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Evaluating the Evidence Evaluating the Evidence Behind the Surgical Behind the Surgical

Treatment of Lumbar Treatment of Lumbar StenosisStenosis

Joseph Beshay, MDJoseph Beshay, MDAssistant Professor of Neurological Assistant Professor of Neurological

SurgerySurgeryUniversity of Texas SouthwesternUniversity of Texas Southwestern

http://www.utsouthwestern.edu/index.html

Lumbar StenosisLumbar Stenosis

Narrowing of the Spinal canal with Narrowing of the Spinal canal with encroachment on the neural structures by encroachment on the neural structures by surrounding bone or soft tissue.surrounding bone or soft tissue.

Typical presentation: Radicular symptoms Typical presentation: Radicular symptoms or neurogenic claudication. or neurogenic claudication.

Back pain common but not a result of Back pain common but not a result of lumbar stenosis per se. lumbar stenosis per se.

May be asymptomaticMay be asymptomatic Most common reason for lumbar surgery Most common reason for lumbar surgery

in adults over 65in adults over 65Deyo et al. Spine 1993Deyo et al. Spine 1993





TreatmentTreatment Surgical: Laminectomy / laminotomy / Surgical: Laminectomy / laminotomy /

foraminotomy/ Open vs MIS technique, foraminotomy/ Open vs MIS technique, Interspinous process device, Extension limiting Interspinous process device, Extension limiting device, Interspinous decompression, device, Interspinous decompression, “chimney” laminectomy……“chimney” laminectomy……

Non-Surgical: Epidural steroids, Physical Non-Surgical: Epidural steroids, Physical therapy, NSAIDS, Narcotic analgesics, spinal therapy, NSAIDS, Narcotic analgesics, spinal manipulation, back exercises…..manipulation, back exercises…..



In any given week I see at least one In any given week I see at least one patient with ‘lumbar stenosis’ and at least patient with ‘lumbar stenosis’ and at least one patient with ‘LOW BACK PAIN’one patient with ‘LOW BACK PAIN’

Preconceived ideas……….Preconceived ideas……….


Lumbar StenosisLumbar StenosisThank you for

seeing me today, Doctor

I won’t take up much of your time

If you can help with my leg pains, I would be thankful

If you can’t help me, I thank you anyways

I baked you this pie…


Back PainBack Pain


Back PainBack PainHey! Fix my back

pain.

I want to be able to go bowling

again!

Don’t you tell me to

lose weight!

Hey! Refill my Lortab

Fill out this stack

of disability

forms


Lumbar StenosisLumbar StenosisThe EvidenceThe Evidence

TreatmentTreatment Where is the data?Where is the data? Paucity of head to head randomized trialsPaucity of head to head randomized trials Many small non-randomized observational type Many small non-randomized observational type

studies.studies. Most randomized studies are smallMost randomized studies are small Two large studiesTwo large studies

Maine Lumbar Spine StudyMaine Lumbar Spine Study SPORT (Spine patients outcomes research trial) SPORT (Spine patients outcomes research trial)

lumbar stenosis arm.lumbar stenosis arm.


Lumbar StenosisLumbar StenosisMain Lumbar Spine StudyMain Lumbar Spine Study

Observational StudyObservational Study Surgical vs Non-Surgical treatment Surgical vs Non-Surgical treatment

determined by Surgeon and Patientdetermined by Surgeon and Patient 148 patients enrolled between 1990-1992148 patients enrolled between 1990-1992 Excluded patients with prior lumbar Excluded patients with prior lumbar

surgery, cauda equina, fractures, surgery, cauda equina, fractures, infections, malignancies…etc.infections, malignancies…etc.

Reported results at 1, 4 and 10 yearsReported results at 1, 4 and 10 years

Atlas et al. Spine 2005



97 patients available for follow-up97 patients available for follow-up Surgical group had more severe baseline Surgical group had more severe baseline

symptoms and worse functional statussymptoms and worse functional status Leg pain relief and back related functional Leg pain relief and back related functional

status favored surgerystatus favored surgery Low back pain relief similar between both Low back pain relief similar between both

groupsgroups









SPORT - BackgroundSPORT - Background

The The SSpine pine PPatient atient OOutcomes utcomes RResearch esearch TTrial (rial (SPORTSPORT) was designed to assess the ) was designed to assess the relative efficacy and cost-effectiveness of relative efficacy and cost-effectiveness of surgical and non-surgical approaches to surgical and non-surgical approaches to the treatment of common conditions the treatment of common conditions associated with low back and leg pain.associated with low back and leg pain.

