Good morning. I'm Mehul Desai. Welcome to our Advanced Pain and Spine Interventions discussion, a debate pro-con style session that we've put together. Really excited to be here. I want to thank the Academy for hosting this and doing such a great job pivoting to this virtual visit, I mean, virtual conference, pardon me, virtual visits in telemedicine are on my brain. My name is Mehul Desai. I practice in Washington, DC, and I'll be moderating this debate. Just so you're aware, due to the high volume of CME and high participation in the meeting, there is a lag in transferring your participation data to the online learning portal for certain sessions. Rest assured that your participation in all sessions is recorded. The Academy is currently working on the backend to speed up the data transfer. They will send a notification to all registrants once the process is updated and all the data has been transferred. Really excited to have this group of speakers together. This is my disclosure, none of which is relevant for today's conversation. We've divided this up into three cases. The first case is spinal cord stimulation versus peripheral nerve stimulation for low back pain. And we've got Dr. Rispoli doing the pro for spinal cord simulation and Dr. Karanopoulos doing the pro for peripheral nerve simulation. Then we'll go over to radiofrequency ablation versus fusion for sacroiliac joint pain. Dr. Lin will advocate on behalf of RFA and Dr. Singh will advocate for fusion. And then we'll wrap up with minimally invasive lumbar decompression versus indirect decompression via interspinous spacer for lumbar spinal stenosis with Dr. Leong taking the mild side of the argument and Dr. Weissbein taking the interspinous spacer side of the argument. Each person will take about eight minutes to give their talk. I'll introduce each case. And then at the end of all the cases, we'll have three different polling questions about the cases that we discussed. Scenario one, case one is a 45 year old male with chronic low back pain of 12 months duration. His low back pain is worse with standing, sitting and walking, not completely relieved by recumbency, no significant lower extremity pain in any dermatoma fashion, mild bilateral buttock pain with prolonged sitting, no significant medical history, no prior spinal surgery. Previously had 80% transient relief with epidural steroid injections and good greater than 80% relief with lumbar medial branch blocks, but non-durable short-term relief with bilateral radiofrequency ablation, no neurologic signs on examination. And this is, you can see previously this was the sagittal MRI and this is the axial cut. Without further ado, I'll pass it over to Dr. Rispoli to introduce herself briefly and go through her slides. Hi, I'm Leah Rispoli from Los Angeles, California. Thank you for having me today. I'll be talking about spinal cord stimulation in this case scenario for low back pain. So I have no relevant financial disclosures. Just some brief background, which most of you probably already know, so it's a review. But this spinal cord stimulation ideas developed from the gait control theory, which was coined in 1965 by Wal Melzack. Two years later, dorsal column stimulation developed to now where we implant about 50,000 of these a year. Metal contacts are placed in epidural space. Electrical stimulation causes activation of these dorsal column axons. Charges delivered, specific pulses, widths, and amplitudes, and where it's developed over the last few years having these novel modalities and waveform programs versus what we used to call conventional is now developed into other types of high-frequency, DRG, burst, 3D targeting, which we'll discuss a little bit more of. Mechanism of action, conventionally, we know that the stimulator causes activation of these dorsal column fibers. Resulting in developments or variable effects on sensory and pain thresholds. And then there's some data that we'll discuss later about measurable alterations in the higher order of cortical processing. The novel waveforms, a lot is not completely understood, but the theorized mechanism of actions is a combination of segmental and supraspinal mechanisms, whether or not there's modulation of neurotransmitters, why dynamic range neurons, glial cells, not completely understood, still studied. A lot of data coming out in the last few years about the support of which mechanism of action is the most efficacious. So clinically, where do we apply spinal cord stimulation most? Felt-back syndrome, CRPS, diabetic peripheral neuropathy. I highlighted this one, the chronic intractable pain of the trunk and or limbs, because this is interpreted a lot by pain physicians as axial low back pain, the intractable pain of the trunk. But it's mostly used traditionally in radicular pain syndrome. So as we know, there's a trial for seven days where a patient is evaluated after seven days with a not permanently implanted. And if considered successful, then it is permanently implanted. Clinical relevance of spinal cord stimulation. So a lot of the studies when compared to conventional therapies and the chronic low back and leg pain have shown favorable outcomes, being more cost-effective than chronic, sorry, conventional therapy for chronic low back pain, shorter hospital stays, lower complication rates. And it's also associated with significant improvement in health-related quality of life, health status, and quality adjusted life years. So in this particular clinical scenario, you know, that some of the background is a little limited. So bear with me. The MRI in axial view, it definitely has some consistent central stenosis, whether or not it's ligament of the labrum hypertrophy causing mostly symptoms. I expect this patient to have some neurogenic claudication symptoms, whether or not he recognizes them as symptoms or not. The buttock pain he describes could be, or she, sorry, it could be a symptom of neuropathic symptoms. Found it interesting also this 80% but transient relief with the epidural steroid injection. It's a reasonable, in my opinion, a reasonable treatment option to offer this patient since he sounds like they failed conventional treatments. I'm going to briefly touch on the low back pain data for spinal cord stimulator use. There's all these competing companies that's, you know, recently trying to push emerging quality data, proving efficacy in low back pain. So we have our SENZA Act or SENZA, I'm sorry, SENZA randomized control study, paresthesia high frequency spinal cord stimulation compared to low frequency stimulation for treatment of chronic low back pain. The cohort that is applicable to this patient is the non-surgical refractory low back pain because the patient has not had surgery. So kind of puts them in a different category, but 80% of these patients reported a greater than 50% reduction from baseline. And then we move on to Lumina study, which is a little bit more recent. I'm using the anatomically guided 3D neural targeting and 32 contact leads. These patients at 24 months showed a responder rate of 71% versus the 41% for traditional and conventional spinal cord stimulation. DRG, you