5/31/2013. Disclosures. Lumbar Facet Joint Pain: Evidence. I have nothing to disclose

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1 Disclosures : Evidence I have nothing to disclose David J. Lee, MD Professor Pain Management Center Department of Anesthesia Facet Joint Pain Prevalence Spinal pain 54-80% lifetime 80-90% resolve in 6 weeks 5-10% persistent 25-75% recurrent and persistent 60% multiple regions Facet Joint Pain 60% with degenerative changes by age 30 Clinical history, physical exam and diagnostic imagings are unreliable for facet joint pain and can not reliably predict response to diagnostic facet injections There is no tissue diagnosis to confirm facet joint pain Facet joint pain 54-67% chronic cervical pain 42-48% chronic thoracic pain 15-45% chronic lumbar pain 1

2 Diagnostic block (single vs comparative) Therapeutic intervention (intra-articular injection vs medial branch block vs radiofrequency ablation) Repeat radiofrequency ablation Spinal fusion Validity of comparative local anesthetic blocks confirmed with placebo controlled diagnostic blocks Comparative local anesthetic blocks in the diagnosis of cervical zygapophysial joints pain Barnsley et al 1993 Pain The utility of comparative local anesthetic blocks versus placebo controlled blocks for the diagnosis of cervical zygapophysial joint pain Lord et al 1995 Clin J Pain Barnsley L, Lord S, Bogduk N: Comparative local anesthetic blocks in the diagnosis of cervical zygapophysial joints pain. Pain 1993; 55: Lord SM, Barnsley L, Bogduk N: The utility of comparative local anesthetic blocks versus placebo-controlled blocks for the diagnosis of cervical zygopophysial joint pain. Clin J Pain 1995: 11: False positive rate: high placebo (18-32%) sedation liberal superficial local anesthetic spread of injectate False negative rate:11% Hogan QH, Abram SE: Neural blockade for diagnosis and prognosis: a review. Anesthesiology 1997; 86: Kaplan M, et al: The ability of lumbar medial branch blocks to anesthetize the zygapophysial joint: a physiologic challenge. Spine 1998; 23: Retrospective review 438 patients Comparative local anesthetic blocks Outcome: >=80% pain relief and ability to perform painful movement Multiple regions: 38% Patient Single Double Prevalence False Positive Bilateral Cervical % 45% 72% Thoracic % 42% 80% Lumbar % 45% 79% Manchukonda R, et al: Facet joint pain in chronic spinal pain: an evaluation of prevalence and false-positive rate of diagnostic blocks. J Spinal Disord Tech 2007; 20:

3 Diagnostic block (single vs comparative) (2) Therapeutic intervention (intra-articular injection vs medial branch block vs radiofrequency ablation) Repeat radiofrequency ablation Spinal fusion 10/2004 to 12/2006 Comparative local anesthetic blocks Outcome: >50% pain relief Cervical: strong/ii Thoracic: moderate/iii Lumbar: strong/ii Intra-articular injections vs medial branch blocks Sehgal N, et al: Systematic review of diagnostic utility of facet (zygapophysial) joint injections in chronic spinal pain: an update. Pain Physician 2007; 10: Marks RC, Houston T, Thulbourne T: Facet joint injection and facet nerve block: a randomized comparison in 86 patients with chornic low back pain. Pain 1992; 49: to 6/2012 Lumbar medial branch blocks Single or comparative local anesthetic blocks Outcome: 50-74% or % pain relief and ability to perform painful movement Level of evidence: U.S. Preventive Services Task Force (USPSTF) Single block, 50-74% relief (1) Single block, % relief (4) Comparative blocks, 50-74% relief (5) Comparative blocks, % relief (13) Evidence Poor Limited Fair Good Falco F, et al: An update of the systematic assessment of the diagnostic accuracy of lumbar facet joint nerve blocks. Pain Physician 2012; 15: Falco F, et al: An update of the systematic assessment of the diagnostic accuracy of lumbar facet joint nerve blocks. Pain Physician 2012; 15:

4 Level of Evidence Adapted and modified from methods developed by U.S. Preventive Services Task Force (USPSTF) Grade Good Fair Limited or Poor Definition Evidence includes at least 2 consistent, higher quality RCTs or studies of diagnostic test accuracy. Evidence is includes at least 1 higher quality RCT or study of diagnostic test accuracy. Evidence is insufficient to assess effects on health outcome. Retrospective 262 patients Single local anesthetic block Outcome: >=50% pain relief after radiofrequency ablation persisting >=6 months and Global Perceived Effect (GPE) Degree of pain relief from medial branch blocks does not correlate with outcome from radiofrequency ablation Not to be extrapolated to controlled or comparative local anesthetic blocks Patients Pain Relief GPE >=50%<80% % 67% >=80% % 66% Cohen S, et al: Lumbar zygapophysial (facet) joint radiofrequency denervation success as a function of pain relief during diagnostic medial branch blocks: a multicenter analysis. The Spine Journal 2008; 8; Strong evidence for diagnostic accuracy No consensus Intra-articular injection vs medial branch block >=50% vs >=80% Comparative blocks: decrease false positive rate, increase false negative rate Diagnostic block (single vs comparative) Therapeutic intervention (intra-articular injection vs medial branch block vs radiofrequency ablation) (4) Repeat radiofrequency ablation Spinal fusion 4

5 11/2004 to 12/2006 Outcome: pain relief, functional improvement, psychological status, and return to work Intra-articular injections and medial branch blocks Short term: <6 weeks Long term: >=6 weeks Radiofrequency ablation Short term: <3 months Long term: >=3 months Level of evidence: Manchikanti et al Evidence Evidence Short Term Long Term Cervical Intra-articular (1) Limited IV IV MBB (1) Moderate III III RFA (1) Moderate III III Thoracic MBB Moderate III III RFA Indeterminate V V Lumbar Intra-articular (2) Moderate III III MBB (2) Moderate III III RFA (1) Moderate III III Boswell M, et al: A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician 2007; 10: Boswell M, et al: A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician 2007; 10: Level I Level II Level III Level IV Level V Level of Evidence Conclusive: Research-based evidence with multiple relevant and high-quality scientific studies or consistent reviews of meta-analyses Strong: Research-based evidence from at least 1 properly designed randomized, controlled trial; or research-based evidence from multiple properly designed studies of smaller size; or multiple low quality trials Moderate: a) Evidence obtained from well-designed pseudorandomized controlled trials (alternate allocation or some other method); b) Evidence obtained from comparative studies with concurrent controls and allocation not randomized (cohort studies, case-controlled studies, or interrupted time series with a control group); c) Evidence obtained from comparative studies with historical control, 2 or more single-arm studies, or interrupted time series without a parallel control group Limited: Evidence from well-designed nonexperimental studies from more than 1 center or research group; or conflicting evidence with inconsistent findings in multiple trials Indeterminate: Opinions of respected authorities, based on clinical evidence, descriptive studies, or reports of expert committees Manchikanti, et al: Methods for evidence synthesis in interventional pain management. Pain Physician 2003; 6: to 12/2008 Diagnostic with controlled local anesthetic blocks Outcome: >=80% pain relief and ability to perform painful activities Therapeutic facet intra-articular injections, MBBs and RFA Primary outcome: pain relief and long-term follow up Secondary outcome: improved functional status, psychological status, return to work, and reduction in opioids Datta S; et al: Systematic assessment of diagnostic accuracy and therapeutic utility of lumbar facet joint interventions. Pain Physician 2009; 12:

6 Level of evidence: USPSTF Grade of recommendation: Guyatt et al Diagnostic (7) Evidence I or II1 Recommendation Intra-articular Injection III Limited2C/very weak Medial Branch Blocks (2) II1 or II2 Strong 1B/1C Radiofrequency Ablation (1) II2 or II3 Strong 1B/1C Datta S; et al: Systematic assessment of diagnostic accuracy and therapeutic utility of lumbar facet joint interventions. Pain Physician 2009; 12: Grade of Recommendation/Description 1A/strong recommendation, high-quality evidence 1B/strong recommendation, moderate quality evidence 1C/strong recommendation, low-quality or very low quality evidence 2A/weak recommendation, high-quality evidence 2B/weak recommendation, moderate-quality evidence 2C/weak recommendation, low-quality or very low quality evidence Level of Recommendation Benefit vs Risk and Burdens Benefits clearly outweigh risk and burdens, or vice versa Benefits clearly outweigh risk and burdens, or vice versa Benefits clearly outweigh risk and burdens, or vice versa Benefits closely balanced with risks and burden Benefits closely balanced with risks and burden Uncertainty in the estimates of benefits, risks, and burden; benefits, risk, and burden may be closely balanced Methodological Quality of Supporting Evidence RCTs without important limitations or overwhelming evidence from observational studies RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Observational studies or case series RCTs without important limitations or overwhelming evidence from observational studies RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Observational studies or case series Implications Strong recommendation, can apply to most patients in most circumstances without reservation Strong recommendation, can apply to most patients in most circumstances without reservation Strong recommendation but may change when higher quality evidence becomes available Weak recommendation, best action may differ depending on circumstances or patients or societal values Weak recommendation, best action may differ depending on circumstances or patients or societal values Very weak recommendations; other alternatives may be equally reasonable Adapted from Guyatt G et al. Grading strength of recommendations and quality of evidence in clinical guidelines. Report from an American College of Chest Physicians task force. Chest 2006; 129: (104) to 6/2012 Therapeutic facet intra-articular injections, MBBs and RFA Primary outcome: >=50% pain relief or >=3 VAS change Short term: <=6 months Long term: >6 months Secondary outcome: >=40% functional improvement, psychological status, return to work, and reduction in opioids Level of evidence: U.S. Preventive Services Task Force (USPSTF) Evidence Short Term Evidence Long Term Intra-articular (2) Limited Limited MBB (3) Fair to Good Fair to Good RFA (7) Good Good Falco F, et al: An Update of the Effectiveness of Therapeutic Lumbar Facet Joint Interventions. Pain Physician 2012; 15: Falco, F, et al: An Update of the Effectiveness of Therapeutic Lumbar Facet Joint Interventions. Pain Physician 2012; 15:

7 Level of Evidence Adapted and modified from methods developed by U.S. Preventive Services Task Force (USPSTF) Grade Definition Good Evidence includes at least 2 consistent, higher quality RCTs or studies of diagnostic test accuracy. Recommendation: Guyatt et al, adapted by van Kleef et al Radiofrequency ablation: recommended Intra-articular steroid injection: reserved for nonresponders to RFA Comparative local anesthetic blocks: false negative rate Fair Limited or Poor Evidence is includes at least 1 higher quality RCT or study of diagnostic test accuracy. Evidence is insufficient to assess effects on health outcome. Recommendation Radiofrequency Ablation 1B+ Intra-articular steroid injection 2B+/- van Kleef M, et al: Evidence-based medicine: pain originating from the lumbar facet joints. Pain Practice 2010; 10: Level of Recommendation Score Description Implication 1 A+ 1 B+ 2 B+ 2 B+/- 2 C+ 0 2 C- 2 B- 2 A- Effectiveness demonstrated in various RCTs of good quality. The benefits clearly outweigh risk and burdens One RCT or more RCTs with methodologic weaknesses, demonstrate effectiveness. The benefits clearly outweigh risk and burdens One or more RCTs with methodologic weaknesses, demonstrate effectiveness. Benefits closely balanced with risk and burdens Multiple RCTs, with methodologic weaknesses, yield contradictory results better or worse than the control treatment. Benefits closely balanced with risk and burdens, or uncertainty in the estimates of benefits, risk and burdens Effectiveness only demonstrated in observational studies. Given that there is no conclusive evidence of the effect, benefits closely balanced with risk and burdens There is no literature or there are case reports available, but these are insufficient to suggest effectiveness and/or safety. These treatments should only be applied in relation to studies Observational studies indicate no or too short-lived effectiveness. Given that there is no positive clinical effect, risk and burdens outweigh the benefit One or more RCTs with methodologic weaknesses, or large observational studies that do not indicate any superiority to the control treatment. Given that there is no positive clinical effect, risk and burdens outweigh the benefit RCT of a good quality which does not exhibit any clinical effect. Given that there is no positive clinical effect, risk and burdens outweigh the benefit Positive recommendation Positive recommendation Positive recommendation Considered, preferably study-related Considered, preferably study-related Only study-related Negative recommendation Negative recommendation Negative recommendation van Kleef M, et al: Evidence based guidelines for interventional pain medicine according to clinical diagnoses. Pain Pract. 2009; 9: Sehgal et al 2007 Falco et al 2012 Boswell 2007 Datta et al 2009 Falco et al 2012 Diagnostic Intra-articular MBB RFA II Good III III III I or II1 III II1 or II2 II2 or II3 Limited Fair to Good Good Comparative blocks: best available diagnostic method Radiofrequency ablation: best available treatment Intra-articular injection: reserved for non-responders to RFA 7

