Anyone Using Intracept for Vertebrogenic Back Pain?

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drusso

drusso

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It looks like doing a vert without squirting in anything. I hear people are expecting a good buzz about it at SIS next week! Nothing more fun that cannulating a pedicle!

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Training today. Low key affair. S1 could be difficult. My cadaver was probably a 130 lb tiny man so that made S1 more difficult due to the iliac crests.
 
i'm trying to get trained but it seems this procedure is also only feasible in the hospital at the moment. no ASC or office
 
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Medicare uses the unlisted code and around $12,500 today but I have closer to $10,000 listed in some emails from last month. HOPD will make $3000-$6000.

Private insurance depends on contracting but is typically slightly better. They stated physician fee is typically 3x a single level kypho.
 
They are happy if 2-3/5 private patients identified get the procedure done due to insurance issues or lost to follow up.
 
Medicare the facility will get paid but the physician might get zero’d completely on his fee. Rec ABN
 
Its legitimate. 2 RCTs. Specific indication. Good IP. It will be a great tool going forward for all commercial insurances not just limited to medicare like mild and vertiflex. Studied versus sham.
 
BobBarker said:
Medicare uses the unlisted code and around $12,500 today but I have closer to $10,000 listed in some emails from last month. HOPD will make $3000-$6000.

Private insurance depends on contracting but is typically slightly better. They stated physician fee is typically 3x a single level kypho.
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Let me know if that money actually shows up. I think that if I told my biller (whose compensation I bonus on % collections, clean claims, bad debt, and A/R's) that I want to start doing procedures with unlisted codes on Medicare patients she'd kick me in the nuts.
 
I most likely would never know, same as any procedure I would do. I don’t have the same worries as you in my arrangement.
 
I believe Calvin Borel (maybe it was Ron Turcotte?) was at training today as well. Perhaps, he will opine a bit more.
 
ASC is break even or just under right now for Medicare. Commercial insurers don’t cover. I’m thinking of offering as cash pay at 8500.
 
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How do you diagnose vertebrogenic back pain? Do you have to do a discogram to rule out discogenic back pain first? And run through facets, ESI etc.
 
Patient Inclusion Criteria
• >6 months of chronic axial lower back pain
• >6 months of conservative treatment with no response
• Type 1 or 2 Modic changes visualized on MRI scans (or the equivalent – see
above) or similar language

Patient Exclusion Criteria
• Radicular pain/radiculopathy greater than back pain
• Osteoporosis
• Spinal stenosis with neurogenic claudication
• Instability
• ≥ Grade II Degen Spondylolisthesis
• Gross instability
• Spondylolysis
• Severe Scoliosis
• Predominant facet or SI joint pain
• Failed Back Surgery Syndrome
• Prior surgery: Fusion that impedes diseased level access
 
Agast said:
How do you diagnose vertebrogenic back pain? Do you have to do a discogram to rule out discogenic back pain first? And run through facets, ESI etc.
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Dont need discogram. Its vertebrogenic. Histopath supports nerve innervation of the endplates. This is back by basic science and histopath. Not voodoo even though everyone would like to assume and hope it is so they can act their baseline pessimistic selves. 🙂
 
Ok, but reading through their first trial, it looks like there was a 5 point difference in ODI between sham and active, and I don’t see any data for VAS reduction in the sham group, just active treatment vs baseline. In the discussion they do note that there was a large placebo response in the sham group so they did within subject before and after comparisons. If that’s the case it seems like a huge misrepresentation to call it a sham controlled trial. Can anyone more familiar with the trial tell me if I interpreted that paper correctly?
 
Ducttape said:
Please post. Both RCT.

Just saying that there is anRCT tells us... next to nothing.
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Posted on their website: https://www.relievant.com/clinical-evidence/

INTRACEPT trial, allegedly sham-controlled

Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study

Background: The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up. Methods: A...
www.ijssurgery.com www.ijssurgery.com

SMART trial, compared vs procedure care
 
Sorry- how come vertebroplasty/kyphoplasty doesn't cure back pain? The cement would kill any viable neuronal elements, yet people still have pain.

Addtionally, when have you seen a patient that has one isolated degen disc? Lastly, there is little correlation between the MRI and pain. How do you select patients?

Why didn't IDET (when done on severely degen discs, such that the endplate was heated) cure back pain?
 
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"check pubmed" can lead to a lot of confusion. and for pretty much every positive study out there for pain medicine, there will probably be a negative study.

relying on articles posted on a marketing website is likewise suspect.

the study does appear promising and well done. only concern the authors did not address is that it is still an industry funded study (of course, given its initial investigative role). further studies could confirm (or disprove) the purported benefits.
 
