the clouding. Okay so good evening everyone or in wherever you're watching good afternoon or good morning. I'm Mehul Desai and I'm moderating this session on integrating advanced therapies into your practice. Over the last several years there's been a tremendous growth in the number of advanced interventions that are being performed by physiatrists and as such we put together a really great panel of folks to talk about some of the evidence around advanced therapies and also how they integrated these advanced therapies into their practices. This evening we've got Dr. Patrick Buchanan, Dr. David Lee and Dr. Gurtej Singh who have joined us to talk about their various topics. Unfortunately Dr. Reese was supposed to be here, David Reese, but he had a flight issue so we're going to sort of take the next hour to dive into some of these therapies, have some conversation, ask some questions and we're going to go from there. Thank you for joining us and I'm going to pass it over to Dr. Buchanan who's going to share his screen with us and we'll go from there. Thank you Dr. Desai. So my name is Patrick Buchanan. I'm in my fifth year at a private practice in Camarillo, California. I did my residency training at Kessler in New Jersey and I also did my fellowship at Loma Linda. So I'm fortunate to talk about minimally invasive sacroiliac joint fusion and the evidence behind it. So I think it's a really interesting time with us as interventional physiatrists right now with all these emerging technologies. So it's really important to really study and follow the data for these new procedures. Next slide. Just a couple of my disclosures. I am a consultant for Abbott and PainTech and I'm also one of the primary investigators on the Abbott and PainTech research studies. Next slide. So as we as physiatrists all know, sacroiliac joint pain is a very common cause of low back pain. It's in between 15 to up to 30 percent of our patients with low back pain and one of the biggest risk factors for this is low back surgery resulting in 29 percent of the incidents there. And it's a very likely source of patients having undergone either lumbar or lumbosacral fusion surgeries. And then when you look under radiographs of these patients that have had fusion surgeries, about 75 percent in five years have some kind of SI joint degeneration. And we'll talk about that when I briefly go over the biomechanics. But, you know, this does affect a large portion of patients, but it's still, in my opinion, very often overlooked and undiagnosed. I think we as physiatrists, though, have the advantage of, you know, coming from our backgrounds in MSK and physical exams of how to differentiate those pain generators between facets, SI joint pain, piriformis pain, radiculopathy. So I think we have definitely the advantage of being able to discern that through our SI joint provocative maneuvers, as well as for cell loading and so on. Next slide. So before I get into the procedure, just want to briefly talk about the biomechanics kind of make sense of all this. So as we know, the SI joint is kind of like the shock absorber. It basically connects the sacrum to the pelvis and absorbs those vertical forces from the spine and transmits them down to the hips and legs. So like I've been mentioning, a common theme is these patients after back fusions and back surgery have this pain because what you get is that adjacent segment disease transmitting those forces down to the SI joint and causing and putting more pressure on it. Next slide. A lot of the times the SI joint can become unstable when ligament laxity occurs, especially the interosseous and posterior ligaments. So, you know, that's why there's a higher incidence of SI joint pain in patients after pregnancy, too, because you have the relaxin hormone creating that laxity of the SI joints and causing more of those sheer forces as well. So you have the laxity of the SI joints and you also have the degeneration and shearing forces of that joint. So, you know, just to summarize, you know, this is a mechanical problem. So we need to be looking for a mechanical solution to a mechanical problem. You know, I remember way back when I was a resident Kessler with Dr. Brett Gerstmann and I published treatment options for SI joint pain. And back then there was very limited evidence, right? So you have medications such as muscle relaxers, anti-inflammatory, obviously physical therapy, intra-articular injections, and radiofrequency ablations, but we really couldn't find any great long-term data to help our patients with SI joint pain. All these procedures basically had short to intermediate benefits at best. So that definitely kind of triggered my mind to search for some of these long-term options for our patients. Next slide. So I just want to quickly talk about there are two ways to do minimally invasive SI joint fusions. There's the lateral approach and the posterior approach. So I'll just briefly go through this, a little bit of the pros and cons for both. So for the lateral SI fusion, you are going through the hip basically, so laterally. So you're basically using titanium screws and you're passing through fascia and muscle tissue for that. Because of that, you know, your patient has to be under general anesthesia. And because of that, postoperatively, they have to be non-weight bearing or toe touch weight bearing. So there's a little longer recovery time. However, there is level one evidence supporting this procedure. So I think that that's huge. As for the posterior approach, this has kind of come on recently over the last couple of years of trying to get this more minimally invasive, going through less tissue. You can use either a bone allograft or titanium for this, depending on which company you use. Like I said, you're not passing through those glute muscles. You're not passing through any of that stuff. It's just kind of the same directions as you would for an SI joint injection. These patients could be done under MAC. They don't have to be done under general anesthesia. And for postop, their weight bearing is tolerated. So, you know, they don't have to be off that leg for an extended amount of time. There is really ongoing evidence on this. Right now, there's retrospective evidence, as I will show in the next coming slides. However, there is also ongoing multicenter prospective studies for this as well. So this is kind of the emerging field of where SI fusion is going towards. Next slide. So I just want to go over quickly about the lateral SI joint fusion evidence. So this was a level one prospective randomized controlled study over two years. And really, you know, 148 subjects, that's a pretty good patient population there. There was an 83% sustained responder rate, meaning over 80% of the patients reported more than 50% pain relief in their VASc scores. And this was the biggest thing that jumped out to me when I was looking into these long-term therapy options for my patients with SI joint pain. 68% improvement in ODIs, which is a functional score, compared to less than 10% in non-surgical treatment, two years. So, you know, this is huge, I think. You know, you have over 60% in functional scores compared to less than 10% in patients that have undergone physical therapy, radiofrequency ablations, and SI joint injections over two years. There was also statistically significant difference in SF36 scores as well, which is another functional scale. However, there were five serious adverse events in this study, and three required revision surgeries. So one of them, as you can see here, there was a sacral nerve impingement. If you can see through this fluoroscopic view, that top screw, you have to be very careful in not going through, or even the second through, going through the foramen, neural foramen right there. One incidence of an iliac fracture and some