JAMA's Fake Science/Hit Piece on SCS for Chronic Radic after Spine Surgery

[drusso]

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If I were an SCS KOL, I'd be pissed...

Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients After Lumbar Spine Surgery

This placebo-controlled, crossover randomized clinical trial compares the effects of spinal cord burst stimulation vs placebo stimulation in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders.

jamanetwork.com

 

[Agast]

What’s placebo stimulation? The stimulator was on standard paresthesias programming? I thought the main benefit of burst was long term. 6 months doesn’t seem like it would be enough to show a difference.

 

[lobelsteve]

Can we say Burst doesn’t work?
No definition of placebo stim noted.
Patients not given access to their remote programmer during the study.

Bad design. Bad outcomes.

 

[drusso]

Can we say Burst doesn’t work?
No definition of placebo stim noted.
Patients not given access to their remote programmer during the study.

Bad design. Bad outcomes.

Wheels are in motion. KOLs and Super-Partners will be convening.

 

[drusso]

Can we say Burst doesn’t work?
No definition of placebo stim noted.
Patients not given access to their remote programmer during the study.

Bad design. Bad outcomes.

What's the difference between a physiological Burst and clustered tonic stimulation masquerading as Burst?

Why is JAMA publishing studies on fake waveforms and fake PRP and calling it science? Why are the reviewers not doing their jobs? Is there enough true content expertise on these emerging therapies on these topics in "high impact" journals?

 

[drpainfree]

why JAMA? what do THEY know about SCS?

 

[Agast]

I thought Burst was specifically an Abbott thing, does it make a difference that they used a Boston Scientific stimulator?

 

[painfree23]

I thought Burst was specifically an Abbott thing, does it make a difference that they used a Boston Scientific stimulator?

Every stim does the same stuff, just call it something different..don’t fall for the marketing tricks. Only difference is the 10k hertz nevro has “patented”

 

[pmrmd]

I thought Burst was specifically an Abbott thing, does it make a difference that they used a Boston Scientific stimulator?

Boston has burst capability from their IPGs but it isn’t the novel waveform that Abbot uses. But I haven’t found that to be that great either.

 

[epidural man]

Seems like a hit piece on Abbott, not on SCS.

 

[lobelsteve]

Seems like a hit piece on Abbott, not on SCS.

Same thing 2 years ago on Nevro. Was article written to drop stock price for someone else's personal gains in shorting the stock (or whatever it is called).

 

[DOctorJay]

What's the difference between a physiological Burst and clustered tonic stimulation masquerading as Burst?

Why is JAMA publishing studies on fake waveforms and fake PRP and calling it science? Why are the reviewers not doing their jobs? Is there enough true content expertise on these emerging therapies on these topics in "high impact" journals?

we've seen some really poorly designed articles recently related to stim, PRP, and RFA that some how get through the peer review process.

 

[OutofNetwork]

JAMA really doesn't like interventional pain. I don't think I've seen an article in the past 5 years supporting the field of interventional pain (correct me if im wrong).

This is interesting because I would assume the JAMA readers have a lot of chronic pain patients who they probably want to get off opioids...

 

[Ferrismonk]

JAMA really doesn't like interventional pain. I don't think I've seen an article in the past 5 years supporting the field of interventional pain (correct me if im wrong).

This is interesting because I would assume the JAMA readers have a lot of chronic pain patients who they probably want to get off opioids...

I remind myself that the AMA has proven over and over that it does not represent doctors or medicine. It supports primary care APPs, public policy that leans liberal, and it's own insurance plans. Once you realize that, every article in JAMA makes sense.

 

[gaspasser127]

JAMA really doesn't like interventional pain. I don't think I've seen an article in the past 5 years supporting the field of interventional pain (correct me if im wrong).

This is interesting because I would assume the JAMA readers have a lot of chronic pain patients who they probably want to get off opioids...

The Nevro PDN study was published in JAMA Neurology

But I agree with your point re: JAMA in general

 

[Orin]

This isn't BurstDR but whatever.
It's a poorly designed thing.

Trial with tonic.
Implant with Burst.
Sham with stim off.
50 implants from 65 trials looks like my trial to perm ratio as a salvage academic doc.
Complication rate of about 20% is rather high but I guess expected for neurosurgeons doing perc leads
No control for oral meds.

So focused on showing that stim is all placebo response but ignoring the nocebo response of following a tonic trial with paresthesia free programming

Would love to see how they did when they went back to tonic

 

[gaspasser127]

This isn't BurstDR but whatever.
It's a poorly designed thing.

Trial with tonic.
Implant with Burst.
Sham with stim off.
50 implants from 65 trials looks like my trial to perm ratio as a salvage academic doc.
Complication rate of about 20% is rather high but I guess expected for neurosurgeons doing perc leads
No control for oral meds.

So focused on showing that stim is all placebo response but ignoring the nocebo response of following a tonic trial with paresthesia free programming

Would love to see how they did when they went back to tonic

They didn’t describe in the article (as far as I recall) what placebo stimulation was. We assume the stim was just turned off… but is that what they did?

