Newest Literature on mILD procedure vs alternatives

[DrCommonSense]

Newest literature on the mILD procedure using a prospective RCT conisting of 302 patients followed out for 1 year with confirmed central stenosis compared to other conservative treatment measures.

VAS and functional scales appear to have positive benefit. Another trial will be completed by December under CMS guidelines.

So far, the literature looks very strong compared to alternatives.

http://www.painphysicianjournal.com/current/pdf?article=MjcwNQ==&journal=96

The question that remains: What is the BEST and most cost effective method to treat lumbar spinal stenosis patients, particularly those due to ligamentum hypertrophy?

Considering most central stenosis patients are in their 70s, most of these patients have high levels of morbidity already.

Is subjecting them to fusions surgeries the best option? Or how about laminectomy?

Or should we just run them on a treadmill and say there is nothing else we can do for you if this doesn't work?

Thoughts?

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[lobelsteve]

Looking at funding for study and some of the investigators is pause for concern. Will give a full SIS style EBM review as soon as i get some time.

 

[DrCommonSense]

Looking at funding for study and some of the investigators is pause for concern. Will give a full SIS style EBM review as soon as i get some time.

This can be argued for "studies" done by almost field of medicine.

By that logic, all of the recent pharma studies should be thrown out since they FUND the studies, pay for "consultant" physicians to perform the studies, do the stats on the studies themselves, etc.

Also, the same could be said for almost all studies in cardiology, neurosurgery, etc. Almost any studies on stents for stable CAD or fusion surgeries are done by surgeons who are "consultants" for the device companies.

In fact, the mILD procedure study has less of a quid pro quo than the majority of other studies in the other literature.

If we can't use "consultants" to study these projects now, then this has to be the case ACROSS THE BOARD in EVERY specialty and pharma. This is definitely NOT the case.

 

[Ducttape]

I would argue you are right,it should be across the board.

The unique nature of pain is that we were forced to directly confront the failures of the system due to the opioid crisis. The system failed completely and thousands have died. That hasn't happened in the other specialties... Yet.



Because of this crisis, I would argue that pain medicine across the board, including IPM, now is much more introspective and more critically thinking - through people like Kolodny, Ballantyne, even 101N - than any other specialty other than IM.


(IM has always debated amongst themselves... It's in their nature...)


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[drpainfree]

just to say I can't wait for MILD to be FDA-approved and offer it my elderly patients who can't benefit from anything else.

 

[DrCommonSense]

I would argue it is across the board.

The unique nature of pain is that we were forced to directly confront the failures of the system due to the opioid crisis.

I argue that pain medicine now is much more introspective and doubting more - through people like Kolodny, Ballantyne, even 101N - than any other specialty other than IM.


(IM has always debated amongst themselves... It's in their nature...)


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Thats fine but the current system is setup that way. Either IPM follows EVERYONE else in procedural medicine (incidently, this study conform to the standards that CMS required) with the same standards or we hold everyone accountable with "totally" independent authors of studies.

If we held those standards for cardiology, back surgeons, ortho surgeons, etc., most of their procedures would be out.

Also, I would argue that even the "introspective" doctors need to be watched as well. They have alternative goals that benefit them financially as well. For instance, PROP is supported by REHAB clinics that make money off of drug treatment. They are actively trying to get federal funding in the tune of billions of dollars to pay for this. So an argument can be made that they are far from "independent" either.

I don't support high dosages of narcotic meds, however, I find PROP to be just as dishonest on the issue as Purdue/AAPM in the opposite direction.

IM can be introspective, it doesn't perform procedures that have a financial stake in their benefit. "Introspection" is rare when there are financial interests at hand.

 

[lobelsteve]

This can be argued for "studies" done by almost field of medicine.

By that logic, all of the recent pharma studies should be thrown out since they FUND the studies, pay for "consultant" physicians to perform the studies, do the stats on the studies themselves, etc.

Also, the same could be said for almost all studies in cardiology, neurosurgery, etc. Almost any studies on stents for stable CAD or fusion surgeries are done by surgeons who are "consultants" for the device companies.

In fact, the mILD procedure study has less of a quid pro quo than the majority of other studies in the other literature.

