Lumbar Discogenic Pain Treatment Options

1. Lumbar Discogenic Pain Treatment Options J. Scott Bainbridge, MD www.DenverBackPainSpecialists.com Denver Spine Institute Winter Meeting February 24-27, 2011

2. Disclosures • International Spine Intervention Society Research Committee Chairman • Research Director for Nimbus Concepts • Ownership interest in ASC • No specific medical devices will be endorsed or discussed

3. Low Back Pain (Discogenic) Case Study • AS – 21yo F • 1 ½ years of disruptive axial LBP • ODI 26, hold on masters program and only working part time (as host) due to pain • Pain scores: 3-8/10 • Pain with: bend/lift/sneeze/sit • PT (manual, exercise) • ESI x 2, non-dx facet blocks • TENS • Medications (Prozac, Elavil, Soma, Valium, Zomig)

9. LBP Diagnostic Tools • Medial Branch Blocks (Zygapophysial Joint) • Sacroiliac Joint Blocks • Discography (Provocative, Functional Anesthetic)

10. Diagnosis of Disc Pain – Criterion Standard is Provocation Discography

11. Yin/Bogduk; Bonica’s Management of Pain, 4th Edition

17. Unequivocal L5-S1 Discogenic Pain • L3-4: Normal, P0/P0 • L4-5: Normal, P0/P0 • Disc Level: L5-S1 • Pain Response: P2/P2/R1. • Opening Pressure: 6. • Pressure to Pain: 18. Pain response 8/10 axial low back pain, which was concordant. • Disc Architecture: Posterior annular tear, grade III. • Comment: Concordant pain response rated 8/10, at 12 PSI above opening pressure with associated grade III posterior annular tear.

18. www.spinalrestoration.com

19. Conservative Therapies for LBP • Various approaches with various grades of evidence • Chou (American Pain Society, Health Technology Assessment Program, Spectrum Research, Inc.) (2008,2009,2010) • The Spine Journal 8(1) (2008) -dedicated issue

20. Chou, Systematic Reviews, and Policy • Chou, R. (2009). "Same trials, different conclusions: sorting out discrepancies between reviews on interventional procedures of the spine." Spine J 9(8): 679-689. • Chou, R. (2010). "Pharmacological management of low back pain." Drugs 70(4): 387-402. • Chou, R., S. J. Atlas, et al. (2009). "Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline." Spine (Phila Pa 1976) 34(10): 1078-1093. • Chou, R., J. Baisden, et al. (2009). "Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline." Spine (Phila Pa 1976) 34(10): 1094-1109. • Chou, R., J. D. Loeser, et al. (2009). "Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society." Spine (Phila Pa 1976) 34(10): 1066-1077. • Chou, R., A. Qaseem, et al. (2007). "Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society." Ann Intern Med 147(7): 478-491. • Spectrum Research, Inc. > Health Technology Assessment Program • http://www.hta.hca.wa.gov

21. Conservative therapies for LBP – Education, Watchful Waiting, Activity • Pradhan Spine J 2008

22. Conservative therapies for LBP – Physical Therapy Approaches • Standaert Spine J 2008 • Stabilization – moderate evidence, not sig different from manual therapy or general exercise May Spine J 2008 McKenzie – good evidence of efficacy

23. Conservative Therapies for LBP – NSAIDS, Muscle Relaxants, Opiods, Others • Malanga Spine J 2008 • Chou 2007, 2009 • Individualize and consider combination therapies • Consider risks

24. DATA SYNTHESIS: We found good evidence that NSAIDs, acetaminophen, skeletal muscle relaxants (for acute low back pain), and tricyclic antidepressants (for chronic low back pain) are effective for pain relief. The magnitude of benefit was moderate (effect size of 0.5 to 0.8, improvement of 10 to 20 points on a 100-point visual analogue pain scale, or relative risk of 1.25 to 2.00 for the proportion of patients experiencing clinically significant pain relief), except in the case of tricyclic antidepressants (for which the benefit was small to moderate). We also found fair evidence that opioids, tramadol, benzodiazepines, and gabapentin (for radiculopathy) are effective for pain relief. We found good evidence that systemic corticosteroids are ineffective. Adverse events, such as sedation, varied by medication, although reliable data on serious and long-term harms are sparse. Most trials were short term (< or =4 weeks). Few data address efficacy of dual-medication therapy compared with monotherapy, or beneficial effects on functional outcomes. Chou 2007

25. Conservative therapies for LBP – Adjuvant Medications • Chang, Gonzalez, Akuthota Spine J 2008

26. Conservative Therapies for LBP – Nutritional Supplements • Gagnier Spine J 2008

27. Conservative therapies for LBP – CAM • Ammendolia Spine J 2008 • Acupuncture effective short term – good for combination with other therapies Bronfort Spine J 2008 Manipulation – mixed evidence – viable option with similar outcomes to exercise, other

28. American Recovery and Reinvestment Act of 2009

29. American Recovery and Reinvestment Act

30. Conservative therapies for LBP • Low cost, or • High co-pays, or • Costs shifted to patients (OTC, CAM) • Consumer driven health care (limited niche)?