Three arms studying lumbar HNP, Stenosis Three arms studying lumbar HNP, Stenosis and degenerative spondylolisthesisand degenerative spondylolisthesis

13 medical centers in 11 States13 medical centers in 11 States Randomized as well as observational Randomized as well as observational

cohortscohorts

Weinstein et al. NEJM 2008


SPORT – Lumbar StenosisSPORT – Lumbar Stenosis

Inclusion CriteriaInclusion Criteria Neurogenic claudication or radicular symptoms for Neurogenic claudication or radicular symptoms for

at least 12 weeksat least 12 weeks Cross sectional imaging confirming dxCross sectional imaging confirming dx Surgical CandidateSurgical Candidate

Exclusion CriteriaExclusion Criteria Spondylolisthesis (studied separately)Spondylolisthesis (studied separately) Instability (4mm translation or 10 degree Instability (4mm translation or 10 degree

angulation)angulation) Most patients had received some form of non-surgical Most patients had received some form of non-surgical

tx for their symptoms prior to enrollment (PT 68%, ESI tx for their symptoms prior to enrollment (PT 68%, ESI 56%, Chiropractor 28%, NSAIDs 55%, Opioids 27%).56%, Chiropractor 28%, NSAIDs 55%, Opioids 27%).



SPORT – Lumbar StenosisSPORT – Lumbar Stenosis After verifying eligibility, patients were After verifying eligibility, patients were

allowed to enroll in the allowed to enroll in the randomized randomized or or observationalobservational cohort. (Observational cohort. (Observational group avoids ‘enrollment bias’)group avoids ‘enrollment bias’)

To aid in decision making, patients To aid in decision making, patients shown “evidence-based videotapes” shown “evidence-based videotapes” with “standardized information” with “standardized information” regarding surgical and non-surgical regarding surgical and non-surgical treatments.treatments.



SPORT – InterventionsSPORT – Interventions Surgical: “Surgical: “Standard posterior Standard posterior

decompressive laminectomydecompressive laminectomy.”.” Non-Surgical: Non-Surgical:

““Usual careUsual care”” “…“…..at least active physical therapy, at least active physical therapy,

education or counseling with home education or counseling with home exercise instruction, and the exercise instruction, and the administration of non-steroidal administration of non-steroidal antiinflammatory drugs, if toleratedantiinflammatory drugs, if tolerated. .



SPORT – Outcome measuresSPORT – Outcome measures Outcomes of bodily pain and disabilityOutcomes of bodily pain and disability SF-36, Modified Oswestry Disability Index, SF-36, Modified Oswestry Disability Index,

other patient indices including overall other patient indices including overall satisfaction, pain, “Leg pain bothersomeness satisfaction, pain, “Leg pain bothersomeness scale”scale”

Follow-up at 6 weeks, 3 months, 6 months, 1 Follow-up at 6 weeks, 3 months, 6 months, 1 year and 2 years.year and 2 years.

Effect of treatment was defined as the Effect of treatment was defined as the difference in the mean change from baseline difference in the mean change from baseline between surgical and non-surgical groups. between surgical and non-surgical groups.



SPORT – PatientsSPORT – Patients

So far so good…..


SPORT – PatientsSPORT – PatientsWhat really happened..What really happened..

Randomized CohortRandomized Cohort Surgical arm: At two years Surgical arm: At two years 67%67% had undergone had undergone

surgerysurgery Non-Surgical arm: At two years Non-Surgical arm: At two years 43%43% of patients had of patients had

crossed over and had surgery.crossed over and had surgery. ~55%~55% of the randomized patients had surgery. of the randomized patients had surgery. ~40%~40% of the randomized pt’s crossed over of the randomized pt’s crossed over

Observational CohortObservational Cohort Surgical arm: At two years Surgical arm: At two years 96%96% had undergone had undergone

surgerysurgery Non Surgical arm: Non Surgical arm: 22%22% crossed over to surgery crossed over to surgery ~66%~66% of observational patients had surgery of observational patients had surgeryWeinstein et al. NEJM 2008


Bottom line:Bottom line: Lots of crossover – the Achilles heal of studies Lots of crossover – the Achilles heal of studies

comparing surgery to non-surgical tx. comparing surgery to non-surgical tx. Investigators maintained good follow-upInvestigators maintained good follow-up

Interesting findingsInteresting findings Pt’s in observational cohort had more ‘signs of nerve Pt’s in observational cohort had more ‘signs of nerve

root tension’root tension’ Exhibited a stronger treatment preferenceExhibited a stronger treatment preference Group undergoing surgery tended to be younger, Group undergoing surgery tended to be younger,

more likely to be working, had more pain and lower more likely to be working, had more pain and lower level of function. Also exhibited ‘more severe’ level of function. Also exhibited ‘more severe’ stenosis on imaging.stenosis on imaging.




