Notable Spine & Pain Medicine Papers - 2015 AAPMR Annual Assembly Michael J DePalma, MD President,...
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Transcript of Notable Spine & Pain Medicine Papers - 2015 AAPMR Annual Assembly Michael J DePalma, MD President,...
Notable Spine & Pain Medicine Papers - 2015 AAPMR Annual
AssemblyMichael J DePalma, MD
President, Medical DirectorDirector, Interventional Spine Care Fellowship
Virginia iSpine Physicians, PCPresident, Chairman, Director of Research
Virginia Spine Research Institute, Inc
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
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)
Discogenic LBP- Methodology
• Prospective, observational, IRB approved study of CLBP pts
• Private IP practice in Australia• Study prevalence and features using PLD
Discogenic LBP- Methodology
Discogenic LBP- Methodology
Discogenic LBP- Results
Discogenic LBP- Results
Discogenic LBP- Results
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)
Thank you- Questions?
• 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
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
Navigable Perc Decompression Device (L’DISQ)- Results
L’DISC- Results
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
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
Thank you- Questions?
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)
Intradiscal Cooled RFA - Intro
• 2 probes positioned to produce bipolar configuration
Intradiscal Cooled RFA - Intro
• Compare effectiveness of intradiscal cooled RFA to placebo for discogenic LBP
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
TDB- Methods
• RCT: TDB vs Sham, double blind
Intradiscal Cooled RFA - Methods
• Outcome measures:– SF-36– NRS– ODI– Opiate use (daily morphine equivalent)– 1,3, 6, and 12 mon.s
Intradiscal Cooled RFA - Results
• 1894 patients screened• 64 enrolled– 32 in tx and sham groups each– 27 underwent tx– 25 underwent sham
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)
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
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
Thank you- Questions?
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
ID Autologous PRP- Intro
• Does a single injection of autologous PRP result in clinical benefit for discogenic LBP patients
ID Autologous PRP- Methodology
• Prospective, double blind, RCT of patients with chronic discogenic LBP
ID Autologous PRP- Methodology
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
ID Autologous PRP- Methodology
• Functional rating index, NRS, SF-36, mod NASS Outcome Questionnaire @ baseline, 1, 4, & 8 wk.s
ID Autologous PRP- Results
ID Autologous PRP- Results
ID Autologous PRP- Results
ID Autologous PRP- Results
ID Autologous PRP- Results
ID Autologous PRP- Results
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
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
Thank you- Questions?
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)
IA A-O Joint Injections- Intro
• Evaluate effectiveness of AO IA steroid injection re pain relief
• Demonstrate patterns of AO referred pain
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
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
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
IA A-O Joint Injections- Results
IA A-O Joint Injections- Results
IA A-O Joint Injections- Results
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
Thank you- Questions?