know, this is a smaller subset of patients, but this is a pretty, you know, impacting case study at least to keep in mind that when used bilaterally at the T12 level, eight month follow-up, half these patients had relief of over 80%. And this is all low back pain patients with substantial improvements in physical mental health. The DTM randomized control study using glial cell modulation is fairly new, but it's showing promising data with patients that have about 84% of these patients with over 50% improvement at 12 months. A couple more, just brief touching on some studies. Burst has been around a while. There's a lot of data on burst versus traditional, but the cohort that applies most to us is the study that included 60 odd patients for chronic low back pain and leg pain at three, six, and 12 months that showed some rewarding results. And then finally, these new companies, the closed loop evoke spinal cord stimulation system looks also very promising. At 12 months, axial low back pain patient population average sustained improved 80% relief in function, disability, and sleep. So there's a lot of data out there, but this is just kind of summarizes what is kind of hearsay talk amongst the pain physicians and what's seeming promising for use of spinal cord stimulation and axial low back pain. So next two slides are just kind of my opinions and anecdotal experience to argue spinal cord stimulation over peripheral nerve stimulation. So peripheral nerve stimulation, it's in its role and I've been trained in it and I'm more waiting to see the emerging evidence over the next few years. I think we're a lot further along with spinal cord stimulation data. A lot of the data is emerging and looks promising. A lot of pain trained clinicians have spinal cord stimulation experience, but less peripheral nerve stimulation experience. Maybe they're only briefly trained in it or they've taken one weekend course. So, you know, it's still not considered. I think everyone being comfortably trained in it enough to offer patients. Most spinal cord stimulation implants require a psyche valve. I like that even though, you know, I think it's another step, but it also intensifies the screening process of patients that we choose to pursue spinal cord stimulation. This point is taken with a grain of salt. It could be good or bad, but there's definitely a lot more companies that are driving the competitive nature of spinal cord stimulation. So there's also, you know, push for it to be utilized and we have to be careful about how, you know, our patient selection, but it also drives the nature of, you know, data and studies and the competition of who, you know, which company is going to be able to emerge is like the first, you know, company to really have some really powerful data for this patient population. Then just a couple of smaller points. Peripheral nerve stimulation, there's companies that have a 60-day implant and then removal. I'd be interested in the number, percentage of relapse rate in these patients and interested in the rate of complication and infection compared to spinal cord stimulation, which we'll hear next. And, you know, I find it anecdotally like pretty rare to have people that just have axial low back pain alone. I mean, that's like not including buttock or hamstring or any kind of lower extremity symptoms. So I like that spinal cord stimulation can cover other related pains and is more likely to have a long-term efficacy. And then there's the evidence of the spinal cord stimulator having altering, sorry, the higher cortical processing of chronic pain, which is an interesting thing to think about in a lot of these patients as another way to treat their pain. So that's my argument. Thanks for having me. Dr. Karanopoulos, I think you're up. Good morning, can you hear me? Good morning. This is Alexios Karinopoulos. I apologize for the technical difficulties. I am the chief of PM&R at a large academic medical center affiliated with Brown in Providence, Rhode Island. I am a subspecialist in pain medicine, and I'm happy to be here. I'm friendly with this group, and I think we are a great collaborative group that can discuss the pros and cons of all of these things. So thank you for having me. So in terms of the burden of low back pain, there's a huge economic problem related to this, and obviously a human problem related to chronic low back pain in terms of years of quality of life lost. And you know, I think it's a really big problem that's facing America, and interestingly during our pandemic, our business hasn't slowed down at all. In fact, I think the stress and anxiety related to pain in general in people with chronic low back pain has unfortunately blossomed. So we see a lot of patients, we're seeing more than ever, perhaps who can't manage or deal with their back pain. But in any case, there are generally two types of back pain, and you really can look at it in terms of nociceptive or neuropathic. And in terms of neuropathic pain, the traditionally peripheral nerve stimulation has been a newer advancement in terms of dorsal column stimulation. I think traditionally over years, the technology was really based upon spinal cord stimulator or dorsal column stimulator electrodes. So over time, there has been a significant evolution, and now there's a great opportunity for peripheral nerve stimulation. So in terms of the peripheral nerve system, there are 43 pairs of motor and sensory nerves, and these connect to the entire body in terms of managing sensation and function. Because they're so small and fragile, they can be damaged easily. But it does provide an opportunity for targeted therapies that are using some of the newer technologies to really treat chronic low back pain. And traditionally, in patients with spinal cord stimulation or dorsal column stimulation or even DRG, there has been a lot of data demonstrating improvement in both aspects of pain and function. And these leads are put in the epidural space, they're durable, they have known targets, and the complication rates are relatively low. Peripheral nerve stimulation, in contrast, doesn't have the same amount of data in part because the technology wasn't available at the time. So next slide. So in looking at the difference between peripheral nerve stimulation and spinal cord stimulation, really one needs to consider the fact that there can be a response that's either restorative or palliative, meaning you're treating the pain and the related symptoms, or you're actually changing the pathology and retraining the muscles and perhaps preventing low back pain. So in terms of studies for chronic low back pain, most studies using peripheral nerve stimulation really don't look at the long-term data when evaluating efficacy. And currently, they're looking at data that's based upon older systems. So in terms of palliation of treatment, you're really targeting nerves that would transmit pain signals to the brain. There's a tiny implant, which is really a thin wire, a group of electrodes that's placed over a peripheral nerve. It delivers electrical impulses. It changes the way the brain perceives pain. And electrical pulses