Radiofrequen y A bl at ion for the Treatment of Orthopaedic and Spinal Pain https://www.oxhp.com/secure/policy/radiofrequency_ablation_61O.html Ox ord Health Plans> Medical and Administrative Policies> T it le o f P ol ic y Radiofrequency Ablation for the Treatment of Orthopaedic and Spinal Pain The services describe d in Oxfo rd po licies are subject to the terms, condi tio ns an d limitations of the Membe r's co ntr act or certificate. Un less otherwise stated, Oxford policies do not apply to Medicare Advan ta ge e nrolle es. Oxford re se rve s the rig ht, in its sole d iscre tio n, to modify p olicies a s necessary with out p rior written no tice un less othe rwi se requ ired by Oxford's administrative pro cedur es. Th e term Oxford include s Oxfor d Heal th Plans, LLC and all of its subsidiaries as app ropr iate for these p olicies a s well a s Se cu reHorizon s ~/Oxfo rd and Ever ca re. Certain po licies ma n ot be ap plicab le to Self-Funde d Members an d certain insured products. Refer to the Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or ifthere are any exclusions o r be nefit limitations applicable to anyofthese policies.lfthere is a difference between an y p olicy and the Memb erm pl an of benefits or Certifi ca te of Coverage, the plan of benefits or Certificate o f Coverag e will g overn. Policy #: PAIN 021.1 T2 Coverage Statement: Policy is applicable to: Commer cial pl ans Conditions of Coverage I~en~fit!y~e Ie;~ ~~r~I?~n~fit~p~c~~ge Referral Requir ed Yes - Office (Does not apply to No - Ou tpat ient non-gatekeeper products) Authorization No - Office 1 (Pr ece rti fic ation always Yes - Outpatient required for inpatient admission) Pre cer tif icatio n with N0 1 MD Revi ew Site(s) of Se rv ice Office, Outpatient (If not listed, MD Rev iew required) Special 1 Pulsed radiofrequency ablati on (unl is ted CPT code 64999) Considerations r eq ui re s Me di ca l D ire ct or r evi ew i n a ll s it es o f se rvi ce . Description of Service/Assessment/Background Information: Spinal pain, particularly low back and neck pain, is a leading cause of disability. Most spinal pain will resolve spontaneously or can be treated with conservative and noninvas iv e therapies such as medication, exercise, physical therapy, immobili za tion, trigger point inject ions and transcutaneous nerve stimulation. Surgery may be required for the conditions wi th underl yi ng pathology as docu me nted by ra di ological findings. Spinal pain can originate from musc les, l ig ame nt s, i nf la mma ti on o f n erve s a nd re fl ex symp at he ti c d yst ro ph y a s we ll a s f ro m i nt er ve rt eb ra l d iscs a nd j oi nt s. I t is es ential that other causes of spinal pain be ruled out through clinical and radiology examination. Typically, a facet injection is completed to confirm the facet joint as the source of the spinal pain. Subjective improvement of at least 8 0% i mp ro ve men t i s re ga rd ed as a p re req ui si te t o p er for mi ng ra di of re qu en cy a bl at io n. (D re yf us 2 00 0) T wo t yp es o f r ad iof re qu en cy a bl at io n a re u se d. On e i s n on -p ul se d o r t he rma l a bl at io n. T he rma l a bl at io n i nvo lve s t he p ercu ta ne ou s p la ce me nt o f a n ee dl e o r e le ct ro de w hi ch ca rri es a h ig h f req ue ncy cu rr en t i nt o t he t is su e r esu lt in g i n high temperatures (60 to 90 degrees Celsius) that destroy the bone lesion or nerves around the facet joint. The other t yp e o f r ad io fr eq ue ncy a bl at io n i s p ul sed R FA ( PR FA ) w hi ch h as b ee n i nt ro du ce d a s a n ona bl at ive a lt er na ti ve t o R FA . PR FA d el ive rs sh or t b urst s o f r ad io fr eq ue ncy ( RF) cu rr en t, i ns tea d o f t he co nt in uo us f lo w o f R F cu rre nt p ro du ce d b y 1/6/2011 2:33 PM
