Dr. Vinny Fancio has been involved in the advancement and innovation of pain medicine and provides an overview of many of the novel approaches to treating pain.
Um, we have Doctor Vinny Francio, who completed his physical medicine, and rehabilitation residency at the University of Kansas Medical Center, where he serves as chief resident and was honored with both the Outstanding resident of the Year award and the Resident Research Award. He then Pursued a pain management fellowship in the anesthesiology-based fellowship program at KU where he demonstrated ongoing commitment to clinical work and research. He is currently an instructor of anesthesiology with the pain management program at Barnes Jewish Hospital with the Washo physicians. He currently sees patients at the Central West End location. So thank you so much for Joining us today and speaking for us today, um Doctor Francio and I will let you go ahead and have the floor. Awesome, thank you. Uh, can you guys hear me OK? All right. I hear you. Thank you. Um, well, thank you very much. Uh, my name is Vinny Frencio. I'm a pain physician here at the uh Uh, Barnes Jewish Hospital at Washington University. I practice primarily at the main, uh, camp building here. Um, my information is available here, uh, for an email if you guys want to exchange information and ask any additional questions, we can also send these slides out if needed. Uh, I am a consultant for Mainstre Medical Company and I have uh received research funding from Navro uh corporation. I am not paid to present this educational information. My training background, thank you, Nikki for summarizing that. Uh, I am a physiatrist by training, physical medicine and rehabilitation from the University of Kansas, and then I did an anesthesiology pain medicine fellowship also at the University of Kansas, and then I moved here last year to um start my practice. Uh, before I was, uh, before I, my medical training, I was a chiropractic uh doctor and I practiced in uh Texas and Oklahoma. I also got a master's degree from National University of Chicago, uh, in clinical research. I'm dual board certified in pain medicine and physical medicine and rehabilitation, and I have leadership positions in some of our societies in the field of spine and pain medicine. My clinical practice here started in October. Uh, my practice focuses on comprehensive spine care and pain care, academic medical education with the involvement of fellows, residents, and medical students, as well as clinical research. Uh, my expertise or my focus is with the interventional management of spine, musculoskeletal, cancer related and chronic pain conditions. In addition to the traditional interventions in pain medicines such as epidurals, nerve blocks, radio frequency ablations, my practice offers cutting edge therapies such as neuromodulation, spinal cord stimulation. Um, restorative nerve stimulation, basic vertebral nerve ablation, uh, percutaneous indirect decompression, kyphoplasty, uh, central to my practice is really focused on the patient centered approach. Uh, I like to provide a lot of patient education, have the patient involved in their own decision, providing them options, and together we make a decision so we can um have clear uh. Attainable goals uh to each individual patient's needs. So this presentation today, we'll focus on some of this new technology that I brought to Washi and BJC since I joined here in October. some therapies that we were not doing, not a lot of people in Saint Louis have been doing this, so we brought some new technology. We are gonna talk about two therapies for chronic back pain. We're gonna talk about 1 therapy for spinal stenosis, one therapy for chronic spinal pain, and 1 therapy for peripheral neuropathy. So, I think it's important for me to kind of be talking to you um as port of entry, primary care providers, APPs because we know that every patient deserves improved care, efficiency, and access to these new therapies. Early referral is key to optimize the patient's success and improve their function. A lot of patients come to me after 3 to 10 years that they've been suffering from pain and they have done multiple things, which makes my job much harder and the likelihood of an improved outcome much more difficult. If we are able to provide early diagnosis and earlier treatment and we are treating the cause of the sym the pain and not necessarily just the pain itself or the symptom, um, I think we can be more successful with patient, uh patient outcomes. So it's a big toolbox. Collaboration is key when we are treating patients with chronic pain. And this therapies that I'm gonna discuss today is an evolution in the field of pain medicine that we are not treating the symptom of pain anymore. We are really targeting the cause of the pain. So these are target treatments for specific diagnosis that now we have available that can actually help the cause, but not necessarily just treating the pain symptoms. Most important slide here, how can we collaborate and you guys can share patients with me and we can make that collaboration is by referring to WaU Pain Management Center. Our phone and fax information is right there. You can use API secure message and directly exchange information with me and ask any additional questions. I'm always available, um, and I'm happy to see. Patients with chronic back pain, chronic neck pain, musculoskeletal pain, vertebral compression fractures, uh, radiculopathy, just to name a few. Uh, you can find the information on my website, uh, also on pain.w.edu and um you can send a direct referral on API using my first name, last name that is available there for you. So let's kind of get directly to the point here. So we have this patient, Gloria, she's 57. Um, she's the mother of 5 children, and she has worked for decades as a cleaner. She has progressive and debilitating back pain with banding, stooping, lifting, and sitting. She's worried that she will lose her job because of the pain. She's concerned that she doesn't have enough time to exercise because of her responsibilities with family and work. She has already tried physical therapy, she has already tried muscle relaxants, anti-inflammatories, and oral steroids. She comes back to you and ask, you know, what do I do next? And what do we do next? What will the primary care, the port of entry do? Maybe get a lumbar MRI, potentially start some pain medications, refer to spinal surgery? Very typical presentation that we have, right? So, Uh, early referral to someone like me in the field of pain medicine can help optimize all that. Um, and then we're gonna get a lumbar MRI. We're gonna see, you know, a patient has failed multiple things. Hopefully, you know, if you are comfortable as primary care provider to get that MRI that is also very reasonable. And then we get this MRI right here. Well, I can. Tell you that there's degenerative disc disease right here. You can see the blue circle, right? You can see that disc that has changed compared to the one above and below, and there's