Piedmont Interventional Pain Care – Superion® Indirect Decompression System by Vertiflex for Relieving Lumbar Spinal Stenosis

Laura 0:04
Welcome to the MedSoup Podcast, where we talk about trending healthcare topics. I’m your host Laura Schumacher. Let’s dig in.

Laura 0:16
Today we are joined by Dr. Robert Wilson, the founder and medical director of Piedmont Interventional Pain Care. Dr. Wilson has served patients in Salisbury, in the greater Rowan County region for over 15 years. He is board certified in both anesthesiology and pain medicine by the American Board of Anesthesiology. He completed his residency in anesthesiology and a fellowship in pain medicine at Wake Forest University Baptist Medical Center in Winston Salem, North Carolina. Dr. Wilson is trained in the latest pain management techniques and therapies and is an avid speaker providing information to the public and medical professionals across the United States about the latest interventional pain treatments. He is an active advocate for the prevention of opioid abuse and serves on the opioid task forces for the Department of Health and Human Services, the Industrial Commission of North Carolina, the North Carolina Medical Board, and the North Carolina Medical Society. Additionally, Dr. Wilson is the president elect of the pain Society of the Carolinas, also known as PSoC, a long standing member of the PSoC and has served as chairman of the government advocacy committee. Alright, today we’re with Dr. Robert Wilson from Piedmont Interventional Pain Care in Salisbury, and we are going to discuss lumbar spinal stenosis and some very interesting treatment options available for patients who have this condition. Hi, Dr. Wilson, how are you?

Dr. Wilson 1:44
I’m doing well today? How are you?

Laura 1:46
Fine, thank you.

Laura 1:47
So some people are familiar with lumbar spinal stenosis, also called LSS. But describe to us what this condition is.

Dr. Wilson 1:58
What it really amounts to is, over a period of time as we age, we have a spinal canal that is fairly wide and paitent. In most of us, sometimes people were born with a congenitally narrowed spinal canal, but most of us have plenty of room for the spinal cord to lay in the spinal canal. And what happens as you develop arthritis, as you develop bulging discs, etc, it’ll start to crowd the central canal or the nerve, nerve roots or hub as well as the spinal cord. So what happens you have to kind of imagine that it just tightens around these nerve endings.

Dr. Wilson 2:37
The classic symptoms of it happen when you stand up when you stand erect or just stand, you have a little bit of extension to your lumbar spine. And that is accentuated when you do stand. What happens is because you’ve got this stenosis in the lumbar spine in the canal, it causes pressure on the nerve endings that are hub there. And of course, the main ones that are there, the ones that are the nerves responsible for your motion of your legs and the sensation in your legs. So what happens is when you stand up for very long or that you walk very long, you start putting more pressure on it because the extension of your spine, it’s made worse by the chronic conditions of arthritis and degeneration that are occurring as well as you grow older. And so what happens is that this will this will occur when you walk or stand then when you sit down, within seconds, your your lower back, your legs will feel better, you’ll find patients who will sit down and kind of lean forward that sort of flexes your lumbar spine, which again opens up that canal and takes the pressure off the nerve ending. So lumbar spinal stenosis is something that, again, you can’t really keep from happening. And some patients, obviously it’s worse than another’s. But it’s just really part of the aging process. For most of us those who are born with congenitally narrowed canal, when you have a little bit of arthritis and stenosis it gets worse much quicker. But in all of us as we age, these kind of conditions can start to develop.

Laura 3:41
So a person who’s experiencing these symptoms is usually an older person.

Dr. Wilson 4:16
It is. The youngest person I’ve done has been 65 years of age and it is patients usually around the age of 60 may start to develop it where it becomes more of a problem but my patient population the youngest patients been 65 that I’ve implanted this device we’re going to speak about in and the oldest patient is 90. So it generally is the older population because all these osteoarthritic and degenerative processes take place over years and years and start to become more of a problem in your 60s.

Laura 4:51
And this condition is not to be confused with the type of condition where you’ll see someone kind of hunched over like they have a little bit of a hump on their back from osteoporosis, correct?

Dr. Wilson 5:02
Correct. Yeah, that’s more of what we call kyphosis in the thoracic spine and that is completely different and patients do develop that especially we see it in postmenopausal females tend to have more osteoporosis that occurs and different conditions in the spine, spinal compression fractures, vertebral compression fractures occurs, which accentuates that problem, too. But no, this is completely different, and really just affects the lumbar spine that we that we treat.

Laura 5:32
So what are some of your initial treatment options for a patient who’s experiencing the pain from lumbar spinal stenosis?

