Carolina Neurosurgery & Spine Associates’ Dr. Andrew Sumich is one of a handful of physiatrists across the country participating in trials of Relievant Medsystems' revolutionary technology that can reduce long-term pain for patients with chronic low back pain: the Intracept Spine Procedure.

The secret to the procedure lies in new research, which deepens the medical understanding of spinal anatomy. While most patients experiencing low back pain are treated for discogenic pain, recent findings have revealed that pain can actually originate from vertebral endplates, the bones found on either side of the disc.

Intracept targets the basivertebral nerve in a minimally invasive outpatient procedure, which improves function and decreases pain, even in the long term — a differentiating factor from many other low back pain treatment options.

Dr. Sumich has worked with approximately 40 patients in FDA-approved trials and has seen remarkable results firsthand, claiming that many procedures have resulted in “a home run” for pain relief.

He shares when the procedure is a viable option for those experiencing chronic lower back pain, when other treatment options may be a better fit, and discusses the profile of an ideal candidate for the revolutionary procedure.

Tune in to episode #41 of Back Talk Doc with Dr. Sumich to learn about the nitty-gritty of this medical procedure and how it’s transforming patients’ lives by reducing low back pain.

💡 Featured Expert 💡

Name: Andrew Sumich, MD

What he does: Dr. Andrew Sumich is a member of the Carolina Neurosurgery & Spine team. He is a board certified physiatrist, specializing in interventional spine care.

Company: Carolina Neurosurgery & Spine Associates

Words of wisdom: “Where we put medicine matters in terms of what's hurting or not.”

Connect: LinkedIn

⚓ Anchor Points ⚓

Top takeaways from this Back Talk Doc episode

★    There’s no one-size-fits-all for treating pain. There are many different causes for pain. Pain generation is an essential part of a medical diagnosis because it signals which treatment plans are most likely to benefit the patient. Not all pain indicates the same root cause, so while The Intracept Procedure may be a good fit for some candidates, it’s not a cure-all.

★    The Intracept Procedure targets vertebrogenic pain. Medical understanding of the spine continues to evolve. The role of endplates in the spine have just recently gained increased attention.

While most cases of chronic low back pain are treated as discogenic disorders, advanced and new understanding of the role of vertebral endplates has changed how to decrease pain for some patients. Vertebrogenic pain, unlike disc-oriented pain, is transmitted through the basivertebral nerve. The Intracept Procedure targets the nerve with a one-time ablation.

★ The results are “staggering.” Intracept’s parent company, Relievant Medsystems, has tracked results of the surgical procedure over a five-year period — a shockingly long time period for medical technology studies. The long-term efficacy of the procedure is unlike anything else that Dr. Sumich has seen in spine care. He’s also seen anecdotal evidence in the improved quality of life from the trial participants he’s treated.

⚕️ Episode Insights ⚕️

[00:00] Check out our sponsor: QxMD builds mobile solutions that drive evidence-based medicine and clinical practice.

[01:42] Introducing Dr. Sumich: Dr. Andrew Sumich returns to the podcast to talk about a novel technique to treat low back pain: the Intracept Spinal Procedures. Dr. Sumich previously discussed spinal injections on one of our most downloaded episodes of Back Talk Doc.

[03:59] A breakthrough for back pain: The Intracept Procedure is a recent advancement in helping with neuropathic pain. Dr. Sumich shares the development of the procedure and how the field’s understanding of spinal anatomy has evolved.

[05:54] Pain generators, explained: There are many different things that can cause back pain.  Identifying which spinal structure is the biggest source of pain is essential to determining a treatment plan.

[9:15] Parts of the spine: The vertebral endplate is the anatomical focus for intracept spinal procedures. The understanding of endplate anatomy and how endplate health influences pain is a recent evolution in neuropathic medicine.

[10:13] Procedural options for back pain: Dr. Sumich provides an overview of treatment options for patients experiencing lower back pain (without pain that travels down the legs). Many patients have similar symptoms, but need different treatment plans.

[18:54] New knowledge creates new solutions: Medical breakthroughs in better understanding discogenic pain have allowed doctors to develop new treatments that better target root causes to pain.

[22:39] Durable pain relief: Unlike lumbar facet joint ablation, which needs to be repeated, intracept spinal procedures do not need to be repeated and results in long-term relief.

