Hi, everyone. Thank you so much for joining us this evening. We are very excited to be hosting the first NANS APP webinar of 2024, as well as the first webinar on the newly established e-learning platform. Very exciting. Before we get started, I would like to give a quick thank you to NANS leadership for all of their support in EPP education, and a special thank you to Kim and Antoinette, our liaisons, for all of their guidance and help in making this happen. We truly appreciate all of the work. We, as in the EPP committee, truly appreciates all the work that you do for us. This is our disclosure slide here. Next slide. Our topic of discussion is restorative simulation, and this is what our agenda will look like this evening. We will start with moderator and faculty introductions, and then that will lead into an overview of restorative simulation. Dr. Gilligan will be discussing all of the current data and evidence to support the therapy. And we will finish with patient identification and patient physical exam. Hopefully, we can provide you with some tips and clinical pearls that you could bring back to practice and use in the real world. And then we will end with audience discussion and Q&A. Please feel free to type in any questions that you have. Nicole and I will be moderating, and we will be looking at that and trying to get to the questions throughout the webinar and most certainly at the end. And with that, we can get started with our introductions. I am one of the moderators. My name is Casey. I am a nurse practitioner in Manhattan, New York. I work at the Spine and Pain Institute of New York in a large interventional pain practice. I have been in pain management now for 11 years, and I am currently the chair of the NANS Advanced Practice Provider Committee. Nicole is our second moderator of the evening, and I will let her go ahead and introduce herself. Nicole? Hi. Good evening, everyone. Thank you for joining us tonight. My name is Nicole Bush. I am a clinical nurse specialist and advanced practice provider out of Austin, Texas. I work for Direct Orthopedic Care, which is an orthopedic practice with a pain management component, which is a service line that I am on. I have been doing interventional pain now for seven years. And as Casey mentioned, I am the co-chair for the APP Subcommittee for NANS. So for those of you who have not yet joined us, please do. And let me pass it on to Dr. Gilligan. Thanks so much. Good evening, everyone. I'm Chris Gilligan. I'm the chief medical officer and chief quality officer and senior vice president at Robert Wood Johnson University Hospital in New Jersey. And I'm also an interventional pain medicine specialist. And very glad to be with you this evening. And I am Kristen Kline. I'm a nurse practitioner out of Long Island, New York. I currently work at New York Spine and Pain Specialists in a large interventional practice as well. And I've been in pain management for about seven years now. And I am also part of the NANS APP Committee, part of the social media. So for all of you that are tuned in, try to get involved. You can link up with us after if you're wanting to join. And welcome all of you guys tonight. I am Mike Farrick. I am a nurse practitioner at Brigham and Women's Hospital in Boston. And I formerly worked closely with Dr. Gilligan before he left us to go to Robert Wood Johnson. I'm going to start us out tonight with an overview of chronic low back pain. If we could go to that slide. So just an overview of chronic low back pain. So we have radicular pain, neuropathic pain, which predominantly results in leg pain and which is often due to failed back surgery. And then would be reoperation, opioids, palliative therapies like spinal cord stimulation. This makes up approximately one third of chronic low back pain patients. The other section that we're more interested in talking about tonight is mechanical or nociceptive chronic low back pain. This is where you have an initial injury or an overload to the spine and you have loss of proprioception and inhibition of the multifidus muscle. This causes a loss of neuromuscular muscle control, which leads to muscle dysfunction and atrophy. This in turn causes instability, which leads to pain. With the muscle atrophy and pain, you're more likely to have additional overload injury, which causes a cycle of worsening, dysfunction, atrophy and more pain. So really what we want to know is what do we do with this? If we could go to the next slide, please. So what we're here to talk about is restorative neurostimulation for mechanical chronic low back pain with multifidus dysfunction. So restorative neurostimulation is a patient controlled implantable device that's designed to stimulate the nerves responsible for contracting the multifidus muscle. The brain senses the muscle contractions and in response can trigger restoration of muscle control. With the multifidus back to providing stability, the continuous cycle of injury and overload, loss of proprioception and inhibition of the multifidus is interrupted by facilitating recovery. The leads for the implantable device are placed at the L2 medial branch, which elicits episodic isolated contractions, overriding underlying multifidus inhibition. Patients will use this device for 30 minutes, twice a day, which over time can facilitate the recovery for mechanical chronic low back pain. So basically we're using implanted leads at L2 to stimulate multifidus contractions, which overrides inhibition, eliciting proprioception, reactivating muscle control, which restores functional spine stability and in turn reduces pain. Next slide, please. So the system where it's placed, the procedure is done under fluoroscopy. Leads are placed outside of the spinal canal bilaterally at the L2 medial branches at the L3 vertebral body, which is the same level that a probe would be placed for radiofrequency ablation. So it's placed at a known target. The leads are always implanted at