Dr. Wilson 5:39
The first thing we do is to, you know, examine them and see what they what their symptoms are, what their history is. A lot of times, they will have again, these arthritic conditions of the small joints in the posterior column of the spine just beside the spinal canal a little bit lateral. A lot of times we can inject those joints and do a procedure called radiofrequency ablation, which could help their back pain and won’t do much for their leg pain. Other times we can do epidurals with epidural steroid injections, I should say, that will go into the central canal and cause a reduction of inflammation in that area. The problem with that is if we’re dealing with lumbar spinal stenosis, and you inject some medicine, in that central canal, because of the consistent and the constant tightening of that canal, the nerves may get relief for a while because that compression is there, their pain will come back quickly. So I don’t spend a lot of time doing procedures on patients that don’t get some type of long term benefit. If we do one or two procedures, maybe two different types of procedures and their pain comes back fairly quickly, it’s probably time to move on to either this type of procedure we’ll discuss or get a surgical consult.

Laura 6:55
So discuss this fairly new procedure that’s available to patients with this condition that you’re offering now in your office.

Dr. Wilson 7:04
The procedure is a procedure the device is called the Superion® is made by a company called VertiFlex®, and it’s been out for, I’d say about two years now. I’ve been doing the procedure about 13 months. And again, our classic patient presentation is going to be when a patient has pain or weakness in their legs when they walk or stand. They sit down, they lean forward, the pain goes away, we have something called the shopping cart syndrome. If you catch a patient in the grocery store, walking around leaning over on a grocery cart, most likely they’re doing that not for balance, but they’re doing that because it flexes the spine forward, and it helps relieve their their pressure going down their hips, their back their hips and their legs. This device that we implant goes between the spinous processes of the lumbar spine. And what it actually does on sort of a microscopic level is that it causes flexion to occur at the level of the spine where their stenosis is the worst. We get an idea of the patients who are candidates for it simply by their history. We confirm on lumbar MRI studies, that the stenosis is there, I view the different ones and it could have more than one area that is synoptic. But when I do place these, I’ve got a patient with two or three levels, about always they have one that is more severe than the other. And in those patients I’ve done this on, I will pick the worst area, place the device in there to cause a flexion to occur at that level. And generally all of them get better. It was just about a month ago. And then I placed the second one in another lady I’d placed previously about six months ago, she continued to have pain in one leg and not the other because the first placement got rid of her leg pain in that one leg. But the other one showed compression at the level above, and it was pinching the nerve as comes out of what we call the foramen when I placed the second device and it flexed her spinous process and all opened up it flexed her forward in her canal and gave that foramen an opening it didn’t have before so her leg pain got better in the contralateral leg.

Laura 9:23
So this is a procedure that provides a permanent option for treating that compression.

Dr. Wilson 9:30
It is. Rather than doing injections that, again, with steroids, or do cautery… I’m sorry… radio frequency procedures are which are a type of recovery procedure, we actually really treat the underlying condition rather than just treating the symptoms that they have we treat the underlying condition by changing their anatomy and flexing their spine forward at that level, which helps get rid of the stenosis and you have to understand they may be very stenotic, but they just need one or two or three millimeters of flexion forward to get the canal opened up enough where the nerves aren’t compressed. So that’s why we like to do just one level at a time. I don’t ever want to do anything that’s unnecessary and do two or three levels. The reality is, a lot of times you do their worst level that takes care of their problem, but it does treat the underlying condition. Unlike a lot of times and pain management, we have to treat the symptoms as actually treats underlying condition.

Laura 10:31
And then when you treat the underlying condition that takes majority of the pain away, if not all of the pain away, correct?

Dr. Wilson 10:37
It is amazing what it does. We actually this has been looked at and studied for five years before it was released by the FDA. It was studied at 29 centers, 470 patients all together were implanted with the Superion® device, they were followed for five years. At the end of five years, 80% of the patients continued to have reduction in leg pain. Their back pain, 70% of the patients had continued reduction in back pain. And overall the patient satisfaction was 90%. And another thing, in this opioid-conscious world that we’re we live in now, in the opioid crisis that we’re dealing with that, 85% of the opioid users who’ve got a Superion® device implanted, ceased using opioids at five years as well.

Laura 11:26
And I think that’s a good point that you mentioned, the FDA has looked at this and this is FDA approved

Dr. Wilson 11:32
It is exactly. Sometimes different devices, procedures come out that don’t have FDA approval, and this is one that was studied at length, again, at 29 different centers, almost 500 patients, before they gave their stamp of approval on it, because the outcomes are so good. They did approve the device.

Laura 11:55
I noticed on your website, that one of your patients who gave a testimonial about this procedure even mentioned that she basically had stopped walking from one of her house to the other. And now that kind of pretty much changed your life. I mean, it was pretty significant. And if you think of an older population, the benefit of them having movement and being active, and you take that away from them, not only are they going to have problems with their lumbar spinal stenosis, but it’s going to start affecting their other joints and even just their mental attitude because they can’t do what they used to do.

