Notable Spine & Pain Medicine Papers - 2015 AAPMR Annual Assembly

1. Notable Spine & Pain Medicine Papers - 2015 AAPMR Annual Assembly Michael J DePalma, MD President, Medical Director Director, Interventional Spine Care Fellowship Virginia iSpine Physicians, PC President, Chairman, Director of Research Virginia Spine Research Institute, Inc

2. Disclosures • Co-investigator: Mesoblast; Spinal Restoration; ATRM/Depuy; Stryker Biotech; St Jude Medical; NIH funded LSS/ESI trial; SI Bone; Vertiflex; Halyard • SIS AUC Comm; NASS Clinical Guidelines Comm • Spine Section co-editor, Pain Medicine • Consultant: Vertiflex; Zyga; Biobridges • CAB: Mesoblast; Medtronic; Halyard

4. Discogenic LBP- Intro • Painful lumbar discs degrade, lose ECM/cells, and fissure • Diagnosing painful discs is elusive • Prevalence estimates demonstrate painful discs exist (Schwarzer, DePalma) • Disc stimulation is useful (Wolfer) • Has been contested (Carragee)

5. Discogenic LBP- Methodology • Prospective, observational, IRB approved study of CLBP pts • Private IP practice in Australia • Study prevalence and features using PLD

6. Discogenic LBP- Methodology

7. Discogenic LBP- Methodology

8. Discogenic LBP- Results

9. Discogenic LBP- Results

10. Discogenic LBP- Results

11. Discogenic LBP- Conclusions • Discogenic LBP in Australian IP PP = 22% (95% CI: 17,26) • Cohort w/ mean age = 55 • Discogenic LBP = 74% (95% CI: 68,80) • Cohort w/ mean age = 43 • Prevalence of discogenic LBP associated with patient age (DePalma, Pain Med 2011)

12. Thank you- Questions?

14. Navigable Perc Decompression Device (L’DISQ)- Intro • Painful discs contain innervated annular fissures • Navigable perc decompression device • Wand rotates to access annulus • Deploy plasma energy to ablate soft tissue • Study clinical outcomes of device for discogenic LBP

15. Navigable Perc Decompression Device (L’DISQ)- Methodology • Prospective, IRB approved cohort • PLD performed using SIS standards • VAS, ODI, RM, SF-36 BP at baseline, 1, 4, 12, 24, and 48 wks • Successful outcome: • > 50% reduction in VAS

18. Navigable Perc Decompression Device (L’DISQ)- Results

19. L’DISC- Results

20. Navigable Perc Decompression Device (L’DISQ)- Results • Clinical success defined as > 50% reduction in VAS: • 60.0 (38.5,81.5) @ 1 wk & 4 wk.s • 45.0 (23.2,66.8) @ 12 wk.s • 55.0 (33.2,76.8) @ 24 wk.s & 48 wk.s

21. Navigable Perc Decompression Device (L’DISQ)- Conclusions • Pilot data suggests treatment effect • Clinically significant improvement in LBP • Perhaps reduced disability • Prospective pilot liable to report better results than RCT • More rigorous study warranted

22. Thank you- Questions?

24. Intradiscal Cooled RFA - Intro • Intervertebral disc = common source of chronic LBP (Schwarzer, DePalma) • Annular fissures stimulated during PLD are source of clinical LBP (DePalma) • NNT for IDET = 5 (Pauza)

25. Intradiscal Cooled RFA - Intro • 2 probes positioned to produce bipolar configuration

26. Intradiscal Cooled RFA - Intro • Compare effectiveness of intradiscal cooled RFA to placebo for discogenic LBP

27. Intradiscal Cooled RFA - Methods • Exclusions: • Prior L/S spine surgery • HNP/free fragments • Radiculopathy • Spondylolisthesis • Competing MSK conditions • WC; litigation • BMI > 30 • CLBP > 6 months despite: • Conservative care: PT; NSAID’s • LBP > LL pain • + PLD • > 50% disc height intact

28. TDB- Methods • RCT: TDB vs Sham, double blind

29. Intradiscal Cooled RFA - Methods • Outcome measures: • SF-36 • NRS • ODI • Opiate use (daily morphine equivalent) • 1,3, 6, and 12 mon.s

30. Intradiscal Cooled RFA - Results • 1894 patients screened • 64 enrolled • 32 in tx and sham groups each • 27 underwent tx • 25 underwent sham

31. Intradiscal Cooled RFA - Results • 27 Tx arm patients: • 5 dropped out after unblinding @ 6 mon.s • 22 patients @ 12 mon.s (18.6% lost to f/u) • 30 Sham patients: • 24 elected to cross over after unblinding @6 mon.s • 20 cross over pts @ 6 mon.s (16.7% lost to f/u)

34. Intradiscal Cooled RFA - Results • Binary definition of clinical success: • > 15 pt SF-36 increase • > 2 pt NRS decrease • 36% (95%CI: 16,56) @ 12 mon.s

35. Intradiscal Cooled RFA - Conclusions • Treatment effects were durable: • Mean outcomes of PF (SF 36), pain, disability, & opioid usage @ 6 mon.s maintained @ 12 mon.s • Cross-over patients reported improvement in mean PF, pain, disability, & opioid usage @ 1, 3, and 6 mon.s

36. Thank you- Questions?

38. ID Autologous PRP- Intro • Advantages • Cost effective (harvesting/procurement) • Mixture of GF, cells, fibrin • Disadvantages • Small amount/variable composition of delivered GF • Cell count variable • Cell homogeneity

39. ID Autologous PRP- Intro • Does a single injection of autologous PRP result in clinical benefit for discogenic LBP patients

40. ID Autologous PRP- Methodology • Prospective, double blind, RCT of patients with chronic discogenic LBP

41. ID Autologous PRP- Methodology

42. ID Autologous PRP- Methodology • Randomized into 2 parallel groups in 2:1 ratio (tx:con) • Independent observer for randomization and f/u assessments • Upon concordant pain and outer annular disruption during PLD, covered syringe containing 3-4 ml PRP or contrast was connected

43. ID Autologous PRP- Methodology • Functional rating index, NRS, SF-36, mod NASS Outcome Questionnaire @ baseline, 1, 4, & 8 wk.s

44. ID Autologous PRP- Results

46. ID Autologous PRP- Results

47. ID Autologous PRP- Results

48. ID Autologous PRP- Results

49. ID Autologous PRP- Results

50. ID Autologous PRP- Results