probably 0 surgeons out there that will see this patient and and offer surgery, OK? Um, even though that the patient has tried physical therapy and medications, the evidence for surgery for this is very it's 0, OK? Um, so, They will go see the pain pain providers, and a lot of pain providers will do epidurals and things like that, but it's not clinically indicated for this condition. We do have now a treatment that I brought here to wash you and BJC that we can treat the cause of this dyscogenic pain. So if you look at this MRI, hopefully you can see my pointer. You can see the disc, the generator, and you can see this changing color just above and below the disc, and we call those modic changes, though they were developed by Doctor Modi, a radiology, not developed, uh, named by Doctor Modi after himself, um, for this uh changes that you see on the vertebral body as a consequence of disc degeneration. So we call that dyscogenic or vertebrogenic pain. A lot of, you know, the old name would be degenerative disc disease, right? And, you know, it's the problem is not just the disclog, OK? But the disc connects to the top and the bottom of the bone, and we call that uh superior and inferior. Plate and those end plates can get that bright or dark color and that in the on the MRI suggest edema and inflammation and that is a biomarker for chronic back pain uh from the discogenic or disco vertebral complex. And there have been multiple studies that they analyze under microscope. Uh, and then under MRI's and other studies that those are sources of pain, and we, uh, those those endolates will release uh pro-inflammatory markers like TNF, prostaglandins, interleukin 6, that is responsible for, it's a highly vascular area that is responsible for mechanical dyscogenic pain. As you can see right there in the image, OK? And that is what you see on a normal MRI. You see the normal disc and you see the basal vertebral nerve, which is this nerve that looks like a tree inside the vertebral body with the nerves on the top and on the bottom of the bone. And there's a procedure called basal vertebral nerve ablation or burn that we go inside that nerve and we burn that nerve. Therefore, we are treating the inflammatory changes of that disc, OK? And that end plate of that bone to really treat the cause of the problem. So we are treating the cause with basic vertebral nerve ablation. It's a procedure that we get into the vertebral body, insert a probe right there and burn that nerve on that specific location, kind of hook it up to this machine right here. So the classical patient that will benefit from this is someone with chronic axial back pain that obviously has lasted for 6 months or longer, someone with midline back pain, not a radicular pain, sciatica going all the way down into the leg, all the way down into the toes, into the foot. Sure, maybe a little bit of buttocks pain, it's fine. But it's primarily what bothers the most is the back. The ping is what we call a dynamic or changes with movement, and is usually worse when the disk is getting extra loading, such as putting the socks on in the morning, bending forward, uh trying to touch their toes, sitting for a prolonged period of time, driving for a prolonged period of time. They have to get out of the car, they get, you know, gotta go back and change different positions. That does a lot of loading on the disc. So those are kind of clinical cues that you can think about for these patients. And then, you know, if you order an MRI or I look at an MRI we'll see those discs generated and we'll see those changes on the superior and inferior, the top and the bottom. Of the disc that suggest we call modic changes. If we have that clinical symptom of chronic mechanical back pain with these changes on the MRI my ras already thinking, hey, I think this is a good patient, OK? Then, uh, we look at the previous treatments, so obviously physical therapy, medications, exercises, and. And we consider this treatment modality uh very early for patients and the results have been very, very successful. So I'm gonna leave this, the slide here for a few more seconds. Maybe you can screenshot or take a picture of your phone. There's a QR code as well that you can get more information, but this is kind of like the home run slide about when you think about this intervention, OK? So the procedure is very simple. Uh, we access the pedicle, which is the bridge of the bone. We create this channel, we place this radio frequency probe, and then we burn that nerve, OK? That nerve has no myelin around, so it's a one and done deal. The nerve does not regenerate, does not grow back. It's only a sensory nerve. It's not a motor nerve, so there's no changes to motor function of the legs or anything like that, OK? So under the X-ray machine in the operating room, this procedure is done. It usually takes about 30 minutes per area that you're gonna do. So I usually do about, you know, 2 areas to kind of cover the superior and the inferior disc plate and plate, and then it takes me about an hour in the operating room. Patients can be under general anesthesia or conscious sedation based on the preference of the patient and the anesthesiologist, go home on the same day, no incisions, no staples, very easy procedure. Just a little nick, and that's it. No restrictions following the procedure. Patients can go back to daily activities within 48 hours. Let's talk briefly about the evidence, OK? So, I was part of the society guidelines for the American Society of Pain and Neuroscience that we did a study on, uh, looking at this particular procedure, and it's considered level one evidence, highly recommended for medical societies with randomized controlled clinical trials, less than 0.2% complication rate. Uh, the data is durable up to 5 years. So in my field of pain medicine, there's only 2 interventions that we would talk about both today that can we have evidence of more than 5 years or at least 5 years of actually improvement in symptoms. Everything else is short term. That's why I'm telling you about actually fixing the problem here, treating the cause. So this is one of those interventions when we have evidence up to 5 years of fixing this patient's chronic back pain. And what's interesting on this graph here is you can see that we have 12344 different studies here, OK, you can see the lines and all studies kind of follow the same trajectory, right? So at about 3 months, you start seeing that major difference and then longitudinal improvement, and those are randomized controlled trial studies and real worst studies done by, you know, in the general public. What does that Tell me that tells me if I do the procedure and then my colleague does the procedure in Chicago or in Florida, if we all train and we know how to do this, we should expect the same results. epidurals are not like that. Other ablations are not like that, stimulators are not like that. So the reproducibility of this intervention is super, super high, which give us more confidence to help patients. With