hardware loosening, and there was also an incidence of a hematoma, which does make sense because you are going through muscle and fascia, so it's really important to make sure you control the bleeding at that time. Next slide. Now, for posterior fusion, there are two multi-center retrospective studies that are published in peer-reviewed journals right now. The first one had a patient population of 50 patients, and the other one had a study group of 111 patients. Currently in progress right now, there is a biomechanical study that is awaiting submission to a journal. So one of the big questions is how could one of those little bone grafts interposteriorly help kind of stabilize that joint? So one of the theories behind it, and that's been proved by the, will be proved by the biomechanical study, is basically it's stabilizing the joint. It's doing two things. One, it's distracting or opening up the joint to prevent the degeneration, and it's also stabilizing or bringing that joint into its pre-disease state. So normally you have about one to two degrees of nutation and counter-nutation. That's basically what this posterior fusion is doing, is bringing that back to those same degrees of motion as you would normally. And then last but not least, there is also a multi-center prospective study that's in progress right now, and I'll briefly talk about that at the end. Next slide. So for that first real-world study, this was the one that involved 50 patients, and they looked at, retrospectively, the follow-up for about a year. And of note, there were no other SI joint interventional procedures done after the fusion, and there were no, I think the biggest thing was there was no major complication or adverse offense as we saw in the lateral fusion side of it. So as you can see here with the graphs, you know, you probably, you have about a 50% reduction in the NRS scale, and they divided these patients with fusions or history of lumbar surgery and those with no fusions as well. And overall, 66% of the patients, I'm sorry, patients reported overall average of 66% pain relief. And you have a little variation between lumbar fusion and the ones with no surgery. Next slide. The other retrospective study had a little big, larger patient population group of 111 patients, and the mean follow-up time for this was about 290 days. And really, this kind of interestingly divided up into patients that had other procedures but still kind of had back pain after these procedures, specifically spinal cord stimulation, interspinous spacers, intrafecal pumps, and minimally invasive lumbar decompressions. And so it kind of broke it up into those three, four areas. Next slide. As you can see here, also very encouraging results too with mean pain reduction, about 67%. And 52 patients had greater than 80% pain relief. And that's kind of what I'm seeing in my practice too. A lot of these patients are kind of home runs where most of their pain has gone from that SI joint region and also have no serious adverse reactions in this study as well. Next slide. So I was talking about SECURE study, which is the first ever prospective data on posterior SI joint fusion. And just full disclosure, I am one of the principal investigators in this study. And so, so far, we have about over 100 patients recruited for this study. And basically, this study mirrors the INSIGHT study, the RCT for lateral SI joint fusion. So basically, it's kept the same inclusion and exclusion criteria of those patients. So we can have an apples-to-apples comparison of the outcomes for this and compare it to both the treatment arm and the control arm as well. And so, this study is measuring not only the VAS scale, but also the functional outcomes as well, such as the ODI, the PROMIS-29, and also looking at opioid reduction, patient satisfaction, and obviously, adverse events. So there's been some very encouraging data points so far with this study as we have VAS improvement scores at 61% and 72% in three months and six months respectively. Though promising, this is currently a small sample size, so not enough to make definitive conclusions yet. But so far, it is looking like it has non-inferiority to that lateral fusion study as we were talking about. Next slide. So just to wrap it up, the challenges to incorporate in our physiatry practice, you have to make sure you really know this is the SI joint that's causing major pain because it's requiring a surgical intervention for this. So the diagnostic intraarticular junction is the golden standard for this. I do mine under fluoroscopy. There's one study showing a 98% success rate under fluoroscopy versus an 87% success rate done ultrasound guidance. This is a surgical procedure, as I mentioned. It cannot be done in your office. It has to be done either at an ambulatory surgical center or at a hospital, although this is, like I said, minimally invasive. So as you can see here on the right of the screen, this is from a posterior SI fusion, and really, the incision's about a centimeter and a half for that. Also challenging, like I said, for the posterior SI fusion, there is emerging evidence on that, so we have to keep an eye on that. And the biggest challenge, I think, is where do we as physiatrists incorporate this in our treatment algorithm? Do we do the injections and go straight for fusion? Do you do an RFA? How long do you wait? How much relief? So a lot of that stuff is trying to incorporate this into our treatment algorithm. Next slide. And here are my references for the lecture. Thank you. Dr. Buchanan, can you hear me? Yes. Okay, perfect. So I just had a couple of questions for you about this, because I think that was excellent, and I think you did a great job presenting this sort of in a digestible, succinct manner. So just out of curiosity, do you have any concerns about sort of the evidence gap that you're seeing? You mentioned that it's being worked upon, which is fantastic, but it still doesn't quite exist. So how do you see that sort of disconnect between therapies that are being performed and therapies that don't quite have a full breadth of evidence just yet? Yeah, thank you, Dr. Sai. Yeah, as I mentioned, you know, I think the biggest concern is that multicenter prospective studies, the level one, level two studies that we need to see to make sure, not only in the short term, but also the long-term follow-up, one, two, five years down the road, that biomechanically this is holding up and, you know, functionally, and also with the pain relief for our patients. Oh, great. You know, what's interesting is you answered one of the questions I had during your talk, which is sort of, you know, maybe some of the theoretical differences or advantages, disadvantages between the lateral approach and the posterior approach. What's interesting is sort of for people who might be interested in these sort of details, most of these things are like sort of predicate devices that were built upon other data sets. One of the things that is also noted with the lateral approach is that it's probably technically, you know, possibly more challenging, but also there's a chance you could get into the neurovascular bundle anterior of the sacrum. So you can get into the iliacs theoretically, or even some of the plexus if you really get turned around with your anatomy. Last couple of questions. Where do you see, where does this fit into your algorithm? So, for example, there are practices obviously that do a fair number of SI joint injections, and then there are also practices that do sacroiliac joint radiofrequency ablation. Do you see this as something in your practice that has replaced ablation, added to ablation, or is it sort of a different patient population that you think of for this? Yeah, great question. Honestly, the more of these I do and the more abused results I'm getting, I'm