the L2 medial branch. The location is not changed based on pain presentation because at this location you get the best full length muscle contraction at L2, which is where the nerve that normally innervates that muscle. The leads are self-anchoring. They utilize tines which face each other and are embedded into the intertransversary muscle. Next slide. There's a picture here of the tines. You can kind of see that the tines are facing each other. This causes the leads to be embedded securely into the intertransversary. During implant the fixation is confirmed by a push-pull test. Just to make sure that it's secure. You're going to use twitch testing for multifidus muscle contraction, which is performed to verify lead positioning. Then the leads are then tunneled subcutaneously into a generator pocket. Overall the case takes about an hour. Mike, so it's my understanding that this is not a, there's no trial for this particular device, right? It's just an implanted situation. When you're speaking to your patients, how is it that you're speaking to them about the fact that there is no trial for it and that it is just an implantable device? So when you're talking to patients, it's really important to discuss that this is restorative and that you're not going to, you can't expect results right away. So you want to describe it like it's almost like an internal physical therapy and that you're, that like physical therapy or working out, you want to build that muscle back up and it takes time to work out, which is why we have patients use it twice a day for about 30 minutes. And it also can be beneficial to show them the, like a video of the actual twitch testing that they use. So that's actually the next slide. Which, you know, you really can, you know, with the probes kind of sticking out there, you really get the gist of what it is. Next slide, please. So restorative neurostimulation, the goal is to facilitate recovery. This is a patient controlled therapy, like I said, 30 minutes twice a day. This patient is utilized remote control to start it. Again, one way to think about this is as an internal physical therapy or passive physical therapy. The device invoked rehabilitative mechanism aimed at restoring multiple neuromuscular control of the lumbar spine, lumbar sensibility by treating the actual source of the problem. We talked about there's no trial because it is restorative. It's like working out. And again, the leads are always implanted at the L2 medial branch and not changed based on pain presentation. Next slide, please. The device is MRI compatible with conditional clearance, 1.5 T for full body, 24 minute max scan duration with the patient being spine. Next slide, please. So just an overview of the multivitous muscle. It is the primary stabilizer of the lumbar spine. There's extensive information in the literature about multivitous dysfunction and atrophy, how they're both associated with chronic low back pain due to arthrogenic inhibition. The multivitous muscle is the most important stabilizer of the lumbar spine. It's also a key sensor for proprioception. Input in the really fundamental thing about the muscle is that it's involuntary so you can't contract it purposely. Because you can't contract it purposely, it makes it very difficult to work with physical therapy to rehab this muscle, which is why a device like this is actually so important. And because it contracts purposely, it actually contracts in the anticipation of movement. Kristen will go over some of the multivitous muscle testing where you can actually show kind of like that millisecond or so that it's contracting before the actual movement happens. And that's pretty much it. I will pass off, I believe, to Dr. Gilligan. Mike, thanks so much. So these are some of the slides that, excuse me, rather, some of the papers that we published over the years about this therapy. A couple that I would draw attention to is the five-year that's got a red border on it right in the middle. Just for point of reference, there's no other neurostimulator that five-year prospective outcomes have been published for. And so we're very proud of that. And we'll also look a little bit at some of the data in older patients and Medicare patients. That's the paper with the red outline just to the right of that. Next slide, please. So let's talk about the data for this therapy. The biggest trial that we've done on it was the REACTiVADE-B trial. And that was a trial of 204 patients. It was prospective, randomized, sham-controlled, and double-blinded. And we have completer analysis that we're going to look at on 126 patients. So 62% of the patients who got stimulation through the five years. We also have an intent to treat analysis that accounts for all of the patients, 204 patients. And we did that with a very conservative imputation model called the mixed model repeated measures. And it's really the totality of the short and long-term evidence for this therapy that supports the safety, the durability, and effectiveness. Next slide, please. So this is what the general characteristics of those 204 patients. On average, they had 14 years of low back pain and had pain on 97% of the days in the prior year. All of the patients, 100% had failed physical therapy. On average, they had been to 31 physical therapy sessions. 100% had failed pain medications. And 37% of our patients were on opioids at baseline. 100% of them had a positive prone instability test on physical exam. And 52% had failed interventional pain therapies, radiofrequency ablations, epidural steroid injections, etc. Key exclusion criteria were any prior low back surgery or any current indication for low back surgery. So they couldn't have an unstable spondylolisthesis or a critical spinal stenosis. They also couldn't have leg pain greater than back pain. We wanted patients who had predominantly no susceptible or mechanical pain rather than patients who had predominantly neuropathic pain. It was okay if they had some leg pain, but it couldn't be greater than their back pain. So if you look at that graphic on the right, that shows where our patients started on average. On average, they had a pain score of 7.3. Obviously, that's severe pain. And they had an Oswestry disability index of 39. That's right where moderate meets severe disability. Next slide, please. So here are some of the pathologies that the patients in the trial had. 70% of our patients had grade three or higher disc degeneration. 