Ducttape said:
"check pubmed" can lead to a lot of confusion. and for pretty much every positive study out there for pain medicine, there will probably be a negative study.

relying on articles posted on a marketing website is likewise suspect.

the study does appear promising and well done. only concern the authors did not address is that it is still an industry funded study (of course, given its initial investigative role). further studies could confirm (or disprove) the purported benefits.
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Read the intracept study closely though - maybe I’m wrong but it looks like they largely ignore the results of the sham group because sham did nearly as well as the intervention. They admit as much in the discussion, and the results section presents very little data comparing the outcomes vs sham.
 
Im glad you dissected it. Theres two sides to every article. If you apply your concept to pain as a whole - why do we practice interventional pain at all... 😛 I would love to see what perfectly pristine evidences based services you offer in your practice so I can adapt.
 
Needlejockeys said:
Im glad you dissected it. Theres two sides to every article. If you apply your concept to pain as a whole - why do we practice interventional pain at all... 😛 I would love to see what perfectly pristine evidences based services you offer in your practice so I can adapt.
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It is certainly a novel approach. I agree with the problem concerning the sham group, as well as the fact that it was an "open label" study. Placebo response is increased in open label studies, as well as with procedures for which the patient is paying more money (not the case in this particular instance).

Given that the concept is somewhat unique, I think the best thing is to go an learn more about it. Even if one is not going to perform such procedures, it is good to get some education about it.

After this discussion, I contacted the bunch to get to a training course. I am always skeptical of new procedures, but try to learn about them, as even if you don't incorporate such treatments, you can walk away with some "pearls". They also talk about treating multiple levels; I don't know about the rest of you, but ramming an introducer through pedicle at multiple levels seems a little dicey. Also, we are accustomed to putting introducers through the pedicle in osteoporotic people, not those with healthy bone. I am wondering about difficulty vs higher incidence of fractures in this population.
 
hawkeye2009 said:
It is certainly a novel approach. I agree with the problem concerning the sham group, as well as the fact that it was an "open label" study.

Given that the concept is somewhat unique, I think the best thing is to go an learn more about it. Even if one is not going to perform such procedures, it is good to get some education about it.

After this discussion, I contacted the bunch to get to a training course. I am always skeptical of new procedures, but try to learn about them, as even if you don't incorporate such treatments, you can walk away with some "pearls".
Click to expand...
truth
 
hawkeye2009 said:
Sorry- how come vertebroplasty/kyphoplasty doesn't cure back pain? The cement would kill any viable neuronal elements, yet people still have pain.

Addtionally, when have you seen a patient that has one isolated degen disc? Lastly, there is little correlation between the MRI and pain. How do you select patients?

Why didn't IDET (when done on severely degen discs, such that the endplate was heated) cure back pain?
Click to expand...

Ah so you're looking for a theory as to why something might work...

The major difference between IDET/BKP and the Intracept procedure in my limited understanding appears to be primarily based on what is occuring. The better comparison for Intracept would probably be Osteocool/thermal RFA of tumor in the body.

- IDET ablates the disc nerves and possibly the end plate. That may help some for discogenic pain, but even if you were to ablate the nerve terminals to the end plate, they would grow back, and you likely don't ablate much if any of the nociceptors there.
- BKP might cause a neuropraxia to the BVN due to pressure or direct toxicity from cement, but we know vessels/nerves are malleable and over time would regenerate. I suspect again it's not a supremely durable contributor.

Intracept's ablation is a 85 degree C bipolar burn for 15 minutes. I suspect it's getting the BVN and also the blood supply to the body/end plates. I suspect that leads to a relatively inert bone state and the 100 mm lesion size likely contributes to minimal regrowth. I suspect down the road that vertebral body may be higher risk for fracture, although they report animal data suggesting the bone health is fine. The vascular embolization might help for pain, much like geniculate artery embolizations help for knee pain, but I am not bullish on it yet.

We looked at the Intracept papers a bit ago, but the benefit in the sham arm was impressive at 15 points on the ODI, with a gain of 20 point. It's an "active" sham though as you're still putting a trocar into the region which may decompress things and create trauma. It's a great study design, but it's tough to be sure.

To be clear, this is one study with an interim analysis paper I am basing this off of:
link.springer.com

Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study - European Spine Journal

Purpose To evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate...
link.springer.com link.springer.com

I would probably try it on a refractory patient with Modic changes that wasn't interested in medications/implants/pumps, but it's good to have options.

Disclosure - Never trained/done IDET/Intracept
 
There is a 30 year old surgical study where they were trying to determine what parts have sensory innervation or
not. They didn’t find the disc to be very well innervated but the end plate was. I haven’t read it since fellowship.

@Mister Mxyzptlk do you recall the study? I can’t think of it.
 
I actually think this could work

BUT, there is no way to know who the appropriate patients would be. Selection criteria is too vague, but i cant think of any way to improve the selection criteria.

I'd guess maybe 1 in 3 patient you try it on would like the results.
 