[24:17] Profile of an ideal patient: Dr. Sumich discusses FDA-approved indications that qualify potential patients for the new procedure.

[28:37] Insurance coverage for new technology: As is often the case, health insurance agencies are hesitant to cover new procedures. Parent company, Relievant Medsystems, can be a resource for individuals looking to pursue the procedure, but needing help coordinating insurance coverage.

[30:03] When a procedure hits a homerun: Dr. Sumich has helped approximately 40 patients at Carolina Neurosurgery & Spine Associates since 2020. He is pleased with the success rates and patient feedback.

[31:36] When a lumbar fusion is the better bet: Sometimes a lumbar fusion is a better solution to back pain. This depends on the patient’s level of instability. In some circumstances, a lumbar fusion is a better option, especially for those with narrowing foramen. Intracept spinal procedures are better suited for those in the early stages of disc degeneration.

[35:35] The upsides and downsides: Dr. Sumich shares the benefits of the new technology and outlines potential risk factors.

[39:43] Yoga as a health tool: Morning yoga has become a regular part of Dr. Sumich’s well-being regimen during the pandemic. A personal favorite is “5 Sun Salutation As +Bs” on YouTube.

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👉 If you enjoyed this episode of Back Talk Doc, check out our recent episode These Simple Exercises Will Keep Your Back Healthy With Jackson Bellis, DPT.

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Back Talk Doc is brought to you by Carolina Neurosurgery & Spine Associates, with offices in North and South Carolina. To learn more about Dr. Lakhia and treatment options for back and spine issues, go to backtalkdoc.com. To schedule an appointment with Carolina Neurosurgery & Spine Associates, you can call us at 1-800-344-6716 or visit our website at carolinaneurosurgery.com.

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Welcome. You're listening to Back Talk Doc, where you'll find answers to some of the most common questions about back pain and spine health. Brought to you by Carolina Neurosurgery and Spine Associates, where providing personalized, highly skilled, and compassionate spine care has been our specialty for over 75 years.

And now, it's time to understand the cause of back pain and learn about options to get you back on track. Here's your Back Talk Doc, Dr. Sanjiv Lakhia.

Working in the field of spine care, I've come to learn it really is a results-oriented business. Almost everyone who comes through the office to see me and my colleagues is here for some relief, pain relief particularly, and we've covered a lot of different approaches to back pain and spine care on this podcast for the last two years.

But sometimes, when you're out there, and I know you're listening, sometimes you're just looking for some relief, and it's really amazing to have advanced techniques, advanced technologies that can literally provide that for you when in the past it wasn't available. That's why I'm so excited today to welcome y'all to the show.

We're going to be interviewing my friend and colleague, Dr. Andrew Sumich, about a real exciting novel technique. Andrew, who goes by Turtle, welcome to the show.

Thanks, Sanjiv. Great to be back. I'm excited for this.

Yes, and for those who may recognize his voice, Turtle was on the show in the beginnings, one of the first few episodes where he talked quite a bit about injections. We'll link to that in the show notes. For your reference, it is the third most popular episode of Back Talk Doc behind the ones about surgery that Dr. Smith and Cheadle did. That's a pretty good feather in your cap, I think.

Yeah. That was the best nonsurgical one. That's great.

Absolutely. Okay, let me introduce you, again, for individuals who are listening for the first time. Turtle is a Board Certified Physiatrist like myself. We actually trained together in residency at the Charlotte Institute of Rehabilitation in Charlotte, North Carolina. Turtle is a graduate of Louisiana State University Medical School and did a fellowship after residency in interventional spine care. He's one of our go-to experts in the practice and really in the entire Charlotte region for interventional spine care done in an evidence-based responsible manner.

He's also done quite a bit of work, and one of the reasons I want to bring him on is he's really on the cutting edge. He's been involved in some research trials for stem cell treatments for discs. I know you, and you like to look at new things.

Yes, that's true. Particularly in those challenging cases and challenging patients. Not that the patients themselves are challenging, but the problem being challenging where a lot of times we know the issue, know what's causing the pain, but don't really have a lot of good solutions or good options for that.

There's been some progress, in particularly in the low back pain part in the last few years. It's really changed the game and changed our ability to help those people. Not certainly for everybody that's ever had low back pain for whatever reason, but there certainly is a chunk of people and a chunk of patients that previously we didn't have a whole lot to offer, but now we do.