pushing more towards going from the injections straight to the fusion and bypassing radiofrequency all together. A lot of the times with radiofrequency, as I talked about, the data is, you know, short to intermediate at best, and a lot of times the insurance carriers don't even authorize the radiofrequency ablations. Also, this is a mechanical problem, so a mechanical problem requires a mechanical solution, not a neuropathic treatment option, and so that's why I'm more, you know, encouraged with the results with the SI fusion. No, that's fantastic. I really appreciate your comments. I think this is a really exciting therapy. As you mentioned, some of the outcomes from a variety of other therapies that are offered to patients with sacroiliac joint dysfunction, which, you know, honestly can be just as disabling and debilitating as lumbar radiculopathy or a number of other chronic medical diseases. There's a lot of promise for this therapy, and I think there's the fact that folks are committing to developing the evidence and publishing the evidence is really a cause for optimism. So, with that, I'm going to pass it, and thank you, Dr. Buchanan. I'm going to pass it over now to Dr. Lee. I'm going to mute myself. Yeah, I appreciate that. Patrick, that was great. I learned some stuff here as we go along, too, and I've done a couple of SI joint fusions myself, and I've had some pretty good outcomes, but it's, that was a great, great synopsis lecture. So, I'm going to kind of turn the tables a little bit. We're going to be talking about a therapy that's been recently brought to market probably a couple of years ago. It's been done in Europe for much longer than that, of course, but we're still talking about chronic low back pain, but we're going to go a little bit higher up from the SI joints from that of the typical mechanical low back pain patient that you might see in your guys' practice. Next slide. These are just some of my disclosures. Next slide. So, some of the learning objectives that we want to accomplish here today. Would you understand the rationale behind this multifidized stimulation? I'm going to discuss exactly what that entails, how it differs from the present interventional treatments that we have available, introduction to studies on the multifidized stimulation, discussion of appropriate patient selection so that you can use it pragmatically, provocative maneuvers for multifidized dysfunction, which for us as physiatrists is extremely important, and I think we probably have a better appreciation oftentimes than our anesthesia pain counterparts, and then also a case report and real-world application as Mahul discussed earlier. Next slide. So, just mechanical low back pain. I don't have to go over this in too much detail. Most of you are pretty well versed in this, but just to discuss it, we're talking about non-neuropathic back pain. So, back pain that is axial in nature that's typically worse with certain types of activities like sitting for a long period of time, standing, you know, flexion extension, those type of things. The one thing that I found interesting with this type of novel therapy was that, you know, when we as physiatrists often see a person who comes in with mechanical low back pain, almost automatic by nature, we send them to physical therapy, right? I tell my colleagues most of the time who are referring patients to me, 99% of my patients are going to end up going to physical therapy of some sort or chiropractic or some kind of, you know, treatment, and along with that, in my physical therapy prescription, I put core strengthening, right? But when the patient then comes back to us and they failed physical therapy for, you know, multitude of reasons, right? And there's people who cannot tolerate physical therapy because it's too painful. There's patients who have kinesiophobia and they just, they feel like if they do kind of any kind of remotely anything active that they will injure themselves or have more pain or they have other comorbidities that prevent them to do so. They're obese and they're out of shape, they're completely deconditioned. But when they come back to us, instead of then going, continuing the trend of treating that core instability, you know, oftentimes historically, we turn to our anatomical targets, right? We have discogenic pain, we have facet-mediated pain, we have now vertebrogenic pain. And so all the therapies that previously existed are really intended to target, you know, a specific anatomical structure rather than the instability itself. So if you look at this diagram on the right-hand portion of the slide, you can kind of see this broken cycle, right, that a lot of our patients get into. There's usually some kind of inciting event or maybe just degenerative changes as a whole that then create overload in the spine, then there's subsequent pain as a result of that. This leads to inhibition, particularly in the paraspinal muscles, multifidi, and then that leads to instability. And then, of course, more overloading, more pain, and more inhibition, etc. So the idea with that is that let's try to break the cycle, right, instead of ablating the cycle or just covering it up with, you know, epidural injections. And again, we know with a lot of these therapies, they're great, they're good, we're not here to argue against those, but they also have limited value to a certain degree. There are going to be people who obviously fail epidural injections, facet blocks, and even, you know, radiofrequency on occasion. Next slide. So in practice, it is often difficult to, you know, strengthen the multifidi selectively, right? I mean, usually when you're doing some kind of core stabilization exercise and you're prescribing it, or you yourself are doing it, you're recruiting, you know, multiple different muscles. Part of the glute, you're probably, you know, activating the latissimus dorsi on both sides, amongst other paraspinal muscles and supporting structures. So that has been kind of always the difficult thing to do. If you identify that somebody has, you know, some functional instability, you know, trying to target this muscle can sometimes be difficult. In addition to that, we discussed some of the real-world difficulties in also trying to get people to strengthen those muscles. Sometimes they can't. There has been identified, in addition to kinesiophobia or just, you know, different comorbidities, but also arthrogenic muscle inhibition, which is believed to be a centralized inhibition of the muscle, which can typically occur after surgery or some kind of traumatic event or even from, you know, having pain for an extended period of time. Selective transcutaneous stimulation, we use neuromuscular electrical stimulation oftentimes to help patients who have, you know, injured shoulder, particularly very common in sports medicine, but you can't do that selectively. And if you use a TENS machine, you know that it's stimulating the entire area broadly, so you're not getting selective multifidized stimulation. So theoretically, if you can target this multifidi and by way of stimulating the medial branches rather than ablating them, then one might be then possible to strengthen the muscles surrounding the spine and then breaking that cycle, as we discussed on the last slide. Next slide. So the initial multifidized stimulation study was conducted by Deckers. It was a prospective case series of sorts, as 53 subjects were implanted with this medial branch neurostimulator, and they were followed up for a year. Responder rates at the year was, at 90 days, was 58 percent. And people would argue, you know, at that number, it's kind of lukewarm. I don't necessarily disagree with that. But still, there was, this is kind of an early study showing that, you know, this particular type of stimulation could be advantageous