Game-changer? Interosseous nerve ablation RCT achieves primary endpoint

[drusso]

Relievant | The Intracept Procedure

“Stopping a Level I trial early for superiority is an extremely rare event and we are thrilled with this result,” said Kevin Hykes, CEO of Relievant Medsystems. “The Intracept Procedure has demonstrated compelling and consistent clinical results in both sham-controlled and real-world Level I studies. The combined strength of these studies provides convincing evidence of the outcomes that patients and physicians can expect from the Intracept Procedure.”

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[hyperalgesia]

I've heard of stopping trials early when they are toxic or when there is life to be saved.

Stopping a trial of an elective procedure based on somewhat subjective criteria is highly suspicious.

 

[painfree23]

I still remember at one of their meetings the doctor bragged about how a radiologist called him on a patient who had an MRI after the procedure and was like wtf did u just do? Radiologists see a lot of images and if they thought it was that weird, I don’t know how the rest of the medical community will feel

 

[lobelsteve]

Meet Our Team - Georgia Spine

Bendiks. Not a reassuring website.

 

[SSdoc33]

this procedure actually might have some legs. I can get my heard around WHY it might work, unlike the other "disc" pain procedures out there. I don't love that they are using modic changes as a de facto diagnosis of discogenic pain, but I suppose it is better than provocation discography -- certainly less invasive. if this pans out -- which is a big IF -- then it would fill a gaping hole in our ability to treat legitimate back pain. I fear that this is the sort of thing that insurances wont authorize, even if the literature looks good......

 

[Ducttape]

it is concerning that the study was stopped early.
there was no reason to do so, and doing so puts the results in question whereas completing the study would have lead to more validity for this industry sponsored study.

outside of this study, there may be other data out there that suggests that this study may be beneficial in the long run.

Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-c... - PubMed - NCBI

 

[drusso]

this procedure actually might have some legs. I can get my heard around WHY it might work, unlike the other "disc" pain procedures out there. I don't love that they are using modic changes as a de facto diagnosis of discogenic pain, but I suppose it is better than provocation discography -- certainly less invasive. if this pans out -- which is a big IF -- then it would fill a gaping hole in our ability to treat legitimate back pain. I fear that this is the sort of thing that insurances wont authorize, even if the literature looks good......

...just offer it for cash.

 

[deleted185747]

This looks promising, I wish I’d thought of it first!!!

This was presented at NANS 2018 and I’m looking forward to trying it

 

[SSdoc33]

...just offer it for cash.

im sure they are going to charge an arm and a leg for that introducer thingamabob. hopefully there wont be any proprietary restrictions with which RF generator can be used. this pay put the cost out of reach for many. we'll see, but im cautiously optimistic. it has been a while since anything new and legit has occurred in our field

 

[lobelsteve]

Data is not believable and stopping a trial early because of reported good results invalidates the entire study.

 

[geauxg8rs]

Data is not believable and stopping a trial early because of reported good results invalidates the entire study.

It’s not like they are curing cancer. No reason to stop the study

 

[hyperalgesia]

It’s not like they are curing cancer. No reason to stop the study

Only one reason.

They got the result they wanted and knew it wouldn't be sustained. So they quickly aborted.

 

[Orin]

Data is not believable and stopping a trial early because of reported good results invalidates the entire study.

I can't comment on the data as I have not reviewed them yet, but it's reasonable if the stopping criteria were met at interim to save money and harm/risk to trial vs placebo patients.

In this case, we can argue about the harm/risk to placebo more so than with cancer drugs or something, but this is standard procedure. The amount of benefit at the interim analysis though seems minimal in my opinion to not fully complete the study.

 

[drusso]

I can't comment on the data as I have not reviewed them yet, but it's reasonable if the stopping criteria were met at interim to save money and harm/risk to trial vs placebo patients.

In this case, we can argue about the harm/risk to placebo more so than with cancer drugs or something, but this is standard procedure. The amount of benefit at the interim analysis though seems minimal in my opinion to not fully complete the study.

This is the correct answer. In fact, some IRB's will REQUIRE that a trial is stopped if PRE-planned, PRE-specified criteria are met...continuing to expose patients to possible unintended harms after you have obtained a result with statistical certainty would be deemed unethical.

 

[unchockey21]

Know of a doc who did a few of these and had the tip of the probe break off in the vertebral body. Twice. I hope they’ve improved the structural integrity. It seems like reimbursement would be a nightmare too if they’re just using a generic spine code.