Right, so today's topic I'm going to be discussing with Turtle, the concept of the Intracept Spinal Procedure to help with low back pain. It's a novel technique and he has been involved with this for some time, and we've got some experience under our belt. It's really worth a conversation at this point and time. I like to tell patients who come in with back pain and who say to me, "Why can't we fix it?" I just personally feel like we're almost in the pre-antibiotic era of spine care, still.

When you and I are sitting back looking back on our careers, we're going to see how far things have traveled. Do you remember, Turtle, when Gabapentin came out on the market? It was like the big new thing to help with neuropathic pain. There are some of these tipping points as you go through your career in treating and helping patients. I kind of feel like this Intracept Procedure, from what I've read and observed the work you're doing, could be one of those.

It is, and as we go through the thought process behind it and how it was developed, there's a little bit of, "Oh, my goodness." For reference, I graduated from med school in 2001. While that's 20 years ago, it's not that long ago. A lot of not just the techniques and development of the procedure, but some of the basic science behind it, some of the spinal anatomy behind it we never got taught.

There are journals in Journal Anatomy describing some of these things from 2012. That's like we haven't figured everything out on the cadaver yet? The answer is no, which is great in some ways because there's still more out there. But it does speak to the fact that we don't know everything and there is the ability to do more.

That's exactly correct. Let's do this, before we jump into the procedure itself, I want to walk people down just some background information so they can understand it better. In the world of spine care, and in particular interventional spine care, we often mention the phrase pain generator. Can you review that concept for the listeners?

Sure. Absolutely, and it's a really important concept. When we think about back pain, that's a symptom. That's not a diagnosis. Right? Lots of things can cause back pain, just like lots of things may be able to cause stomach pain. You might have stomach pain because you ate some off food. You might have stomach pain because your little brother punched you in the stomach when you were a kid. You might have it because you have appendicitis, and so obviously, you would have to have different treatments to try to treat all those sources of stomach pain correctly.

The same applies for back pain. While a lot of it feels the same, lower back pain, across the waste, maybe favor one side, maybe not. There are different things that can cause that pain. How I think about it is while there's a myriad of causes of acute back pain, including soft tissue injury, muscle spasm, muscle strain, ligament strain, those typically get better with conservative treatment or even just time often.

I think that the patient population that we're talking about is just more chronic back pain; six-plus months of back pain that really just lingers and lingers. Maybe waxes and wanes but never really goes away. From there, we've always thought of in terms of ruling out outliers such as tumors, fractures, and those sorts of things. In the general degenerative spine world that we spend a lot of our time, we tend to think of the posterior column or the back part of the spine, which is essentially made up of facet joints. The little joints in the back part of the spine. Or the anterior column, the front part of the spine, which is where the disc and the vertebrae are.

For the longest time, we knew that we hypothesized that if the disc hurt somebody would have a good chance of disc disease, and it would cause pain. We weren't very good at treating it, but it did cause pain. We also knew that the facet joints could cause pain in the same way that your knee or your hip or any other joint would cause pain and we were pretty good at treating that. But identifying which one of those structures is the biggest source of pain is really important because you've got to know which one to treat.

Yeah, exactly. That's a good review. It just speaks with regards to low back pain how complex it can be and difficult it can be to figure out where the pain is coming from. That's why a multidisciplinary approach is often the best. Our physical therapist will work on the muscle ligamentous fascial pain. MRI studies look at the health of the discs, the facet joints, or as we call the knuckles of the spinal canal. Also, they do give you information about literally the vertebral body, and in this case, what you've been focusing on with this procedure is the vertebral endplate.

For those who don't know anything about the spine, explain to them what an endplate is.

The endplate, in simple form, is the end of the bone. It's more important to understand it is a part of the vertebra. The vertebra is the bony part of the spine. In between each vertebra is the disc, which is a cartilage structure, the cushion, or the shock absorber of the spine. Where that disc meets the vertebrae is the endplate, and so that's the bony endplate. At the bony structure where it interfaces with the disc.

Right. You are absolutely right. When we were in residency, we looked at MRIs, and we would see these signal changes in the endplates, and I didn't really think much of it other than it's a sign of aging and wear and tear. That thinking has definitely evolved, and the anatomy has been teased out.