for patients who are recalcitrant to other conservative management. At one year, additional 57 percent of subjects had a greater than two point reduction in NRS, 60 percent had greater than 10 point improvement in ODI, and also 81 percent improvements in EQ5D. So all across the board, improvements shown at the follow-up mark. At that point in time, they were still kind of working out the kinks in terms of how to implant this device. They actually ended up changing the implantable technique because there were a lot of complications. And so if you do read this study, keep that in mind. I know that I was initially alarmed that the adverse events were so high, and a lot of them were due to fractures of the actual leads themselves, because when they were placing the leads, it was actually getting sheared due to various fascial planes moving against each other. Next slide. So this is a follow-up study that was recently published in Neuromodulation by the similar authors. Deckers wasn't the first author for this, it was Mitchell, but basically took the same study from the Deckers trial and extended it out to four years. And what basically the study showed, and kind of tracking this data, was the durability of the therapy. And if you think about it, that makes sense, right? So we're no longer ablating something or just injecting cortisone into a space, but we're stimulating the muscles. And so, like any kind of rehabilitation, the longer you do it, the better the numbers should get, and the more durable the therapy should get. The additional thing that's intriguing here is in the neuromodulation field, and I only mentioned it because it was published in Neuromodulation, is that oftentimes we know that neurostimulation, people can develop tolerance to that therapy. It's one of the hardest things to go around. And so they're doing different types of waveforms and cycling of stimulation. But in this particular case, the longer you use it, the actual strength in that muscle is improved. So hypothetically, patients in the future, if they're getting explanted from this device, it could mean that they're doing it as a success versus what we have traditionally seen as failures. Next slide. So this was the big study. This was the one that was conducted by Gilligan. It also was what got the multifidized stimulation FDA approved. Those 204 patients, and you can see the stats here, I won't go over all that, but essentially big points here are where the inclusion and exclusion criteria. So 100% of them failed physical therapy. Again, you know, we're not suggesting that this is a replacement to physical therapy, but, you know, that you should still try conservative management. A lot of them had also in addition failed pain medications, and many of them were still on opiates at the time of the trial. Excluded were people who had any kind of potential neuropathic source of back pain, sciatica, or, you know, radiculopathy, or had more leg than back pain. Next slide. This was a slide that's, excuse me, this was a chart that was taken directly from that study. And I love this chart because it, you know, picture's worth a thousand words. So if you look at here, this was a randomized double blinded control trial. So they had actually a sham group where they implanted these patients, and then they had an active group. And one thing that's, you know, obviously amazing, but maybe not surprising for us in physiatry is that in the first like 30 to 60 days, you can see that both those lines were pretty consistent with each other, and we know that there's a very high placebo effect when it comes to treatment of low back pain. It's probably one of the biggest challenges with designing a randomized control trial when you're trying to use a therapy to treat low back pain. But as the, but the authors knew this, a lot of them understood that there was going to be an issue. So they, what they did was they wanted to extend the trial as long as possible. And this initial one was done for a year. And so as you can see at about the 60 day mark, when you start to depart from there, there is an actual change, right? The dark line, which represents the sham group and the light green line, then start to, starts to separate. And at the 120 day mark, eventually what they had to do is they, they had to do a crossover. So once all those sham patients crossed over, then boom, then all of a sudden the line dropped dramatically showing that this therapy was in fact efficacious. Now you'll see that the chart, I said that this study was a one-year study. You'll see that the chart extends much further than that. And that's because what's about to be published is some two-year data. Next slide. So this is, so, so disclosure to everybody, this isn't actually published yet. This is about to be within probably the next several weeks. So we're getting kind of first dibs on how this looks. This was actually initially presented. Some of this data was presented at NANS at the 2021 annual conference. But what you can see here is that they had three markers on these charts, and it kind of helps, you know, summarize things a little bit, but they did change of VAS of 50% greater than or equal to 50% of VAS reduction of less than or equal to 2.5. And then a greater than, excuse me, change of VAS of greater than equal to 70%. And what you can see here is that, as again, that durability of effect as you go from, you know, six months, 12 months, And what you can see here is that, as again, that durability of effect as you go from, you know, six months, 12 months to then two years. And one of the things that I find extremely impressive and encouraging being, you know, our PM and our backgrounds is that the thought of, okay, if we, if we strengthen this muscle, the back pain should get better and the person, you know, should respond better. I mean, it actually seems to be true. Next slide. So this is the same thing using ODI as, as the outcome measure here. You can see that the durability still remains at the 24 month mark. Next slide. So, so patient identification, let's talk about, you know, the, the, the crux of why we're having this discussion and how to integrate this into one's practice. So again, you want predominantly mechanical low back pain without any symptoms or findings of radiculitis. So, you know, symptoms or findings of radiculopathy, you have to, I just, because they have low back pain, doesn't necessarily mean that they have multifidi dysfunction or atrophy. So you need to do physical examination. It's that's, you know, the most important part, if you will. And then it's imperative that you read your own MRIs or at least have a radiologist who's actually looking for it. But reading your own MRIs is going to allow you to visualize and actually see, you know, how this atrophied muscle looks. And you can see it quite readily in most cases on both axial and sagittal reconstructions, but axial being the most obvious. And then one thing that's intriguing to me is that, you know, once I learned about the therapy and I look back on old patients or patients will come back in and they have back pain or the new MRI, you know, the updated MRI, I should say, I look and now I see it all over the place. You know, it's like been under our nose the entire time. Of course, you want to have patients fail conservative management. So I'm not doing this on anybody who hasn't already done, you know, physical therapy, chiropractic, acupuncture, exhausted, you know, at least a couple of different, you know, conservative treatment options. And then of course, you know, medications and anti-inflammatories, pain medications, etc. Those are excluded, pretty much mimics that of the previous study that I brought up by Gilligan, was that, you know, candidates who have had some spine surgery in the past or they have neuropathic, radicular, SI