really interrupt or change the pain signals sent from the nerve to the brain. So that's the general idea of spinal cord stimulation, dorsal root ganglion stimulation, for the treatment of pain. Whereas restoration using peripheral nerve stimulation really stimulates muscles. It restores functional segmental stability. It prevents the stimulation of the muscle fibers themselves. And the main objective is to really restore control of these segments. And essentially, what it does is it prevents chronic low back pain over time. Next slide, please. So there have been several systems that have hit the market. And the first one that really started to revolutionize peripheral nerve stimulation was StimWave. And StimWave has gone through several years of advancements. But essentially, it was a new opportunity for targeting the peripheral nerve system using specific electrical equipment that was designed for peripheral nerve stimulators. And one of the advantages of this system was that it had an external battery. So for some patients who were undergoing stimulation therapy and who undergo it now, the idea of having an implanted battery in their body is just not palatable. So in some of these scenarios, having an external battery over time that can be applied using a specific garment has been very attractive. So this is an evolution from dorsal column stimulation in terms of its applicability and generalizability to a specific target population. Next slide. So there have been some advances in the StimWave technology. One of the newer companies is Nalu, and another one is Bioness. And essentially, these are both variations of a theme. The technology is getting smaller and smaller, and you can still attach the electrodes to either a permanent implant or a temporary implant, whereby you can train the nervous system without having to do a permanent system. Next slide. So in terms of restorative therapy, there are two new systems that are out there. Next slide, please. So as we were saying before, restoration of neuromuscular control is really something that is of value, especially to the physiatric community. And in the Reactivate system per se, this is a company that just got FDA approval in the United States, the neural target is actually the medial branch of the dorsal ramus. And these electrical targets are stimulated twice a day for 30 minutes to really override underlying inhibition of the muscle from atrophy and lack of use to reactivate muscular control of the system, and over time, restore the functional stability of that segment, and in turn, reduce pain. So it's a very interesting cycle which is predicated upon impaired control of the muscle structures and the stabilizers of the spine from lack of use lead to functional instability. This specific therapy can target these muscles, retrain them, restore stability, and over time, lead to prevention of low back pain. Next slide. In particular, in terms of Reactivate and the latest studies that led to FDA approval in the United States, although the primary endpoint of the study wasn't achieved, because the secondary endpoints, which had so much value in terms of quality of life and pain and function, were achieved, this led to FDA approval in the United States, and this included functional measures such as Oswestry Disability Index, the EQ5D, the percent of pain relief, the resolution of back pain. So over time, these are something that have been shown to continue after a break point in the study, which was 120 days, when the two groups actually crossed over. Next slide. So when looking at this latest technology in terms of targeting the multifidi muscles, there is another system that is competing with Reactivate and the mainstay device, and the idea is that you don't necessarily have to have an implant that's in place longitudinally, but that you can actually stimulate the muscles in a short burst or several months of therapy to retrain them and not have to undergo a battery placed into the body. So more to follow, there's some evidence that continues to need to be gathered on that. Next slide. So there have been a lot of, there's been a lot of burgeoning research in terms of peripheral nerve stimulation for the treatment of chronic low back pain. Again, there's an option for palliation of back pain by treating or changing the way that the nerve fibers are perceived versus targeting the actual segments and the muscles that are providing stability and function for the low back that can also be targeted. Next slide. So what's the real difference between peripheral nerve stimulation in terms of palliation and restorative therapy? Well, both target the population with chronic low back pain that can be very disabling. Restorative therapy really addresses the mechanical or musculoskeletal component of low back pain, whereas peripheral nerve or palliative therapy really addresses neuropathic qualities of pain with ridiculous symptoms. They have two different mechanisms of action. One restores, the restorative therapy really aims to restore multifidus control, where the palliative peripheral nerve stimulation interferes with the perception of pain. They have different delivery schedules. Restorative therapy can be done in a pulse setting, meaning having a short burst of stimulation to these muscles can help to enhance control over time, whereas an implanted device traditionally delivers stimulation 24-7. And the responses to treatment are really different. With some of the latest studies that have been done on Reactivate, the ability to retrain the muscles over time really has a longitudinal trajectory that takes time to take effect, whereas peripheral nerve stimulation for palliation really works in a short time frame and remains relatively stable through one year, but as we're seeing with dorsal column, there has been a waning effect longitudinally, and maintenance of therapy is affected for this very expensive technology. Next. So, in terms of the next case, there's a 63-year-old male with SI joint pain of six months' duration. This is a very active person. He has findings radiographically of degenerative disc disease, spondylolisthesis, spondylolisis, so multiple pain generators. On provocative exam, this patient has a positive Yeomans test, focal tenderness over the PSIS, and they do respond to intra-articular sacroiliac joint injections, as well as medial and lateral branch blocks, which provide significant relief. So, the question would be, in this scenario, which type of therapy would be applicable? And that is a nice segue into our next presenter. Thank you. So, I think I already, Dr. Karanopoulos already introduced the case. It's a case of SI joint dysfunction with who's been recalcitrant to therapy. We're going to just, these are just the imaging studies for that patient, and he already reviewed the scenario. So, I'm going to pass it over to Dr. Lin, and hopefully, we'll get back here on time a little bit. Hi. I'm Dr. Ellen Lin. I've been in San Antonio in private practice for 14 years. I'm also a clinical professor for both the PM&R program for sports medicine, as well as the pain fellows here locally in San Antonio. So, this is