But before Intracept came on the market, what procedural options patients can look at or be considered for when they present with just back pain? Without the pain going down the leg, what have you been offering your patients up until you got into this?

Sure, that is an important part. We are distinguishing this is just the back pain, not the leg pain or the radiating pain, or radicular pain. Early on, we start with that conservative thought which is with time, education, some sort of rehabilitation program, usually physical therapy directed transitioning to a home program, medications can play a role in that area, as well. Also, complimentary things [inaudible 00:11:01], chiropractic treatment, acupuncture all can play a role in that initial treatment.

As symptoms persist or don't respond is when we typically have imaging with MRI being the gold standard. Then we get into those interventional procedures and that's where the pain generator matters. Right? Where we put medicine matters in terms of what's hurting or not. There's that facet-oriented pain, which you can inject facet joints. There's a procedure called radiofrequency ablation to treat more chronic fact pain. Then there's traditional epidural injection, which, as you know, Sanjiv, don't do a great job for just traditional back pain, but admittedly we probably do them sometimes with a lack of a better option.

The other beyond interventional procedures traditionally would have been surgical offering, but that is either disc replacement or fusion, which oftentimes fits into that category where the solution is worse than the problem.

It certainly can be. In fact, I just had a conversation this morning with a patient in terms of injections and indications for an epidural and there just wasn't one. Her main presentation was quite simply axial or non-radiating back pain. It was a difficult conversation, Turtle, because the expectation was, and I know a lot of you out there listening you're in pain, you're in discomfort and you're hopeful that an injection or procedure can eliminate that.

But as you just clearly defined, it really matters where you're injecting because an injection can be done correctly technically and can be perfect. But if you're injecting around a structure where the pain is not coming from, it will not help you. That is a conversation I have quite frequently with people.

It is challenging. It's a challenging conversation, but it's not a fun conversation to have because we want to help people.

Absolutely.

Right? We want to have something to offer. To do a procedure even as closed and safe as the injections are if it is unnecessary it isn't the right thing to do and it's just going to lead to disappointment anyway. There certainly are challenging cases. I think you might run into this as well. Often times that patient perspective comes from a family member or a friend who might actually be your patient, as well, and said, "Oh, you did that injection for them and they were better. I need that."

That goes back to the pain generator. Right? They might have very similar symptoms, but very different pain generators and hence different treatment plan.

I think a take home if you're listening, and we have a variety of people who enjoy this podcast. There certainly are clinicians who listen, physical therapists, and mostly still potential patients. If you're suffering from back pain, a question that you should be trying to get answered is why does my back hurt? Is there an ability to identify which structure is contributing to the pain?

That leads into something positive here, some hope with this new procedure; the Intracept Procedure. You've done a good job breaking down the concept of pain generator and we talked about facets, discs, and ligaments. Let's dive right in. Give us a general synopsis of what the Intracept Procedure is, and then we'll go through some of the indications and how to use MRI to help to decide whether or not somebody is a candidate.

Absolutely. I'll tell you what it is first, but then I think it's worth taking a step back and understanding how we got here; why we treat it the way we do. What the Intracept Procedure is, it is ablation using radiofrequency waves through a blade and burn the basivertebral nerve. The basivertebral nerve is a nerve that lives in the vertebrae but supplies those endplates we talked about earlier.

It is an interventional procedure. It's done under x-ray, done under live fluoroscopy with a little nick in the skin. Certainly not an open surgery, but probably a little bit more than the traditional injection. We use the x-ray to guide and tunnel down to the vertebral body with a special tool to help create a tract through the basivertebral nerve and eventually ablate it.

Outpatient procedure. It is typically done under general anesthesia because that's how I've done all mine. Some people across the country I know started doing it on what's called MAC, which is a deep anesthesia. Regardless, it's a little bit more than just a regular injection. Where it comes from or why haven't we been doing this forever is because I think it's worth the history.

You mentioned earlier about the endplate changes on MRI that certainly we learned about in residency and even med school and you said you never thought much of them. The reason you didn't think much of them, because nobody did. We thought it was an interesting radiographic finding with very little, or zero clinical significance. There are changes, while now they're described for what they are, were actually first described by Michael Modic who certainly don't know, but understand that he was a radiologist I believe at the Cleveland Clinic who described this in the 1980s.