Dr. Wilson 12:32
Exactly. A lot of the patients will come to me and just like that. So a lot a little old ladies, I call my patients, that just can’t go to church on Sunday, because it just hurts too much. Or they can stand on the choir and sing. And this one lady you referred to that was one of her complaints, it just hurt too much. And she’d actually already had back surgery, and was headed towards a second one when I offered this to her. And she is now back doing virtually everything she wants to do. One of the things we find when we place this device in patients who have been unable to do a lot of things, a lot of physical activity, they’ll come back to us, always follow them up at six weeks, they’ll say you know, my pain that you put this in for is gone, my leg pain is gone. But I have these these leg cramps and these aches that occur that weren’t there before. An explanation is really quite simple. The reality is are so much more active, they got muscles, and joints that have been so deconditioned over time, that they’re now more active. And when you point that out to them, you’ll ask well how much more you’re walking and you know, where they could walk a block before now they’re walking half a mile or so and things like that. So the patients when they recognize what the reason for that pain is are actually quite excited. So we’ve had a lot of good outcomes. It’s been a life changer for a lot of people because you have to understand these patients who can’t get up and do their daily activities. And now can do it and get out and shop and travel more and all that it does change your life.

Laura 14:00
So you mentioned that that particular patient who also had back surgery, so that’s not something that would prohibit them from exploring this option.

Dr. Wilson 14:09
Exactly. I would say that because what we have to have for this device to be placed is we have to have what’s called the spinous processes in place at the level where the stenosis is. And there’s one other gentleman I mentioned that was 90 years old, my oldest patient, he had had a bigger back surgery where he’d had a decompressive laminectomy performed at L one, L two and L three in the lumbar spine. So I looked at him under under X ray and the spinous processes which I need to have in place were taken out with that operations, a fairly big operation. But what he did have at the four or five level, which were not previously operated on the spine, his processes were intact. I looked at his MRI and he had stenosis that occurred at that level. So at the age of 90, rather than sending back to the surgeon who probably couldn’t operate on him because of his other health problems, and just as general age, I was able to place this device and he was one of the patients that got up out of recovery. and walked out. As we talked to him about this at his post op, he said, I walked out of the recovery room feeling better. And that happens about 60 or 70% of the time, when the patients have this done, they actually feel better immediately with presenting pain that they had and he continues to be much more active now, just about four weeks post op,

Laura 15:28
Now is something that’s done in a surgical center?

Dr. Wilson 15:32
It is. We can’t perform this operation since his incisions made a very small incision, but need to have a absolutely strict sterile environment. So it’s done in the operating room. And the anesthesia that’s required for this is not a general anesthetic. Again, we get back to this point of patients who are not good candidates for lengthy operations, general anesthesia, etc. But we can do this procedure in 20 or 30 minutes with just heavy sedation, I don’t have to have them completely unconscious or anything like that. And we can place this device and patients do quite well when they wake up from it quicker. An hour or so after surgery, they’re up ready to go home, etc. So it’s something has to be done in outpatient surgery setting, but doesn’t require a big anesthetic or lengthy anesthetic or operation.

Laura 16:23
So what’s the recovery like after the procedure?

Dr. Wilson 16:26
what we asked for the patients to do for the first four to six weeks is try not to bend and stoop a lot. We ask them not to lift anything heavier general rule is nothing over, you know, the weight of a gallon of milk, and just kind of walk and do things normally don’t want them going outside and starting to bend over doing yard work, etc. like that for a period of four to six weeks. This device, when I place it, it is tapped down to the lambda the spine to the bony part of the spine in the posterior area that and it is going to stay in place. But if you twisted or bent or did too much activity, the possibility at least exists and it could move. So we ask patients for the first four to six weeks just to use, you know, good posture and bending, stooping twisting too much, just be careful about that. Other than that, they’re free to walk and do things that way that they feel like they’re able to do.

Laura 17:25
And then in terms of any, you know, post op pain relief is could they just take something over the counter typically for that,

Dr. Wilson 17:32
Usually it is. If we have a patient that undergoes this operation with me, if they’re on some pain medication, I never write for anything extra if they take a few pain pills a day for other conditions, etc. But if they’re not taking any opioids, I don’t prescribe it for this operation, they can take Tylenol or over the counter anti-inflammatory medications as they need to because just not that much of a post-op painful condition.

Laura 17:58
But this seems like a procedure that will be worth exploring, rather than going direct to surgery. I mean, why would anyone want to have back surgery unless they really absolutely had to have it?