how I would approach this patient. Since the patient's very active as a cyclist, really, okay, I don't really have any disclosures, except for Nebro Boston Scientific that's unrelated to this subject of radiofrequency ablation. So, I'm going to make a plea for this patient who is very, very active as a cyclist. There's a plethora of randomized control studies for radiofrequency ablation of SI joint, and I'll just let you read the slides since we're a little bit crunched for time here. And also, there's a large meta-analysis demonstrating really good scientific evidence to argue for radiofrequency ablation of SI joint for this patient's pain. And now, there are increasing studies and evidence, prospective studies, also arguing in favor of cold RF. And so, as this patient who is a very active person, I would propose that we do a radiofrequency ablation of the S1, S2, and maybe even the S3 lateral branches, since he's already got some really good pain relief from the diagnostic blocks. And so, these are the innovation for the SI joint as demonstrated in this cartoon over here. And the next slide, this is an example of radiofrequency ablation of lateral branches. And you see, the reason why you see four needles over here is I, in my practice, I use a bipolar technique, so it creates a larger lesion. And so, some of the products out there, the radiofrequency machines out there can give you that bipolar, larger lesion. And so, this is a striker machine. So, the top two needles are oriented so that it's about one centimeter, centimeters apart. And radiofrequency temperature is done traditionally at 80 degrees Celsius. And so, this is a pretty good demonstration of that radiofrequency ablation. And the last two bottom needles are also oriented right at the lateral part of S2 foramen. And the next slide shows the striker machine. It's done on a bipolar and set at 80 degrees Celsius for 90 seconds. And the next, this is just like a reminder that we don't just radiofrequency of the lateral branches of the SI joint, we may want to really think about the medial colonial nerve entrapment syndrome. So, these can contribute to SI joint pain through symptoms, okay? And so, as you see, the medial colonial nerve is innervated by the S1 through S3 branches. And so, in my practice, if I find the syndrome like that, I will consider doing a medial colonial nerve block, therefore, subsequently, radiofrequency ablation of the SI medial colonial nerve who might have a contribution to the SI pain. Next slide. Okay, so, the CoolRF is a more recent development and technology that may offer you longer pain relief, longer than maybe perhaps three to six months of pain relief, because it creates a larger lesion, because the RF energy is done through a water-cooled and larger volume spherically shaped lesions, and it's about 45% beyond the tip of the needle. And the moving fluid can really act as a heat sink and removing the heat away, so you create a larger lesion. So, the next slide shows that the equipment that's involved and a cartoon demonstration of the CoolRF. And this is Dr. Caporal's slide that I borrowed from him, and that shows the CoolRF probes being positioned in the lateral branches of S1 through S3 of the SI joint. And again, it creates a fairly large lesion so that the SI joint can be denerated. The next slide is my own patient with the middle colonial nerve radiofrequency ablation. And again, traditionally, I like to use the radiofrequency machines that I have available and just make a bipole at the middle colonial nerve, as demonstrated just slightly lateral to the SI joint right there in a bipolar technique. And so, next presenter is Dr. Singh, and he's going to argue about the sacroiliac joint fusion. management, as well as some fellowship training in stem cell and regenerative medicine. I'm a partner and director of interventional spine and pain procedures at Orthopedic Associates of Central Maryland in the suburbs of Baltimore, part of the Centers for Advanced Orthopedics. I certainly want to thank the Academy, Dr. Desai, and my distinguished co-panelists for the opportunity to be a first-time presenter here at the Academy, and certainly look forward to seeing everyone hopefully live next year. No relevant disclosures for today's talk. I do believe that as someone who's going to enter the world of interventional and minimally invasive procedures, understanding anatomy is critically important. I advise all of my colleagues to spend a lot of time, not just on the weekend courses, but taking time themselves to go through the anatomy textbooks and really understand what they're getting themselves into. The sacroiliac joint, when compared to other joints of the body, is more three-dimensional and has multidirectional accesses. While it doesn't move very much, and there is lots of evidence to show that it auto-fuses as we all age, it is a complex joint and does, unfortunately, bear stress from the hip joint below and the spinal segments above. We also know that SI joint pathology can be multifocal, whether it's coming from the capsules, the ligaments, or the interarticular surface itself. Finally, we also have seen that patients with longer lumbar fusion constructs, as well as those that are fused into the sacrum, do tend to cause a higher incidence of SI joint pain and or pathology. The literature shows that anywhere up to 17 to 30% of a back pain or spine clinic will see SI joint pathology. We know females suffer from this condition more so than males. I did a quick search. I work with another physiatrist in a large orthopedic group, so I did a quick search over the last two months, and of all the spine injections that the two of us performed, only 6% were actually SI joint injections. The history of SI joint fusion begins way back in 1926, and we won't go through the whole history, but it was very interesting in producing this talk today to see that across PubMed, there were very few papers about SI joint fusion, and then starting in about 2013, there's been an escalation that's growing. This will be a very exciting ... This is where I really would bridge some of our older physiatrists, those in my dad's day and age who clearly saw older technology and SI joint fusions not working versus the new data that continues to emerge and is very exciting. My opinions in terms of why in the past it didn't work very well, whether it be primitive screws, lack of bone graft, poor technology, or poor imaging. There's old data that suggested that touch guidance or non-image guided SI joint injections only actually got the needle into the SI joint 10% of the time. Nowadays, many of us all use some form of guidance, whether it's ultrasound, CT, or fluoroscopy. This has allowed us to be more accurate in our assessment style and help the patient really achieve a diagnosis and therefore a treatment program that can help them. It's my opinion that in the present day and age, these advances allow us to move more to an SI joint fusion treatment. There are a few different techniques and approaches, and I've illustrated them here on this slide. I do apologize that the text gets muffled a little at the bottom, but