 

[hyperalgesia]

This is the correct answer. In fact, some IRB's will REQUIRE that a trial is stopped if PRE-planned, PRE-specified criteria are met...continuing to expose patients to possible unintended harms after you have obtained a result with statistical certainty would be deemed unethical.

I can see them stopping early if poor response but they are claiming the response is so great it's unethical to NOT do this procedure.

What procedure do we have in pain that it's ever unethical to NOT do?

If the study was designed to be stopped if the procedure seemed to work, it's not really a study. It's a series.

 

[drusso]

I can see them stopping early if poor response but they are claiming the response is so great it's unethical to NOT do this procedure.

What procedure do we have in pain that it's ever unethical to NOT do?

If the study was designed to be stopped if the procedure seemed to work, it's not really a study. It's a series.

Stopping guidelines for an effectiveness trial: what should the protocol specify?

 

[lobelsteve]

Lets see the original protocol.

 

[Ducttape]

This is the correct answer. In fact, some IRB's will REQUIRE that a trial is stopped if PRE-planned, PRE-specified criteria are met...continuing to expose patients to possible unintended harms after you have obtained a result with statistical certainty would be deemed unethical.

I disagree, because the other arm is non-surgical management arm from what I read of the study. I agree with steve - lets see the original protocol, because if this "nonsurgical management arm" is indeed conservative treatment such as PT, then you are essentially stating that doing standard of care is more harmful than the procedure and you have to stop it, and no patients should get nonsurgical treatment and that we should all immediately perform these procedures.

Should less evidence be required to stop the trial for harm than benefit?
The prudent answer to this question is likely to be “Yes” based on the ethical maxim of primum non nocere and the need to protect patient safety [33, 34] and to focus the limited resources for clinical trials on therapies most likely to be beneficial.
Yet it is uncertain exactly how much evidence of harm should be required, or in Bayesian terms, what probability of net harm is high enough to stop a trial. For treatment harms as for benefits, interim findings extreme enough to be statistically significant or to have high Bayesian probabilities are likely to be more extreme than those obtained if more patients are studied [6, 28, 35, 36].

if the report of the study is true, then there was no net harm from the treatment.

Would the evidence of benefit meet state-of-the-art standards for treatment recommendations and practice guidelines?
These standards address many factors beyond statistical significance [19, 20, 32]. At least for comparative effectiveness trials that compare commonly used therapies and are conducted to provide definitive results to guide clinical practice, a strong case can be made to continue the trials if such standards have not been met despite meeting conventional stopping guidelines [1, 2].

long and short - put out the study first....


unless... the study is worthless and they are trying to get some publicity out of this....

 

[drpainfree]

so this procedure for so-called "vertebrogenic pain", or chronic LBP with modic change on MRI...

not sure about you guys, I certainly haven't seen "It is estimated that over five million CLBP patients in the US have vertebrogenic pain and are candidates for the Intracept Procedure".

but if it works really (it does makes sense for treating so-called vertebrogenic LBP), it adds another tool at our disposal.

I don't see this procedure being limited to spine surgeon, do you?

 

[Ducttape]

IMO, spine surgeons are poor performers of percutaneous interventions.

 

[Aether2000]

It's all about money. With a handful of positive results, they can launch this technique much like 20 patients launched IDET in the 1990s.

 

[hyperalgesia]

It's all about money. With a handful of positive results, they can launch this technique much like 20 patients launched IDET in the 1990s.

Yes. We really have to be better at detecting BS. If not us, who?

 

[lobelsteve]

SIS Evidence Analysis Committee.

About Our Society - Spine Intervention Society

 

[nvrsumr]

So this should work for vetebral insufficiency fracture pain?

 

[SommeRiver]

Such a brutal diagnosis to treat and multiple treatments have fizzled out in the past and here you have this new treatment and you stop the trial early?

 

[lobelsteve]

So this should work for vetebral insufficiency fracture pain?

DDD.

 

[nvrsumr]

So what is vertebrogenic pain exactly?

I get they are aiming at treating what I would call discogenic pain but shouldn’t dennervation of the basivertebral nerve theoretically help insufficiency fracture pain? Maybe it would only help with fx that go thru end plates?

 

[Taus]

I’m no statistician, but the data they presented at SIS this year, although sounding positive, barely looked better than sham...

 

[Papa Lou]

Message me if you are performing this procedure and getting good results. I will pay cash.