The MOTION Study: Changing the Game for Spinal Stenosis

[drusso]

https://onlinelibrary.wiley.com/doi/10.1111/papr.13293

Pain Pract. 2023 Sep 3.
doi: 10.1111/papr.13293. Online ahead of print.

The MOTION study: Two-year results of a real-world randomized controlled trial of the mild® procedure for treatment of lumbar spinal stenosis​

Timothy R Deer 1, Timothy B Chafin 2, Shrif J Costandi 3, Huaguang Qu 4, Christopher Kim 1, Navdeep Jassal 5, Kiran Patel 6, Aaron Calodney 7
Affiliations expand

• PMID: 37661347
• DOI: 10.1111/papr.13293

Abstract​

Objective: The MOTION study is designed to measure the impact of percutaneous image-guided lumbar decompression as a first-line therapy on patients otherwise receiving real-world conventional medical management for lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. This prospective, multicenter randomized controlled trial uses objective and patient-reported outcome measures to compare the combination of the mild® percutaneous treatment and nonsurgical conventional medical management (CMM) to CMM-Alone.
Methods: Test group patients received the mild procedure after study enrollment. Test and control groups were allowed conventional conservative therapies and low-risk interventional therapies as recommended by their physicians. Subjective outcomes included the Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire. Objective outcomes included a validated Walking Tolerance Test, the rate of subsequent lumbar spine interventions, and safety data.
Results: Two-year follow-up included 64 mild + CMM and 67 CMM-Alone patients. All outcome measures showed significant improvement from baseline for mild + CMM, whereas the majority of CMM-Alone patients had elected to receive mild treatment or other lumbar spine interventions by 2 years, precluding valid 2-year between-group comparisons. Neither group reported any device- or procedure-related adverse events.
Conclusions: The durability of mild + CMM for this patient population was demonstrated for all efficacy outcomes through 2 years. Improvements in walking time from baseline to 2 years for patients treated with mild + CMM were significant and substantial. The lack of reported device or procedure-related adverse events reinforces the strong safety profile of the mild procedure. These results provide support for early interventional treatment of symptomatic LSS with the mild procedure.
Keywords: mild; CMM; hypertrophic ligamentum flavum; low back pain; lumbar spinal stenosis; neurogenic claudication.

© 2023 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.

This is a bar plot that shows the mean improvement in different outcome measures for two different treatments, CMM-Alone and mild+CMM, after one year and two years. The outcome measures are ODI (Oswestry Disability Index), NPRS-Back (Numerical Pain Rating Scale - Back), NPRS-Leg (Numerical Pain Rating Scale - Leg), ZCQ-Symptom severity (Zigler-Scott Questionnaire - Symptom severity), and ZCQ-Physical function (Zigler-Scott Questionnaire - Physical function).

The bar plot shows that the mean improvement in all outcome measures was greater for the mild+CMM treatment than for the CMM-Alone treatment after one year. The difference was particularly large for the ODI and ZCQ-Symptom severity measures. After two years, the mean improvement was still greater for the mild+CMM treatment, but the difference was not as large as after one year.

Overall, the bar plot suggests that the mild+CMM treatment is more effective than the CMM-Alone treatment in improving outcome measures for people with spinal stenosis.

Walking Tolerance:

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[hyperalgesia]

A company pays a KOL a lot of money and the KOL produces a study that supports the company.

It's not a game changer. It's the same game.

 

[MitchLevi]

Open Payments Data - CMS

openpaymentsdata.cms.gov

 

[lobelsteve]

Open Payments Data - CMS

openpaymentsdata.cms.gov

View attachment 376670

Yay Timmy.

 

[Ducttape]

living the good life i guess...

 

[Espn123]

So..::besides a general dislike for Tim Deer, is there any value to this study? Personally I think it’s an easy and safe procedure with at least moderately good efficacy

 

[ridethecliche]

Was this all just for single level?