essentially you have an open technique. The percutaneous techniques are either true lateral, ipsilateral oblique, or posterior. What you will see with almost all of the devices today is that there is some form of bone grafting that occurs. The data is continuing to emerge, and it is very positive for those who wish to consider SI joint fusion. There has been one company that has tended to put out a lot of data, so it'll be exciting to see if other companies are willing to jump on board and replicate that. In essence, the data is now spanning outwards of four to six years and continues to show that an SI joint fusion population has higher satisfaction rates, significantly lower VAS scores, significantly lower ODI scores, as well as return to work rates when compared to conservative medical management or compared to radiofrequency ablation. I think the biggest concern when we're talking about SI joint fusion is as a physiatrist or as an interventional specialist, are you ready to handle complications? And the greatest detractor to doing an SI joint fusion would be those complications. Infection tends to be the number one, and certainly sterile technique, processing, antibiotics would all be considered. The other would be a non-fusion or a pseudoarthrosis. And I do believe that as technology continues to improve and as we continue to use more bone grafting, we will see higher fusion rates. It was very interesting in looking at a few meta-analysis studies. A lot of people who are not in favor of SI joint fusion point to the one study that shows a 59% pseudoarthrosis rate. However, the other meta-analysis out there clearly show a very high fusion rate. The future debate as we go forward in our interventional skills will be a trans-joint procedure or an intra-joint procedure. But Mehul will have to set us up for that in another year. In conclusion, as it relates to SI joint fusion, I think we should understand the RF data is very robust for cooled RF. It's not a technique that I typically use. So therefore, in my practice, it would be very difficult to offer someone an SI joint RF with straight traditional thermal radiofrequency ablation. That being said, with this patient being 63, being very active, being male, having had greater than six months of conservative management, as well as tremendous improvement with diagnostic intervention, SI joint fusion is pretty simple, straightforward, and I would advocate this for this particular patient every time. Thank you so much. All right. Thank you. Thank you, Dr. Singh. So I just wanted to encourage folks to put their questions into the Q&A because we're going to try to answer them live as I think we're kind of back on, back up to speed here with our timing. So this next scenario, and I'll try to answer them live after this next case is debated. So scenario three is a 68-year-old female with a four-year history of bilateral leg pain consistent with neurogenic claudication. Current complaints include bilateral circumferential leg pain and heaviness with ambulation relieved with forward flexion and rest. Vascular workup was negative. Past medical history is significant for hypertension and COPD. Poor candidate for open surgery based on past medical history and patient preference. Good transient relief greater than 50% with L5-S1 intralaminar epidural steroid injection and no neurologic deficits on examination. These are the, this is both, what we have here is a sagittal cut of an MRI and you can see that there's L3-4 spinal stenosis that appears to be at least from a sagittal view and it's corroborated on the axial view on the right with tricompartmental stenosis, diffuse disc bulge, so that's heart hypertrophy and ligamentum flavum hypertrophy. So with that, I'm excited to hear what Dr. Leong and Dr. Weisbein have to say about their respective positions. Dr. Leong. Hi, everyone. Dr. Desai and the Academy, thanks for inviting me to be part of this. I'm very honored. So, for my disclosures, these actually aren't mine. I actually don't have any disclosures for any device company. I'm working with a couple of pharmaceutical companies for some treatments for cancer pain. So that's mine. And I'm involved in a couple other societies as well. Okay. So when you think about any kind of procedure, I think of it with the KISS principle, which is to keep it simple and a bad word, at least my kids tell me. So with any kind of lumbar spinal stenosis, if you can, I think it's worthwhile to consider the percutaneous interlaminar decompression or mild procedures since that's the only company that has it. Now, lumbar spinal stenosis is a common cause of back pain. And if the patient has neurogenic claudication and ligamentum flavum hypertrophy of greater than 2.5, then I think you should consider the pilot procedure first. It's got a great safety profile, similar to epidural injections. It doesn't complicate anything that comes later, either surgery or some of the things that are going to be discussed in just a moment. And it also doesn't destabilize the spinal column or endanger the spinal canal below L2. So for me, this patient is a perfect candidate for this percutaneous lumbar decompression. So I am an anesthesiologist and pain management specialist. So I actually had to cheat. And I went to my former fellow who is a radiologist. And the key thing that I have on this slide is that moderate canal stenosis is caused by disrecrusion. And it's also in the level where I would think that a mild procedure would be extremely effective and actually pretty common, Dell 4-5. So according to NAS guidelines, which you all know, there's a condition, lumbar spinal stenosis is a condition of diminished space, secondary to degenerative changes. Typically for people older than this number, it gets to be a little bit closer to my heart all the time. And in the US, there's approximately 500,000 people in current estimate, but probably more. And it's going to go up. So these procedures will be important in the future. For this, what I tell the fellows is that any of the symptoms we have for spinal stenosis, you can confuse it with vascular claudication. So you need to be careful about what you ascertain on physical exam. So our current treatment algorithm or kind of spectrum includes the conservative things that we should all follow, which are physical therapy, medications, possibly epidurals. But we're going to get to that in just a minute about why that may or may not be the greatest idea for long-term. Mild procedure and then these inner spinous spacers and surgery. So again, I get back to keep it simple. Patient's got spinal stenosis, back and leg pain, neurogenic claudication, ligamentum flabium hypertrophy. Mary could be a great candidate for this procedure. And if you haven't done it before, it's actually really simple. It all comes, mostly, everything comes in this one kit with all the items that you can see here. And it's really a very short, possibly short, four-step procedure. I'm at Stanford University and so my fellows tend to join me and they kind of want to get their hands on a lot of things. But it really is actually pretty simple. So you have to get