Low Back Pain (LBP) Prevalence. Low Back Pain (LBP) Prevalence. Lumbar Fusion: Where is the Evidence?

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1 15 th Annual Cleveland Clinic Pain Management Symposium Sarasota, Florida Lumbar Fusion: Where is the Evidence? Gordon R. Bell, M.D. Director, Cleveland Clinic Low Back Pain (LBP) Prevalence Lifetime prevalence: 80-90% 25% of adults have at least one day of LBP in prior 3 months Low Back Pain (LBP) Prevalence Chronic LBP: 3 months By one year after acute LBP episode, 20% of patients report persistent LBP 1

2 Low Back Pain (LBP) Economic Impact 5% of pts with LBP 75% of costs Most costly condition for lost work days and disability Direct & Indirect economic losses in U.S.: $90 billion annually $55 billion Direct Switzerland: direct costs of LBP account for 6.1% of GDP Low Back Pain (LBP) Issues Favorable natural history Most better within 6 weeks; 90% better within 3 months Pain generator(s) Difficult to identify Can be multiple Is not synonymous with degenerative disc disease (DDD) MRI No pathognomonic findings for painful axial degeneration Dark disc and end plate changes reflect aging of spine, not symptomatology 30% of asympotomatics have abnormal discs Boden, et al JBJS, 1990 MRI findings not predictive of future LBP Borenstein, et al JBJS,

3 Indications for Lumbar Fusion Instability Difficulty in defining instability Prior surgery (e.g. recurrent herniation) Deformity Particularly progressive deformity Spondylolisthesis (isthmic and degenerative) 10% of women > 60 y/o have degenerative slip Scoliosis 6-10% of population have de novo scoliosis Mechanical Low Back Pain (LBP) Growth in Spinal Fusion Surgery ( ) : Spinal fusions - 77% THR/TKR % 14% 250,000 spinal fusions in 2000 Deyo, et al NEJM, 2004 Variation in Rates of Lumbar Spine Surgery Overall surgery: Discectomy/laminectomy: Fusion: 6x 8x 20x 3

4 Ratio of Rates of Lumbar Fusion to U.S. Average fold variation in rates of lumbar spine fusion nationally Dartmouth Atlas of Health Care-2006 Inpatient Medicare Reimbursement for Back Surgery Overall spending: 2x Disc/lami lami: 10% Fusion: 500% Lumbar Fusion 1992: 14% of total spending for spine surgery Lumbar Fusion 2003: 47% of total spending for spine surgery Dartmouth Atlas of Health Care-2006 Growth in Spinal Fusion Surgery ( ) Reasons for increase in surgery: Demographics (changes in population) Technological advances (e.g. cages) Lack of consensus regarding indications Wide geographic variations Financial incentives Surgeons Hospitals Device industry 4

5 Fusion for LBP The Major Issue Identifying pain generator Asymptomatic radiographic changes common Many patients with severe, multi-level level DDD have no LBP Many patients without significant DDD have severe LBP Only provocative test: discogram Discography Only provocative imaging test Very controversial Has not improved fusion outcomes Role for discography: Patients contemplating surgery for failed non-op op management Positive MRI Psychologically normal patients Low false pos. in patients without chronic pain and with normal psychometrics Carragee, at al Spine, 1999 Interventional Therapies, Surgery, and Rehabilitation for LBP: APS Guidelines Recommendations Discography not recommended as diagnostic procedure for discogenic LBP (S) No evidence discography improves clinical outcomes Intensive PT with CBT recommended (S) Chou, et al Spine,

6 Fusion for LBP The Issues (cont d) Weak association between solid fusion and pain relief Lack of definitive methods to confirm a solid fusion (especially posterolateral fusion) Placebo effect of surgery for pain relief Psychosocial factors Litigation Depression Income Age Fusion for LBP Technical Issues Multiple types of fusion Various techniques with varying levels of morbidity Instrumentation/no instrumentation ALIF, PLIF, TLIF, MIS, circumferential (360 ) Different bone substrates Autograft,, allograft, BMP, etc. LBP and Type of Fusion Interspace can still be source of pain with solid posterior fusion ALIF relieved LBP in 5 patients with prior solid posterolateral fusion Weatherly, et al JBJS (Br),

7 Fusion in Medicare Patients Associated Issues 2x risk of complications 6x rate of blood transfusion 2x postoperative mortality assessed at six weeks. Deyo, et al Spine, 1993 Trends in Lumbar Fusion studies 12 prospective 6 randomized, prospective 2 dealt specifically with fusion for DDD Use of instrumentation 1980s: 23% 1990s: 41% Bono, CM and Lee, CK Spine, 2004 Trends in Lumbar Fusion Dearth of good data Bono, CM and Lee, CK Spine,

