Surgical vs Conservative Management of Back Pain

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Surgical vs Conservative Management of Back Pain

• Jennifer Morrison
• ACC Conference
• June 6, 2007

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Outline

• Cases
• Brief background
• Recent Study Results
• Practical Application to our Clinic Patients

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The Cases Mr. WM. and Mrs. PR.

• WM is a 49yo AAM w/ DM, HTN, and depression who
  presents w/ 2 month hx of low back pain and pain
  radiating down lateral left leg. Denies trauma,
  denies bowel or bladder incontinence.
• Exam SLR and crossed SLR (elicits pain and
  paresthesias along L lateral thigh and calf), no
  overt sensory loss, strength testing intact,
  DTRs intact, no muscle atrophy.
• Imaging disk herniation at the L4-L5 level.

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The Cases WM and PR

• PR is a 58yo AAF w/ DM, HTN, and HL presents w/ 2
  month hx of low back pain and pain radiating into
  her buttocks and thighs with walking, better with
  sitting. Denies bowel or bladder incontinence.
• Exam wide stooped gait, pain in buttocks
  thighs w/ lumbar extension, improved when sitting
  or w/ lumbar flexion. Somewhat diminished ankle
  jerk, intact LE sensation, strength intact.
• Imaging spondylolisthesis at the L4-L5 level,
  degenerative changes of the facet joints, spinal
  stenosis.

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Low Back Pain- DDx

• Mechanical- lumbar strain, degenerative disease,
  disk herniation, spondylolisthesis,
  spondylolysis, spinal stenosis, compression
  fracture
• Infection (OM, diskitis, paraspinous abscess)
• Cancer (MM, metastatic disease)
• Spondyloarthropathy (AS, RS)
• Other (pyelonephritis, nephrolithiasis,
  pancreatitis, AAA)

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How should our pts be managed?

• The May 31, 2007 issue of NEJM published 2 papers
  concerning role of surgery vs conservative
  treatment in the management of disk herniation w/
  associated sciatica and degenerative
  spondylolisthesis w/ associated spinal stenosis.

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Spondylolisthesis
Disk herniation
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Diskectomy
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Laminectomy and Spinal Fusion
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Surgery vs Prolonged Conservative Treatment for
Sciatica

• Peul, et al. NEJM. 356(22) 2245-2256.
• RCT, nonblinded- pts w/ 6-12 wk hx of severe
  sciatica were randomized to early surgery or
  conservative treatment w/ surgery later if
  needed.
• Early Surgery- microdiskectomy w/in 2 wks. In
  conserv. group, if sciatica persisted 6 mos,
  surgery was offered.
• 1? Outcomes disability, leg pain, patient
  perceived recovery
• Intention-to-treat analysis

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Peul et al.- Early Surgery vs Conservative
Treatment for Sciatica

• Inclusion 18-65, disk herniation w/ radicular
  syndrome for 6-12 wks
• Exclusion cauda equina syndrome, severe
  weakness or paralysis, similar episode during
  previous 12 mos, previous spine surgery,
  spondylolisthesis, bony stenosis, pregnancy,
  severe coexisting disease

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Peul et al.- Early Surgery vs Conservative
Treatment for Sciatica

• 283 pts were randomized
• Pt population
• Mean age early 40s
• 63-68 male
• Mean BMI 26
• Duration of sciatica 9.5 wks
• Most had L4-L5 or L5-S1 disk herniation

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Peul et al. Results

• 89 in early surgery group and 39 in
  conservative group underwent surgery.
• There was significant improvement in leg pain in
  favor of early surgery (P lt0.001).
• Back and leg pain were relieved earlier with
  surgery than w/ conservative mgmt but at 1 year,
  nearly equal recovery rates were noted.
• Time to recovery (median) was 4 wks for early
  surgery group and 12 wks for conservative mgmt
  group.
• Complications in 1.6- 2 dural tears and 1 wound
  hematoma.

