Spinal Stenosis: Surgical vs. Medical Treatment
Transcript of Spinal Stenosis: Surgical vs. Medical Treatment
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Spinal Stenosis:Surgery or Not?
Suzannah Stout, MD
April 30, 2008
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Lumbar Spinal Stenosis
Narrowing of Intraspinal CanalMost Common: DJD of spine or trauma
Disc protrusion Stress loading of posterior spine (facets) Hypertrophy of facets or ligamentum flavum Osteophyte formation
Later: Spondylolisthesis
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Lumbar Spinal Stenosis
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Lumbar Spinal Stenosis
Less Common Causes Space-occupying lesions Post-traumatic or -surgical fibrosis Skeletal Disease (Pagets, ankylosing
spondylitis, RA) Congenital (spina bifida, achondroplasia)
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Common Sx
Low Back Pain (often mild)--65%Neurogenic Claudication--94%Numbness/tingling, weakness--40-60%Worst with standing or walkingRelieved with sitting or lying downThose with narrowing found incidentally on
imaging are often asymptomatic
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Traditional Treatment
Physical Therapy (regimens not well studied)
Corticosteriod Injections (also not well studied)
Indications for surgery not fully agreed upon
Most common reason for back surgery in >65yo
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2005 Cochrane Review
31 RCTs, often with small #sLack of long-term outcomes beyond 2-3
yrsMany trials were heterogeneous: spinal
stenosis, disc nerve compression, and spondylolisthesis
Bottom line: studies inconclusive for benefit of surgery, esp. fusion
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But then….
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Study Objective
Analyze the relative efficacy of surgical vs. nonsurgical treatment for spinal stenosis without degenerative spondylolisthesis based on patient self reported pain, function, and disability scales
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Methods
13 US medical centers Included:
patients with neurogenic claudication or radicular leg sx >12 weeks
confirmatory imaging Previous PT (68%), epidural injections (56%), NSAIDS
or opioids OK
Excluded: Spondylolisthesis Lumbar instability
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Methods: Interventions
Non-surgical Therapy: “usual care” but not standardized PT Home exercise instruction NSAIDS
Surgery: posterior decompressive laminectomy A small amount also received instrumented or
noninstrumented fusion (5%)
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Methods: Outcome Measures
Primary Bodily pain and physical function scores on SF-36
Survey and modified Oswestry Disability Index
Secondary Pt-reported improvement satisfaction with sx and care Bothersomeness of stenosis and back pain via several
standardized scales
F/U at 6w, 3m, 6m, 1yr, and 2yrs Treatment Effect = (mean in score SURG) -
(mean in score NON-SURG)
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Methods: Two Cohorts
Randomized Cohort 289 patients enrolled 138 assigned to
surgery arm 151 assigned to
nonsurgical treatment
Observational Cohort 365 patients enrolled 219 chose surgery 146 chose
nonsurgical treatment
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BUT, patients don’t always……
BEHAVE !
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Methods: Unintended Crossover
Randomized Cohort 138 assigned to
surgery --> only 67% had surg by 2yrs
151 assigned to NON-surg tx --> 43% had surg by 2yrs
Observational Cohort 219 chose surgery-->
96% had undergone surg by 2yrs
146 chose NON-surg tx --> 22% had surg by 2yrs
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Methods: Statistical Analysis
Almost like 3 studies: Randomized, Observational, and Combined
Demographics/Baseline data: Rand vs Obs cohorts, Surg vs Nonsurg
Intention-to-Treat: analyzed randomized cohort Needed 185/group to detect a 10-point
difference in 100-point scale Time: from enrollment
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Methods: Statistical Analysis
As-Treated Analysis: Time
Surgery: time starts at date of treatment Nonsurgical: changes from baseline (even if
eventually chose Surg) included here Randomized and Observational Cohorts
analyzed separately and combined Predictors of Treatment Received in
Randomized Cohort
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Results: Patients At Baseline
Rand Cohort vs Obs Cohort All very similar demographically, sx severity, and level
of stenosis Observational Cohort: More nerve-root tension and less
lateral recess stenosis Randomized Cohort: Two Randomized Groups
(Surg vs Nonsurg) All categories very similar
Combined Cohorts: Surg vs Nonsurg Surg: younger, more working, more reported disability,
more with “pain worsening”, more severe stenosis
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Results: Treatment Received
Nonsurgical Treatment: Similar, but more in Rand vs Obs Cohort visited
surgeon and got injectionsSurgery:
Looked at # levels decompressed, OR time, blood loss, post-op mortality, complications
Complications: dural tear (9%), wound infection (2%), transfusion (7%)
Reoperation by 2yrs in 8% (<1/2 for stenosis) 6 Deaths (vs. 7 in Nonsurg group)
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Results: Treatment Effects
Intention to Treat (Randomized Cohort): Lost power from crossover Only statistical significance: more change in
surgery group (8 points) in bodily pain score at 2yrs
No statistically significant change in Surg vs Nonsurg groups: physical function or disability index
At early times (6w, 3mo) physical function treatment effect went down
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Results: Treatment Effects
As-Treated Analysis Rand vs Obs Cohorts:
Change in scores from baseline were statistically similar in the two groups
Global Hypothesis Test Rand vs Obs Cohorts: Surg vs Nonsurg
Favored surgery in 3 main primary outcomes in both groups over all time periods
Statistically Similar-->Combined Cohorts
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Results: Treatment Effects
As-Treated Analysis Combined Cohorts: Surg vs Nonsurg
Peak change from baseline was 6months Bodily Pain: treatment effect of surgery was 17-point
difference at 6mo, 14-points at 2yr Physical Function: 16 points at 6mo, 11 points at 2yr Disability Index: 14 points at 6mo, 11 points at 2yr Secondary Outcomes: pt-reported “satisfied with
symptoms” and “major improvement” Improvement from baseline in Nonsurg group too
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Surg Nonsurg
Treatment Effect
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Study Strengths
Randomized and Observational Cohorts were statistically similar at baseline Allowed for data to be combined to study both
cohorts together As-treated analysis adjusted for many
confounding variablesThe reality of patient choice about surgeryOnly looked at Spinal Stenosis (not
Spondylolisthesis or other disc disease)
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Study Limitations
Randomization Surgery vs Nonsurgical Treatment: never blind Self-reported symptoms (less after 6mo?)
Unintended Crossover Limited intention-to-treat analysis Combining Cohorts: eliminating benefit of randomization Those who ultimately chose surgery were different at
baseline
No standard of nonsurgical treatment
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Bottom Line
Little risk of harm in surg vs nonsurg txBoth surg and nonsurg tx improved
symptom scoresThere is improvement in patient-perceived
pain, function, disability, and satisfaction* (*although, these patients were worse off from the start)
Advice to patients: still try noninvasive tx first, but may be helped by surgery
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Discussion? Questions?
How can you set up a study to prevent confounding but recognize patient choice?
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References
**Weinstein, JN et al. Surgical versus Nonsurgical Therapy for Lumbar Spinal Stenosis. N Engl J Med 2008;358:794-810**
Gibson, JN, Waddell, G. Surgery for degenerative lumbar spondylosis. Cochrane Database Syst Rev 2005: CD001352
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THANKS FOR LISTENING !