notable spine & pain medicine papers - 2015 aapmr annual assembly michael j depalma, md...

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?