up to 5 years improvement from this is just showing the pain score from 7 to 2, which is obviously remarkable for these patients. OK. Uh, any questions so far? All right. I don't have access to the chat, but I don't, I didn't see any in there or in the Q&A yet. OK, all right, you feel free to ask questions on the chat, um, and then, uh, if someone keep it, if you can keep an eye on there, you can just interrupt me at any time. Absolutely. Thanks. All right. Of course, let's move on to the second case we'll be talking now about a different intervention, OK? So this is Tania, she's a 68 year old female. She's now retired after 4 decades of school teaching. God bless her. She has progressive and debilitating back pain that is worse with activities, and she said it's very difficult to get in and out of the car, get in and out of the chair, gardening, uh, other simple activities such as leaning over on the kitchen counter to cook, loading the dish. Washer, all those simple activities, she has a lot of pain. She has done multiple times physical therapy within the past 2 years. She went to see another pain doctor. She had a couple of epidurals, she had a nerve ablation on the nerves, not the one that we just talked about a different type of ablation, uh, with a different community pain doctor. She saw a spine surgeon. The surgeon said there's nothing here for me to operate. You're not a surgical candidate. She returned to the primary care provider for further advice, OK? She had an MRI in the past about 1 year and a half years ago, 2 years. What do you do next, OK? I'm, I don't know your practices, but I'm assuming that this is probably a common scenario in your practice. Uh, so, what do we do next, right? Do we consider opioids, or has this patient, you know, failed everything else? Maybe a new lumbar MRI, OK? So, again, that's when this new therapy come in place here, uh, when we do a, you know, here wash you up, you know, a comprehensive approach. So we get a new lumbar MRI. Let's pretend we got a new lumbar MRI and what we are gonna be looking at here is we're gonna now pay attention to something that we, it's always been there, but we really never focus on, which is beyond the disc, beyond the facecat joints, beyond the stenosis, but let's look at are the paraspinal muscles important here, OK? And as you can clearly see on the left, we have here uh the MRI of a very normal healthy patient with the multifidus or the paraspinal muscles with very nice and uh dark muscles there on the yellow. OK. And the same thing here, you don't see any changes on the next picture, OK? But then as the pain becomes more subacute to chronic, and this is a study that was done in Australia where they look at the role of this muscle called multifidus, we'll talk about here in a second. In patients with acute, subacute and chronic pain. In acute pain, there's no changes in muscle, uh, function or structure, but as the chronicity of pain gets worse, that patient gets subacute pain 3 months, 6 months, and so long, you can clearly see here the transformation of muscle structure, OK, on the MRI where those muscles are now getting more fibrotic, more fatty. The muscle fiber composition actually changes from type 1 to type 2, and then the whole complex of degenerative changes of the muscle and the spine starts to kick in, OK? So that is the multifaous muscle that we see right there on the MRI. Well, guess what? Physical therapists, chiropractors, uh, Physiatrists, physical medicine, and rehabilitation doctors always knew that this was an important biomarker for pain, but we didn't have anything else to offer these patients other than continuous physical therapy. Then this therapy came into place that we're gonna talk today called reactivate restorative neurostimulation. And now we have a therapy that we can do and offer these patients reconditioning and retraining uh sorry, reconditioning and retraining of these muscles that are a source of back pain. So this is, there was a there was a question in the chat is basic vertebral nerve ablation readily covered by the pay, Medicare, commercial insurance or Medicaid? Yeah, absolutely, good question. Um, sorry that I didn't touch on that, but yes, uh, no problem with Medicare, Medicaid, as you may find very difficult but possible commercial, usually not a problem. Uh, the good thing about this is that the accessibility continues to improve, OK? And then the company. Has a lot of pro bono and they have a lot of opportunities where the company will fight for it and kind of helping get it approved with people from the company helping us kind of get this approved. Uh, I can tell you that since I've been doing this um since October, I think, um. I may had out of 20, maybe 2 that got denied by the insurance that we are on the in the process of um uh appealing uh after peer to peer and all that. And the same is for this next therapy that we are talking about multifidu dysfunction or restorative neuro stimulation right now is the exactly same thing, new therapy, been in the US market now for about 3 years or so, getting more popularity just got coverage by Blue Cross Blue Shield, Medicare. So, um, so I would say, you know, Blue Cross Blue Shield, Medicare, um, usually no problem. Essence usually no problem, uh, Aetna Cigna, Aetna a little bit more diff uh, Aetna actually good, uh, Cigna and Unit a little bit more challenging, but certainly not impossible, and we have done it before. So it's just a matter. Of time and obviously that's not up to you guys. You can decide that kinda like, you know, uh, trouble, think about that. That's my job and my team and, and, and, and I work on that. But yes, there is accessibility in the patients. Uh, Medicare, uh, Medicaid, not a problem, commercial insurance is hit and miss, but I would say more than 50%. Thank you for the question. Oh, sorry. OK, hoping that you can still see my slides. We can still see your slides. OK, we're gonna move on or continue now with multifidu dysfunction, OK? So multifidu is the muscle dysfunction not working correctly. So back in the day, we used to call this nonspecific mechanical back pain. People would look at MRI X-rays and say, well, there's nothing wrong here, OK? Move on. You have non-specifical back pain. Well, now we are starting to pay attention to different things. Because the evidence is pointing us that this muscle called lumbar mtafius, which is a stabilizer of the spine innervated by the lumbar medial branch nerve, uh, plays a major role in back pain, OK? A major role, a very significant role. Um. One thing that is important about this muscle is that number one, a few things. Number one, it's involuntary, OK? So you can't really say, oh, let me work out my m for this, right? No, it doesn't work like that. It's sort of like your tongue, right? It's you are not, or your diaphragm. You're not really. Thinking, but it's always working, right? Different than your biceps or your quads that you can actually think and work it out. This one you cannot. So it's an involuntary muscle that