjointpainismuchgreaterthancurrentlyestimated,orunlessplacebo-controlledblocksareusedtomakethediagnosis35.Underthoseconditions,comparativelocalanestheticblocksarethebestavailable,mostpracticalmeansofestablishinganindicationforfacetRFneurotomy,ifcompletereliefofpainisthedesiredoutcome.Nootherstudyhasshownthatcompletereliefofpaincanbeachievedusinganyindicationotherthancomplete,ornearcomplete(atleast80%),reliefoftheindexpainfromcomparativelocalanestheticblocks.CONCLUSIONTheSpineInterventionSocietyhasproducedpracticeguidelinesfortheconductoflumbar,thermalfacetRFneurotomy1aswellasguidelinesfortheconductoflumbarmedialbranchblocks2,bywhichpatientsareselectedfortreatmentbyfacetRFneurotomy.BasedonthemostrigorousstudiesusingvaliddiagnostictechniquestoselectpatientsandusingoptimaltechniquesoffacetRFneurotomy,

• Over50%ofpatientstreatedwithlumbarfacetRFneurotomycanexpecttoachievecompletereliefofpain,accompaniedbyrestorationofactivitiesofdailyliving,resumptionofwork,andnoneedforotherhealthcarefortheirbackpain,foramediandurationof15months,withaninterquartilerangeof10-28months26.

• Intheeventofrecurrenceofpain,completereliefcanbereinstatedbyrepeatingthe

treatment26.Suchoutcomesareunrivalledbyanyotherinterventionforbackpain.Nootherinterventionhasbeenshowntobecapableofachievingcompletereliefofpain,accompaniedbyrestorationtonormallife,andcessationofhealthcarefortheconditiontreated.Theavailableliteratureshowsthattheseoutcomescanbeachieved.Italsoshowshowtheycanbeachieved.Surelypayerswouldsupportpracticesthatachievesuchoutcomesandwouldensurethattheyareavailabletopatients.

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Theundersignedsocietiesappreciatetheopportunitytoprovidethesecomments.Ifyouhaveanyquestionsorwishtodiscussanyofoursuggestions,pleasecontactBelindaDuszynski,SISSeniorDirectorofPolicyandPractice,[email protected],AmericanAcademyofPainMedicine

AmericanAcademyofPhysicalMedicineandRehabilitation

NorthAmericanSpineSociety

SpineInterventionSociety

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