70% had grade two or higher bicep joint degeneration. 30% had modic changes. 18% had a stable grade one spondylolisthesis. And 7% had scoliosis. They had to have a calve angle less than 25 degrees. So the point here is that these are patients who had chronic mechanical low back pain that was disabling in the setting of a multifidus dysfunction with multi-level degenerative changes. They are not folks who had a pristine MRI other than multifidus atrophy. Next slide, please. And here's the data through five years in terms of their low back pain. They're measured on visual analogue scale. So the green line is half the patients who got therapeutic stimulation from the beginning. The dashed red line is the patients who got sham stimulation for the first 120 days. And then it turns into a black line when they got crossed over to therapeutic stimulation. So from day 120 on, everybody is on therapeutic stimulation. And this is prospective observational data. And what you can see is over time, a profound improvement in their pain. And that improvement is maintained through five years with no loss of efficacy. So we're not seeing any tolerance, habituation, et cetera. We're seeing complete durability of the therapy through five years. Next slide, please. Dr. Gilligan, one of the audience attendees asked a question. The question is what is sham control or sham treatment? Oh, sure. So the sham was everyone got implanted. Half the patients got turned on to therapeutic stimulation right away. Half of them got turned on to an impedance check. They were completely blinded and we did a careful script with them. They were blinded, the physicians who implanted were blinded, the people doing the assessment were blinded, and we did what's called the James Blinding Index, where you test whether the blinding is effective, and the blinding was quite effective. If you go back actually one slide for just a moment, one thing that you'll notice there, that extra red line, is that there is a pretty profound sham effect. You know, it starts to wear off after about four months, after 120 days, but a sham effect for an interventional therapy is actually very profound, and that's through 120 days. So I would think about that if you, when you see a response to a 60-day therapy, think about that curve from that sham as you're assessing that. Next slide please. So here we're looking through five years at disability, the Oswestry Disability Index on the left, pain, the visual analogue score in the middle, and healthcare-related body of life, EQ5D on the right. The light green is the completers. So I put the number of patients who completed the 60 months, 126 for Oswestry, for example, on the light green bars. So if we start with Oswestry and the completers light green, patients started on average at 39.1. After five years of stimulation, on average, they were 16.5. Anything less than 20 on the Oswestry is minimal disability. In terms of pain, patients started on average at 7.3, and after five years of stimulation, on average, they were 2.4. Anything less than 2.5, we commonly call a low back pain remitter. And after five years of stimulation, the EQ5D, healthcare-related quality of life, on average was 0.807. That's approaching a normal healthcare-related body of life for this age group. So after five years of stimulation, you go from moderate to severe disability down to minimal disability. You go from severe pain to low back pain remitter, and you go back to a normal healthcare-related body of life. Now, you could ask, are those results so impressive? Because we're only looking at the completers, 126, 124, who got to five years. That's where the dark green lines come in. That's all 204 patients from that Intensive Treatment Analysis. And you can see that whether we look at just the completers, or all 204 patients, the results are almost equally impressive for disability, pain, and healthcare-related quality of life. Next slide, please. What about opioids? Here, I'd draw your eye to the far right, to the five-year outcomes. And after five years of stimulation, 46% of the patients on opioids had vulnerable had voluntarily eliminated them, and 23% had voluntarily reduced them. Next slide, please. And let's look a little bit more closely at the accountability. So we have five-year follow-up on 92% of our patients, 188 out of 204, which is pretty remarkable to have 92% patient follow-up. Only 8% lost a follow-up at five years. 62% of our patients reported their outcomes at five years, 126 who got stimulation for the whole time. 13%, 27, were explanted for inadequate response to the therapy. 9%, 18 patients were explanted for resolution of pain. So that's something we've never seen with stimulators before. That's 9% of the patients really got cured by this therapy and said, I don't have any more back pain anymore. We always say to them, hey, turn it off for three months, six months, so make sure your back pain doesn't come back. But if it doesn't, and they want to get explanted, we let them get explanted. 5%, 10 patients were explanted for MRI. As Mike pointed out, there's no need for that anymore. The devices are now completely MRI compatible. And 2% were explanted for infection by patients. Next slide, please. So how can we summarize this five-year evidence? On average, pain improved from 7.3 to 2.4. Oswestry improved from 39 to 16. 78% of our patients had a 50% or greater improvement in pain and or disability. And 69% of our patients on opioids at baseline eliminated, that was 46%, or reduced their opioids 23%. 