Jeremy Fairbank MD FRCS Professor of Spine Surgery NDORMS University of Oxford

Transcription

1 Towards a paradigm shift in chronic low back pain? Identification of patient profiles to guide treatment Surgery and combined physical and psychological treatment as competitive treatment options for all patients with longstanding LBP: one size fits all? Randomised controlled trials in low back pain: 10 year follow up head to head comparison of surgery vs CPPº What have we learnt? Jeremy Fairbank MD FRCS Professor of Spine Surgery NDORMS University of Oxford

2 What can we learn from surgical RCT s of LBP? Do RCT s tell us about case selection or stratification? Is there any advantage of one technique over another? Is fusion better than non-operative care? How much placebo effect is there in these interventions? Should intensive rehabilitation with CBT be the gold standard intervention? What are the long term outcomes?

3 Four previous RCTs comparing fusion and non-operative treatment in clbp patients Mirza & Deyo 2007, Systematic Review Spine 32(7):

4 Do RCT s tell us anything about case selection/stratification? Fusion Disc replacement

5 Inclusion criteria for fusion studies Fluency in the native language (all countries) Age y (UK), y (Sweden), y (Norway) Duration of at least 1 year (UK and Norway), 2year (Sweden) Disability level of 7 of 10 points on the Function and Working Disability scale (Sweden) or 30/100 on the ODI (Norway), no criterion for in UK Degenerative changes (spondylosis) at L4 L5 and/or L5 S1 (Sweden and Norway), no criterion for this for UK Willingness to participate in a clinical trial and be randomized to treatment. Mirza, S. and R. Deyo (2007). "A Systematic Review of Randomized Trials Comparing Lumbar Fusion Surgery to Nonoperative Care for Treatment of Chronic Back Pain.." Spine 32(7): All trials enrolled similar subjects!

6 The hypotheses for suggesting lumbar fusion for chronic low back pain are: 1. Pain is caused by disc degeneration and segmental instability 2. Pain mechanisms are complex 3. No diagnostic test can reliably select patients

7 Is there any advantage of one technique over another? Swedish Spine trial Fritzell, P., O. Hagg, P. Wessburg, A. Nordwall and S. L. S. S. Group. "Chronic Back pain and fusion: a comparison of three surgical techniques: a prospective multicentre randomized study from the Swedish Lumbar Spine Study Group." Spine 2002; 27: Prodisc study Zigler, J., R. Delamarter, J. Spivak, R. Linovitz, G. Danielson, T. Haider, F. Cammisa, J. Zuchermann, R. Balderston, S. Kitchel, K. Foley, R. Watkins, D. Bradford, J. Yue, H. Yuan, H. Herkowitz, D. Geiger, J. Bendo, T. Peppers, B. Sachs, F. Girardi, M. Kropf and J. Goldstein. "Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc(R)-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease." Spine 2007; 32(11):

8 Disc replacement ProDisc study Disability score abuse Adjacent Segment Disc Degeneration/Adjacent level degeneration? Reduced but our evidence suggests no impact on pain

9 ODI Score 65 Surgical treatment of back pain Baseline scores 60 55% %

10 ODI Score Surgical treatment of back pain Baseline scores? 55% %

11 Is fusion better than non-operative care?

12 Patients from long term fu of spinal fusion trials Participants in long-term follow-up had: more often had previous surgery for disc herniation (19.3% vs 11.8%) a longer duration of back pain (105 months vs 88 months) more often had fusion as the actual treatment (72% vs 54%) compared with those who did not attend LTFU. No difference was found for age, gender, smoker, and baseline primary outcome.

13 Flow of patients through the study N= lost to FU by 13y ITT as treated 369/767 (48%) 20%

14 Non-operative treatment included cognitive behavioral intervention (Norway and UK) and usual care /traditional physiotherapy (Sweden)

15 as treated follow up results Demographic and baseline clinical data of the patients who had and had not undergone fusion by the time of the long-term follow-up All patients at baseline Fusion at long-term follow-up Yes No p Number Baseline Age (y) 42.0 (8.3) 43.1 (7.8) 41.4 (8.3) 0.09 Gender (%M) 48.6% 45.6% 49.5% 0.51 Duration of LBP (y) 8.2 (7.1) 9.0 (7.7) 8.4 (7.1) 0.53 Smoker (% yes) 44.1 % 39.4% 42.7% 0.57 ODI (0-100) 46.1 (13.1) 46.7 (12.6) 41.9 (11.9) Mid-term FU (1-2 y) 12 or 24 mo ODI 35.9 (19.7) 35.7 (19.6) 32.3 (17.8) 0.15 Change ODI, pre to months 10.3 (17.7) 11.0(18.0) 10.0 (14.6) 0.67