Trialing with tonic and then using burst post implant is definitely a major wtf.

As we all know, there’s zero prospective evidence supporting Boston’s “burst”

 

[Agast]

How does garbage like this even get published?

 

[drusso]

How does garbage like this even get published?

Because it satisfies the ideological agenda of therapeutic nihilists, there are A LOT of people whose livelihoods and careers depend upon doctors doing nothing and nothing working.

 

[Ducttape]

actually, study was fairly well designed.

prospective, blinded, cross-over. powered adequately based on their numbers.

the primary study focus - "is burst really beneficial over placebo stim".

not "does stim work at all".



if you look at the final graph - stim did reduce ODI from 44.7 baseline to 34 and 35.4. it did improve mean leg pain from 7.3 to 5.9 and 6.1, though only 1.4 points difference, not 2, which some people like to attach value to.

now fortunately the study was not to compare stim to no therapy, so the authors cannot claim that stim did not work at all..... we can make suppositions on this forum that this study does not rule out the possibility that stim is effective...

 

[drusso]

actually, study was fairly well designed.

prospective, blinded, cross-over. powered adequately based on their numbers.

the primary study focus - "is burst really beneficial over placebo stim".

not "does stim work at all".



if you look at the final graph - stim did reduce ODI from 44.7 baseline to 34 and 35.4. it did improve mean leg pain from 7.3 to 5.9 and 6.1, though only 1.4 points difference, not 2, which some people like to attach value to.

now fortunately the study was not to compare stim to no therapy, so the authors cannot claim that stim did not work at all..... we can make suppositions on this forum that this study does not rule out the possibility that stim is effective...

It wasn't real Burst. It was fake Burst. Just like the JAMA PRP study used a fake PRP. The problem is because JAMA is "high impact," these fake false studies work their way into the hearts and minds of the therapeutic nihilists who use them as justification for creating policies to restrict access. Some KOLs have made their career doing this. Think Roger Chou.

 

[Ducttape]

and how do you say that it was fake Burst?

look at the study.

they do note that there may be concerns about fine tuning programming, but, from the study itself...

This study has several limitations. First, the blinding of this treatment prohibits the fine-tuning of stimulation parameters in a completely open dialogue with patients. A thorough review of the spinal cord stimulation system prior to each new treatment allocation was therefore conducted and stimulation programming was performed according to the manufacturer’s recommendations.

addenda they do note that there are other burst programs available that might have had an effect, as a possible limitation.

 

[DrMDAware]

In interventional pain we’re moving more towards a surgical approach.

JAMA wants us to go more towards psych and behavioral health.

 

[drusso]

In interventional pain we’re moving more towards a surgical approach.

JAMA wants us to go more towards psych and behavioral health.

There's no data for that. If you tried to tell me that my radiculopathy was all in my head, I'd be pissed.

 

[MitchLevi]

LOL at pain psych.

It's BS, and I trained at the place that does it the best.

 

[DrMDAware]

There's no data for that. If you tried to tell me that my radiculopathy was all in my head, I'd be pissed.

Lol I agree

I ask them to show me the NNT for a statin and they look at me like I just murdered a puppy with my hands in front of a room of preschoolers.

 

[Ducttape]

playing devils advocate: show us the data that injections - that we all do - has changed the course of chronic pain in the US.


if you want a good summary about the paucity of data supporting epidurals for anything outside of short term pain relief, go to the CMS LCD on epidurals.

 

[epidural man]

There's no data for that. If you tried to tell me that my radiculopathy was all in my head, I'd be pissed.

I get it. People do get mad when I tell them this truth.

Pain is all in the head. Without cognition and thought - pain doesn't exist. And how we think about our pain makes A LOT of difference.

 

[epidural man]

JAMA really doesn't like interventional pain. I don't think I've seen an article in the past 5 years supporting the field of interventional pain (correct me if im wrong).

This is interesting because I would assume the JAMA readers have a lot of chronic pain patients who they probably want to get off opioids...

You guys rely on consults.

I don't really - so it is a different perspective for me.

I get SUCH CRAPPY consults from PCMs. I think about this idea a lot. The PCMS don't believe in interventional pain, and they want to take those tools away from me and rely on the tools that they have and use - yet they still send me patients to me for interventional pain that CLEARLY will get no benefit from interventions (think 22 y/o with normal MRI and low back pain) and they refuse to lift a single finger in helping these patients with the stuff that would work (ie...mind body medicine, exercise, weight loss, mental health).

 

[Ferrismonk]

Here it goes....

Insurers call for ban on spinal cord stimulator subsidies after new trial

An independent scientist and private health insurers are calling for Medicare to stop funding spinal cord stimulators after a new study found devices were no better than a placebo for treating a key type of chronic pain.

www.smh.com.au

 

[Ducttape]

hopefully, what happens in Australia does not happen in the US.