Dr. Wilson 18:09
I completely agree. If it was, you know, my mother, my brother that had a condition like this or myself, that I could have relief from the pain and in a very extended fashion as least as far as what the five year study show, I certainly want to explore this first. Now one thing to say sometimes we’ll see patients who have just multiple levels of spinal stenosis, and it’s hard to pick out and they’re all severe, let’s say it’s hard to pick out one level that we could do, etc. You know, those patients may be better at least being sent to a surgeon for consideration of a bigger operation if they’re able to undergo that. But if that surgeon looks at it and says that the operational take five or six hours are not a good anesthetic risks, there may be two elderly, and certainly come back out explore this option with them. But there are times where I see patients who have a lot of spinal pathology that don’t think that this condition… sorry… that this procedure would work well for them and those kind of patients, I get a surgical opinion about them first. And again, sometimes we move on and have the surgery, sometimes they come back here to explore this option that we can do for them.

Laura 19:23
I think it’s also important to note that you have quite a few videos on your website that are about this procedure and even patient testimonials discussing their experience. And I mean they’re real patients that have gone through that and talk about how much their life has changed from that.

Dr. Wilson 19:40
It is. It’s always good to have these patients that come back and I think from memory the three patients that talk on the video were probably three of my first five patients have performed this on. And yeah, again, patients who are looking or thinking about this patient of back pain will see what we have to offer etc etc. Our website has a lot of things on it, including this. But now I am always happy to see these patients and have them come back. And I do a lot of procedures in here, where I know that I’ll do an injection, or an ablation procedure that I know they’re going to come back to me in three to six months. These patients, what I found to be true, in my 13 months of doing this, is generally when I do this on them, I just don’t see them again. They tend to do well and stay well. So not to say that that everybody is 100% when this is done, but the effects of this procedure, as far as the benefit to the patients, compared to a lot of things, I see both surgical and procedural like what I do, it’s been very rewarding to see this because of their, their benefit that they get. And again, because we’re treating the underlying condition, it tends not to reoccur again, and they just have a more healthier lifestyle.

Laura 20:55
And this is something that is covered by Medicare?

Dr. Wilson 20:59
It is. Medicare does cover it as well as all the Medicare replacement plans. Like with any insurance company, when it comes to Medicare replacement plans, sometimes we have to convince them that it is covered, they’ll initially deny it, but then we we have ways of letting them understand that it is covered by traditional Medicare, and they’re bound to have to to cover it. The insurance companies themselves if you’re under 65, and you have commercial insurance, not say that you can’t get covered, but it is more of a fight to get that done. We usually involve the company Vertiflex® to help us out with those approvals. But yeah, without question and I guess the good part about all this is that the patients who need this are generally Medicare age may catch on a little bit before Medicare age. I’ve got one gentleman now 64, he’s gonna turn 65 he needs this procedure. And basically, he’s just waiting until he gets Medicare to get it done. So it is something that maybe over time, we’ll see insurance companies stepping forward and covering something like this. If you can do this procedure for a reduced cost and get the patients to do as well as what they do when they have an open decompressive laminectomy. They would have to look at that and be happy to pay less money to have a benefit that each would provide.

Laura 22:15
Yes, and for it being minimally invasive, the recovery period is so much quicker than an open back surgery.

Dr. Wilson 22:23
Exactly, it is just a small incision. I tell patients, if you took a nickel and put it on the edge and looked down on it, that’s about the length of the incision. I guess that’s about an inch or less. And that’s it. I mean, they come back here nine or 10 days, just to look at the wound to make sure it’s doing okay and healing okay and that’s it. It’s a very simple procedure. It’s amazing what technology has came up with for us and who do interventional pain to take care of these patients. And before there’s nothing like it to be offered, you had to go and major medical institution to have a big operation recovery time was three to six months, etc, etc. And you can take now patient to an outpatient surgery center, somebody’s 90 years old, and they can leave there not having the pain that they walked in with is pretty amazing.

Laura 23:14
So if someone wanted to be evaluated, potentially for this procedure for treatment for lumbar spinal stenosis, do they need a referral? Or what would they do?

Dr. Wilson 23:23
At our office, we get a lot of patients by referral. But no, you don’t need to have a referral to get in the office, you can just contact us. Our phone number is 704-797-0065 and make your own appointment. We may have some preliminary questions about you or from you that we need to find out what we’re going to be treating etc. But sometimes patients come here with all their x rays or MRIs and ready to go. Other times patients come here just say “my back hurts I don’t know why”. So we started with our differential diagnosis of what’s going on and do our own studies and order them etc. So yeah, referrals are not necessary, you can make your own appointment without referral.

Laura 24:04
So again, if you want to learn more, or schedule a consultation, you can call Dr. Wilson’s office or visit his website at piedmontpaincare.com. There’s a lot of information on the website and the phone number is there. So hopefully, you’ll be able to help some more people with this procedure.

Dr. Wilson 24:24
Thank you, Laura. Appreciate your time.

Laura 24:26
Thank you!