67% of our patients, two-thirds of our patients were low back pain remitters. So that's really one of the things that I point out when I'm talking to a patient about this therapy is there's a two-thirds chance that you'll be a low back pain remitter. We also saw a favorable safety profile compared to other implantable neurostimulators. And importantly, we saw zero lead migrations through five years. And lead migrations, of course, are one of the most commonly reported complications of spinal cord stimulators, dorsal ganglion stimulators, et cetera. So if we look at the red dot where the patient started on the right, the green dot is where they ended up. Next slide. Now, one of the things that we commonly see, unfortunately, with spinal cord stimulators is that we'll see great results in clinical trials, but we can't reproduce those same great results with real-world patients. So here, what we did is we took the A and B study, which are two clinical trials, are two clinical trials. Those are the dark blue lines here. And then the two real-world studies that we did, the two registry trials that we did, the C and the BMCF, those are the light blue lines. And here we're looking at the Oswestry Disability Index over time. And what you can see is whether we look at clinical trial patients or real-world patients, the results for disability are equally impressive in both groups. Next slide, please. Here, we're looking at the same thing, but for pain. And again, we're seeing that clinical trial patients and pain patients get the same clinical trial patients and pain patients get the same excellent outcomes. Next slide, please. And finally here for healthcare-related quality of life. Again, the clinical trial patients and the real-world patients are getting the same outcomes for quality of life. And this has been published, Simon Thompson and colleagues in the UK have published on these real-world patients. Next slide, please. So you mentioned during the study, the, one of the contraindication, I'm not, one of the things that was excluded was anybody who had had previous back surgery. Is that a contraindication for having restorative stimulation done? That's what I'd say. All of the evidence that I'm showing you here is, and I'm glad you asked the question, is on patients who didn't have spine surgery. So really this is the FDA labeling, et cetera, is, is, is for non-surgical low back pain in patients who have multipitous dysfunction and mechanical chronic low back pain. So, so I would say yes. There are certainly some clinicians who will implant, you know, for patients had a hemilaminectomy or a, you know, an anterior approach on a single level disc, but that that's clearly off label. Unlabel is non-surgical low back pain, to be clear. Next slide, please. Oh, I'm sorry. The, yeah, the, the point here is, the identification of the patient really comes down to patient history, clinical presentation. And when those line up, that's when we really should be thinking about the restorative neurostimulation. Fantastic. Thank you so much, Dr. Gilligan. I think Kristen will be presenting some of the clinical pearls for patient history at this point. Terrific. Thanks so much. All right. So we're going to take a little deeper dive into patient selection ID. What to look for on physical exam and MRI findings with these patients. Because right, like everything that we do, patient selection is key. And we want to find the right therapy for the right patient. With this therapy, you really don't want to discriminate with age. In the studies, it shows that patients that are elderly, middle aged, even younger, all did really well with the therapy. And as APPs, patient selection is key. We're doing a lot of education with our patients. These are patients that you may be identifying where they're getting multiple epidurals, medial branch blocks, maybe multiple radiofrequency ablations, and maybe they're not getting enough relief, or these ablations and therapies helped initially, and maybe are not lasting long enough or not just doing well enough as they keep on getting them time after time. And it's important to note, as these patients continue to get radiofrequency ablations, we are weakening that multifidus muscle every time they get that denervation. If you guys prescribe opioids in your practice monthly for chronic low back pain, and maybe you've exhausted efforts with injections, failed stim trials, and so forth, take a look at the patient again. Take a look at their history, their presentation, their physical exam, their MRI findings, or get an MRI if they haven't had one in a while. And you may find out, hey, they really are a candidate for this. So, old and new patients may be a great option. So, with the next slide, we're going to kind of dive into what does the MRI findings look like. And when I was learning about this, I had to kind of bring this back into the algorithm of when you go through your MRIs, you read your MRIs a certain way. I introduced this into my algorithm, and now it's become part of what I do with every single MRI that I read. So, with these patients, they'll have some fatty infiltration or atrophy of the multifidus muscle. So, you can see the picture on the left, the normal multifidus. You can see there it looks pretty good. And then over time, it can become more moderate or severe through that whole pathophysiological process that Mike talked about. So, you want to look at these patients with the more moderate or severe atrophy. And a lot of times, I get asked by patients, like, how did this happen? Or why did this occur? And they may be weary about having something implanted in them. And a little tip that I learned from another physician who was doing this procedure actually taught her patients, and this is part of her talk track, where she'll go over the MRI with the patient that's more recent. And then if you