you, you, uh, stabilize and strengthening by doing other activities, OK? So that's principle number one. That's why it's so difficult when patients are too far past the point of physical therapy to really have physical therapy strengthen these muscles again, OK? The second thing is that this muscle is not a big mover, so it's not, if he doesn't, this muscle does not make you arch backwards or touch your toes. It's very tiny muscle like this big, as you can see in the picture and you'll see more pictures. It's actually more about stabilizing little movements than actually big movements. The third thing is that it has a lot of proceptors. So if you recall from school, proprireceptors are tiny innervations. Or innervation organs like uh muscle spindles inside the muscle fibers and muscles that are like that, such as your eyeball, OK? They are responsible not so much for movement, but basically tell the position in space, OK? So this muscle tells the position of your spine and joints to your brain. And your brain understands and received that information and then sends back a feedback to the joints and to the muscles and say, OK, we are safe, we're not gonna fall off, you can go ahead and reach out for that cup of coffee, OK? If there is a miscommunication between that propriceptive feedback, where the muscle is not working right, the joints get overloaded, your brain goes like, oh, maybe I shouldn't do that. OK. So that is what I want you to understand, and that's what this triangle diagram here is trying to show that the muscle connects to the joints or the spine, which sends feedback to the brain and vice versa, OK? So, Hopefully that is somewhat clear. Now, if we have multifidu dysfunction, that muscle is not working properly. That information that goes to the joints and to the brain and vice versa, it's lazy, it's inhibited, it's not working as its best. So obviously you anticipate that patients will have symptoms of chronic back pain and instability. So multiitous dysfunction, that is the ICD 10 code there. The only reason why I'm showing you this is that, that tells that the CDC, the FDA acknowledge that this is a real problem, a real condition with a real treatment, OK? So I want you to understand that, um, not that it matters for you to know the diagnosis or what not, OK? So how did these patients present? OK? It's very similar than the one that we talked about the basic vertebral nerve ablation with the disc, OK? But the disc is on the front of the spine, between the tube vertebrae, the disc is kind of like the cushion. The multifidus is kind of the supportive structure in the back, OK? So it's like the posterior column. These patients are also gonna have primarily just my back pain hurts. My back, my pain, my back hurts, just back pain. I have no paresthesia, no numbness, no tingling, no shooting pain going down into my legs, OK? However, different than the previous uh disc pain, discogenic pain or. Hegenic pain that we talked about, that will be patients that I can't sit down for too long because it loads my disk too much. I gotta go up and down, up and down, and I'm always changing positions. These patients are the opposite. They have pain when they are doing activities, transitional activities, simple things like get in and out of the car, it's terrible. Oh yeah, I can drive to Chicago, but man, getting in and out of the car, it is a pain. OK. OK, or get up and down the chair, the sitting on the chair, OK? Or simple what we call transitional or trivial small movement activities, for example, waking up early in the morning, leaning over the sink to brush your teeth or comb your hair, or leaning over the kitchen kitchen counter to make a dish or sandwich or something. All those little activities that you are barely moving, OK? But your multifidus needs to squeeze in your spine and keep it stable. That's when you see patients like that. Uh, that are an indication for this procedure, or at least you should think multiitous dysfunction perhaps, OK? Now, I don't anticipate or expect all of you to know this, um, but I want you to recognize that now we have a treatment for patients that comes with those complaints into your practice, and I guarantee that you see this every day. Or at least every week, OK? Uh, my job is to figure out which intervention is more appropriate and follow up with you and say, hey, this is what I think, but I want you to kind of keep your radar on on this uh clinical cues, OK? A lot of patients say, I have, um, what do they call it? My, uh, I feel that my back is unstable, or I get frequent stuck episodes. I get better when I use a back brace or I lean over on the chair or you see a patient get up from the chair, they have to help them. Cells with the arm support or on their legs, you ask them to touch their toes and when they come back up, they have to help themselves with their arms, OK? That is all signs of this muscle not activating properly and now working and therefore inhibited and dysfunctional. This is the story of this problem, OK? I'm gonna read this, you can read it. It's a bullet point that a story that I created part of one of the research studies that we did. So these patients, they have symptoms that usually start with brief self resolving episodes. They last a few days. Patients would take some medications, anti-inflammatories, they get some rest, maybe they do some home exercises, they get better. They never see you again, they never see me. Over time, these episodes will be more frequent. They're not lasting only 2 days. They're lasting now 7 days. They're more intense, and it takes not only 2 days to recover, but it takes maybe a week now to recover, and it's getting a little bit more chronic. And then they say, you know what, this time it's just not getting as quick as as better as quick as before. Let me go see my doc. They go see a primary care provider, get some physical therapy, maybe some medications, get some x-rays, nothing crazy, OK? Some will improve, some will not. Then they'll go back to see you, and maybe you get that MRI and that MRI doesn't show anything. And it's like, oh, maybe, you know, you should see a surgeon. They go see a surgeon. Nothing operative here. Well, patients kinda get stuck in the cycle, OK? And what do we do? They basically don't get the access of care that they need and that's my job is to really help you improve that accessibility to your patients where we are seeing them early, preventing surgeries, preventing procedures, preventing opioids, things that they might not need, OK? Um, so some of them may go to a doctor in the community that does not do this procedure, for example, but guess what, they'll do epidurals, they'll do nerve blocks, even though it's not indicated, they'll still do it, and then patient gets this repetitive, repetitive, repetitive cycle of unsuccessful therapies. These treatments do not address the underlying cause of the problem that we talked about, the multiitous dysfunction. So eventually patients are told there's nothing else that I can do for