joint pain, I think is an important one that you want to distinguish that doing an SI joint block, you know, is not out of the question. And in fact, you know, people will ask me, well, how about, would you do a medial branch block? And I said, sure, why not? You know, if you can at least then give the patient the option, we can then stimulate this nerve or we can ablate this nerve and, you know, the patient can then choose based upon your discussion with them. The one thing that I would say is important and, you know, I didn't quite grasp this initially either, was that, you know, if you look at that study, these patients didn't have perfect backs, they had disc degeneration, facet arthropathy, modic end plate changes, spondylolisthesis, disc bulges, herniations. So it doesn't necessarily exclude them from utilizing this therapy or responding from the therapy. You know, a lot of these changes that you see on the MRI or the imaging, you know, is hypothetically a result of the multifidi being atrophied or being dysfunctional. So when you see something like this, don't get scared of it. You can still offer this therapy to that patient. Next slide. So physical exam provocative maneuvers, there are two main ones that the, you know, the manufacturer of the company that makes the device has recommended. The multifidus lift tester, the MLT, it's a palpation technique designed to test the multifidi dysfunction. So essentially the patient lies prone and then lifts their arm or shoulder off the table while you, the examiner, are actually palpating the multifidus muscle. And this is taken directly from the study from Herbert. We operationally define abnormal contraction as occurring when there is little or no palpable contraction of the muscle during the arm lift. So what you can do is you can test both sides, right? And that's the kind of nice thing. And if they have, if they're weak on both sides, then that's great. But oftentimes you'll see some asymmetry there, which makes it quite obvious. You can also go up higher in the back, you know, and see where it gets stronger versus typically in the lower back where you have a lot of multifidi dysfunction or atrophy, it may become more dysfunctional and more obvious. Next slide. This is the prone instability test. So this is the second of the two provocative maneuvers that I alluded to. So again, you're having this patient in prone position. You're going to be placing the kind of ball of your hand against the back, kind of in the spinous processes area, and kind of rolling it to put pressure on each individual lumbar segment. So you can do this literally from L1 down to S1. And then you see if it creates painful response. What you do then is in the picture on the right-hand side, and this is Dr. Kiesel, he's a physical therapist who has done a lot of this kind of teaching of these provocative maneuvers to physicians. But you have the patient actually lift their legs off the floor. What that does is it activates the multifidi. And if the pain then goes away, then you have a positive response. Next slide. So you know the provocative maneuvers. We know what patients would be good for this. And so this is my own personal case report that I wanted to present here today. So this 37-year-old female, she was a previous Cirque du Soleil performer with previous history of chronic low back pain at greater than 10 years, turned mother recently. And she came to me in the later stages of her pain management. She had been to multiple pain physicians, came to me, had tried obviously facet blocks in the past. We, in fact, did a medial branch block in a rate of frequency ablation, which provided her with some relief, but not as much as we thought from the medial branch. Again, most people in practice will tell you that they have these patients, unfortunately, that you think are going to be home runs for facet medial pain, but then just don't do well for whatever reason. And then she had been, so I sent her back to physical therapy, again, previous injections, chronic opioid use, and then we implanted her on 6721. So she reported a 50% VAS reduction already, and then a 30% in her modified ODI. So we do these forms for every single patient that comes into our office. I had her do it more recently, and she still has durable pain relief at this four-month mark now. So I'm really encouraged by it. And if you look at this picture here, I included her actual MRIs. You can see that multifidi atrophy on both sides. What you can see is that kind of fatty infiltration. We often talk about, like, it goes from looking like a kind of a grade A steak to a more Wagyu-style steak, you know. And then you can even see it, it's pretty impressive on her MRIs, you can even see it on the sagittal. If you look, you know, on this particular view on the sagittal image, you can see all that kind of white fatty infiltrate there. Next slide. So conclusions, initial evidence has shown permanent medial branch nerve stimulation to be a viable option for treatment of nociceptive mechanical lobe back pain. Further data is necessary to discern the full therapeutic potential for medial branch stimulation. Because medial branch nerve stimulation is thought to be restorative, fully accrued long-term treatment effect is likely not yet discernible. You know, we want, this is a new therapy, but again, because we're activating a muscle, we're restoring a muscle, we're probably not going to know how well that patients are going to do until maybe another couple, two, three, four years down the line. But four-year data from prospective case series has been, you know, positive. The Decker's paper and with their two-year data coming out relatively soon, excuse me, the Gilligan paper with their two-year data coming out soon is also consistent with durability as well. Thanks, Mahul. Fantastic. Thanks so much, Dr. Lee. That was really, really great. So I really only have one major question for you, also in the interest of time. So I think there's a lot of compelling data, especially the 24-month data I think is meaningful. Do you have any comments? Actually, maybe I have two questions. Any comments about the sort of some of the modest data in the past? Do you think this is a cumulative thing or do you have any thoughts on that? Yeah, I mean, I think it's a great question because I, to be honest, had similar questions myself when I was initially approached and started reading up on this myself, you know, kind of being intrigued with the therapy. You know, my thoughts are quite simple, is that this is not a therapy that's going to benefit a person probably in three, four months, five months, even six months. In fact, the case report that I present, I think, is a little bit unfair. And I told the patient herself that, you know, I was very happy with that because now four months out, you know, you probably aren't going to have as much placebo effect. But that I wanted, I didn't want to, you know, the jury wasn't out until probably a year. So I think that's what the hard part is just the logistics of the studies that are out right now. It's too early. So I think the longer, the more time we have and the more data we have, and I agree, we need probably more real world pragmatic studies on this too to really get behind it. But I think it just needs time. So the other question I had is, you know, the understandably the focus in your talk was about this one specific version of medial branch stimulation. Do you have any comments on some of the other therapies that are out there? Some that are temporary therapies that you have some data out there? Yeah, I've seen some good stuff out there. I think it has the, like, you know, I never would say that there's not a place for those. I think that there are definitely places and certainly have offered those to some of my own patients. Like