 

[MitchLevi]

So..::besides a general dislike for Tim Deer, is there any value to this study? Personally I think it’s an easy and safe procedure with at least moderately good efficacy

I don't generally dislike him; I just don't trust these guys. They're all bought and paid for by industry.

 

[RoloTomassi]

Yeah no hate here. Companies are going to pay someone, good on him for getting the bag. I don't dislike Jordan for promoting McDonald's. If you can't read a study or nutrition facts for yourself that's on you.

 

[cowboydoc]

Yeah no hate here. Companies are going to pay someone, good on him for getting the bag. I don't dislike Jordan for promoting McDonald's. If you can't read a study or nutrition facts for yourself that's on you.

I’m a Jordan fan, but his commercial is not making me any more likely to eat McDonald’s. Likewise, a Deer study is not going to make me more likely to use a product.

 

[hyperalgesia]

Does anyone else find it odd that Tim Deer is first author? Usually you would see a fellow or someone trying to get their name out and who does the leg work. I would expect Deer to be the anchor author. I don't know if it's an ego thing or his sponsor requesting it. I've actually seen that happen with other pain docs too where a very well-established doc comes out swinging like they're a new kid on the block.

 

[Espn123]

Yeah no hate here. Companies are going to pay someone, good on him for getting the bag. I don't dislike Jordan for promoting McDonald's. If you can't read a study or nutrition facts for yourself that's on you.

People don’t hate on MJ for doing commercials the way they hate on Tim Deer in this forum, that’s for sure.

My original question/comment was more in relation to MILD. Lots of comments about Deer, no comments about the MILD procedure…

 

[lobelsteve]

Does anyone else find it odd that Tim Deer is first author? Usually you would see a fellow or someone trying to get their name out and who does the leg work. I would expect Deer to be the anchor author. I don't know if it's an ego thing or his sponsor requesting it. I've actually seen that happen with other pain docs too where a very well-established doc comes out swinging like they're a new kid on the block.

For that kind of money you get the top spot.

 

[Agast]

Didn’t Tim Deer post some nonsense about the virtues of having a PA see all his patients and how highly trained they are, just as good as seeing the doctor? That’s a pretty nice racket. Make $4 million on the side in consulting fees and spend your time growing that part of your business while the PA does the actual work. He’s like the Thomas Kincaid of pain management. It’s a brand and nothing more.

 

[MitchLevi]

He’s like the Thomas Kincaid of pain management. It’s a brand and nothing more.

Damn...

I've told this story repeatedly, but in my NANS New Attending course, an instructor told me he'd implanted like 75 pts with DRG leads (150+ leads), and had never seen one migration, had one adverse effect or seen one failure. He is a guy you all know by name...

 

[Ducttape]

Yup. You never see lead migration if you never leave the OR....

 

[Agast]

Yup. You never see lead migration if you never leave the OR....

I’m suspicious of anyone who claims their implant is are % indicated and 100% successful 100% of the time

That’s better results than the studies we use to validate these interventions.

 

[MitchLevi]

I’m suspicious of anyone who claims their implant is are % indicated and 100% successful 100% of the time

That’s better results than the studies we use to validate these interventions.

That initial DRG study showed like 30% adverse event rate.

 

[Asclepius186]

I’m suspicious of anyone who claims their implant is are % indicated and 100% successful 100% of the time

That’s better results than the studies we use to validate these interventions.

Next time I go to any new device/procedure talk or training I want to ask the presenter to tell me about 1 or 2 of their biggest failures or complications with that procedure or device.

 

[cameroncarter]

https://www.painphysicianjournal.com/current/pdf?article=NzM3Nw%3D%3D&journal=140

Just read this study about positive use of SCS for NC secondary to LSS for 2 years. Most patients even had severe LSS on MRI. Does this feel consistent with your experience?

 

[Espn123]

Next time I go to any new device/procedure talk or training I want to ask the presenter to tell me about 1 or 2 of their biggest failures or complications with that procedure or device.