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Peul et al. Conclusions

• Though sx relief was twice as fast in those
  treated w/ early surgery, there was no better
  overall functional recovery rate at 1 yr in the
  early surgery group (vs prolonged conservative
  mgmt w/ offer of surgery later).
• Limitations
• Not blinded
• Research nurses participated in pain mgmt- not
  usual care
• Heterogeneity of treatment interventions
• Treatment group crossover

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Surgical vs. Nonsurgical Treatment for Lumbar
Degenerative Spondylolisthesis

• Weinstein, et al. NEJM. 356(22) 2257-2270.
  SPORT trail.
• Randomized and observational cohorts- pt choice.
  Treatment groups standard decompressive
  laminectomy (w/ or w/out fusion) or usual care
  (PT, education, epidural injections, opioids,
  NSAIDS).
• Inclusion at least 12 wks sx due to degenerative
  spondylolisthesis, surgical candidate
• Exclusion spondylolysis, isthmic
  spondylolisthesis, cancer, infection, fracture
• 1? Outcomes general health and disability at 6
  wks, 3 mos, 1 yr, and 2 yrs.
• Intention-to-treat and as-treated analyses

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SPORT- Surgical vs Nonsurgical Treatment for
Spondylolithesis

• 303 pts in observational cohort- 173 chose
  surgery, 130 chose nonsurgical treatment
• 304 pts in randomized cohort- 159 assigned to
  surgery, 145 assigned to nonsurgical treatment
• Pt population
• Mean age 66, 66-71 female (mostly Caucasian)
• Mean BMI 29
• In surgery vs nonsurgery groups, pts were more
  likely to be younger (65 vs 68), to be
  compensated, w/ more perceived pain and
  disability (P lt 0.05).

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SPORT- Surgical vs Nonsurgical Mgmt of
Spondylolithesis- Results

• Intention-to-treat analysis showed no significant
  effects
• Severely limited by treatment crossover

Randomized To Surgery
Randomized To Nonsurg Mgmt
6 wk 3 mos 6 mos 1 yr 2 yrs
9 36 53 57 64
8 24 38 44 49
of group that underwent surgery
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SPORT- Surgical vs Nonsurgical Mgmt of
Spondylolithesis- Results

• As-treated effects for combined cohort were
  statistically significant in favor of surgery for
  all outcomes (sx relief, improved function)-
  stable for 2 yrs.
• Complications
• 9-11 dural tear or CSF leak
• 1 vascular injury
• Transfusions (34-36 intra-op, 16-26 post-op)

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SPORT- Surgical vs Nonsurgical Mgmt of
Spondylolithesis- Conclusions

• Pts w/ degenerative spondylolisthesis and
  associated spinal stenosis treated surgically may
  have greater improvement in pain and function
  than pts treated nonsurgically.

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Study Limitations

• Marked degree of nonadherence to randomized
  treatment.
• Potential confounding factors, bias.
• As-treated analysis
• Heterogeneity of treatment interventions
• Nonsurgical mgmt
• Surgical procedures
• Not blinded.

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Application of these Data to our Patient
Population

• Sciatica- may achieve sx relief faster w/ surgery
  but in the long run, no clear benefit
• Degenerative Spondylolisthesis- no clear
  benefits, trial was flawed which limits the
  conclusions we can draw.

• Use data presented in the above trials to have
  informed discussions w/ pts, weigh risks and
  potential benefits, consider the tolerability of
  sx/pain, etc.

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References

• Deyo, R.A. Back Surgery- Who Needs It? NEJM.
  2007. 356(22) 2239-2243.
• Peul, W.C., et al. Prolonged conservative
  treatment or early surgery in sciatica caused
  by a lumbar disc herniation rationale and design
  of a randomized trial. BMC Musculoskeletal
  Disorders. 2005. 6(8) 1-11.
• Peul, W.C., et al. Surgery versus Prolonged
  Conservative Treatment for Sciatica. NEJM.
  2007. 356(22) 2245-2256.
• Weinstein, J. N., et al. Surgical versus
  Nonsurgical Treatment for Lumbar Degenerative
  Spondylolisthesis. NEJM. 2007. 356(22)
  2257-2270.
• Weinstein, J. N., et al. Surgical vs
  Nonoperative Treatment for Lumbar Disk
  Herniation The SPORT A Randomized Trial.
  JAMA. 2006. 296(20) 2441-2450.
• Weinstein, J. N., et al. Surgical vs
  Nonoperative Treatment for Lumbar Disk
  Herniation The SPORT Observational Cohort.
  JAMA. 2006. 296(20) 2451-2459.
• www.uptodate.com and references herein.