For decades, it was just an interesting finding that even a medical student could notice on an MRI, but it didn't mean much. That began to change in the mid to early 2000s. Prior to that, we knew we had degenerative disc and we believed that it was a potential pain source and just couldn't treat it very well. A few things happened to change that perspective or change that thinking. The first one was Dr. Jeffrey Lotz who is a PhD at UCSF began to study cadaver vertebrae with Modic changes versus non Modic changes more normal endplate.

What he found is that the endplate of a damaged vertebra, so with the Modic changes had two to three times the amount of pain receptors than a healthy endplate. That starts the thinking of wait a second. Maybe something is going on there that this endplate could actually cause pain and it's not just the disc. What also happened was that there was better understanding of the process of Modic and what that actually represented on MRI. The biggest thing was that as the disc degenerates, this is a simplified version but it's how I like to think about it. It no longer is supplying as much cushion or protection of those endplates.

Because those endplates are very thin, they eventually can get these little cracks and fissures in there. Simultaneously, the disc is generating and some of those proteins and contents of the nucleus of the disc can actually transfer across the endplate because of those cracks and fissures and they cause this big inflammatory reaction in the vertebral body. That is what Modic represents. There are different types of Modics, but for simplification, that represents inflammation in the vertebral body.

Now we know we've got inflammation, which certainly can hurt. We know it's innervated, and actually overly innervated once it exists. Then the third thing that happened with a better understanding of the basivertebral nerve. Now, the basivertebral nerve, as I mentioned, that's the nerve we eventually ablate in the Intracept Procedure. Prior to the last 10-15, years we knew it existed, we just didn't realize it carried pain messages. We thought it was just a nerve strictly for bone health. It made the connection that it actually carries a pain message.

Now, we have a structure that can hurt. We know it's innervation, and then that started the plan for, hey, can we treat it? Can we target that nerve to help treat the pain coming from that structure?

That's a huge explosion in understanding.

Gigantic. The biggest thing is we're treating an old symptom, that back pain. We are thinking about it totally different. It's not that we created a new widget to treat discogenic pain. It is a new understanding of what we thought was discogenic pain is actually or could be considered, vertebrogenic pain, meaning coming from the vertebral body. That was it.

Sanjiv, I think it's important to clarify, too, that this is still a degenerative disc problem meaning the degenerative disc usually triggers this cascade, but degenerative disc disease actually makes the vertebra hurt rather than the disc itself hurt. Again, that's simplified because there probably still is some disc pain mixed in there but, it was a real jump that degenerative disc disease might actually cause the bony endplate to hurt rather than just the disc itself, so we had this new structure to treat and a totally new way to think about things.

I liken it to, and I don't know if this is an appropriate analogy, but when I have patients that come in with knee arthritis and you can start to see that the cartilage between the bones is wearing down, and now you see cystic changes in the bone. I think a lot of people can understand the concept of bone-on-bone pain in the knee because the cartilage no longer provides that cushion.

It's somewhere similar here, I think. You're not getting the shock absorption. The energy is transferring through the endplates now, which aren't really meant to absorb everything, and then you see inflammatory reactions now that we weren't sure of in the past, but now it does appear to be an inflammatory, pain-generating response. That's how I conceptualize it.

I've got to tell you. I was looking back and preparing to talk with you today, I was looking through the company's website that designed this intervention that the research desk put out there, and the smart trial in particular. What really struck me is, and you and I have looked at industry sponsor research and stuff like that over many, many years. Sometimes you're a bit skeptical about it and then you check the source and the journals that it's published in.

What I couldn't get past was how this smart trial longterm relief for five years. There's literally nothing that I think in the world of spine care that I could look someone in the eye and say, "It's been researched and followed for that duration of time for showing efficacy, not just with pain but with function." I don't know if this is real data, and I'm sure it remains to be seen if it's going to be replicated and even in the real world, but that's just staggering.

It is. There's been no studies that I'm aware of either that has that type of follow-up. They published a five year follow-up, and I think even the average mean follow-up was actually 6.4 years. Their second randomized controlled study called the Intracept Study, so their first smart study referred to was a randomized controlled study blinded against placebo. I guess a sham procedure.

Then the follow-up study was also randomized and a control trial that was against standard of care. Basically, the things that we had been doing off the bat. That data, the 12 month has been published and I think the 24 month has been presented but not published yet. It's holding up, and that really is unprecedented.