You should

 

[HyperSonic]

So..::besides a general dislike for Tim Deer, is there any value to this study? Personally I think it’s an easy and safe procedure with at least moderately good efficacy

I would not bluntly say “safe procedure” and would not recommend people be mislead about “0%” adverse outcomes in the study above.
Procedure is done around neuraxial space and inherently associated with possible major complications.
One guy in our town completely transected cauda equina doing MILD, paralyzed patient waist down and lost his license.
Stay safe guys.

 

[bedrock]

I would not bluntly say “safe procedure” and would not recommend people be mislead about “0%” adverse outcomes in the study above.
Procedure is done around neuraxial space and inherently associated with possible major complications.
One guy in our town completely transected cauda equina doing MILD, paralyzed patient waist down and lost his license.
Stay safe guys.

OMG!

 

[Agast]

One guy in our town completely transected cauda equina doing MILD, paralyzed patient waist down and lost his license.
Stay safe guys.

Is one catastrophic injury enough to cause a doctor to lose their license? I’m sure there are spine surgeons who have caused spinal cord injuries and are still practicing

 

[MitchLevi]

I would not bluntly say “safe procedure” and would not recommend people be mislead about “0%” adverse outcomes in the study above.
Procedure is done around neuraxial space and inherently associated with possible major complications.
One guy in our town completely transected cauda equina doing MILD, paralyzed patient waist down and lost his license.
Stay safe guys.

I'm actually not even sure that can happen TBH.

 

[cowboydoc]

Is one catastrophic injury enough to cause a doctor to lose their license? I’m sure there are spine surgeons who have caused spinal cord injuries and are still practicing

Right?!? Unless hookers and/or blow were also involved. Don't think we're hearing the whole story.

 

[bedrock]

Is one catastrophic injury enough to cause a doctor to lose their license? I’m sure there are spine surgeons who have caused spinal cord injuries and are still practicing

Good point.

There seems to be a major double standard between surgeons and non surgical interventionalists. Pain , cards, GI, etc.

A surgeon seems to be allowed to cause all kinds of complications that doesn’t raise an eyebrow, yet if anything goes wrong after a procedure from a non surgeon , then the patient, hospital, and board will all scream bloody murder and apply much harsher punishments that would be applied to a surgical complication.

 

[HyperSonic]

Right?!? Unless hookers and/or blow were also involved. Don't think we're hearing the whole story.

I do not think is anything else to that story to be honest.
He had to sell his solo practice.
Happened within last couple years.

 

[HyperSonic]

Good point.

There seems to be a major double standard between surgeons and non surgical interventionalists. Pain , cards, GI, etc.

A surgeon cab cause all kinds of complications that doesn’t raise an eyebrow, yet if anything goes wrong after a procedure from a non surgeon , then the patient, hospital, and board scream bloody murder and apply much harsher punishments that would be applied to surgical complications.

Agreed, looks like the Board could be ridiculous in punishments.

 

[nvrsumr]

I thought I read mild is gonna get an office code? Anybody have any idea if true?

thanks

 

[Ducttape]

done properly, the injection is posterior to the neuraxial space.

unless someone did this without fluoroscopy, then this would be so out of the norm.

btw, how would one have this complication, get sued, and lose license in less than 3 years? i remember being able to first do the procedure in 2020...

 

[Ducttape]

I thought I read mild is gonna get an office code? Anybody have any idea if true?

thanks

they are trying.

it would kill the payment but per the reps would guarantee its continued existence.....

 

[MitchLevi]

done properly, the injection is posterior to the neuraxial space.

unless someone did this without fluoroscopy, then this would be so out of the norm.

btw, how would one have this complication, get sued, and lose license in less than 3 years? i remember being able to first do the procedure in 2020...

I can't imagine how one could transect the CE with the MILD tool. The exact details of the malpractice would be interesting. Prob a lot more to the story.