have access to an MRI maybe from years ago, you can actually show the patient the progression of that fatty infiltration or atrophy that has occurred over time and let them see how this has progressed and what the problem is. And sometimes, they're more inept to want to undergo the treatment if they kind of see, wow, there's a problem that's progressing over time, and now we have a therapy to fix it. Next slide, please. So, a lot of these patients will come in, as we said, with more axial low back pain, right? So, it has to be more back pain than the radicular component. A lot of times, they'll say that the back feels unstable. It could feel weak, fatigued. They may have some sudden pain or spasms when doing light tasks or a sudden little movement. So, a lot of the times, getting up from a sitting to standing position may cause some pain or just those little movements here and there. They may have feelings of pain, weakness, fatigue when standing up in front of the sink, such as doing dishes or unloading or loading the dishwasher, brushing their teeth. And they may have to sit down or rest after doing all of these things. They may feel better with a back brace because it's helping to support the weakened or their low back pain that they're having. And they may even have to, like, lean over a counter or support themselves with their arms to help basically get the pain to get a little bit better and help with that weakness. And like everything that we do, right, we always want to say what hobbies or activities of daily living or things that you love to do were you able to do in the past and now you're not able to do. So, I always have the patients write down three goals of anything with work or hobby-related. And those are the goals that we want the patient to get back to do with any intervention. Next slide. Before you move on, we did have a question that was asked regarding the MRI findings of atrophy. Have you seen evidence of reversal of this atrophy after using restorative stimulation to date? So, I believe that the company, and I know Dr. Gilligan can probably speak to this, but the company is, the MRI conditionality just came out in February. So, I think, I believe these patients are being studied. We don't have any data that's published yet, but they are looking at any changes, I believe, now that these patients are able to get MRIs. Yeah, that's exactly right. The only thing I would add to it is we do have a sheep study with histology and sheep showing reversal of the changes after six months of stimulation, but that's exactly what Kristen said in terms of the MRIs. So, keep on the lookout for that in the future. Next slide, please. So, obviously, as APPs and providers, right, we want to hear our patient's story, have them tell the story of when they get their pain, and confirm with your physical exam testing and then your MRI findings. And with this type of patient, you're still going to do all your other tests, any pain with flexion, you're going to go through everything straight leg just to make sure you're ruling out any other pain generators and to make sure that the patient's not symptomatic of multiple pain generators. There are three tests that we show here. And if you guys go on to the website, it will show you an in-depth video of how to do the test, a little bit with a demonstration. We'll go over them briefly. You don't have to have all three to be a candidate for the procedure. You can just have one. If they have all three, great, it just helps confirm your diagnosis. Of note with the pronunciability test, 100% of them had a positive finding with the REACTIVATE-B study that Dr. Gilligan spoke about. The easiest test to do is the multipitous toe touch test. That's easiest probably for an elderly patient. And if you're not, if you don't have access to an exam room table at your office, so this is going to test for motor control dysfunction. And essentially, what you're going to do is have your patient bend over or flex forward as far as they can, and then have them come back up. And a positive finding to this test is if they have pain after they flex and come back up, if they have to basically walk their hands up their legs to help them straighten back up, that's a positive GOWR sign, or if they kind of have to sway their back from one side to the other to help lift themselves back up. Those are all positive findings. And that's the easiest to do in your office setting. The next test you see on the far left is the prone instability test, or the PIT test. It's going to test for painful dynamic instability. And with this, it can be a little challenging sometimes for elderly patients or patients that are in a lot of pain, or again, if you don't have access to an exam table, so you kind of have to just ad lib. But what you want to do is have your patient lie prone, as you can see there with the legs at a 45-degree angle. And you want to maintain the spine in a neutral position. You don't want them to have any lordosis or anything like that, because that can cause a false positive to the test. And what you're going to do is find the iliac crest on either side, and then drag that across to the L4-L5 spinous process. And you can really work your way up and start from L1 all the way down to L5. But typically, as you work your way down to the L4-L5 region, you'll get more of a positive response right away. So if you're short on time, you may just want to start at the L4-L5 level. And what you're going to do is basically use the pisiform of your where your hand meets your wrist and kind of glide right off the spinous process straight down. When the patient experiences pain when you do that, you're going to have them lift their legs. And if the pain goes away when the patient's legs are lifted, that's a positive test finding. So you can start from L1, go all the way down to L5, and keep going down until they elicit that pain and have them lift their legs up. But again, if you're short