8 Trends in Lumbar Fusion Bono, CM and Lee, CK Spine, 2004 Trends in Lumbar Fusion Bono, CM and Lee, CK Spine, 2004 Trends in Lumbar Fusion Conclusions: Significant increase in use of instrumentation Clinical benefits (outcome) unclear. Bono, CM and Lee, CK Spine,

9 Surgery for LBP Review of Evidence for American Pain Society Clinical Practice Guidelines Literature search through randomized trials identified Only 4 compared surgery with non-op op care American Pain Society Criteria for optimal outcome: Minimal or no pain No or minimal narcotics Return to high-level function Chou R, et al Spine, 2009 Lumbar Fusion Outcome Small to moderate benefit compared to standard nonsurgical therapy. No more effective than intensive rehabilitation with cognitive behavioral therapy (CBT) emphasis 16% surgical complication rate Less than half of patients had optimal outcome (sporadic pain, slight functional restriction, occasional analgesics) Chou R, et al Spine, 2009 Fusion for Mechanical LBP Other Factors Controversial in younger patients Risk of adjacent level degeneration Multi-level level fusion associated with poor outcome 9

10 Ideal Candidate for Fusion for LBP Psychologically normal Professionally satisfied Mechanically unstable, single level, painful, motion segment Fusion for LBP without Stenosis or Spondylolisthesis Only 2 Randomized clinical trials identified Ftitzell,, et al Spine, 2001 (Class I supporting fusion vs conservative care) Brox,, et al Spine, 2003 (Class III supporting non-op op with CBT) Resnick, et al J Neurosurg Spine, 2005 Fusion vs Non-op op Rx for Chronic LBP 35 RCT for surgical treatment of LBP (prior to 2006) 4 studies identified: 3 RCT from review + 1 additional study Numerous methodological problems Failure to report data by intent-to to-treatrea (1) Underpowered (2), high cross-over over (1) All failed to meet the FDA threshold for clinical meaningful differences Mirza, SK and Deyo, RA Spine,

11 Fusion vs Non-op op Rx for Chronic LBP Mirza, SK and Deyo, RA Spine, 2007 Fusion vs Non-op op Rx for Chronic LBP Surgery may be more efficacious than unstructured nonsurgical care but may not be more efficacious than structured cognitive-behavior therapy. Mirza, SK and Deyo, RA Spine, 2007 Cognitive Behavior Therapy (CBT) Type of psychotherapeutic treatment that helps patients understand the thoughts and feelings that influence behaviors Short-term, term, focused; deal with a very specific problem (e.g. LBP) Underlying concept: thoughts and feelings play a fundamental role in behavior 11

12 Swedish Lumbar Spine Study Group Overall 2 Year Outcome RCT of surgery vs non-op op Rx of DDD 23 year follow-up Non op (72 pts.) Surgery (222 pts.) 3 techniques (not separately analyzed in study) Fritzell, et al Spine, 2001 Swedish Lumbar Spine Study Group Overall 2 Year Outcome LBP ODI Depression Much better/better (Much better) RTW Complication rate Surgery 33% 25% 20% 63% (29%) 36% 17% Non-op op 7% 6% 7% 29% (15%) 13% ---- Fritzell, et al Spine, 2001 Swedish Lumbar Spine Study Group Overall 2 Year Outcome Fritzell, et al Spine,

13 Swedish Lumbar Spine Study Group Criticisms Magnitude of surgical benefit small Pain and functioning improved by only 30% Only 1/6 of patients became pain free Non blinded study Surgical benefit decreased between yrs Only 63% better / much better Heterogeneous non-surgical Rx Swedish Lumbar Spine Study Group Conclusions Fusion - superior to unstructured non-op op care for DDD Surgery can reduce pain and disability in select group of patients with chronic LBP 63% better / much better However, only 29% reported much better Fritzell, et al Spine, 2001 (Swedish Lumbar Spine Study Group) Fusion Techniques Fusion rate: Post. pedicle instr. + interbody > post. pedicle instr. > noninstrumented (more hardware = more fusion) Fritzell, et al Spine, 2002 (Swedish Spine Study Group) # procedures = cost = morbidity Not necessarily correlated with better outcome 13

14 Summary Posterior pedicle screw instrumentation Improved fusion rate Better lordosis Prevention of deformity progression Effect on outcomes unclear Ideal Candidate for Fusion for LBP Psychologically normal Professionally satisfied Mechanically unstable, single level, painful, motion segment Thank You! 14

15 Chou R, et al Spine,

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