an epidural ground first. You have to have an epidural either at the level or above the level. Sometimes we use a caudal with a caudal catheter. You create a portal. You decompress the bone and then the tissue and then check. And so with the epidural ground and the contrast, you can know where you are at all the times and you can get real live feedback using fluoroscopy in order to make sure that you're staying safe. And so this is one patient that I did actually at an outpatient surgery center that everyone was really concerned. You know, when you bring a new procedure into a new place, they're just like, wow, you know, we don't want a problem to happen. Eighty-plus-year-old patient, one single level, simple, went in. After four minutes, that's the result. And everyone just fortunately was amazed and things actually went very, very smoothly. It doesn't always go like that. And I actually have to schedule for a lot longer, especially if I'm training other people. But it can be a very, very simple procedure. So then how does it compare? I got an academy lecture I have to do a little bit of literature review here. So the mild since 2010 has had eight studies. And people talk about this MIDUS Encore trial, which the two-year follow-up. And that one has got the most data and the most support. Superion, which you're going to hear about in a minute, since 2010 has five studies. And has five-year improvement of 84% of patients and all the parameters you see listed. Now according to the MIST guidelines, it's the best guideline that we have right now since 2018. Mild and Superion have level one evidence, both of them, but they're both based on a single randomized trial. So if you've got two devices or two techniques, then to me, I pick the easiest one first. Back pain is high frequency in adults, lumbar spina stonus common reason for surgery, epidurals. We're worried about steroids, not just for accumulation over lifetime, but also for COVID for suppressing the immune system possibly. This one mild has been approved twice. It's a bridge, should be considered first. And it's easy to teach and train people. So I'm going to go forward and hand over to Dr. Weissbein. Thank you so much, Dr. Leong. So really interesting talk because I have actually been on both ends of this discussion. My name is Jackie Weissbein and I am an interventional pain management physician, physiatrist in Napa, California. I am in a orthopedic group and I am here to talk about interspinal spacers. So essentially what I would like to talk about today are just a couple of things. I somehow just managed to, of course, adjust my screen size so I can't move forward, but I fixed it. So anyhow, that being said, I have some disclosures. I'm a consultant for a number of companies, including Virtos for mild, as well as Boston Scientific. I guess I'm going to talk briefly about how to identify patients for VertiFlex or the spinous spacer. You want to talk about a medical history, patients with symptoms, what kind of prior treatments that they have, do they have relief inflection? So whenever I'm thinking of any kind of decompression, whether it's a piled or an interspinal spacer, I want to know, does the patient have relief when they're sitting down? So if they're up and walking, they're that classical, you know, leaning over the shopping cart symptoms that we all learned about during residency, but then also more importantly, do they have relief sitting down? And then I want to look at their imaging. So if you're not currently looking at your imaging, you want to look at the x-ray. You want to make sure that there's not a spinal low lacesis that's greater than grade one for these patients. And you also want to see what kind of stenosis you're looking at. There are a number of contraindications for this procedure, again, greater than grade one spinal low lacesis, as well as anybody that has any degree of osteoporosis. So if you're concerned, you know, your patient's already had a compression fracture, probably not someone that you want to put a spacer in because there is a risk of a spinous process fracture. And then also, can this patient do some non-surgical options? Have they done physical therapy? Have they done epidurals? Now, one thing that is really important to note is that having great success with an epidural is not an indicator for either piled or an inner spinous spacer. So if they don't have relief with an epidural, it doesn't mean that they're going to fail these decompressive techniques. So just keep that in mind. When I'm thinking about these patients, again, so pain, relief, inflection, do the imaging support symptomatic neurogenic claudication, and do they have any issues with the limitations? If they do, any of those things are, you know, a no, then they are not a great candidate. But if they do have yeses to all those things, where they're not a bad candidate, then obviously moving forward with Vertiplex is a really great option. Now, when we think about spinal stenosis, it is true, Dr. Liang definitely talked about the fact that not everybody only has central canal stenosis. But you can see that on the left picture, this is an MRI of a patient with more specifically central stenosis. But we do see a majority of patients have both central stenosis and lateral recess stenosis. Now, one can make a claim that when you do a mild procedure, it's kind of like a little bit like a laminectomy, you're just removing more debulking tissue from that area. So realistically, it's almost like a laminectomy and should decompress some of those areas in the foramen. But as we all know, from our patients who have had laminectomies, it doesn't always necessarily decompress that foramen. So what this is, is essentially a little bit of an extensive extension blocker. So if we think about the mechanism of actions, when you have patients, you know, in a cadaveric study, we were able to see that when you put that extension blocker in there, you are diminishing ligamentum flavum thickness, increasing the foraminal width and height and the area, and therefore preventing some of those symptoms. Now, again, if a patient has severe stenosis, probably not going to do as well as someone with mild to moderate stenosis. Again, one of the things I think in comparison to mild, you want to think about too, is the area of thickness from the ligamentum flavum. Because really, what the piled procedure is doing is actually just debulking part of that ligamentum flavum and some of the bone. But what we can see with the posterior spinal fusion, I'm sorry, spacer, that there is inflection and extension, you know, an increased area compared to the ligamentum flavum. But when we extend that area with the spina spacer, we're decreasing the thickness of that posterior ligamentum flavum that can be hypertrophic and contributing to this. But again, simultaneously increasing the room into the foramen that these patients are suffering some of their symptoms from. Now, again, you can see here that the majority of patients don't have only central stenosis. In fact, only 35% have central stenosis only. And the majority of the patients have a mixed stenosis, 