31. Interdisciplinary Rehabilitation • Chou (Spine 2009) APS Guidelines • Physical rehab/exercise with cognitive/behavioral emphasis • Strong recommendation

32. Interventional Therapies for LBP – Epidural Steroid Inj., SIJ, Facet Blocks • Washington State sponsored Health Technology Assessment (APS Guidelines heavily referenced) • 3/18/11 hearing at Washington State Legislature Chou – Spine 2009

33. 1. AJNR Am J Neuroradiol. 2010 Jul 8. Therapeutic Trial of Fluoroscopic Interlaminar Epidural Steroid Injection forAxial Low Back Pain: Effectiveness and Outcome Predictors. Lee JW, Shin HI, Park SY, Lee GY, Kang HS.Departments of Radiology and Rehabilitation Medicine, Seoul National University Bundang Hospital, Gyeongi-Do, Korea. • BACKGROUND AND PURPOSE: An ESI for managing LBP is one of the most commonly performed interventions. The purpose of this observational study was to assess the effect of a therapeutic trial of a fluoroscopic interlaminar ESI for axial LBP and to analyze the outcome predictors. • MATERIALS AND METHODS: All patients who received an interlaminar ESI for axial LBP at our facility in 2007 and 2008 were included. Initial short-term follow-up was done at <1 month after ESI. ESI was considered effective if patients had a reduction of >50% in their pain scores. In July 2009, telephone interviews were conducted by using formatted questions including the NASS patient-satisfaction index. The symptom-free interval was computed by the Kaplan-Meier method. Outcome predictors such as age, sex, duration of LBP, and MR imaging findings were statistically analyzed by the Mann-Whitney U and the Fisher exact tests. • RESULTS: Eighty-one patients (male/female = 16:65; mean age, 49.9 years; range, 17-77 years) were included in the study. The interlaminar ESI was effective in 63 of the 81 patients (77.8%) at initial short-term follow-up. For the 63 patients in whom ESI was effective, the median symptom-free interval was 154 days (95% CI, 96-212 days). Among 68 patients for whom telephone interviews were possible, 44 patients (64.7%) replied positively to the NASS patient satisfaction index (NASS patient-satisfaction index, 1 or 2). There were no significant outcome predictors. • CONCLUSIONS: The therapeutic trial of a fluoroscopic interlaminar ESI was effective for axial LBP without significant outcome predictors. Courtesy RE Wright

34. Nucleoplasty • Derby, Baker, Lee 2008 Spine J • No strong evidence of support

35. Intradiscal Therapies for Low Back Pain – Yin, Bogduk; Bonica’s Management of Pain, 4th Edition • Regenerative Therapies • Investigational • Not covered by payers

36. Intradiscal Therapies for Low Back Pain – Yin, Bogduk; Bonica’s Management of Pain, 4th Edition • Denervation • Ramus communicans lesions • Intranuclear radiofrequency • Sinuvertebral nerve lesions • Intradiscal electrothermal therapy (IDET)

37. Intradiscal Therapies for Low Back Pain – • Thermal Therapies (IDET) • Derby, Baker, et al. 2008 Review: • 6 IDET studies: 38-94% (ave. 71%) with > 50% relief of pain for 6-24 months • Andersson 2006 Review – positive/comparable to fusion • Chou 2009 – not supported • Payor Coverage: • UHC, Anthem, Medicare – no coverage

38. Intradiscal Therapies for Low Back Pain – Yin, Bogduk; Bonica’s Management of Pain, 4th Edition • Chemical Therapies • Intradiscal steroids - Chou • Etanercept • Methylene blue – positive RCT (Peng 2010) • Ozone • Proliferants - Derby

39. The use of methylene blue for the treatment of discogenic LBP J. Scott Bainbridge, MD

40. Mechanisms of Action • Inhibition of guanylate cyclase and nitric oxide synthase • MB blocks degradative effects of NO (Yin/Bogduk) Weak neurolytic effects

45. Surgical Options for LBP • Options: various fusion/fixation/movement sparing options • Increasing utilization (Deyo 2005) • Payer Coverage: variable without instability • Case presented > MB failed, fusion denied • HTA – Washington State • North Carolina • Milliman Care Guidelines

47. Chou (Spine 2009) APS Guidelines

48. Milliman Care Guidelines • www.careguidelines.com • Originated as Milliman & Robertson • Milliman is among the world's largest independent actuarial and consulting firms, with revenues of $676 million in 2010. Founded in Seattle in 1947, we currently have 54 offices in key locations worldwide. Our staff of 2,500 people includes more than 1,300 qualified consultants and actuaries. We are owned and managed by approximately 350 principals—senior consultants whose selection is based on their technical, professional and business achievements.