Sanjiv, this is a good time, to ... I always try to preempt people's questions on what might be confusing to them. We've mentioned ablation a couple of times now. The Intracept Procedure is an ablation to the basivertebral nerve. We have also been doing radiofrequency ablation through those lumbar facet joints in back of the spine. That has been going on for decades and is well established and does a really good job if the pain is coming from the facet joints. But of course, it doesn't do a good job if it's not.

The lumbar facet ablation, which I would say most people are more familiar with, or if you're just in a regular community environment and you're talking to a friend. "Oh, I had ablations to my back." At this point, they most certainly would have had a facet ablation. Those nerves regenerative. It is expected that lumbar facet ablation would need to be repeated. That's not the case with the Intracept Procedure, hence the durable pain relief. The reason being in that the nerve does not regenerate because it is in the vertebral body and it's unmyelinated, which means it doesn't have [inaudible 00:23:54] coating that some nerves have so it makes it difficult to regenerate.

Thank you for pointing that out. That's a very important distinguishing feature of this procedure that I wasn't quite aware of. I appreciate you sharing that. I know you've peaked people's interest if they've followed along this far into the episode. There are people listening saying, "I wonder if I'm a candidate for this?" Break down real quick who is the ideal person to have a discussion about this procedure?

I would tell you that this procedure got FDA approval in 2016 and started being used commercially in 2018 and really ramping up in the last two years. The official requirements, or indications for the procedure based on the FDA approval is six months of chronic low back pain with six months of failed conservative treatment. That would include anything that we're used to seeing; physical therapy, medication, trials, home exercises, injections.

With the Modic endplate changes, and they're indicated from the L3 through the S1 vertebra, so basically the three bottom discs will qualify. You've got to fall in that category to meet the indications for the procedure. I know that's a lot of wordy, medical talk. Well, practically, what this patient physically looks like is someone who has dealt with back pain for a long time. It's usually way more than six months. It's usually more like three, four, five, six years. It is a chronic persistent low back pain that waxes and wanes. For the most part, they live with it. They feel it every day, but they can live, they can work, they can play, they can workout. They may just not be able to do it as hard or as much as they used to want to.

They might be subject to a couple of more intense flare-ups once or twice a year that they have to get through, but it is this chronic background with back pain. The classic presentation is sitting intolerance. These people hate to drive, they hate to be in an airplane, sitting at a long dinner can be difficult. They tend to be better if they can change positions a lot. Another question I've begun to ask people, and this was actually reversed engineered. I had a couple of patients that came in after the procedure. I asked them how they were doing and the first thing they told me was, "A week into it I sat up in bed without pain for the first time."

I started screening patients with that question of asking them can you sit up in bed or do you have to do the logroll out of bed? Once you're out of bed, who's putting on your socks and shoes? Are you asking somebody to do it for you or do you have to get on the floor to do it? That's another screening thing for that. The terminology has been thrown around vertebrogenic pain or anterior column pain, but what we used to think of is discogenic pain. Those are the type of characteristics that will [inaudible 00:26:57] presentation.

For the most part, while there's no age limit other than being skeletally mature on the young end, then just being healthy enough to stand the procedure on the older end, I would say the sweet spot is that 40-50 year old person with one to two levels of degenerative disease.

If you've had microdisc surgery, does that disqualify you from something like this?

No, not at all. Microdiscectomy, laminectomy, even at your target level it does not disqualify you. Those patients were included in the study, so they are also indicated for the procedure. Oftentimes, you've seen these patients, Sanjiv, where you have a herniated disc, that pinched nerve, had the microdiscectomy and they generally do really well. Leg pain is better and then six to 12 weeks later they start having this debilitating back pain. You look and they either had or have developed Modic changes. I've probably had five or six patients in that kind of presentation where the surgery took care of the leg pain, the pinched nerve pain, but the back pain was still there.

Yeah, no, for sure. It's exciting just sitting here thinking and listening to you. Help me understand where you see ... We'll touch on a few things. I want you to touch on, because I know initially you were observing the State of the Union in terms of insurance coverage. I want to get your thoughts on that. Also, where do you see this procedure heading as far as acceptance in the role of spine care and where it fits into our treatment algorithms.