on time, you can start around the L3-L4-L5 region, and you probably will see that they have a positive test finding right away. Then the last test is the multipetous lift test or testing for multipetous activation. And again, the patient is lying prone for this. And you can put a pillow, as you can see there in the diagram, onto the pelvis if there is lordosis. You want a neutral spine. So again, you're going to find that L4-L5 level. And around the spinous process, you're going to kind of work your two fingers right off the midline of the spine to find that gutter in between. And you're going to push down and if you're on the right side of the patient, you're going to have the patient lift their left arm, and you're going to feel for muscle contraction. You want to feel and make sure that the muscle is contracting. And you can do that on the opposite side as well, if you're on the left side of the patient pushing down, you're going to have them lift their right arm. If the contraction does not occur, that is a positive finding. So that's obviously showing weakening of that muscle. So any of these three would suffice. All three are great. But again, for insurance purposes and for indications for the procedure, you don't have to have all three. And next slide, please. So kind of tying it all together, taking a good history. Right? Hearing your patient's story. When do they get their pain? What makes it worse? What makes it better? Do they have six months of physical therapy or conservative medical management? So you want them to have chronic low back pain, right? Not a surgical candidate. More axial low back pain, more so than the neuropathic or radicular component, right? So back pain has to be greater than leg pain. And you want them to have that for at least six months, as well as having pain that's refractory to physical therapy and at least medications. There is no pre-diagnostic test for this. But like I said, a lot of the patients that are living in your pain practices or neurosurgery practices that have undergone epidurals, MBBs, RFAs, and so forth may be a good candidate. The physical exam testing is helpful to confirm your diagnosis. And they have to have some sort of fatty infiltration or a multipetous dysfunction present on your MRI. Once you have all of that, those are your clinical cues to indicating your patient for a restorative neurostimulation. Next slide, please. I think we have some questions. I don't know, Nicole, do you want to get on that? We actually have several questions I was waiting for you to finish. No, no, no, I got you. I'm so sorry. So one of them actually ties into a question we were talking about a little bit earlier as to whether or not you had to fail any particular procedures prior to considering restorative stimulation for low back pain. One of the questions that was asked was, you know, based on the criteria that was discussed, almost everyone with mechanical low back pain could potentially be a candidate for restorative stimulation. So what would be the differentiating criteria for restorative stimulation versus choosing something different? You know, is the MRI the main thing? I think it comes down to the patient's story and their physical exam. So you want to hear from the patient, does your back feel weak? Does it feel fatigued? All of those signals that we saw on the prior slide, making sure the back pain is more axial in nature and not radicular. And just little movements, spasms, weakness, sit to stand transitions, that's all a good indicator. And a lot of these patients that live in our practice have undergone epidurals, RFAs, intradiscal injections, BVN ablation. This is a great adjunct for patients that may have gotten some relief with some of those therapies, but still continue to have persistent symptoms or feel like they've been in rounds and rounds of PT for months. And they're just plateauing and not getting better. Because again, as Mike said, this muscle is so hard to essentially activate, right, or rehab and get stronger. So these are all excellent candidates, especially after those other therapies too. So would that be, well, I guess number one, do you have to fail these procedures prior in order to be able to have something like restorative stimulation approved? Or no, it is not a requirement. And then second, would that be, I mean, are you often waiting for them to have failed? I mean, even though it's not a requirement, often waiting for them to have failed before looking at their MRI again to see if they have these fatty infiltrates. I think for sure you want to see how long their back pain is going on for. So it has to be at least six months. And if they're coming to you with a flare-up of back pain, you want to ask the patient, have you ever had back pain like this before? Because maybe sometimes there's exacerbations and remissions that go on for years or decades. So that's important as part of your history taking. If they're coming in and it's only been a month or two, obviously you want to try them on some NSAIDs, get them into physical therapy, a good rehab program to strengthen their low back, their core, their legs, and then see them again in six, eight weeks and kind of see how they progress over time. But again, the minimum you want is at least six months of chronic low back pain. We also got the question, is there any role for EMG studies when selecting patients for restorative stimulation? Is that, is that? Yeah, not in clinical practice. In the research setting, we do EMG fine wire for these folks and we see in chronic low back pain patients will have decreased EMG activation of the multipetus, but no need for EMG in the clinical setting. And we actually have a question directed at you, Dr. Gilligan. The hypothetical scenario was given to us. You identify an ideal patient for this procedure and you're unable to get the procedure covered and have exhausted options. What would be your next treatment of choice? Sure. I