Non surgical treatmentNon surgical treatment Similar between observational and Similar between observational and

randomized cohortsrandomized cohorts More patients in the randomized group More patients in the randomized group

reported visits to a surgeon (45% vs 32%). reported visits to a surgeon (45% vs 32%). Also more use of ‘injections’ (52% vs 39%) Also more use of ‘injections’ (52% vs 39%) - ? An attempt to keep them in their - ? An attempt to keep them in their randomized group?randomized group?

More observational patients used ‘other’ More observational patients used ‘other’ medications such as gabapentinmedications such as gabapentin




Surgical TreatmentSurgical Treatment Similar between both groupsSimilar between both groups Instrumentation in 6% of patientsInstrumentation in 6% of patients 9% durotomy rate9% durotomy rate 8% re-operation rate at 2 years with <50% 8% re-operation rate at 2 years with <50%

for recurrent stenosisfor recurrent stenosis No mortality directly attributable to surgeryNo mortality directly attributable to surgery




Crossover largely ‘predictable’Crossover largely ‘predictable’ Pts who crossed over to surgery had more Pts who crossed over to surgery had more

severe symptoms and self-rated disabilitysevere symptoms and self-rated disability Pts who crossed over to non-surgical tx had Pts who crossed over to non-surgical tx had

less bothersome sx’s and favored non-less bothersome sx’s and favored non-surgery at baseline.surgery at baseline.

Observational cohort very similar to Observational cohort very similar to randomized group though. randomized group though.



SPORT SPORT How They Analyzed the DataHow They Analyzed the Data Randomized group:Randomized group:

Surgery vs no surgery with ‘intent to treat’ Surgery vs no surgery with ‘intent to treat’ analysisanalysis

Surgery vs no surgery with ‘as treated’ analysis Surgery vs no surgery with ‘as treated’ analysis Observation group:Observation group:

Surgery vs no surgerySurgery vs no surgery Looked at primary outcomes of bodily pain, Looked at primary outcomes of bodily pain,

physical function and mean ODI. physical function and mean ODI. Secondary outcome dataSecondary outcome data


SPORT SPORT What they foundWhat they found

Randomized Group




SPORT SPORT What they foundWhat they found

Observational Group




Statistical AnalysisStatistical Analysis

In RCT’s not all patients adhere to protocol In RCT’s not all patients adhere to protocol they were assigned to.they were assigned to.

Non complianceNon compliance CrossoverCrossover Lost to follow-up / drop-out Lost to follow-up / drop-out

This makes your data set imperfect and more This makes your data set imperfect and more difficult to analyze.difficult to analyze.

Per protocol analysis – Per protocol analysis – Deviate from protocol and you’re outDeviate from protocol and you’re out Intent to treat analysis – Intent to treat analysis – As randomized, so analyzedAs randomized, so analyzed As treated analysis – As treated analysis – Analyze based on tx not Analyze based on tx not

randomizationrandomization


Statistical AnalysisStatistical AnalysisOrigin of RandomizationOrigin of Randomization

R.A. Fisher in 1923 studied the effects of R.A. Fisher in 1923 studied the effects of different fertilizers on potato yields.different fertilizers on potato yields.

Some fields (or even parts of a field) are Some fields (or even parts of a field) are more fertile than others though.more fertile than others though.

Decided to apply the fertilizer to small Decided to apply the fertilizer to small plots.plots.

Randomly assign fertilizers to plots/rows. Randomly assign fertilizers to plots/rows. Randomization destroys any connection Randomization destroys any connection

between soil fertility and treatment.between soil fertility and treatment.


Statistical AnalysisStatistical AnalysisRandomizationRandomization

Any difference between groups that Any difference between groups that arises after randomization should be arises after randomization should be due to consequences of the due to consequences of the randomized treatment assignmentrandomized treatment assignment

Adjusting the analysis of treatment Adjusting the analysis of treatment effect by post-randomization group effect by post-randomization group differences could introduce biasdifferences could introduce bias


Statistical AnalysisStatistical AnalysisIntention to Treat AnalysisIntention to Treat Analysis

Includes all randomized patients in the Includes all randomized patients in the groups to which they were randomly groups to which they were randomly assigned, regardless of their adherence assigned, regardless of their adherence with the entry criteria, regardless of the with the entry criteria, regardless of the treatment they actually received, and treatment they actually received, and regardless of subsequent withdrawal from regardless of subsequent withdrawal from treatment or deviation from the protocoltreatment or deviation from the protocol

(Lloyd) Fisher et al., 1990(Lloyd) Fisher et al., 1990



What happens when the crossover is great and there is, in fact, a difference between the two treatments?