Sure. It is a new procedure, and because of that it can be a challenge to get it approved. As you know, FDA approval is a big step but does not guarantee or mean that any insurer has to pay for it. Like with most new technologies, they tend to fight it and try not to pay for it. To be fair, off and on new technologies don't work so they want to see it out there for a little bit. Let somebody else pay for it and see if this really sticks or not.

It is a battle. It can get approved. It just immediately goes into usually an appeal state. The parent company, Relievant is motivated to get these things approved, obviously. One, to try to help people. Two, they want to continue to grow. They do the heavy lifting in terms of writing letters and setting up a peer-to-peer discussion or even an outside review that sometimes I'll get involved with. That process takes about three months, now. It takes time. It's not a matter of you show up in the office, you're a great candidate, let's do this next week. It does require some patience and some frustration at times. Usually, they're getting about 70-75% approval across the country. That number is gently kicking upward.

The real world experience, I did my first one of these, I got engaged with it in the summer of 2019. By the time I did the training and got our first patient through the approval process, it was January of 2020. We're going on two years of experience now and approximately 40 patients in our practice. People are getting better. It's working. I think the results are very consistent with the findings in the smart trial. There is about one-third of the patients that are just total home runs. They come in pain-free, which never happens in our world.

Then another big chunk of those patients, 75% get at least 50% relief. Then about 50% is getting about 60-70% relief. Really good results with a decent chunk of complete home runs. That's holding up. I bring that up to answer the question about where they're headed in the treatment paradigm. I think it's going to become the standard of treatment for degenerative changes. Degenerative disc disease with a Modic changes, I should say, and the clinical presentation that fits. It's just working for this subset of patients and it's going to be [inaudible 00:31:14].

I'll throw a wild card at you here. It occurs to be when we see patients come in that have back pain and they have the Modic endplate change. Working with our neurosurgical colleagues, many of them will look at the endplate changes as a sign of spinal instability and a potential indicator for lumbar fusion.

Do you consider this procedure to be a potential alternative to lumbar fusion? Where do you think it fits in comparative to that?

Can my answer be sort of?

Absolutely. [crosstalk 00:31:51]

If there is true instability, it's not going to fix that. If there is significant endplate changes and significant facet arthropathy that causes [inaudible 00:32:04] and you take care of the endplate pain, it's not going to take care of all the pain that person is likely to feel.

The other thing that it doesn't do is it doesn't stabilize or stop degeneration. If somebody has narrowing of their foramen where the nerve exits, as a result of the degenerative changes and collapse of the disc, that can become symptomatic and cause some of the more leg pain and obviously it wouldn't help those symptoms.

While really advanced degenerative changes are not necessarily a contraindication, the patients that seem to do well are on the more beginning end or earlier stages of degeneration. Earlier stages of degeneration might happen for five years. Right? It's not necessarily just new pain, but they don't have super advanced degenerative disease and therefore not really in that unstable or instability category.

A lot of our surgeons, to their credit, they have patients that they can certainly justify fusing and quite honestly would probably do well fusing especially the anterior approach in those lower L5-S1 degenerative discs, but we'll refer them if people want to try to avoid an operation [inaudible 00:33:24] and this patient to do well and they [inaudible 00:33:26] about a surgery and save them potential trouble down the line with adjacent [inaudible 00:33:31] disease from the spinal fusion.

Well, it's pretty exciting. I look at back pain treatment as almost like a funnel. At the top the widest part of the funnel people are going to get really well with some of the things you mentioned like PT, chiropractic, holistic treatments. As we come down that funnel we get into injections and I feel like the tip of the funnel is more the lumbar fusion. This might be right before that. I don't know, though. There could be a tidal wave of people coming in over the next five years seeking providers who provide this and offer this service.

This podcast is for informational purposes only. I really strive to get the information out to the listener so that they can be informed and make their own decisions. This certainly is quite exciting and I appreciate you being the tip of the spear on these evolving options to help our patients.

Well, thank you for that. Thanks for the opportunity to talk about it. It is exciting. Especially, really gratifying when you can provide people relief. I had a young lady who was in her 30s I did the week before Christmas. She just came back in and she was a crossfitter before and she hadn't been able to really workout with any kind of vigor in two to three years. She came in for a two week follow-up and said she did a squat the day before for the first time pain free in two years and was anxious to try a box jump. I said, "Let's wait a while on that."

Right.