 

[SSdoc33]

I can't imagine how one could transect the CE with the MILD tool. The exact details of the malpractice would be interesting. Prob a lot more to the story.

more likely the doc chewed up a nerve root and there is some weakness.

im not sure it is even possible to "transect" the cauda equina. its not the cord. it doesnt work like that

 

[MitchLevi]

Prob mangled a nerve root or two, but even then I can't imagine where the paralysis occurs.

What levels were being debulked?

Bad MILD with hematoma?

 

[lobelsteve]

Prob mangled a nerve root or two, but even then I can't imagine where the paralysis occurs.

What levels were being debulked?

Bad MILD with hematoma?

 

[deleted131481]

These only show a fraction of bad outcomes since self-reported by reps, but a few epidural bleeds on MAUDE. It won't let me input url.

 

[Taus]

more likely the doc chewed up a nerve root and there is some weakness.

im not sure it is even possible to "transect" the cauda equina. its not the cord. it doesnt work like that

I could see a more significant injury if the nerve roots were all clumped together with severe stenosis at the level

 

[MitchLevi]

It's very likely there have been a multitude of adverse events with MILD. Think about what you're doing - Debulking the LF without direct visualization through an incision. There's no cadaver lab to train in either...It's a model. At least, mine was a model.

How many referrals have yall gotten where the outside doctor was dumb enough to send procedure pics and they can't even do routine interventions?

100% there's been legit harm done to pts with MILD.

 

[SSdoc33]

I could see a more significant injury if the nerve roots were all clumped together with severe stenosis at the level

thats fair enough. complete paralysis is hard to swallow

 

[Ducttape]

of course, it is obvious that adverse events can happen with any procedure.

after all, this procedure is an epidural plus removal of ligamentum flavum. we have catastrophic events with just epidurals. that hasnt stopped us from doing epidurals.

now if data and studies show the risk is inordinately high, then we should stop doing the procedure. i cant find evidence of that on any published study.


statistically speaking, from the original study and the follow up ones, the rate of complication is less than that of open decompression.


(you may have trained on the model because of covid. many of my colleagues got trained on a cadaver, but that got shut down)

 

[au bon pain]

It's very likely there have been a multitude of adverse events with MILD. Think about what you're doing - Debulking the LF without direct visualization through an incision. There's no cadaver lab to train in either...It's a model. At least, mine was a model.

How many referrals have yall gotten where the outside doctor was dumb enough to send procedure pics and they can't even do routine interventions?

100% there's been legit harm done to pts with MILD.

Totally agree with your last statement. I used to work with one of the MILD talking heads—he was fed tons of candidates and did several per week. He claimed no catastrophic bad outcomes personally but heard that in cases where LF was pierced it was from that duckbill looking tool. He preached only using the cylindrical one.

 

[Espn123]

It's very likely there have been a multitude of adverse events with MILD. Think about what you're doing - Debulking the LF without direct visualization through an incision. There's no cadaver lab to train in either...It's a model. At least, mine was a model.

How many referrals have yall gotten where the outside doctor was dumb enough to send procedure pics and they can't even do routine interventions?

100% there's been legit harm done to pts with MILD.

I don’t think there

 

[Espn123]

This thread shows the range of knowledge and experience about the procedure. The same goes true for most any procedure that we do, including injections. In experienced hands the risk benefit profile is generally favorable. In less experienced hands it may not be.

For me, I do a fair number of mild. Not the most, but regularly. I do not believe I ever go in the epidural space, and it’s hopefully never even a question.

The complication or cauda equina “transaction” and even the description of some of the instruments show a lack of knowledge about how the procedure should be performed.

If you asked me my opinion about a procedure I’m not familiar with, like some craniofacial blocks I see pics of on here, my risk/benefit profile is nowhere near some of my colleagues on here who do this regularly.

Overall highlights maybe a need for better uniformity of training.

 

[Agast]

I wouldn’t surprised if there is an inverse relationship between the likelihood of adverse event and the time spent doing the procedure. I keep hearing abo