Transcript
8/6/2019 Radio Frequency Ablation for the Treatment of Orthopaedic Pain
ofrequency Ablation for the Treatment of Orthopaedic and Spinal Pain https://www.oxhp.com/secure/policy/radiofrequency_ablation_61O.html
continuous RF generators. This allows the tissue to cool between bursts, resulting in considerably lower maximumtemperatures as compared with the continuous mode, and reduces the risk of neighboring tissue destruction. It doesnot destroy targeted nerves and surrounding tissue and therefore requires less precise electrodes placement.Therefore, PRFT may cause fewer side effects than thermal RFA, although PRFT has not yet been studied in largeprospective clinical trials. (Hayes Directory, Radiofrequency Ablation for Low Back Pain, 2007)
Clinical Evidence:
Thermal Radiofreguency Ablation for Spinal ConditionsCervical Pain SyndromeBarnsley (2005) investigated 35 patients with chronic neck pain who underwent radiofrequency neurotomy. Twelvepatients had 2 procedures. Thirty-six of 45 assessable procedures (80%) achieved significant relief of pain. Pain reliefcontinued after a median follow-up of 35 weeks.
The usefulness of radiofrequency ablation (RFA) was investigated in a study of 28 patients with chroniccervicobrachialqia (Shin 2006). Six months following RFA, 19 (68%) patients reported successful outcome and 8(42%) of these patients reported complete pain relief. Four patients had recurrence of pain between 6 and 12months.
A systematic review concluded that there was limited evidence that radiofrequency denervation offers short-termrelief for chronic neck pain and chronic cervicobrachial pain (Niemisto 2003). There was conflicting evidence on theshort-term effect of RFA on pain and disability in chronic low back pain. The meta-analysis included 7 randomizedcontrolled trials of 275 patients, 141 of whom received active treatment.
Thoracic Pain SyndromeThere were no randomized controlled trials evaluating RFA for treatment of thoracic pain syndrome. Evidence fromseveral small, uncontrolled studies indicated that RFA reduced thoracic spinal pain in 40% to 75% of patients(Pevsner 2003, Van Kleef 1995, stolker 1994, Tzaan 2000). Duration of efficacy varied considerably among thetrials; pain relief was maintained for over 2 years in 12% to 49% of patients (Van Kleef 1995, stolker 1994).
Low Back PainThere is conflicting evidence from randomized controlled studies regarding the efficacy of RFA for chronic low backpain. In one randomized trial, RFA did not improve facet joint pain compared with placebo treatment (Brandense2001), whereas two randomized controlled trials documented short-term improvement of symptoms compared withthe placebo procedure (Leclaire 2001, Gallagher 1994). In only 1 of these studies, symptom relief was maintained forup to 6 months (Gallagher 1994). In another study, only 1 of the 5 outcome measures was significantly improved in
the active treatment group compared with the placebo group at 4 weeks, but the beneficial effect was not maintained.By 12 weeks following the procedure, there was no statistical difference between the sham and active RFA groupsfor any outcome measure (Leclaire 2001).
Van Wijk et al. (2005) conducted a randomized double-blind, sham lesion controlled trial of 81 patients with chroniclow back pain who were randomized to undergo RFA (n=40) or sham treatment (n=41). Three months aftertreatment, combined outcome measure indicated no difference between RFA and sham treatment. The globalperceived effect was in favor of RFA.
In a randomized controlled trial conducted by Geurts et al. (2003), 83 patients were assigned to receiveradiofrequency lesion treatment or sham treatment. After 3 months, 16% of RF patients and 25% of the sham grouppatients reported pain reduction.
