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

8. 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. 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 Navigable Perc Decompression Device (L’DISQ)- Intro

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

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. 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

51. ID Autologous PRP- Conclusions PRP introduced in presence of contrast material PLD not performed using strict operational criteria Limited f/u time interval No analysis of cell counts/composition of PRP

52. ID Autologous PRP- Conclusions Double blind, RCT High f/u rate Statistical improvement in mean NRS, FRI, & patient satisfaction @ 8 wk.s (no categorical data) Subsequent, larger studies warranted – Homogenize/measure cell count/content in injectate

53. Thank you- Questions?

55. IA A-O Joint Injections- Intro C2-3 & C1-2 joints, and C3-4 facet joint can cause neck pain and headaches (Cooper) The atlanto-occipital joint is an innervated synovial joint – Capable of producing pain (Dreyfuss)

56. IA A-O Joint Injections- Intro Evaluate effectiveness of AO IA steroid injection re pain relief Demonstrate patterns of AO referred pain

57. IA A-O Joint Injections- Methodology Prospective, consecutive evaluation Chronic, spontaneous suboccipital neck pain > 3 mon.s Failure to respond to medications and PT Tenderness in suboccipital area VAS, NDI @ baseline & 1, 2 mon.s

58. IA A-O Joint Injections- Methodology > 50% reduction in pain s/p 1ml 2% lido Co-intervention disallowed 1 ml IA inj of lido/triam Excluded: – HNP, FS, AA jt arthrosis – C23 joint and FJ pain Negative dx TON/MBB’s

61. IA A-O Joint Injections- Results 29 patients met criteria (24 enrolled) 20 with > 50% pain reduction s/p dx blk 4 men/16 women Mean age 51.1 +/- 13.1 yrs 14/20 patients had headache

62. IA A-O Joint Injections- Results

65. IA A-O Joint Injections- Conclusions Injured Atlanto-Occipital joints present w/ posterior neck pain, headaches, suprascapular, scapular, and UL pain Short-intermediate term reduction in pain and disability s/p IA steroid inj

66. Thank you- Questions?