Lumbar Discogenic Pain Lumbar Discogenic Pain Treatment OptionsTreatment OptionsJ. Scott Bainbridge, MDwww.DenverBackPainSpecialists.comDenver Spine Institute Winter MeetingFebruary 24-27, 2011

DisclosuresDisclosuresInternational Spine Intervention

Society Research Committee Chairman

Research Director for Nimbus Concepts

Ownership interest in ASCNo specific medical devices will

be endorsed or discussed

Low Back Pain (Discogenic) Low Back Pain (Discogenic) Case StudyCase StudyAS – 21yo F1 ½ years of disruptive axial LBPODI 26, hold on masters program

and only working part time (as host) due to pain

Pain scores: 3-8/10Pain with: bend/lift/sneeze/sitPT (manual, exercise) ESI x 2, non-dx facet blocksTENS Medications (Prozac, Elavil, Soma,

Valium, Zomig)

LBP Diagnostic ToolsLBP Diagnostic ToolsMedial Branch Blocks

(Zygapophysial Joint)Sacroiliac Joint BlocksDiscography (Provocative,

Functional Anesthetic)

Diagnosis of Disc Pain – Criterion Diagnosis of Disc Pain – Criterion Standard is Provocation DiscographyStandard is Provocation Discography

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

Unequivocal L5-S1 Unequivocal L5-S1 Discogenic PainDiscogenic PainL3-4: Normal, P0/P0L4-5: Normal, P0/P0Disc 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.

www.spinalrestoration.com

Conservative Therapies Conservative Therapies for LBPfor LBPVarious approaches with various

grades of evidenceChou (American Pain Society,

Health Technology Assessment Program, Spectrum Research, Inc.) (2008,2009,2010)

The Spine Journal 8(1) (2008) -dedicated issue

Chou, Systematic Reviews, Chou, Systematic Reviews, and Policyand 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

Conservative therapies for Conservative therapies for LBP – Education, Watchful LBP – Education, Watchful Waiting, ActivityWaiting, ActivityPradhan Spine J 2008

Conservative therapies for Conservative therapies for LBP – Physical Therapy LBP – Physical Therapy ApproachesApproachesStandaert Spine J 2008

◦Stabilization – moderate evidence, not sig different from manual therapy or general exercise

May Spine J 2008McKenzie – good evidence of efficacy

Conservative Therapies for LBP – Conservative Therapies for LBP – NSAIDS, Muscle Relaxants, Opiods, NSAIDS, Muscle Relaxants, Opiods, OthersOthersMalanga Spine J 2008Chou 2007, 2009Individualize and consider

combination therapiesConsider risks

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

Conservative therapies for Conservative therapies for LBP – Adjuvant MedicationsLBP – Adjuvant MedicationsChang, Gonzalez, Akuthota Spine

J 2008

Conservative Therapies for Conservative Therapies for LBP – Nutritional LBP – Nutritional SupplementsSupplementsGagnier Spine J 2008

Conservative therapies for Conservative therapies for LBP – CAMLBP – CAMAmmendolia Spine J 2008

◦Acupuncture effective short term – good for combination with other therapies

Bronfort Spine J 2008Manipulation – mixed evidence – viable option with similar outcomes to exercise, other

American Recovery and American Recovery and Reinvestment Act of 2009 Reinvestment Act of 2009

American Recovery and American Recovery and Reinvestment Act Reinvestment Act

Conservative therapies for Conservative therapies for LBPLBPLow cost, orHigh co-pays, orCosts shifted to patients (OTC,

CAM)Consumer driven health care

(limited niche)?

Interdisciplinary Interdisciplinary Rehabilitation Rehabilitation Chou (Spine 2009) APS

GuidelinesPhysical rehab/exercise with

cognitive/behavioral emphasisStrong recommendation

Interventional Therapies for Interventional Therapies for LBP – Epidural Steroid Inj., LBP – Epidural Steroid Inj., SIJ, Facet BlocksSIJ, Facet BlocksWashington State sponsored

Health Technology Assessment (APS Guidelines heavily referenced)

3/18/11 hearing at Washington State Legislature

Chou – Spine 2009

1. AJNR Am J Neuroradiol. 2010 Jul 8. Therapeutic Trial of Fluoroscopic 1. AJNR Am J Neuroradiol. 2010 Jul 8. Therapeutic Trial of Fluoroscopic Interlaminar Epidural Steroid Injection forAxial Low Back Pain: Interlaminar Epidural Steroid Injection forAxial Low Back Pain: Effectiveness and Outcome Predictors. Lee JW, Shin HI, Park SY, Lee GY, Effectiveness and Outcome Predictors. Lee JW, Shin HI, Park SY, Lee GY, Kang HS.Departments of Radiology and Rehabilitation Medicine, Seoul Kang HS.Departments of Radiology and Rehabilitation Medicine, Seoul National University Bundang Hospital, Gyeongi-Do, Korea. 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

NucleoplastyNucleoplastyDerby, Baker, Lee 2008 Spine JNo strong evidence of support

Intradiscal Therapies for Low Intradiscal Therapies for Low Back PainBack Pain – Yin, Bogduk; Bonica’s – Yin, Bogduk; Bonica’s Management of Pain, 4Management of Pain, 4thth Edition EditionRegenerative Therapies

◦Investigational◦Not covered by payers

Intradiscal Therapies for Low Intradiscal Therapies for Low Back PainBack Pain – Yin, Bogduk; Bonica’s – Yin, Bogduk; Bonica’s Management of Pain, 4Management of Pain, 4thth Edition EditionDenervation

◦Ramus communicans lesions◦Intranuclear radiofrequency◦Sinuvertebral nerve lesions◦Intradiscal electrothermal therapy

(IDET)

Intradiscal Therapies for Low Intradiscal Therapies for Low Back PainBack 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

Intradiscal Therapies for Low Intradiscal Therapies for Low Back PainBack Pain – Yin, Bogduk; Bonica’s – Yin, Bogduk; Bonica’s Management of Pain, 4Management of Pain, 4thth Edition EditionChemical Therapies

◦Intradiscal steroids - Chou◦Etanercept◦Methylene blue – positive RCT (Peng

2010)◦Ozone◦Proliferants - Derby

The use of methylene The use of methylene blue for the treatment of blue for the treatment of discogenic LBPdiscogenic LBPJ. Scott Bainbridge, MD

Mechanisms of ActionMechanisms of ActionInhibition of guanylate cyclase

and nitric oxide synthase◦MB blocks degradative effects of NO

(Yin/Bogduk)

Weak neurolytic effects

Surgical Options for LBPSurgical Options for LBPOptions: various

fusion/fixation/movement sparing options

Increasing utilization (Deyo 2005)Payer Coverage: variable without

instability◦Case presented > MB failed, fusion

deniedHTA – Washington StateNorth CarolinaMilliman Care Guidelines

Chou (Spine 2009) APS Chou (Spine 2009) APS GuidelinesGuidelines

Milliman Care GuidelinesMilliman Care Guidelineswww.careguidelines.comOriginated as Milliman & RobertsonMilliman 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.

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