you, and they kind of get in this chronic pain cycle, their function declined and the quality of life declines. That's what we need to prevent. So on the MRI you will see atrophy, and you can see here the normal muscle with moderate atrophy and significant atrophy. Now, if I look at this and I say, yeah, this guy needs this procedure, that is not correct. I need to make sure that he has the right clinical cues, the right clinical presentation, the right physical examination findings, and the right pain trajectory to see what happened with this patient. But it is again another biomarker that we are starting to pay more attention to. So you see these patients in your practice all the time. I see it all the time. So, these patients that have multiple cycles of physical therapy, they have failed the traditional epidural injections, nerve blocks, and ablations. They have degenerative disease, they have face arthropathy, they maybe have a little bit of a scoliosis. Maybe the report of the MRI said stenosis, but they don't have shooting pain down the legs. They go see a surgeon, you send in the surgeon, the surgeon said, nothing I can do, OK? These patients are there all the time. The difference now is that we are paying attention to something that it is. Uh, we have a treatment for and it needs to be paid attention carefully because you need physical examination, clinical history, and MRI findings, and that takes time, that takes a lot of thinking. It's not just a problem. I see the problem, I fix it, I do a procedure. No, you have to really think about it from a functional perspective. How does that patient perform? What are the problems, so it takes a little bit more thinking to actually get this right, but they are all there and we can help these patients a lot. Again, here's the home run slide, OK? So for this particular intervention that we call restorative neurostimulation, and it's restorative because we are actually restoring the function of the muscle and the stability of the spine, patients need, again, same thing as before, chronic back pain, 6 months of duration, middle of the back, sides of the back, no shooting pain going down into the legs. Different than the other one when patients will have pain leaning forward trying to touch their toes. This one, the patients will have problem coming back up, like the picture here on the right with the guy with the yellow hands or yellow gloves. He has to kind of push himself up because he doesn't have the stability to get back. Their pain is aggravated by simple daily activities that requires the muscles to engage. Getting in and out of the, the car, getting in and out of the chair, leaning over, things like that that we talked about, OK? Um, they often use their hand support on the thighs, they use that back brace, and they tell you, just my back feels unstable. I get the feeling of frequently getting stuck, OK? That is the clinical cues that we have to pay attention to. We look at the MRI, we do our physical examination findings, and then they obviously have to try physical therapy, medication, exercises to really make sure that this is not something that we are missing here. So this is the home run slide. I'm gonna let you guys maybe take a screenshot here um and then uh I'll move it on here in the next 3 seconds. Any questions in the chat? No? OK. All right. So, why is this a big deal, right? So this is a big deal because again, we are treating the cause and not the symptom, OK? I'm not just simply saying, yep, you have back pain, I'm gonna treat your back pain. I'm treating the cause of the problem and very few things in my field of pain medicine, I can do that, OK? It's different in your field or other fields, but in my field, I, I do palliative care, right? I do pain medicine. I treat the pain. Here I am actually treating the cause. So this therapy called restorative nerve stimulation, restorative, it's rehabilitative. It rehabilitates it strengthens and reactivate the muscles to improve the spine stability. Improves the patient's function, the mobility, and the pain. It treats the cause and not the symptom. Most of the other interventions that I have in my field are palliative. They are pain management. They focus on controlling the pain. Yes, they may help the pain, they may help the function, but I am not treating the cause. They treat the symptom of pain. OK. So this is a very, very big deal. This is the procedure. This is what we are talking about. Reactivate restorative neurostimulation. It is an outpatient surgical procedure. Same day. Patient is under general anesthesia or max sedation, conscious sedation, just like the previous procedure. Go home the same day. I usually don't prescribe any opioids after this. They get some antibiotics, and that's it. You know, they might get about 4 or 5 days of back soreness, super simple, return to daily activities within 2 weeks with no weight lifting restrictions whatsoever, and that's pretty much it. Two small incisions, probably about 3 centimeters or so, one in the middle and maybe a 4 centimeter on the side for the battery, OK? And then the patient comes back after the surgical procedure in about 8 or 10 days so we can actually activate the device. This device is basically two electrical leads that you can see here with 4 lead contacts, which are the dark lead contacts that are placed along the nerve, as you can see here, the yellow nerve, and through the muscle. And then some ties deploy and then it gets stuck in there. So it's not moving and not going anywhere. So that's really, really a good thing, OK? So we place these electrodes next to the nerve and into the muscle, and the patient twice a day will activate the device by laying on their side in bed. They turn it on, they just click, and for 30 minutes, that device is gonna activate. It's gonna deliver energy to the nerve and to the muscle, and the muscles are gonna squeeze. The patient will feel like a gentle massage very deep on their back, and it's super comfortable. Patients fall asleep with this, OK? And after 30 minutes, it shuts off on its own. So usually patients will do it earlier in the morning and then later in the evening when they're laying in bed, to go to bed, they fall asleep, no problem. Twice a day, they do this therapy, OK? This is what it looks like in a real person, and that's what it looks like in a model, as you can see kind of running along those nerves that we are trying to stimulate and the muscle that we are trying to stimulate. We put it on both sides, obviously, OK, so we can do both muscles and as you can see here, the this muscles is the short muscle that kind of goes on from the top to the bottom there. So we did the first case ever in Saint Louis metro area just about 3 months ago, uh, and we have done quite a few now and patients are doing very well. Super easy procedure in the operating room. I have my, myself here, some fellows, and then, uh, patients are doing very well, no complications, um, and then, uh, good procedure, patients return to their activities within a