A systematic literature review of randomized controlled trials on radiofrequency ablation procedures for spinal painperformed by Geurts et al. (2001) reported moderate evidence that radiofrequency lumbar facet denervation is moreeffective for chronic low back pain than placebo.
In another systematic review evaluating medial branch neurotomy, Manchikanti et al. (2003) concluded that there wasstrong evidence for short-term pain relief and moderate evidence for long-term pain relief of chronic low back,thoracic, and neck facet joint pain.
Nath et al. (2008) conducted a randomized controlled study of percutaneous radiofrequency neurotomy in 40 patientswith chronic low back pain (20 active and 20 controls). All patients were examined by an orthopaedic surgeon beforeand 6 months after the treatment (sham or active). Inclusion criteria were 3 separate positive facet blocks. The activetreatment group showed statistically significant improvement not only in back and leg pain but also back and hipmovement as well as the sacro-iliac joint test. There was significant improvement in quality of life variables, globalperception of improvement, and generalized pain. The improvement seen inthe active group was significantly greaterthen that seen in the placebo group. The investigators concluded that radiofrequency facet denervation could be usedinthe treatment of carefully selected patients with chronic low back pain.
Definitive patient selection criteria for RFA as a treatment for chronic spinal pain have not been established. Relativeor absolute contraindications to RFA mentioned inthe reviewed literature include:
ofrequency Ablation for the Treatment of Orthopaedic and Spinal Pain https://www.oxhp.com/secure/policy/radiofrequency_ablation_61O.html
• Neurologic abnormalities• Definitive clinical and/or imaging findings• Proven specific causes of low back pain, including disc herniation, spondylolisthesis, spondylosis
ankylopoietica, spinal stenosis, discogenic or stenotic compression, malignancy, infection, and trauma• Patients with more than one pain syndrome• Lack of response to diagnostic nerve blocks• Patients with unstable medical conditions or psychiatric illness (Hayes Directory, RFA for low back pain, 2007)
American Society of Interventional Pain Physicians (ASIPP): In a practice guideline for chronic spinal pain, theASIPP states that the evidence for radiofrequency neurotomy of medial branches is strong for short-term andmoderate for long-term relief. The evidence for pulsed radiofrequency for this indication is inconclusive. The evidencefor thermal and pulsed radiofrequency of the sacroiliac joint is limited. The guidelines indicate a frequency for medialbranch neurotomy and sacroiliac radiofrequency neurotomy of three months or longer between each procedure, witha maximum of three times per year, provided that more than 50% relief is obtained for 10 to 12 weeks. (Boswell, etaI., 2007)
American Society of Anesthesiologists (ASA): The ASA Task Force on Pain Management, Chronic Pain Sectionstates that there are insufficient data regarding the value of prognostic neural blockade prior to neuroablativetechniques, such as radiofrequency ablation. The Task Force further states that neuroablative procedures should beused as part of a comprehensive pain management regimen, performed only as a last resort when pain is refractoryto other therapies. (ASA 1997)
Quality of Evidence and Additional Research: According to Hayes, the clinical studies of RFA for chronic spinalpain have significant methodological limitations that can affect interpretation of the data. Few randomized controlledor comparative trials of RFA with adequate sample size and follow-up duration have been published; thepreponderance of the evidence is derived from small randomized controlled trials, and prospective uncontrolledstudies, case series, and retrospective chart analyses. Uncertainties regarding several aspects of RFA for spinal painnecessitate additional research. Questions remain about the etiology of facet joint syndrome, the prognostic validity ofdiagnostic nerve blocks, standard outcome measures, the role of the placebo effect intreatment success, and theradiofrequency denervation technique. The validation of radiofrequency for chronic spinal pain management reliesupon the resolution of these technical issues, as well as issues regarding patient selection and long-term efficacy.(Hayes Directory, RFA for Low Back Pain, 2007)