there are certain patients who may not be able to get it like an implantable device because their comorbidities are far outweigh the risk, right? And so I would not, you know, this is a pretty relatively easy, relatively straightforward procedure, but, you know, still it's a procedure, it's an implant. And there are other people who absolutely don't want an implantable device. Maybe they're on their younger side, maybe they're in their teens, maybe, you know, there's other rationale behind that. So I do think that there's a place and time for a lot of these different, you know, medial branch stimulation devices. And you yourself, a clinician, reading up on those and seeing what those have to offer, I think is critical. The temporary medial branch data that's coming out has been particularly intriguing. I agree. I think that there's still promise there as well. Yeah, and I think I'll end with a comment before we go on to Dr. Singh, which is that, you know, I think that when you gave us, you sort of teased us, and I appreciate that with the 24-month data. I think that's a nice preview for folks who haven't had been exposed to that at NANDs or other meetings. But, you know, in 71% of patients having 50% or greater improvement in BAS is certainly nothing to sneeze at. It's actually fantastic. I guess the question becomes for the 29% of patients who would be, per the study protocol written as written, would be considered non-responders. Do you have any concerns? There would be maybe some concerns about cost, right? So if everyone goes on to implant from the beginning, is there a place for either trialing or, you know, where do some of these other systems play a part? So I think, you know, maybe that's food for thought for people to think about as they kind of digest this talk. But again, thank you so much, Dr. Lee. Yeah, absolutely. Great point. Yeah, thank you. And we're going to move on to Dr. Singh. In the last 15 minutes, Dr. Singh is going to talk to us about his topic. And Dr. Singh, you're on the line, I believe. So I'll let you take it away. Well, thank you very much, Dr. Desai. Those are my colleagues, Dr. Buchanan and Dr. Lee. It's certainly a privilege to be here at the Academy again presenting on one of the more passionate things that I enjoy doing within my physiatry practice. Next slide, please. There we go. All right. So, you know, I'm board certified in both physical medicine and rehabilitation as well as pain management. Since fellowship, my career path has taken me down the road alongside with spine surgeons. So I spent the initial six, seven years of my career in a hospital group in the division of neurosurgery and have now spent the last four five years as a partner in the Centers for Advanced Orthopedics. And so in practicing with these surgical colleagues, my style of practice, the type of referrals that I get are certainly more on the surgical side of physiatry, even though I still do plenty of the bread and butter PT and epidurals and RFAs. Next slide. These are my disclosures, quite similar to my colleagues from earlier today. Next slide. So the background over these 15 minutes, my role here, kind of take a background of physiatry and intervention, take a look at some of the literature, which as Dr. Desai I'm sure will ask me about is not all that impressive. And then of course, a little bit on the technique and a case report at the end. Next slide, please. So I do think it's important, you know, as physiatrists, and I'm sure many of those who are tuning in tonight, and thank you for your time and attention, are certainly on the interventional side of things. But that doesn't mean that the non-interventional spine physiatrist shouldn't also be aware of, you know, where our background has come from, right? So many of us pre-1990 obviously didn't do much spine intervention. With the advent of PASR and the NASS fellowships, you know, many more physiatrists started looking into that and becoming interventionalists into 2000, 2010. And since 2010, I think there's been a continued rise and a robust response of PGY2s who probably go into their residency program knowing that and wanting a pain type fellowship at the end. I was not one of those and sort of came to it, you know, through electives and my various rotations. So as we present these advanced topics, I think all of us from the PGY2, all the way through those who are in their later stages of their career, you know, don't shy away from all these potential treatment options that we are offering. So to that, obviously you can see, you know, we have injectors and neuromodulators, we have ablators and fusers, cementers and scopers. What we're gonna dive into today are the decompressors. Next slide, please. Next slide. All right. So, you know, who is the patient for a posterior decompression, whether direct or indirect? Essentially, it's gonna be our patient with spinal stenosis and clinical neurogenic claudication. Certainly to my group of colleagues, I don't need to really explain that, but what I will, you know, there are the traditional approaches of therapy management, physical therapy, home exercise. There are the complementary alternative practices that can also be tried as well. Typically, a lot of these patients end up with some form of injection intervention. And what many of us who do these injection procedures realize is after some time, the response to the procedure is just not as robust, whether that is habituation of the steroid or whether that's progression of disease, probably a fair combination of both. So there are some, you know, procedures that are on the market right now. I will do my best not to be name brand specific, but, you know, in the sense, for example, mild and VertiFlex, there's only one of those currently out on the market. And so many of us have been introduced to the mild procedure, where we can directly remove small bites of the superior and inferior lamina. We can also remove small pieces of the posterior redundant portions of the ligamentum flavum. And whether we choose to do a unilateral bilateral procedure or one level or multi-level, certainly at the clinician's discretion. Thereafter, you know, the VertiFlex does provide some form of indirect decompression. Many of the older physiatrists may have been part of the X-stop phase years ago with that sort of indirect form of decompression. Interlaminar and interspinous processes, I think this is where that, this is where they fit into the algorithm at the moment. And so again, there are multiple access points, whether it's a far lateral approach or a posterior approach, whether it's with direct decompression of the lamina and ligament, or whether it's ligament sparing and therefore just an indirect decompression. And then obviously there are choices whether to prepare the tissues for bone graft and infusion. Finally, right now we refer patients out to our surgical colleagues for a variety of decompressive procedures with and without instrumentation. Next slide. So, and again, many of you are very familiar, what are the causes of central spinal canal stenosis? Your typical causes, whether it's anteriorly from the disc, laterally from the facets. I do think it's responsible for those who are gonna be advanced in their interventional training and surgical techniques to really be able to evaluate an MRI as well as a spinal surgeon can. Remember, we're sort of treading into territory that we've not been in before. And so we need to take our own personal responsibility, or professional responsibility, and be as well-trained as possible, not relying on our radiology colleagues for interpretations, but being able to make direct and accurate interpretations. So to that extent, looking for things like facet cysts within the canal or within the foramen, as well as even epidural lipomatosis. Sometimes