mean, look, the first thing I'd say, well, a couple of things I'd say. One is, um, we really do fight these on appeal after appeal all the way through, because by doing that, we, we put access, uh, you know, on the system to increase patient access. So it really is a chance for all of us to, you know, to do some advocacy through, through the appeals and get patients better access to these therapies. And, you know, we're, we're, we're, we're, we're, we're, we're, we're, better access to these therapies. And, you know, our, our system is not set up when there's an innovative therapy that works, our system still puts hurdles in front of it, but we, as clinicians can all, can all help to knock down some of those hurdles. Um, I think one other thing I'd say is for us, a lot of times we're putting this therapy far ahead of the other therapies, because most of the other ones are ablative or destructive or are palliative symptomatic therapies. And this is restorative, or Dr. Kiran Patel, because of a disease modifying, right. I mean, this is changing the, you know, it's fixing the problem. And, uh, there's something very valuable about that. And there's something that a lot of patients respond to of, look, you're not going to just cover up my pain, you know, that that's what we'll often put this in front. Otherwise, if, if, if really we do all the appeals and we can't get this through, yeah, then we would look at things like basal peripheral nerve ablation, et cetera. So in your practice, Dr. Gilligan, where are you putting this in the algorithm? Ahead of the ablations, um, really they, they have to have failed. They, just like Kristen said, they have to have six months or a year of pain and they have to have failed physical therapy. They have to have failed medications, but, but we're putting it ahead of ablations, we're putting it ahead of, you know, spinal cord stimulators or dorsal ganglion simulators, things like that. And which insurance companies are currently covering it? Do you know? Well, you must know. Of course you know. So, so Medicare covers it. Medicare. Just Medicare. I mean, yeah, I wouldn't, um, so Medicare obviously covers it, but this is a lot of, like the other therapies that have come out in our pain world. And so if you feel even a commercial insurance or a worker's comp, no fault, whatever is a candidate for this, you want to put this through, put the diagnosis code through, which we'll go over and keep submitting. Because as Dr. Gilligan said, this is going to help drive payer awareness. So if they keep seeing this, this is going to help drive payer awareness. So if they keep seeing this, this is going to help drive payer awareness. So if they keep seeing the need for this therapy, the diagnosis code is popular. They're seeing it more and more. They'll hopefully get more positive insurance policies over time. Yeah. And we've gotten coverage from some of the Blue Cross, like Blue Cross, Blue Shield, Alabama covers it, for example. So it's a, you know, it's just a fight region by region, payer by payer, getting more and more access over time for patients. There is another question here. Is there an optimal amplitude when testing intra-op? I don't know if Mike or Dr. Gilligan want to answer that. So the, the, the, the frequency is always 20 Hertz because that gives a smooth titanic contraction of the multipenis. And the pulse width is always the same. The amplitude really is going to vary. That's really the thing that the, that the reps are adjusting is the amplitude. Intra-op is less important because they just want it, you know, they'll turn it high so they can, so you can just feel it and see it. And then post-op they'll turn it. One of the things they'll do is they'll turn it up until it's so strong that it's uncomfortable and then they'll turn it down to 80% of that. Some of the reps will do that. When, when it provokes the contraction, you can, you can see it like in the video that Mike showed and you can feel it and the patients can feel it. They say it feels like a strong, deep tissue massage. So it's pleasant, but it's a strong, it's a strong contraction for them. Another question here. Thank you for the great presentation. Is there a limit to which area of the spine as levels covered? Kristen or Mike, do you want to do one? Do you want to take that? Yeah. Mike, do you want to take, I think, well, Mike presented on it. So it's the same. So, so the, the leads are placed at all two and always placed at all two. And always placed at all two, regardless of the, the, whatever the pain presentation is. We, we, if you, even if you're considering other levels it's always at all two because that's where you're getting the best contraction of the multifidus. And it's always two leads, correct? Correct. Two leads in their time. That's how they're anchored in place. And as another question for Kristen, Mike, I know you two are, you know, lead APPs. How do you encourage your APPs to change how their identity, like their, their, you know, identification algorithm in terms of physical exams and like what they're looking for on MRI? Do you have any tips for any of the APPs listening on, you know, how to change their practice a bit and change some of their habits? Yeah, I think it's just repetition and having, we have a, try to have a meeting, educational meeting every week. But actually mainstay came to our practice and we tested a bunch of patients that had low back pain and that's how they, the physical therapist taught us how to do those three physical exam tests when they came into the practice while testing it on our patients. It was a great educational opportunity to be able to practice on real people and get to learn how to do that testing. And, and basically it was, it was a good day. So I would definitely recommend reaching out. We can get that coordinated for you if you guys were interested in that. And another question, what are the CPT codes for the procedure? Is that something