LARD LARD LLaparoscopic aparoscopic AAntroplasty vs ntroplasty vs RRestricted estricted DDietiet

1000 patients1000 patients Inclusion criteriaInclusion criteria

Obese - BMI >40Obese - BMI >40 Surgical CandidateSurgical Candidate

Exclusion criteriaExclusion criteria Prior surgical interventionPrior surgical intervention Psychiatric issuesPsychiatric issues

Randomized to Bariatric Randomized to Bariatric surgery or diet onlysurgery or diet only

Beshay et al. Bogus Journal 2010



LARD LARD LLaparoscopic aparoscopic AAntroplasty vs ntroplasty vs RRestricted estricted DDietiet

• 1000 patients

•500 randomized to surgery

•500 randomized to diet

• At the end of the study

•350 surgical patients underwent surgery

•250 diet patients underwent surgery

Beshay et al. Bogus Journal 2010

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Statistical AnalysisStatistical AnalysisIntent to Treat AnalysisIntent to Treat Analysis

LARD LARD

LLaparoscopic aparoscopic AAntroplasty vs ntroplasty vs RRestricted estricted DDietiet

In this study 60% of surgical patients experienced a significant drop In this study 60% of surgical patients experienced a significant drop in BMI while 30% of diet patients experienced a similar dropin BMI while 30% of diet patients experienced a similar drop

1000 patients

500 randomized to surgery

500 randomized to diet

200 patients 250 patients

AT IT550 pt’s

330 lost weight

60%

450 pt’s

135 lost weight

30%

500 patients

300 x 0.6 +

200 x 0.3= 240

240/500= 48%

500 patients

250 x 0.6 +

250 x 0.3 = 45%

Intent to treat analysis with large crossover favors the null hypothesis.

SPORT – Lumbar StenosisSPORT – Lumbar StenosisConclusionsConclusions

Lumbar stenosis is common among elderly patients Lumbar stenosis is common among elderly patients and is the number one cause of lumbar surgery in and is the number one cause of lumbar surgery in those older than 65.those older than 65.

When treating neurogenic claudication or radicular When treating neurogenic claudication or radicular symptoms, patients will improve with operative or symptoms, patients will improve with operative or non-operative strategiesnon-operative strategies

There is significantly more improvement with surgical There is significantly more improvement with surgical interventionintervention

Surgical intervention in this group of patients was safeSurgical intervention in this group of patients was safe Beware of Intent to Treat Analysis in studies in which Beware of Intent to Treat Analysis in studies in which

there was a large amount of crossover.there was a large amount of crossover. Don’t underestimate the value of observational Don’t underestimate the value of observational

groups.groups.

Surgical Treatment of Lumbar Surgical Treatment of Lumbar StenosisStenosis

‘‘Standard’ open laminectomy/medial Standard’ open laminectomy/medial facetectomy/foraminotomy – facetectomy/foraminotomy – unilateral or bilateralunilateral or bilateral


Minimally invasive approachMinimally invasive approach Goal is to achieve same results with Goal is to achieve same results with

little muscle disruptionlittle muscle disruption Utilize a tubular retractorUtilize a tubular retractor Incision off the midlineIncision off the midline Muscle splitting techniqueMuscle splitting technique


Minimally invasive approachMinimally invasive approach








Papavero et al. 2009


Papavero et al. 2009


Are minimally invasive techniques Are minimally invasive techniques better?better? In experienced hands same results as open In experienced hands same results as open

surgerysurgery Less hospital stay – modestLess hospital stay – modest Less post op narcotics Less post op narcotics Less muscle disruption as assessed by CK Less muscle disruption as assessed by CK

and follow-up MRIand follow-up MRI ? Less post op instability ? – Maybe..? Less post op instability ? – Maybe..


What about interspinous process What about interspinous process spacers?spacers?


What about interspinous process What about interspinous process spacers?spacers?


What about interspinous process spacers?What about interspinous process spacers? Do they work? Yes, in selected patients.Do they work? Yes, in selected patients.

Kuchta et al. Eur Spine J 2009


Extension Limiting DevicesExtension Limiting Devices


““Other”Other”

Swei-Ming et al. JNS 2006

QuestionsQuestions

Thank YouThank You

Emergency Reversal of Coagulopathy and Platelet Dysfunction in ...

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result of lumbar stenosis

lumbar hnp

surgery nonsurgical

prior lumbar surgery

sport patients

nonsurgical groups

costeffectiveness of

nonsurgical approaches