these things can get left off on reports or they're underappreciated on reports and may become contraindications or relative contraindications for some of these procedures. Obviously, ligamentum flavum hypertrophy and spondylolisthesis are other reasons why one can have canal stenosis. With these procedures, because there is the option in certain scenarios to fuse the level, one has to also understand what is instability and be able to evaluate for instability. To that extent, it'd be critical to have both flexion and extension views of the lumbar spine so that you can determine or even measure if there's any abnormal motion. Fluid within the facet joints, again, reading your MRIs yourself, would be able to also provide you another layer of understanding your instability. Next slide. So when it comes to the literature, unfortunately, there's nothing that's just a home run. So both of my colleagues, Dr. Lee and Dr. Buchanan, provided literature that speaks directly to the procedure in and of itself. I was able to reach out to a couple of companies. Unfortunately, they do have some research pending, but nothing yet to share. So hopefully there is stuff coming to show its safety and efficacy. But until that time, here's what a brief review of the literature looks like. So Kay et al looked at both mild and vertiflex. They are both safe and effective. And I think for the interventionalist who is looking to dabble in some of these more advanced procedures, these would be two examples of pushing past just simply an epidural or an RFA to become more advanced in helping patients with spinal stenosis. Obviously more research and sort of more long-term research are waiting for both of these products, but the safety is certainly there. And the efficacy for those of us who do it are certainly there. I think that the main take-home point is that these procedures and some of the other one that I'll discuss later are disrupting the climate within the surgical spine space. And that's something I'll allude to in another slide. So Kay et al and his colleagues look specifically at a product, it's the ZIP, interspinous spacer, as a form of indirect decompression, but with preparation of the bone tissues for fusion. While it was a retrospective study looking at safety and efficacy, there clearly was no significant adverse events and a very significant improvement in the VAS score. Next slide. Walton et al looked at the Superion or sort of the VertiFlex device. And there are many papers. I kind of was looking for ones that talked about more long-term data. So here was a two-year look at the Superion group and these procedures, and we should be aware as we enter into the space, do have risks and complications. Now, fortunately, none were life-threatening, but many of them here, 44%, showing some form of device complication, whether it was fracture of the spinous process, need for open surgery or revision surgery, or an explantation due to pain. Along the same lines, Agrawal et al looked at device, sorry, user facility device experience data. And so the three devices that they looked at, CoFlex, VertiFlex, and X-STOP, all showed some form of migration and fracture. They all showed worsening of pain symptoms. X-STOP and VertiFlex had a higher reoperation rate when compared to CoFlex. CoFlex had a higher CSF leak complication. I think, you know, so that those of you who may not be super familiar with all these devices, so CoFlex is more of an intralaminar device. The goal there is to remove most or all of the ligaments and flavum, spare most or all of the lamina above and below, and slide the device. And as its name says, CoFlex, it is not a fusion device. And therefore, migration and fracture can be a complication. VertiFlex is more of a percutaneously inserted device through a tube where you do disrupt the interspinous ligaments and then deploy the device there, depending on positioning on the table. And if someone is in too forward flexion, and then if the device is sized at a higher, a larger device size, then will be appropriate when they end up standing up. And if the device is not seated as anteriorly as possible, you certainly can get the spinous process fractures. And then again, X-stop, which is not on the market, actually pulled because of its complications. So good history that we need to know of as we continue to push forward. Next slide. So then again, the reason I mentioned this paper here with the Journal of Neurosurgery and Spine is because at the end of the day, we are stepping on the toes of our spine colleagues. These are patients who could be operated on. In our practice, they end up coming to me or other of my colleagues because the surgeons do not want to operate on them, but yet they still have some sort of experience that they still have significant pathology. But it should not be surprising to us that the Journal of Neurosurgery and even the AANS have put out physician papers and points talking that interventional physiatrists and non-surgically trained spine surgeons should not be doing these procedures. So as we go forward, we do need to be careful both on our evaluation of our patients on the imaging and if this is the right procedure or not, as well as our own surgical techniques. Not all is bad. Actually, Zhang et al showed what's more effective, a decompression alone, a decompression with fusion or an intraspinous process device. So they looked at 10 randomized controlled trials in a retrospective way, 1,250 patients. And the intraspinous process device, excuse me, the intraspinous process device was superior for VAS-ODI, but also did have some complications and consideration for reoperation. Next slide. And then the last paper to sort of go over, I think will lead into where some of this literature and research should go into the future, right? So when you look at an intraspinous distraction device, so something like a X-stop or VertiFlex, it's clearly superior than non-operative management. And then when you look at that device versus open decompression, while the outcomes are similar, you do have a higher complication rate and you do have a potentially higher reoperation rate if those intraspinous distraction devices cause complications. But obviously the cost of any device is gonna be far more expensive than a laminectomy or lamineotomy procedure. When doing an open decompression with interbody fusion versus an intraspinous stabilization device, so those are gonna be your intraspinous fusion devices, the outcomes are similar, but the OR times, blood loss, other sort of comorbid outcomes are in favor of the intraspinous stabilization device. And that there was some suggestion that for grade one spondylolisthesis, the intraspinous devices may be better than an open decompression with fusion. Next slide. So to summarize the literature, these devices are safe. And while I'm sort of presenting more of the doom and gloom, I think that's always important when we get into this kind of a field and we move into these sort of procedures that we weren't necessarily trained on in residency and fellowship. What will be interesting is when do you use these and why? And I think that's where between the mild, the distraction devices, the fusion devices, surgical, endoscopic, I mean, the list is growing. I think that's exciting for the space that we're in, but it's clearly more research is needed. And then that obviously naturally goes to the cost of reoperation rate when looking at this systematically. Next slide. So there's both the percutaneous approach as well as the posterior approach. And I've listed the two there for you to read. Essentially, when it comes to the percutaneous approach, you get more of that indirect decompression of the neural elements. One of the devices does have an application for future arthrodesis. Which one is