Pulsed Radiofreguency for Spinal ConditionsAbejon completed a retrospective analysis of the effectiveness of pulsed radiofrequency (PRF) applied to the lumbardorsal root ganglion in 54 patients who underwent 75 PRF procedures. The patients were divided into three groupsaccording to the etiology of the lesion herniated disc, spinal stenosis, and failed back surgery syndrome. The efficacyof the technique was assessed using a 10-point Numeric Rating Scale (at baseline and, along with the GlobalPerceived Effect (GPE) at 30, 60, 90, and 180 days. The reduction in medications and the number of complicationsassociated with the technique were assessed although not reported. Pain reduction was noted in all groups except forthose with failed back surgery syndrome. No complications were noted. The authors concluded that PRF waseffective in herniated disc and spinal stenosis, but not failed back surgery syndrome. The flaws of this study includethe retrospective design, subjective outcome measures and short term follow-up. (Abejon 2007)
Van Zundert studied the effect of pulsed radiofrequency treatment on patients with cervical radicular pain in aprospective audit that showed satisfactory pain relief for a mean period of 9.2 months. Then a randomized shamcontrolled trial of 23 patients out of 256 screened, met the inclusion criteria and were randomly assigned in a doubleblind fashion to receive either pulsed radiofrequency or sham intervention. The evaluation was done by anindependent observer. At 3 months the pulsed radiofrequency group showed a significantly better outcome withregard to the global perceived effect (>50% improvement) and visual analogue scale (20 point pain reduction). Thequality of life scales also showed a positive trend infavor of the pulsed radiofrequency group, but significance wasonly reached in the SF-36 domain vitality at 3 months. The need for pain medication was significantly reduced inthepulsed radiofrequency group after six months. No complications were observed during the study period. These studyresults are in agreement with the findings of a previously completed clinical audit that pulsed radiofrequency treatmentof the cervical dorsal root ganglion may provide pain relief for a limited number of carefully selected patients withchronic cervical radicular pain as assessed by clinical and neurological examination. Although the study results arepromising for certain patients, the small sample size, the use of subjective outcomes and lack of long term follow-upminimize the generalizations of the conclusions. (Van Zundert 2007)
Cahana completed a literature review of current clinical and laboratory data regarding the use of PRFA. The finalanalysis yielded 58 reports on the clinical use of pulsed radiofrequency in different applications: 33 full publicationsand 25 abstracts. Also six basic science reports, five full publications, and one abstract were reviewed. Theaccumulation of these data shows that the use of pulsed radiofrequency generates an increasing interest of painphysicians for the management of a variety of pain syndromes. Although the mechanism of action has not beencompletely elucidated, laboratory reports suggest a genuine neurobiological phenomenon altering the pain signaling,which some have described as neuromodulatory. No side effects related to the pulsed radiofrequency technique were
ofrequency Ablation for the Treatment of Orthopaedic and Spinal Pain https://www.oxhp.com/secure/policy/radiofrequency_ablation_61O.html
effort, and equipment necessary to provide the service.
The foregoing Oxford policy has been adapted from an existing UnitedHealthcare national policy that wasresearched, developed and approved by UnitedHealthcare Medical Technology Assessment Committee.[2009T0107G]
References:
1. Abejon D. Pulsed radiofrequency in lumbar radicular pain: clinical effects in various etiological groups. PainPract. MAR-2007; 7(1): 21-6
2. American Chronic Pain Association (ACPA). Office of Disease Prevention and Health Promotion. Web site.2004 Available at: http://www.healthfinder.gov/orgs/HR2428.htm. Accessed March 2009.
3. American Society of Anesthesiologists (ASA) Task Force on Pain Management, Chronic Pain Section. PracticeGuidelines for Chronic Pain Management. Anesthesiology. 1997;86(4):995-1004.
4. Barendse GA, van Den Berg SG, Kessels AH, et al. Randomized controlled trial of percutaneous intradiscalradiofrequency thermocoagulation for chronic discogenic back pain: lack of effect from a 90-second 70 clesion. Spine. 2001 ;26(3) :287-292.
5. Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: outcomes in a series ofconsecutive patients. Pain Med. 2005 Jul-Aug;6(4):282-6.
6. Boswell MV, Shah RV, Everett CR, et al. Interventional techniques inthe management of chronic spinal pain:evidence-based practice guidelines. Pain Physician. 2005;8(1):1-47.
7. Boswell MV, Trescot AM, Datta S, et al., Interventional Techniques: Evidence-based Practice Guidelines in theManagement of Chronic Spinal Pain. Pain Physician. 2007; 10:7-111.
8. Cahana A. Pulsed radiofrequency: current clinical and biological literature available. Pain Med. 01-SEP-2006;7(5): 411-23.
9. Dreyfuss P, et al. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial jointpain. Spine 2000;25(10):1270-7.
10. ECRI Institute. Custom Hotline Response. Radiofrequency Neuroablation for Low Back Pain. May 2008.
11. Gallagher J, Petriccione di Vadi PL, Wed ley JR, et al. Radiofrequency facet joint denervation in the treatmentof low back pain: a prospective controlled double-blind study to assess its efficacy. Clin J Pain.1994;7: 193-198.
12. Geurts JW; van VVijkRM; Stolker RJ; et al. Efficacy of radiofrequency procedures for the treatment of spinalpain: a systematic review of randomized clinical trials. 2001; 26(5): 394-400.
13. Geurts, J. w ., van VVijk, R. M., VVynne, H . J., Hammink, E., Buskens, E., Lousberg, R., Knape, J. T., andGroen, G. J. Radiofrequency lesioning of dorsal root ganglia for chronic lumbosacral radicular pain: arandomised, double-blind, controlled trial. Lancet. 2003;361 (9351) :21-6.
14. Hayes Inc. Directory. Radiofrequency Ablation for Cervical and Thoracic Pain. Lansdale, PA: Hayes, Inc.;March 2007. Update search April 2008.
15. Hayes Inc. Directory. Radiofrequency Ablation for Low Back Pain. Lansdale, PA: Hayes, Inc.; March 2007.Update search January 2009.
16. Kornick C, Kramarich SS, Lamer TJ, Todd Sitzman B. Complications of lumbar facet radiofrequencydenervation. Spine. 2004;29(12):1352-1354.
17. Kroll HR, Kim D, Danic MJ, et al. A randomized, double-blind, prospective study comparing the efficacy ofcontinuous versus pulsed radiofrequency inthe treatment of lumbar facet syndrome. J Clin Anesth 2008Nov;20(7):534-7.
18. Leclaire R; Fortin L; Lambert R; et al. Radiofrequency facet joint denervation in the treatment of low back pain:a placebo-controlled clinical trial to assess efficacy. Spine. 2001; 26(13): 1411-6.
19. Lindner R, Sluijter ME, Schleinzer W. Pulsed radiofrequency treatment of the lumbar medial branch for facetpain: a retrospective analysis. Pain Med. 2006;7(5):435-439.
20. Lord S, et al. Percutaneous Radio-Frequency Neurotomy for Chronic Cervical Zygapophysial Joint Pain. NEJM1996;335: 1721-1726.
ofrequency Ablation for the Treatment of Orthopaedic and Spinal Pain https://www.oxhp.com/secure/policy/radiofrequency_ablation_61O.html
21. Lord SM, Bogduk N. Radiofrequency procedures in chronic pain. Best Pract Res Clin Anaesthesiol.2002; 16(4) :597-617.
22. Manchikanti L, staats PS, Singh V, et al. Evidence-based practice guidelines for interventional techniques inthe management of chronic spinal pain. Pain Physician. 2003;6(1):3-81.