couple of weeks. I want to present here a little bit of the data. I don't want to overload you, but it's a very similar graphic graph here, OK? So obviously multiple society guidelines from the Society of Spine Surgery, from the Society of Pain and Neuroscience, a five-year randomized control trial again, this is the only other therapy. In addition to the one that I previously mentioned that there's 5 year data on it, OK? Nothing else, this is it, OK? Um, so as you can see on this chart, um, or this graph here, oops, excuse me, we are now looking at not pain, but now we're looking at ODI and ODI is those Weser Disability index, which is a questionnaire that we provide for patients about their back pain function. Can you do the things that you wanna do, household chores, social life, sleep, sex, whatever that is, those domains we are now uh measuring, not the pain itself, but the function. Can you do go out and do the things that you wanna do in your life, OK? And what we can see here is again that same trajectory, this the, we have 12345 different studies that follow the same pathway, OK? So, reproducibility where I can do it, my colleague can do it in Germany, my colleague can do it in Miami and whatnot, patients would respond fairly equivalent, OK? The big thing about this particular intervention is because we are, we're storing the patient's muscles, OK? You can see that the change actually takes 6 months, OK? Why? Because, you know, all of us, we try to exercise, gain more muscles, lose weight, eat healthy. We know that it takes time, and this is what we are doing with the back. Pain now. Some people are early responders and in 3 months they feel already much better, probably because we are capturing them early on in that cycle. Some people are more in the 6 to 7 months where they are more like late in that cycle that it takes more time for their brain and their body, their joints, the pro perception and the feedback to get back and get restored. But what I wanna show you. Here is a quite a bit of a significant change from from zero being obviously, you know, uh, the problematic level here with a 20 point decrease. So that is very, very, very significant. Most of the interventions that we do get about 5 or 8 point degrees, so this is almost a double, OK? I like to tell my patients that 80% success rate here at 6 months, OK? A couple of things I want to call your attention here is for this study right here called Restore, which is the yellow line. You can only see up to 1 year because it was just published about 2 months ago, but they compared patients with chronic mechanical back pain because of multiitous dysfunction using this therapy, it's a randomized controlled trial, double blinded patients and uh with uh proceed and providers with the ability to cross over. They compared it with conservative medical. Management with medications, anti-inflammatory steroids, and physical therapy, and other types of injections, and these patients did better using this therapy at one year, all of them that had superiority compared to the conservative traditional medical care for chronic back pain. That includes medications, steroids, rest, physical therapy. They all did better on ODI improvement by 20 points and in pain score improvement by I think. 20% or 30%, which is really significant compared to baseline. OK, so that is it on this intervention, on this particular condition again for chronic mechanical back pain. Any questions so far? Anything else? Yes, there is a question. Why does this require an invasive stimulator? OK, that's a good question. So, The device is implanted in the body. It is a surgery. Um, so by those definitions, yes, it is an invasive implantable device. Why does this require a stimulator? If you go back to the beginning when we were talking about this muscle is involuntary, so you can't really think about activating this muscle. It activates when you're doing other daily activities and other simple tasks. So patients sure should go to physical therapy and try physical therapy multiple times, 2 or 3 times, I would say. That's what usually I do. And I specifically write down lumbar spine stabilization exercises focus on paraspinal and multifidu. The problem is that this muscle is small. This muscle is involuntary, and this muscle is reached in. Uh, uh, perceptive muscle spindles. So you are not only trying to stabilize and restrain the muscle, you're trying to improve the communication of those muscle spindles to the nerves, to the joints, and to the brain and kind of recorrect that feedback. And physical therapy, when it's past that point, usually just too late, OK? So that's when we bring this therapy in, we do it for 3 to 6 months, probably at about the 2 month mark. I that's when I usually send my patients back to physical therapy, then they do this in addition to a good physical therapy program to augment that, and we see the much, much better results. So hopefully that kind of answer your question, uh, because the answer is because physical therapy for most patients. It's kind of like too far past the point. Their chronic pain and their behavior and the neuroplastic changes in the muscle, the nerves, and the brain are just too far past the point. If we can fix it with traditional conservative care, I'm all thumbs up for that. Actually, I've done with 2 or 3 patients that I was like, hey, I think you need this, but let me send you to watch UPT. You can work with them. I'm gonna some specific things. They came back and say, hey, that worked great. I'm feeling great. Hey, I'm all about that. But for those patients that don't, that's when we bring this in. Uh, so, hopefully that answers the question. All right. So, um, let's kinda jump in here on a few more, uh, for the next 10 minutes here. Uh, lumbar spinal stenosis, obviously, all of you guys have seen this before on your MRI report, on your, uh, patients and all that. So we're looking at the lumbar spine MRI here, OK? And this is the normal central canal, nice big wide open. OK? This is the severe spinal stenosis when that is really, really squeezed. Patients that have this, OK, it could be because of they were born with a narrow canal or they have a significant amount of arthritis, degenerative disc disease, um, ligamentum flavor thickening, um. They can have a set arthropathy or wear and tear, so there's multiple reasons, right? Patients usually have chronic back pain. And they usually say my back bothers and my legs, and doctor, my legs are terrible. I have so much weakness and heaviness of my legs. They feel like they're burning. I really can't walk from here to the parking lot. I have to take a couple breaks. I gotta lean forward. If I go to the grocery store, I'm leaning forward in the shopping cart because I can't walk that far because my legs are just killing me and my back hurts too. Very different patient presentation than the one that we described, OK? Usually, that is a sign of neurogenic claudication, which is what I described with spinal stenosis, OK? So these patients should