If we can't use "consultants" to study these projects now, then this has to be the case ACROSS THE BOARD in EVERY specialty and pharma. This is definitely NOT the case.

Interesting you are arguing. I did not review it yet, just listed potential bias, and you seem to puff up. Very aggressive. Makes for interesting background...long time lurker? Practice setup?

 

[DrCommonSense]

Interesting you are arguing. I did not review it yet, just listed potential bias, and you seem to puff up. Very aggressive. Makes for interesting background...long time lurker? Practice setup?

The study is the closest to "level 1" evidence you can basically find. It has a RCT trial comparing a procedure to an alternative in 302 patients. A second study with similar comparisons will be finished by December.

The study was overseen by CMS to determine policy, so I'm sure if anyone falsified the data that was patient reported, they could be held legally responsible.

The only "bias" that is possible is that the authors are interventionalists (ASIPP) and want to obtain more possible procedures to perform. I don't think either of them are paid by Vertos directly as "consultants".

However, this "bias" is no different than any other field of medicine that has proceduralists that want something they can make money performing to work. Most of these studies are funded by device companies (not CMS), are performed by "consultant physicians" who work directly for the company and are often statistically managed from the company.

I have been reading this forum for some time but have decided to respond in the last two days. I am off from work today doing my business "studies" and am just answering my alert screen when someone makes a new comment. I find this topic fascinating as I have been studying procedural medicine from a business perspective for some time and find it fraught with conflicts of interest throughout the system that are far from unique to IPM.

My practice is a large group that has behavorial, PT, etc included with interventions, medications, etc. We offer the gamut of procedures.

 

[lobelsteve]

I will run the numbers. No accusations at the authors or the funding. It is just potential bias.

 

[ultm8frisbee]

just to say I can't wait for MILD to be FDA-approved and offer it my elderly patients who can't benefit from anything else.

It is already FDA approved. It just has no CMS based reimbursement

 

[DrCommonSense]

just to say I can't wait for MILD to be FDA-approved and offer it my elderly patients who can't benefit from anything else.

Like stated above, its FDA approved but rejected by CMS for payment.

Two RCT have been setup to determine efficacy of the procedure based on CMS protocols in terms of EBM. Both are supposed to be completed by the end of 2016. I think the one above constitutes the first one already while we're waiting on the second.

 

[ampaphb]

1) this is a study published in Pain Physician, authored by an ASIPP board member, who is one of Lax's cronies

SIS does real science. ASIPP gets us paid.

2) there seems to be a discrepancy between studies performed by consultants, and studies funded by the manufacturer. This study is funded by Vertos. If the data had been unfavorable, they would have buried the study.

3) 20% of asymptomatic subjects have been found to have spinal stenosis on MRI.

4) Independent studies (https://www.ncbi.nlm.nih.gov/pubmed/22407072) do not reach similar conclusions.

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[DrCommonSense]

1) this is a study published in Pain Physician, authored by an ASIPP board member, who is one of Lax's cronies

SIS does real science. ASIPP gets us paid.

2) there seems to be a discrepancy between studies performed by consultants, and studies funded by the manufacturer. This study is funded by Vertos. If the data had been unfavorable, they would have buried the study.

3) 20% of asymptomatic subjects have been found to have spinal stenosis on MRI.

4) Independent studies (https://www.ncbi.nlm.nih.gov/pubmed/22407072) do not reach similar conclusions.

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1) This is just conjecture. ASIPP is no more "biased" in their studies compared to big pharma doing their own studies, device companies doing their own studies or neurosurgeons doing studies on fusions/laminectomy surgeries they make good money off of doing. No one is held to this "standard" in the vast majority of studies in "evidence based medicine", so using this bar would eliminate 99.9% of "studies".

2) There is always a "discrepancy" between studies by device companies and "independent" people. This is true for stents, CABGS, fusions, kyphoplasty, etc.

3) Ok same for all back isuses

4) Who makes this guy "independent"? Does he make money doing fusion/laminectomies? If so, how much more money would he make doing a fusion vs miLD procedure, especially since miLD can be done by pain physicians.

This "independent" guy has a strong motivation to kill of mILD and promote fusion that has been proven by many "independent" studies to "not" work.

Neurosurgeons who make huge salaries off of fusions studying mILD are far from "independent" either.