NEJM Surgical vs. nonsurgical spinal stenosis management

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jimbomd

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interesting study from this week's NEJM looking at surg vs. nonsurg management for spinal stenosis...

ABSTRACT

Background Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.

Methods Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary outcomes were measures of bodily pain and physical function on the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and 1 and 2 years.

Results A total of 289 patients were enrolled in the randomized cohort, and 365 patients were enrolled in the observational cohort. At 2 years, 67% of patients who were randomly assigned to surgery had undergone surgery, whereas 43% of those who were randomly assigned to receive nonsurgical care had also undergone surgery. Despite the high level of nonadherence, the intention-to-treat analysis of the randomized cohort showed a significant treatment effect favoring surgery on the SF-36 scale for bodily pain, with a mean difference in change from baseline of 7.8 (95% confidence interval, 1.5 to 14.1); however, there was no significant difference in scores on physical function or on the Oswestry Disability Index. The as-treated analysis, which combined both cohorts and was adjusted for potential confounders, showed a significant advantage for surgery by 3 months for all primary outcomes; these changes remained significant at 2 years.

Conclusions In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically.

full text at nejm.com. Interestingly, their conservative therapy arm was "usual care," or PT, home exercise, and NSAIDs.

In addition, they have a case discussion in this issue of an elderly patient with spinal stenosis (written by a rheumatologist and an orthopod) that basically discounts evidence for injections ; they cite the recent neurology position paper and a paper from Spine that describes the increase in lumbosacral populations in the medicaid population.

As a fellow, it is upsetting that there is not even a voice from pain management included in this kind of a paper, read by internists, FPs, neurologists, orthopods (our referral base), as well as reported to the general public. Also, the fact that there is no long-term prospective placebo-controlled, randomized clinical trial looking at fluoroscopic-guided interlaminar epidural steroid injections for spinal stenosis is disheartening, considering the number that are done. And I am aware of the Pain Physician article by Botwin et al looking at caudals for spinal stenosis, but they did not even mention this.

I guess I am venting, but if pain management is to gain significant traction as a legitimate subspecialty, the quality of our data needs to be vastly improved. I was at the AAPM meeting in Orlando, and comparing the quality of some of the results presented there to the American College of Cardiology meeting that I've also attended in the past was a joke.

anyone else's thoughts?

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Studies looking at pain outcomes is so poor for many reasons, most are poorly done, on heterogenous populations with vague diagnosis definitions, etc.

It's the same with both pain and PM&R. We have failed as specialties to do the research to show what we do helpes large populations, not just the patient in front of us.
 
dude the study is a total flake

they were comparing

1) surgery for stenosis

versus

2) active PT, education, counseling with home exercises, and NSAIDS

the study patients had neurogenic claudication and their films suggested that they were surgical candidates...

are you kidding me....

this study just lowered my opinion of the NEMJ peer review process...
 
Members don't see this ad :)
Show someone who has progressive spinal stenosis with weakness in his/her lower extremities who is treated conservatively and I will show you someone in a wheelchair in a year.
 
dude the study is a total flake

they were comparing

1) surgery for stenosis

versus

2) active PT, education, counseling with home exercises, and NSAIDS

the study patients had neurogenic claudication and their films suggested that they were surgical candidates...

are you kidding me....

this study just lowered my opinion of the NEMJ peer review process...
I totally agree with you!
 
interesting study from this week's NEJM looking at surg vs. nonsurg management for spinal stenosis...

ABSTRACT

Background Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.

Methods Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary outcomes were measures of bodily pain and physical function on the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and 1 and 2 years.

Results A total of 289 patients were enrolled in the randomized cohort, and 365 patients were enrolled in the observational cohort. At 2 years, 67% of patients who were randomly assigned to surgery had undergone surgery, whereas 43% of those who were randomly assigned to receive nonsurgical care had also undergone surgery. Despite the high level of nonadherence, the intention-to-treat analysis of the randomized cohort showed a significant treatment effect favoring surgery on the SF-36 scale for bodily pain, with a mean difference in change from baseline of 7.8 (95% confidence interval, 1.5 to 14.1); however, there was no significant difference in scores on physical function or on the Oswestry Disability Index. The as-treated analysis, which combined both cohorts and was adjusted for potential confounders, showed a significant advantage for surgery by 3 months for all primary outcomes; these changes remained significant at 2 years.