53% with the other 4% and 8% having either lateral only or foraminal only. So being able to read your MRIs on your own is really important because if you get an MRI reading that doesn't say specifically one thing or another, you're not going to really be able to know what the candidate is that right for. These are the tools that come in the kit. You can see that there is a dilation kit and then a cannula. And essentially, you're going to be rocking this in the AP cephalad and caudate to get everything in space and your final positioning for the appropriate spacer is in the bottom picture. For the sake of time, I'm not going to go through the whole procedure. But there are a number of randomized information that, you know, Michael touched on, five-year data. I mean, but the most important thing I would say is this, that in this post-market data, 80% of the patients had a significant amount of satisfaction at 12 months, which is a pretty big deal because I think, you know, what you want to know is, is this going to be long-lasting for them? And again, patient selection is key, right? So possible complications, device deformation, displacement, spinous postage fracture, increased pain. Sometimes you see patients with facet-mediated pain because you're kind of propping that joint up and so it makes a little tightness on that capsule. So down the road, you might end up having to do some medial branch blocks and RFA. Obviously, with any procedure, there is bleeding infection, more to the pain production of new pain. But again, this can be done under very minimal anesthesia. So like PILD, this is an option for your patients who have the inability to sustain other more advanced and in-depth procedures. I appreciate your time. Thank you so much for having me, Dr. Desai, and I'll turn it back to you so we can do the question session. Thanks, Dr. Weisman and Dr. Leong. That was great. You guys really got us in there under the deadline. So I appreciate it. So let's start with the first polling question for, uh, please. So, um, and while we're, while people are answering the polling questions, I'll go over some of the Q and A questions that came in just in case we run out of time. So, uh, for case, would you, so the first question is, would you refer or perform in, what would you prefer, refer for or perform in case one? So, uh, we're going to go through these answers as people kind of put them in. I've got some questions that while we're waiting. So the first question that came in was, uh, theoretically, what mechanical changes to the lumbar spine, hips, and contralateral SI joint occur after unilateral SI fusion? Um, what is the informed consent about future adverse consequences? what the long-term biomechanical so I think it's something we just need to need to keep folks we had about 50 a little less than 50 people respond I think there's a fairly reasonable echo so what I was saying is that in response I'm not sure exactly how to fix that issue but the majority of people were chose spinal cord stimulation in this setting in case one can we go to case two please or the second question so what would you prefer refer for or perform in case to si RFA SI fusion or neither there was a question from dr. Matthews about studies showing the efficacy of lumber I mean it's part of me of spinal cord stimulation a lot what we did is an interest of slides in the interest of time all the citations are at the back end of the talk so you're certainly welcome to look at those to see if there's any the studies that you're looking for because there are studies demonstrating efficacy for lumber a first spinal cord stimulation in low back pain and there's some fairly sizable studies including those that were mentioned in the slides by dr. spoli so in response to this we had just a few responders but the majority of people were more inclined to perform SI radiofrequency ablation can we go to a case three so what would you refer for or perform in case three percutaneous image-guided lumbar decompression interest by this spacer or neither and hopefully the echo went away so in in this case the majority there's a greater split where more folks were divided between piled and inner spine a spacer and then there's still a significant amount of folks who wanted to do recommend neither can we pull everyone up on the screen and then maybe maybe someone else can read the questions off because I'm clearly my my mics not working so are there more let's see I don't see any more well they're on the left on the left side there in the Q&A section there's a there's all the questions okay so there's some questions one is a issue with mild is a lack of high industry studies and that are independent industry funding and financial incentivize so I think the reality is this I think with everything part of the problem is whether it's mild or VertiFlex whatever you're gonna do I think the issues are obviously the long-term data and we can't get it without people doing it and without reimbursement code so that has been something that has been really difficult to do and I think the more that we as a community in a society can mobilize to help get these things doing clinical trials whether you're in a private practice setting or an academic setting regardless of its stem or PNS that's gonna help us accumulate data so that we can get things approved authorized through the insurance system and the reason that that's why John Collins says that insurance companies aren't approving these treatments is because of that so they have to apply for a code from Medicare and once they get the code then it can be approved so things have to kind of go through and get like a temporary code beforehand and so if you're not involved with this I think you can reach out to any one of these people on the panel here and we can help you get involved I know I'm in PSPS as well with Dr. Leong and you know he's really big and advocating for for changes with regard to treatments in California so you know state societies aside from national societies but these things are how we get these things you know really treated as regard to BMI for mild versus interspinous spacer the reality is as if your trocar or your portal can get down to the area and you feel safe with having a patient prone on the table or they can be on the table I think that's pretty safe I mean I try and stay under 40 BMI but I'm in Northern California and so the majority of patients are under 40 BMI and that might be different in different parts of the country and I think someone asked stimulation of the medial branch nerves won't this cause an increase in axial low back pain we block and ablate these nerves so how would we do this with the set mediated pain the whole do you have speaker again or if you turn off your cell phone are you able to talk or is Leah Leia or or even Ellen able to answer this so medial branch stimulation with like a PNS system well this might be for anywhere it's a good idea because you're right you are denervating some of these nerves are potentially might have long-term consequences and PNS you can put an PNS system right just at the the lateral branches and that has