8 RCT 151 patients Zero, single and comparative local anesthetic blocks 0.5 ml 2% Lidocaine and 5 mg Depomedrol prior to radiofrequency ablation Outcome: >=50% pain relief persisting >=3 months and Global Perceived Effect (GPE) RFA without diagnostic injection: highest success rate 0.5 ml 2% Lidocaine and 5 mg Depomedrol prior to RFA Comparative local anesthetic block: more reliably predict outcome from RFA with lower pain and disability scores Patients Outcome RFA Pain Disability Medications GPE RFA 51 17(33%) 33% % 74.2% 1 MMB + RFA 2 MMBs + RFA 50 8(16%) 39% % 91.7% 50 11(22%) 64% % 100% Cohen P, et al: Multicenter, randomized, comparative cost-effectiveness study comparing 0, 1, and 2 diagnostic medial branch (facet joint nerve) block treatment paradigms before lumbar facet radiofrequency denervation. Anesthesiology 2010; 113: Cohen P, et al: Multicenter, randomized, comparative cost-effectiveness study comparing 0, 1, and 2 diagnostic medial branch (facet joint nerve) block treatment paradigms before lumbar facet radiofrequency denervation. Anesthesiology 2010; 113: RFA without diagnostic injection: most cost effective 1 st Level Subsequent Level MBB $350 $170 RFA $650 $325 Cost (>=3 Months) RFA $ MBB + RFA $ MBBs + RFA $15241 Diagnostic block (single vs comparative) Therapeutic intervention (intra-articular injection vs medial branch block vs radiofrequency ablation) Repeat radiofrequency ablation (3) Spinal fusion Cohen P, et al: Multicenter, randomized, comparative cost-effectiveness study comparing 0, 1, and 2 diagnostic medial branch (facet joint nerve) block treatment paradigms before lumbar facet radiofrequency denervation. Anesthesiology 2010; 113:

9 Radiofrequency Ablation Success with repeat facet radiofrequency ablation Effectiveness of repeated radiofrequency neurotomy for lumbar facet pain Schofferman et al 2004 Spine The effect of repeated zygapophysial joint radiofrequency neurotomy on pain, disability, and improvement duration Rambaransingh et al 2010 Pain Med 10 months duration, same when repeated Radiofrequency Ablation Outcome: Duration of pain relief after initial and repeated radiofrequency ablation Initial: 7 to 9 months Repeat: 6 to 12.7 months Schofferman J, Kine G: Effectiveness of repeated radiofrequency neurotomy for lumbar facet pain. Spine 2004; 29: Rambaransingh B, Stanford G, Burnham R: The effect of repeated zygapophysial joint radiofrequency neurotomy on pain, disability, and improvement duration. Pain Med 2010; 11: Smuck M, et al: Success of initial and repeated medial branch neurotomy for zygopophysial joint pain: a systematic review. PM R 2012; 4: Before Lumbar Fusion Diagnostic block (single vs comparative) Therapeutic intervention (intra-articular injection vs medial branch block vs radiofrequency ablation) Repeat radiofrequency ablation Spinal fusion Evidence does not support using diagnostic lumbar facet blocks as a predictive tool before spinal fusion Cohen et al 2007 Anesth Analg Cohen S, Hurley R: The ability of diagnostic spinal injections to predict surgical outcomes. Anesth Analg 2007; 105:

10 Low Back Pain After Lumbar Fusion Radiofrequency Ablation After Lumbar Surgery Most common source is sacroiliac joint, followed by disc, facet joint, and soft tissue irritation by hardware Sacroiliac joint pain prevalence: 13% in non-fused, 43% in fused Disc pain prevalence: 45% in non-fused, 25% in fused 479 had microsurgical lumbar disc surgery 120 had persistent back pain Comparative local anesthetic and steroid blocks with >=80% pain relief 34 had positive response to diagnostic block Outcome: >50% pain relief for at least 6 months 20 had positive outcome Radiofrequency ablation success rate: 58.8% DePalma M, et al: Etiology of chronic low back pain in patients having undergone lumbar fusi Pain Medicine 2011; 12: Klessinger S: Zygapophysial joint pain in post lumbar surgery syndrome. The efficacy of medial branch blocks and radiofrequency neurotomy. Pain Medicine 2012; 12: Conclusion Facet joint pain: prevalent, bilateral, multiple regions History, physical exam and diagnostic imaging: unreliable Diagnostic block: high false positive rate (45%) and false negative rate (11%) Comparative blocks: best available standard, decrease false positive rate, increase false negative rate Debate: Intra-articular injection vs medial branch block, >=50% vs >=80% Conclusion Radiofrequency ablation: recommended Intra-articular injection: reserved for non-responders to RFA Repeat radiofrequency ablation: duration of pain relief maintained Diagnostic block as a predictive tool before spinal fusion: not supported by evidence Source of pain after spinal fusion: sacroiliac joint (43%), followed by disc (25%), and facet joint Radiofrequency ablation after lumbar surgery: success rate 58.8% 10