Conclusions In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically.

full text at nejm.com. Interestingly, their conservative therapy arm was "usual care," or PT, home exercise, and NSAIDs.

In addition, they have a case discussion in this issue of an elderly patient with spinal stenosis (written by a rheumatologist and an orthopod) that basically discounts evidence for injections ; they cite the recent neurology position paper and a paper from Spine that describes the increase in lumbosacral populations in the medicaid population.

As a fellow, it is upsetting that there is not even a voice from pain management included in this kind of a paper, read by internists, FPs, neurologists, orthopods (our referral base), as well as reported to the general public. Also, the fact that there is no long-term prospective placebo-controlled, randomized clinical trial looking at fluoroscopic-guided interlaminar epidural steroid injections for spinal stenosis is disheartening, considering the number that are done. And I am aware of the Pain Physician article by Botwin et al looking at caudals for spinal stenosis, but they did not even mention this.

I guess I am venting, but if pain management is to gain significant traction as a legitimate subspecialty, the quality of our data needs to be vastly improved. I was at the AAPM meeting in Orlando, and comparing the quality of some of the results presented there to the American College of Cardiology meeting that I've also attended in the past was a joke.

anyone else's thoughts?

Kind of a dumb study in my mind - as others have pointed out.

A better study would be to compare decompressive laminotomy to MILD. Show me that data.
 
Kind of a dumb study in my mind - as others have pointed out.

A better study would be to compare decompressive laminotomy to MILD. Show me that data.

The MILD rep has that data and it looks great! MILD has lower costs (no hospital stay), less complications (0% so far), and better functional outcomes (they actually utilized 4 measurements of outcomes and MILD was superior by all measurements)
 
I have only seen two published articles on this, both in Pain Physian. If your
Rep has more peer-reviewed data, preferably not PP, and not industry paid for,
Do tell.
 
The MILD rep has that data and it looks great! MILD has lower costs (no hospital stay), less complications (0% so far), and better functional outcomes (they actually utilized 4 measurements of outcomes and MILD was superior by all measurements)

Buch of BS. The data is severely lacking.

Once the first dural tear happens, things will change. Complications are a function of time and training.

I also do not believe the biased data collected and outcome measures reported.
I'd like to have a looksy at the methods and logistics of the studies.
 
The MILD rep has that data and it looks great! MILD has lower costs (no hospital stay), less complications (0% so far), and better functional outcomes (they actually utilized 4 measurements of outcomes and MILD was superior by all measurements)

No true. They say there are no complications - but they should say, no complications we either know about - or aren't telling people about.

I know of at least 3. One had severe neurological devestation as the interventionalist was grabbing the nerve root and ripping it out (instead of the ligament).

Also, two horrible dural tears that needed surgical correction.
 
No true. They say there are no complications - but they should say, no complications we either know about - or aren't telling people about.

I know of at least 3. One had severe neurological devestation as the interventionalist was grabbing the nerve root and ripping it out (instead of the ligament).

Also, two horrible dural tears that needed surgical correction.

Shhh, you may hurt the stock value of all the physician/investors.

SML
 
No true. They say there are no complications - but they should say, no complications we either know about - or aren't telling people about.

I know of at least 3. One had severe neurological devestation as the interventionalist was grabbing the nerve root and ripping it out (instead of the ligament).

Also, two horrible dural tears that needed surgical correction.

The exact reason I never had any interest in this procedure.
 
The exact reason I never had any interest in this procedure.

The problems with this procedure - dangerous lack of visualization and ignoring the disc & facets as a source of stenosis - are so glaring that it makes you wonder why any of us would consent to do it. To say nothing of the shills who are pushing it.

There will be a long list of experts poised to jump when the complications start hitting the courts.
 
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