Go or can go to a spine surgeon. And then the spine surgeon is gonna make a decision if they are a good candidate, OK? We usually do from my perspective in pain medicine, lumbar epidural steroid injections. That usually can be quite helpful for these patients. Uh, some of them do it, you know, 3 or 4 times a year, 2 times a year. Some of them you do 1, they come back in 2 years, repeat. But there's a percentage of those patients that are not surgical candidates because they are smokers, they are obese, their blood pressure is not well controlled. They don't wanna do surgery, OK? And they have failed the traditional interventions, epidurals and whatnot, OK? That's when I consider a procedure called minimally invasive lumbar decompression or mild, OK? Those are patients that you should be considering to refer to a pain doctor, OK? When they have fail injections, physical therapy, and they're not candidates for a major surgery or they don't want a major surgery, OK? And it's a very simple procedure that we do in our outpatient practice. It's not in the operating room, it's in the procedure suite. Patients are under general anesthesia, kind of like a colonoscopy. They go home the same day, usually within an hour or less. It's a very small incision, probably the, you know, there's no even staples on it. We just kind of glue and put Steri-Strips on. And we use these devices right here that you can see on the screen. The advance, uh, sorry, excuse me, the uh adverse rate or the side effects are very little, 0.1%. Patients go back to activities within 24 hours, OK? So you can clearly see the difference between doing something like this and doing a lumbar decompression laminotomy when they go to a spine surgeon, they remove the ligament, they stay admitted for a couple of days, they have to do the rehab afterwards. We're not talking about the same treatment here. We're talking about the same condition, lumbar spinal stenosis, but this is way more uh way easier on the patient's body and less invasive. Um, so I work obviously a lot with our orthopedic spine surgeons and neurosurgeons, and for those patients that are not surgical candidates don't wanna do surgery or there stenosis is one level. I usually try this, I talk to the surgeon and send them to the surgeon and say, hey, let's try this first, see how the patient goes. If it doesn't do well, we'll try a more higher level laminectomy and whatnot, and they're usually on board with that. OK. So this is a procedure that we do. We go into this uh epidural space right there. We remove a little bit of the osteophytes and the, the lamina, and then we remove a little bit of that ligament that is thickened, causing the symptoms of spinal canal stenosis, OK? And you can see the stenosis where the thinning of the contrast right there kinda gets better afterwards. This is also supported by society guidelines with level one evidence and randomized control trials. OK. Any questions about the treatment of lumbar spinal stenosis with this new therapy called mild MILD uh that is beyond epidural steroid injections for shortage of laminectomies and laminotomies and spinal fusion. I don't see any questions for that. All right, very good. I'm gonna keep going there. Um, so now I'm gonna talk about chronic pain, and I want to touch on three particular things here. Uh, we're gonna talk about post laminectomy pain syndrome. That's gonna be that patient that perhaps you see that had seen a surgeon before, had a laminectomy, had a spinal fusion, and they are still having pain. They have back pain and they have pain going down the legs, radiculopathy, sciatica. That is the post laminectomy syndrome, OK? Then we talked about neuropathic and peripheral neuropathy. So, for post laminectomy pain syndrome or failed back surgery syndrome, I don't, I don't like that term, I like post laminectomy pain syndrome or persistent pain after spinal surgery. There's really no clear surgical complication. Everything looks fine, but the patient still has this neuropathic nerve-based radicular pain in the back and the legs, OK? Persistent spinal pain syndrome is the new terminology that we are using in our field of spine medicine. Um, so, those patients usually are not a candidate for further procedures. They might get, you know, uh, further surgeries I should say. They might get some epidurals here and there, but it doesn't really help that much. So spinal cord stimulation, which is when we place two electrical wires inside the epidural space, is the classic indication for these symptoms, for these patients, and it works very, very, very well. Um, it is an FDA approved treatment, uh, supported by multiple randomized controlled trials, multiple guidelines for the management of nerve, back pain, leg pain, CRPS after spinal surgeries, including laminectomies and fusions. So when should you consider referring these patients is if they had. Pain for more than 6 months, if they have a history of previous back surgery, either fusions of laminectomies, they have more of this neuropathic nerve-based pain and they have not improved with medications, physical therapy injections, and they're not a candidate for further surgeries. Obviously, you, this may be a little bit too much and you may not be seeing these patients as often, but you might. Uh, what I wanna call your attention is that it's not because that this patient has surgery already that there's nothing else we can do. We can do it. Uh, some injections may be beneficial here and there, but there's a lot of new therapies that we can offer and spinal cord stimulation is one of those. That is very, very beneficial for this patient population. No, spinal cord stimulation is not new. It's been around for 40 years or plus. Medtronic, Abbott, multiple different companies, N, you name it, Boston Scientific. However, I brought a new company here to uh watch you and BJC which has a technological advantage, OK? And we call it closed loop spinal cord stimulation. And I know this is very, very detailed information, which may be beyond what you need, but I wanna tell you why this is important, OK? So until this company and this technology called Closed loop came up just about maybe 5 years ago in Australia. We were placing the stimulators and delivering delivering energy to the spinal cord and the epidural space without really knowing how much energy to deliver, and is the energy that we're delivering enough to activate what we want to activate. So we were pretty much guessing. Well, now we're not guessing anymore. We use this technology with these electrical wires and these leads, they will stimulate the spinal cord. We can actually feedback and sense back how much energy are we delivering and how much energy is necessary to activate. And it doesn't do that sporadically. It's, it does that 4 million times, OK, a second, OK? And it's adjusting 100% of the time. So if the patient is walking, laying down, standing, coughing in the bathroom, leaning forward and touch their toes or arching backwards, all that energy that is delivered