been shown to be effective in some case so you're not denervating these nerves yeah I think if you can hear me so I mean on the contrary I mean I've been involved with the clinical trials I know Dr. Karinopoulos has been involved with a bunch of clinical trials with regards to I think he was part of the reactivate study I'm part of the SPR low back pain study and I can tell you pretty unequivocally I mean when you stimulate those nerves whether you have long-term benefit or not I can't really completely speak to that but or maybe Karinopoulos has some comments on that but from my perspective it makes a profound improvement in their pain I mean because we're talking about when we ablate the nerve we're talking about just the transmission of pain we're not talking about the actual anything but the transmission of pain is now blocked by ablation but by stimulating we're getting some of the same sort of mechanism action effects that we do with spinal cord stimulation and and the effects have been quite profound at least during stimulation periods in my in my experience. Alexios do you have any thoughts on that? Did tech support make it to Dr. Karinopoulos's house? I don't know if I'm on or not I apologize but anyway you're on you're on ablative techniques have a link you know in terms of ablative techniques versus neuromodulatory techniques one of the differences that the after an ablative technique the nerve actually regenerates over time whereas with peripheral nervous stimulation or even dorsal column stimulation you're you're treating you're changing the pathway of the nerve so you can have it on 24-7 you can you can you can retrain the nervous system versus a restorative therapy where you're actually changing the the biomechanics of the spine so there's there's it's nice that we have different options out there. Dr. Singh going back to that question about SI fusion did you have any comments about the biomechanics and how you would consent a patient if you were going to do an SI fusion? Well I think we know in general that the SI joint doesn't move a tremendous amount I think the biomechanics at how it would impact a hip such scenario I don't think that we have enough data on that a lot of times patients at least in my practice they've already had a lumbar fusion so it's actually the fusion above that is precipitating their sacroiliac joint dysfunction. They may be a great thing to look into in terms of consent and no I don't go into extra detail to postulate that there may be some future downstream because I don't think we have great information about that. Thank you for that Dr. Singh. I think the one of the question that I think I saw that we really wanted to make sure we got to is we've been RFing the medial branch and therefore denervating their post-productor 40 years now. Now we're saying maybe we're going to change that paradigm. Why RF at all? Does anyone have any any comments on that? Why would you continue to use RF? Dr. Leong or Dr. Weissbein or Dr. Lin, any of you guys? Anyway jump right in. I mean I think that for me the reality is this is that if they've had like a fusion to their sacrum and the next segment is the SI joint that is unfused. Personally I feel like those candidates tend to do better with SI joint fusion in my practice. Patients who haven't necessarily had that and they just have like an SI joint instability. I mean the problem is I'm a DO so like we learned all about like shears and things like that. I think those patients if they haven't had previous surgery I tend to focus more on trying RF ablative techniques prior to moving forward with fusion and use fusion for a little bit of a last resort for that. But when it's a patient who's already been fused to the sacrum that next segment of movement is essentially the SI joint that's a little overworked and then fusing that segment for me in those patients has been more efficacious. But again that's just my end-of-one practice. I think I can agree with that because SI joint sometimes, I'm a PM&R doc as well, so sometimes these SI joint syndromes is not necessarily an SI arthritis or something that's permanent. It may be just a syndrome or a transient or temporary pain syndrome. So to make something permanently fused like that without maybe just doing an RF and rehabbing them afterwards they may be able to get six months or twelve months pain relief and you know get back to play and maybe the pain will be gone without having to change their anatomical alignment, right? And if I can comment on my SI joint fusion patients, I would, we don't have a lot of data about SI fusion ipsilaterally causing the contralateral problems later on. So I usually tell my patients that there are studies about lumbar spine when we fuse one segment it's a domino effect therefore the next segment might have instability and this might work the same or it might not. Time will be able to tell as we do more SI fusions but I do tell them I don't think I put it on my consent form I do tell them verbally that maybe the contralateral side will become unstable later on. I just want to say one thing real quick there's been a couple of statements about spinal cord stimulation in the chat and the reality is is that this person is concerned that SCS doesn't work patients aren't succeeding because they're not weaned off of their meds and I just want to say that you are seeing a group of people who do a lot of spinal cord stimulation and the reality is that I'm sorry that if in your area there are people that are not appropriately treating these patients and the reality is is that there are many of us in this group who I'm sure offline because we're over time right now would be happy to discuss with you the benefits of spinal cord stimulation in appropriate patient selection and also in conjunction with weaning significant medications. So I think you know your end of one experience I'm sorry it hasn't been great and I'm sorry for your community that hasn't been great but I can tell you that the rest of us around the country are having really great results regardless of the company that we work with and so I hope that you reach out to one of us for further discussion about this offline. All right so I think that we could probably do a Q&A for a long long time which I really that's probably the best part of many of these conversations. I want to take a moment to thank all the speakers there was a bunch of folks who hadn't spoken at AAPMNR that are on this panel for the first time this year so I'm really happy that we were able to have great diverse folks who have very different perspectives I appreciate everyone especially the folks on the west coast who woke up at the with the roosters but also everyone else in the entirely the country. Thank you everyone please stay safe and you know try not to get the big so take care and thank you for all the people who attended.

Advanced Pain and Spine Interventions

spinal cord stimulation

peripheral nerve stimulation

low back pain

radiofrequency ablation

fusion

sacroiliac joint pain

minimally invasive lumbar decompression

indirect decompression

lumbar spinal stenosis

interspinous spacer