16 Hedlund, R., C. Johansson, O. Hägg, P. Fritzell, T. Tullberg and S. L. S. S. Group (2015). "The long-term outcome of lumbar fusion in the Swedish Lumbar Spine Study." The Spine Journal 16(5): Mannion, A., J.-I. Brox and J. Fairbank (2016). "Consensus at last! Long-term results of all randomized controlled trials show that fusion is no better than non-operative care in improving pain and disability in chronic low back pain." The Spine Journal 16(5): Global assessment score better in surgery patients as treated, but not Intention to treat ODI, VAS no difference

17 Conclusions re adjacent segment disc degeneration Fusion was associated with a slightly but significantly lower disc space height at the adjacent segment at LTFU unrelated to clinical outcomes (ODI and pain) The study supports the hitherto controversial contention that fusion of the spine is associated with accelerated degeneration of the adjacent segment in the long-term after surgery; however, the effect appears to be small and of no clinical relevance.

18 How much placebo effect is there in these interventions?

19 Honest fakery Armed with a clearer understanding of how placebos work, researchers are suggesting that inactive substances might be used to mitigate chronic pain. BY JO MARCHANT 1 4 J U LY VO L N AT U R E S

20 Exploiting placebo effects- Jo Marchant The modern idea of the placebo effect stems from 1955, when US physician Henry Beecher analysed the results of 15 studies and concluded that, regardless of a patient s complaint, around one-third showed a significant response to a placebo The effect is now well-established, particularly for conditions that rely on subjective reports, such as pain. If this placebo does not work, I ll give you a stronger one! - Ted Kaptchuk (Harvard Medical School)

21 RCT s with sham surgery controls Wartolowska K, et al. Use of placebo controls in the evaluation of surgery: systematic review. BMJ :02:11;348:11 Results: In 39 out of 53 (74%) trials there was improvement in the placebo arm in 27 (51%) trials the effect of placebo did not differ from that of surgery In 26 (49%) trials, surgery was superior to placebo but the magnitude of the effect of the surgical intervention over that of the placebo was generally small

22 Spinal stenosis surgery Moojen s FELIX Trial

23 Reoperation rates It is so much easier to revise a spacer?

24 THE WAKAYAMA SPINE STUDY Ishimoto, et al Associations between radiographic lumbar spinal stenosis and clinical symptoms in the general population: the Wakayama Spine Study. Osteoarthritis Cartilage 2013;21(6): The purpose of this study was to clarify the prevalence of radiographic Lumbar Spinal Stenosis and its associated clinical symptoms in a population based cohort. Cross-sectional study 938 participants men/women: 308/630; mean age: 67.3 years (range: years) MRI central stenosis was assessed by qualitative measurements and rated on a 4-point scale Clinical symptoms diagnostic criteria for were based on the LSS definition of the NASS guidelines

25 THE WAKAYAMA SPINE STUDY Ishimoto, et al Associations between radiographic lumbar spinal stenosis and clinical symptoms in the general population: the Wakayama Spine Study. Osteoarthritis Cartilage 2013;21(6): MRI findings: 77.9% (731/938) of the participants had moderate central stenosis 30.4% (285/938) had severe central stenosis Clinical findings: The prevalence of symptomatic subjects 12.9% (94/731) with moderate or severe stenosis 17.5% (50/285) with severe stenosis had symptoms 16.1% (25/155) with single level severe stenosis, 19.2% (25/130) with multiple severe stenoses There was no significant difference in the prevalence of symptoms in persons with single level vs. multiple level stenoses

26 Conclusions Do not dismiss interventions as just a placebo They may actually work as well as your definitive operation! Always exploit placebo effects to the full CBT/expectation etc Decisions to re-operate are not carried out when the surgeon and patient are still masked from the intervention

27 Young surgeons fuse Older surgeons re-fuse Old surgeons refuse to fuse Towards a paradigm shift in chronic low back pain? Identification of patient profiles to guide treatment Can we do better?