better, when, why, how, that's all to be still yet determined. And that device does have a pending paper in the works at this time. For the posterior approach, there are some papers on the COFLEX device. They're all gonna be surgical papers. There is that retrospective look at ZIP, and then some of the others are doing some prospective studies as well. Here you have the option of either just indirectly or directly decompressing. So you could take down more of the lamina. You could take down more of the ligamentum flavum. And even if you chose to even expose some of the dura. But here again, exposure, tissue separation, there's a lot of surgical considerations that one would have to take depending on how aggressive you want it to be. Next slide. So the case report here is a 79 year old female, progressive neurogenic claudication. The classic things for an 80 year old to have no significant cardiac history or anticoagulation that we need to worry about. But again, had a surgical consultation was advised of at least multi-level LAMI, if not cage instrumentation and pedicle screws. And obviously was not interested in the family, was very much not interested in an invasive procedure like that. Repeating epidural injections would be another option for her. Facet to RFA or the others that I've listed. And then of course, the lateral versus posterior instrumentation. Next slide. So on the left and on the top, you'll see that, so that's her 2018 MRI. You can see at L4-5, there is that progressive central spinal canal stenosis. There's a significant ligamentum component. There's some facet hypertrophy as well as posterior disc bulging. When you then compare to the 2020, sorry, the 2021 images, and I'm sorry, I didn't label those, but the unlabeled images are 2021. And you can clearly see the progression, the progression of facet hypertrophy as well as facet fluid indicating instability, the increasing ligamentum flavum causing more central canal stenosis. Next slide. So we took her to the operating room about three, four months ago. We were able to make an incision from the L4 to the L5 spinous process. We're able to remove both the supraspinous, the interspinous ligaments, was able to take down some of the lamina of L4 as well as on the top of L5, work my way out and even dissect out some of the ligamentum flavum as well. So to provide more of a full decompression and then obviously placed the instrument as shown here. Next slide. So postoperatively reductions in VAS as well as in ADLs, standing and walking distance both improved. For an 80 year old who was living at home with her daughter and her daughter's family, the improved ADLs has made a dramatic improvement, not just in her life, but in her family's life. Interestingly, and not to be unexpected with these patients, they make it out 60 to 90 days postoperatively and they just say, it's not that I can't keep walking, I'm just tired now. And so deconditioning actually ends up becoming the issue when patients go back and this young lady is back in physical therapy. It was about a 90 minute procedure, minimal blood loss, and all done as the outpatient went home after clearing PACU protocols. Next slide. Hope I made it in there in time there, Michael. Well, I felt compelled to shorten your time. I actually didn't short your time, but both Dr. Singh and I were at the Penn State Maryland game yesterday. And unfortunately his team came out on top, which we win in basketball and academics, they win in sports. So no, I'm kidding. But it was a fun game. But no, I only have in the interest of time, one question for you. You talked about the lateral versus the posterior approach. I think that you handled really well. And the talk in itself, I appreciate the breadth of the data you presented, despite the fact that, as you said, there's not a lot of direct data. Do you have any concerns about folks doing this and then trying to get credentials in the hospital for it? Because you have a unique situation that you outlined at the beginning. You have like this surgical backup because you're in a team, you have like a team approach. But what about for folks who are kind of standalone private practice folks? And this probably applies to, at least the conversation that Dr. Buchanan had and that you had, what happens when the patient goes to the ER or something like that? Yeah, no, that's a fantastic question. I think it has to be dealt individually. First and foremost, the physician has to make a decision. Is this something that you want to take on, right? This is not exactly a procedure that every interventionalist is even gonna want to explore. And then the second question is, if you do decide to take it on, are you taking it on in a more minimally invasive or a more open technique, right? So in the case that I presented, she's certainly not my first. So I've had time to work with my spine surgeons. I've even operated with my spine surgeons before. So I've learned some of their techniques directly. And that is gonna be very unique to compare to a solo interventional practice. But you can do these techniques in taking more of a indirect decompression approach. The problem at the end of the day still is, okay, so that patient goes to the ER, what do you do? So a lot of private physiatrists don't have ER privileges and don't have hospital privileges. There's two large groups in my backyard and not many of them have that privilege that if their patient goes to the hospital that they can go and take care of that. And so you do need to really have an open dialogue with your surgical colleagues. There are lots of surgeons who refer to us. Some are gonna be pro for it. And my colleagues that I work with are, and I have a few neurosurgeons in the community who have told me point blank, please be careful in doing these. We know you are a little unique in your training, but we don't really wanna take care of this if it shows up in the ER and could become a case report for the hospital. So you need to have these open discussions in doing it, but please, that shouldn't stop you if you have the drive and the interest to learn and become dedicated in doing it. Yep. So in summary, I think the takeaway for me, so first and foremost, I wanna thank all three of you for being here. I appreciate the talks you gave Dr. Buchanan, Dr. Lee and Dr. Singh. I think it was fantastic information. I think the future is coming and it will either be prepared for the future or the future will pass us by. So I think that all of these, the procedures that you guys have described have their individual considerations. There are some concerns, but there are also some advantages. The world is moving towards a place where therapies are getting smaller, more efficient, delivered in sites of service that are maybe more convenient associated with lower morbidity and mortality than necessarily what we're used to traditionally. I think it's incumbent on all of us, not only to educate ourselves about these procedures, even if we don't do them, but particularly if we're gonna do these procedures, it's really important that we get the right kind of training and have some sort of commentary as a group about what the minimum required criteria are for these procedures so that we can establish and maintain a standard that we hold ourselves accountable to, but also hold our colleagues accountable to, because that's the only real way to gain credibility with these things. So again, I really wanna thank everyone for being here. Thanks for spending the last hour or so with us. And I hope the folks who listened to this talk find it to be helpful to them. I'm gonna sign off with that.

minimally invasive sacroiliac joint fusion

low back pain

sacroiliac joint pain

lateral approach

posterior approach

studies

diagnosis

patient selection

treating back pain

patient selection criteria