to the target spinal cord is gonna be different based on different positions. This therapy. Number one, can deliver the right amount, send the right amount, and adjust to the right amount. And what that means is if you look to the graphic here, you can see that. Graphic goes all the way up, all the way down, up and down. So the patient is sitting, you have the constant stimulation, the patient coughs. Oh, guess what happened. Stimulation goes up. Walking, stimulation goes up, supine lane, stimulation goes up. So there's a lot of variability, so the patient gets too much stimulation, not enough, he doesn't like it. He's like, this is not working for me anymore. Why? Because we are just guessing. Now, the patient will do all of these movements and we are now able to sense it and adjust spontaneously 4 million times a second, OK? Therefore, that line, as you can see, is steady, OK? We have a perfect dose response curve there, OK? Hopefully, this is not too much information. This is just again demonstrating the difference between what we know that we've done in the past that we were kinda like guessing, and now that we can keep that steady stimulation. And the outcomes are much better. We have data here on 3 years, OK, of of great outcomes. And supported by level one evidence, society, strong level of certainty, improvement in uh multiple domains, as you can see right here, OK? 80 more than 80% people respond, zero expense, that means that out of 200 people that had this done, we removed 0 because they're all doing well. They're happy, they don't want it out. 90%, 89% of the patients would choose this technology again. Improvement in pain, 80% or higher, improving function, improving mood, in sleep, and quality of life. That is pretty remarkable. Data from the US, Australia and the UK. OK. I know I'm running very short here. I have maybe 3 more slides, peripheral neuropathy. This is something else that I'm sure that you've seen in your practice, OK? So very difficult condition to treat very, very hard. Uh, it's a common complication of diabetes involving, you know, chronic nerve pain, feet, legs, hands, also common complication of chemotherapy or small fiber neuropathy, OK? Uh, when What is the general treatment that we do for peripheral neuropathy, right? I'm sure that you know, may know this way more than I do. You will do the gabapentinoids, gabapentin and Lyrica may consider some antidepressants and some, you know, um, anti-seizure medications, then you may consider some light. Can infusion IV that we also do here in our practice. You may even consider some patches to put it on the feet that are capsaicin patches. You may do some alpha lipoic acid or some other supplementation. You wanna optimize the A1C. You wanna ask them to be healthy and exercise and eat healthy and all this sort of stuff. That is all great. That's all exactly that we should do, OK? Then we hit a wall. What do we do next? OK. We don't have an option. Well, now we do, OK? So since 2021, as of 3 to 4 years ago, the FDA has approved treating neuropathy with spinal cord stimulation with high level of evidence with randomized controlled trial and society guidelines, OK, including evidence GMA, diabetes journal, NSA, OK. That this can be very helpful to reduce medications, improve sensation and quality of life, and I'll show you here a uh a study on that. So when should you consider referring these patients to us for uh peripheral neuropathy management with this intervention? So here, we'll be happy to manage gabapentin, Lyrica, all those other medications. Uh, we'll be happy to consider some nerve uh patches like cutenza patches or pepper patches on their feet that can be helpful. Lidocaine infusion, IV can be helpful, but also this is something that we do. Uh, so patients that have, you know, not improved significantly after at least 6 months of conservative medical therapy, they have obviously neuropathic pain and they have failed the conservative approaches. Um, so there's a randomized, uh, sorry, a systematic review and meta-analysis here that was just published about 2 months ago, OK, with 9 clinical trials, OK, with 400 patients, OK. That shows here that uh the patients had had more pain relief and improvement in function with the spinal cord stimulator compared to conservative management or conservative uh medical care. Improvement in pain, improvement in quality of life, uh, and improvement in self-reported, uh, health. So the dismantled analysis specifically said that this is a very effective in helping patients' quality of life in pain with neuropathy. Those are two studies here. Uh, this is from GAMA neurology, this was from neuromodulation, this is from the Journal of Diabetes Science and Technology, and there's also the evidence from the uh Uh, Laet journal. I'm just highlighting here that this is published in high-level uh journals here, uh, and now a lot of endocrinologist, a lot of uh diabetic, uh, associations and neuropathy associations are including spinal cord stimulation as part of their, uh, treatment algorithm. Obviously not super early on, but certainly something that we should keep in mind. Uh, with improvement. This particular study here on the right is probably one of my favorite studies that I've ever seen. I'm just quickly highlighting here the, the methods and results. So they compare patients with conservative medical management alone and then high frequency spinal cord stimulation therapy, and then they cross over after 6 months. So this patients that had spinal cord stimulation, they reported increased number of sensate locations as compared to conservative management, OK? So they had and significantly less likely to develop uh foot ulceration. So ulcerations. So that's remarkable, like you actually see a physiological change in the perception and the sensation of the feet after this therapy. It's really one of the most remarkable things I've seen in my field, at least. Um, and then this was done double blinded, so the examiners were blinded, the patients were blinded, and they were done by neurologists, not by pain doctors examining the foot, but neurologists and podiatrists, people that really know what they're doing, so. All right. Well, that is all I have. Uh, here's again the information about how to refer patients to our practice. Uh, my information is right there. Last name, first name. I go by Vinny Freo, phone number, fax, uh, a little bit of a, um, kinda like a brochure here or a PDF. about um different therapies that we have available. Uh, you can also screenshot the slide and uh I look forward to hearing back from you guys. Please email me, uh, you can text me as well, and I'm always happy to discuss patients if you have any additional questions or concerns. My cell phone number is right there, 563-528-4325. I'll type it on the chat box here in a minute as well as my email. Uh, thank you everybody for your attention. We I have here a few more minutes for questions. If you have any otherwise, please text or um or call or send me, send me an email.