we can, I don't know offhand. Anybody know that's offhand? The CPT codes are peripheral nerve. So it's the same codes as peripheral nerve lead and peripheral nerve IPG. And then the diagnostic code, the ICD-10 codes, there are, there's one which is wasting atrophy of the muscles of the lumbar spine. And then there's another that will be approved very soon, which is a multivitous dysfunction lumbar spine. And those are specific ICD-10 codes along with chronic low back pain. So it is also my understanding for this device that it sometimes can take six months or several months or more to see results. How are we talking to patients who might be? I think this is something where you have to set the expectation off the bat at every encounter and let them know that it can take several months over time for you to slowly get better. And it's not going to be a quick fix where overnight or a couple of weeks or even a month from now, you know, you're going to feel better. It's going to take some time. And also with no trial, right? So it's a little bit of a different talking track to patients. I think you're back now, Nicole. You were frozen there for a second. I think also for the follow-up. So what we typically do is we'll have the patient come in like 10 to 14 days after the procedure, do a wound check, and then the rep will be there to basically turn it on and make sure everything's firing, we're getting good contraction on both sides, and kind of adjust the amplitude and settings as needed. And then we will typically follow the patient and get a VAS and Osteoporosis Disability Index score every visit after the procedure to compare to what was prior. And we usually see them every four to six weeks, at least until six months. And depending on how they're progressing, that's how we'll follow them. And I think there's another question here about where you're facing the IPG recommended spot implant site. So the IPG, the standard IPG placement, just like you would for a spinal cord stimulator, you know, above or below the belt as you would for a stem. And in terms of the no trial, just a couple quick points. One is most patients actually aren't expecting a trial. That's more a thing that we all expect as clinicians, right? And without a trial, we're still getting, you know, 67% of the patients are getting low back pain remitter status. So clinically, there isn't a need for the trial. And in terms of outcomes, we're getting these outcomes without the need for a trial, and it spares the patient, you know, one additional procedure. And just to piggyback on the CPT code. So for the implantable pulse generator, it's 64590. And then for the electrode placement, it will be 64595. We had another question regarding lead placement. It was asked, do you ever need to reposition the lead? Any clinical pearls on how to adjust the lead if it appears to be in the right place, but you don't see a good muscle contraction? Yeah, the main thing is you're really trying to place it, like Mike said, right at the junction, the base of the superior articular process where it meets the transverse process. You know, it's essentially identical to where you try to place a radiofrequency cannula. If it's placed like that, the chances that you'd need to reposition are extremely, extremely low. So it's really just about getting it plugged into that groove right where the base of the transverse process that meets the base of the superior articular process. Any other questions from the audience here? So with that, just as a reminder, NANS is now using the new established e-learning platform. They will require access to the platform, will require membership moving forward. So if you're not a member, please consider joining and becoming a member so that you have access to all of these really educational, you know, great topics and webinars that will be offered. There's a few coming up. We have another APP webinar on June 25th on DRG, another exciting topic. So if you're interested, reach out to any one of us. We're happy to, you know, point you in the right direction to become a member or to get involved. And thank you so much to Dr. Gilligan and Mike and Kristen for agreeing to be faculty. When we were discussing our first webinar of the year, the topic that was requested the most was this one. So we were so excited that you agreed to be here and to speak for us. And there's a lot of excitement around restorative simulation. So thank you for giving us the education and being a part of APP education. We appreciate it. We appreciate you. And thank you so much. Thank you for everybody for attending. Again, feel free to reach out to any of us moving forward. We'd love to meet you and we'd love to network with you in the future. And thank you to Nicole for being my moderator. Before we lose all of our expertise, we do have one remaining question, if we can. Where do you usually make an incision for this device? And is there a rule of thumb that's used? Sure. So you typically make about a centimeter and a half incision right over the L4 spinous process. That's where your needle entry point is going to be. Right in the midline, centimeter and a half or so, right over the L4 spinous process. And then you're going to tunnel from there to your IVG pocket, which you'll do in a standard IPG fashion. And also I want to take the chance to say thank you so much for giving us the chance. Thank you. So I think if there are no more questions, I don't see any trickling through, we can end a little bit early. Thank you everyone for joining. Look forward to seeing you again. Yeah, we look forward to seeing you again.

Restorative Stimulation

Dr. Gilligan

Casey Grillo

Nicole Busch

Mike Ferrick

Kristen Klein

Multifidus Dysfunction

Restoration

clinical data

restorative neurostimulation

chronic low back pain

patient selection criteria

physical exam testing

MRI findings

post-procedure follow-up

patient expectations

insurance coverage

lead placement