23. Markman JO. Interventional approaches to pain management. Med Clin North Am. 01-MAR-2007; 91(2):271-86.
24. Nath S, Nath CA, Pettersson K. Percutaneous lumbar zygapophysial (Facet) joint neurotomy usingradiofrequency current, inthe management of chronic low back pain: a randomized double-blind trial. Spine.2008 May 20;33(12):1291-7; discussion 1298.
25. Niemisto, L. , Kalso, E., Malmivaara, A., Seitsalo, S., and Hurri, H. Radiofrequency denervation for neck andback pain. A systematic review of randomized controlled trials (Cochrane Review). Cochrane Database SystRev. 2003; (1):C0004058.
26. Pevsner Y, Shabat S, Catz A, et al. The role of radiofrequency in the treatment of mechanical pain of spinalorigin. Eur Spine J. 2003;12(6);602-605.
27. Rosenthal 01, Hornicek FJ, Torriani M, et al. Osteoid osteoma: percutaneous treatment with radiofrequencyenergy. Radiology. 2003;229(1):171-175.
28. Rosenthal 01, Hornicek FJ, Wolfe MW, et al. Percutaneous radiofrequency coagulation of osteoid osteomacompared with operative treatment. J Bone Joint Surg Am. 1998;80(6):815-821.
29. Saal JS. General principles of diagnostic testing as related to painful lumbar spine disorders: a criticalappraisal of current diagnostic techniques. Spine. 2002 Nov 15;27(22):2538-45; discussion 2546.
30. Sapir OA, Gorup JM. Radiofrequency medial branch neurotomy in litigant and nonlitigant patients with cervicalwhiplash: a prospective study. Spine. 2001 ;26(12):E268-E273.
31. Schofferman J., et al. Effectiveness of Repeated Radiofrequency Neurotomy for Lumbar Facet Pain. 2004.Spine 29(21): 2471-73.
32. Shin WR, Kim HI, Shin DG, Shin OA. Radiofrequency neurotomy of cervical medial branches for chroniccervicobrachialgia. J Korean Med Sci. 2006 Feb;21(1): 119-25.
33. Stolker RJ, Vervest AC, Groen GJ. The treatment of chronic thoracic segmental pain by radiofrequencypercutaneous partial rhizotomy. J Neurosurg. 1994;80:986-992.
34. Tekin I, Mirzai H, Ok G, Erbuyun K, Vatansever D . A comparison of conventional and pulsed radiofrequencydenervation in the treatment of chronic facet joint pain. Clin J Pain. 2007 Jul-Aug;23(6):524-9.
35. Tzaan w e, Tasker RR Percutaneous radiofrequency facet rhizotomy--experience with 118 procedures andreappraisal of its value. Can J Neurol Sci. 2000;27(2):125-130.
36. van Kleef M, Barendse GA, Dingemans WA, et al. Effects of producing a radiofrequency lesion adjacent to thedorsal root ganglion in patients with thoracic segmental pain. Clin J Pain. 1995; 11:325-332.
37. van Kleef M, Liem L, Lousberg R, et al. Radiofrequency lesion adjacent to the dorsal root ganglion for
cervicobrachial pain: a prospective double blind randomized study. Neurosurgery. 1996;38(6):1127-1132.38. van VVijk,R M., Geurts, J. W, Wynne, H . J., Hammink, E., Buskens, E., Lousberg, R, Knape, J. T., and
Groen, G. J. Radiofrequency denervation of lumbar facet joints in the treatment of chronic low back pain: arandomized, double-blind, sham lesion-controlled trial. Clin J Pain. 2005;21 (4) :335-44.
39. Van Zundert J. Pulsed radiofrequency adjacent to the cervical dorsal root ganglion in chronic cervical radicularpain: a double blind sham controlled randomized clinical trial. Pain. 01-JAN-2007; 127(1-2): 173-82.
Effective Date: June 1, 2010
UnitedHealthcare I Oxford Benefit Management SM I Privacy Policy I Terms & Conditions