That's a real tangible thing. In just two other points before we move on that are important. One is, we just talked about the funnel. This is a really effective treatment for the right patient. Not everybody is ... The right patient with the right diagnosis and the right pain generator. Again, [inaudible 00:35:21] it's not for all low back pain. It's not going to help every ache and creek that you might have ever had, but it's definitely something worth exploring that didn't exist five years ago and it does exist now.

The second part is, the procedure does not leave anything in you or take anything out of you in terms of changes to your anatomy. It doesn't burn any bridges in terms of future treatment. If a patient were to need certainly future injections, but needed a surgery, whether it's a decompressive surgery or a fusion down the line. All that remains on the table. The other thing that I think is important too, at least in my mind, is I still think there's a bit of a golden goose out there of trying to regenerate the disc with whatever. Whether it be stem cell or some other method.

We're not hampering with the disc in any way, so it wouldn't preclude any of these patients from conceivably having that sort of treatment down the line if it ever came to fruition and actually worked.

Are there downsides to it?

The safety profile is remarkable. I think the downside is it's a procedure. Right? It's general anesthesia, so there's always potential risk involved with that. Postsurgical or postprocedure soreness for a couple of days is relatively mild. That's about it. Whenever we're accessing the spine there's always a risk of causing some fracture to the vertebrae itself as we transition across some of the bone to get into the vertebral body. I've not had that happen, but they did have one case in the smart trial they referred to. It caused a fracture. It did heal on its own, but it's still a fracture nonetheless.

The biggest conceivable risk in my mind of when I'm doing these procedures of like hey, this is really what you don't want to do. While there's certainly a safe path obviously to access where the basivertebral nerve is, it runs right by the spinal canal and runs right by where the spinal nerve exits the spinal canal. It's really important technique wise and using good imaging to not do that, basically. That is where the potential risk is involved, but again, we'll take real good care and not do that.

Great. Thank you for sharing that because there's always another side to the coin and I think it's important we share that information. All right, my friend. That was a pretty robust 40 minute discussion on this procedure. We're going to link to the Intracept Procedure website in our show notes. That's not from our group but it's Relievant Medisystems, I think.

Relievant, yeah.

Yeah, Relievant. We'll put a link to that in the show notes for people who are interested in learning more. As you know, I always like to unfortunately torture my guests and pick their brain before they go about their health habits because I'm a health geek and nut obsessed with it. You gave us some really good tips.

If I remember, on your first interview you talked a little bit about some meditation practices. Man, a lot has changed in the world since you and I last did a podcast episode. I'd like to know what's been the biggest health tool whether it's mental health or physical health that's helped you persevere through this pandemic?

I have probably tripled the amount of Yoga I'm doing during the pandemic. That just went from one day a week to probably three days a week. Part of that was my previous Yoga practice was always doing it in a class environment. I valued that. I valued the community. When that wasn't available for the first six or eight weeks. I found a couple of YouTube places that were good. I've developed a habit of doing that.

I used to always be we do an hour class and that was it. If I couldn't do that, I didn't do it. I have all these options of 40 minute classes, 30 minute classes, and 75 minute classes that you can always sneak it in. I found that has helped a lot. I'm still meditating. There's a YouTube class that's a 19 minute thing with just fine vibes and salutation As and salutation B. It makes a world of difference.

On the mornings that I didn't get up early enough to get a workout in or to do a full class, if I can just make time to do that for whatever reason ... I guess that's not for whatever reason. There's lots of established reasons. It's a little bit easier to not get too worked up when things want to get me worked up and just to have a little bit more perspective.

That's great. Again, take home there is be nice to yourself. Even just a little bit of progress is something you should be proud of. Particularly in this day and age. All righty, I really enjoyed the conversation. I can't wait to hear more over the next few years how this evolves. Thanks for your time today, Turtle.

You bet. Thanks for having me and listening to me. You can tell I'm into this and excited for what it will hold for some people.

All right, my friend. You take care and we'll talk soon.

All right. Thank you.

Thanks for listening to this episode of Back Talk Doc brought to you by Carolina Neurosurgery and Spine Associates. With offices in North and South Carolina. If you'd like to learn more about Dr. Lakhia and treatment options for back issues, go to Back Talk Doc.com. We look forward to having you join us for more insights about back pain and spine health on the next episode of Back Talk Doc. Additional information is also available at Carolina Neurosurgery.com.