SSdoc33 said:
I actually think this could work

BUT, there is no way to know who the appropriate patients would be. Selection criteria is too vague, but i cant think of any way to improve the selection criteria.

I'd guess maybe 1 in 3 patient you try it on would like the results.
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It is a very novel approach. Again, I think this is one, given that this approach has really never been done before, that we should carefully evaluate, go to the courses, and see how more data looks.

I agree that the patient selection could be tough, as there is not a "test block" or neurological sign that would point to this treatment. I would imagine that in patients with refractory back pain in whom PT has failed, have negative test blocks, and have modic I and II changes over 1-2 segments would potentially be candidates. Again, time will tell......................... or not.

Let's see how this one unfolds and keep an open mind, while maintaining healthy skepticism. That is one reason I thought working at the VA would be pretty cool- it would be easier to conduct clinical trials, as you don't need pre-auths for new treatments.

PS- I did a lot of IDET and pulsed rf, ect and was made to look like a fool. Thus my enthusiasm is checked a little more now than in the past. I get pretty psyched up about new treatments, but like a kid before Christmas morning, have to slap myself and be patient.
 
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I just had a patient today- axial low back pain, worse with standing in activity, MRI evidence of facet arthropathy, significant modic type one and type two changes in L3 and L5/S1, Mild lateral recess and neuroforaminsl stenosis at age 70. failed mbb/ESI, no significant tenderness over SIJ and provocative testing negative. Obviously this made me think of him. Question is what levels would you do, L3, L5, S1 ? All of them ?
 
Can only do 3 levels at once.

Say l4/5/s1. The procedure will
be very long if you do more
than that. The machine only has one port and it is 15min/ablation
 
BobBarker said:
Can only do 3 levels at once.

Say l4/5/s1. The procedure will
be very long if you do more
than that. The machine only has one port and it is 15min/ablation
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Any personal results as of yet? I am meeting with the regional rep this week to go to a training course to see what it is all about. Again, certainly a novel approach worth exploring.

Is the placement of the cannula/needle similar to doing a vertebroplasty/kypho?

Given this would probably be done in a younger population relative to kypho, any concern about pedicle fractures, as the bone is going to be far less "mushy" than an older osteoporotic women.
 
They certainly said the bone will be dramatically harder but did not mention pedicle fracture.

You access similar to a kypho but you want to be as medial as you can safely be when you enter the vertebral body. You want your RF probe to be no more than 50% anterior and midline for final position. It is a bit similar to trying to do a uniped kypho but you can get away with being a lot sloppier in the kypho.

It will be a month before I do any.
 
BobBarker said:
They certainly said the bone will be dramatically harder but did not mention pedicle fracture.

You access similar to a kypho but you want to be as medial as you can safely be when you enter the vertebral body. You want your RF probe to be no more than 50% anterior and midline for final position. It is a bit similar to trying to do a uniped kypho but you can get away with being a lot sloppier in the kypho.

It will be a month before I do any.
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Okay- thanks

I would think that pedicle fractures would be a potential complication with this, just from what we know about kypho and pedicle screw placement. I guess it is one of those things that time and a larger volume of cases will tell. It certainly will be interesting to see preliminary outcomes when this is more widely implemented.
 
hawkeye2009 said:
It is a very novel approach. Again, I think this is one, given that this approach has really never been done before, that we should carefully evaluate, go to the courses, and see how more data looks.

I agree that the patient selection could be tough, as there is not a "test block" or neurological sign that would point to this treatment. I would imagine that in patients with refractory back pain in whom PT has failed, have negative test blocks, and have modic I and II changes over 1-2 segments would potentially be candidates. Again, time will tell......................... or not.

Let's see how this one unfolds and keep an open mind, while maintaining healthy skepticism. That is one reason I thought working at the VA would be pretty cool- it would be easier to conduct clinical trials, as you don't need pre-auths for new treatments.

PS- I did a lot of IDET and pulsed rf, ect and was made to look like a fool. Thus my enthusiasm is checked a little more now than in the past. I get pretty psyched up about new treatments, but like a kid before Christmas morning, have to slap myself and be patient.
Click to expand...

What do you think about pulsed Rf now?
 
ateria radicularis magna said:
Is the company making it hard to train as with drg/Abbott?
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I don't think so. The rep emailed me and I am meeting with him in a week, There is some little quiz you have to take, but if you have a couple neurons glued together with a spirochete, one can do fine. Call the contact number and they will get you plugged in with a rep to start the process.

Talk to "Bob Barker" here, as he has already attended the training course and would be a great source of info. I have PMed him and he is a very nice guy who I'm sure would give you some helpful pointers.

It is one of those things that we will know a lot more about when more people investigate/attend the course and consider its uses.

It may be great- it may be a bust. Time will tell; let's keep an open mind about a new process while maintaining healthy skepticism.
 
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