tonight for the Spine Community Session. I appreciate you guys taking the time out to come join us today. So we have a sort of wide-ranging topics we're going to talk about today and so again appreciate everyone for joining. If you guys could just make sure you mute your microphone as well as if you want to go off screen that's completely fine and then we'll have time to circle back for questions and for chat. So my name is Aaron Yang. I'm at Vanderbilt University Medical Center. I have no relevant financial disclosures. So I wanted to just poll the audience here and just see where most of you guys are currently practicing or training because I recognize we can have trainees joining us as well. So take a moment and we'll have this poll up. We'll give you a little bit of time and we'll see where everyone is joining us from. All right, seems pretty diverse here. We've got Midwest, Southeast, Northeast represented. Got a few from the Northwest and the West. All right, great. So we're going to move on from here. So this is our agenda for today. So I'm going to give a brief introduction, just introducing our speakers and what we're going to talk about. Then we're going to get into a point-counterpoint session. It's going to be about trigger points for spine pain. And so we're going to have Dr. Amit Nagpal be on the pro side of the argument and Dr. Byron Schneider on the con side in terms of trigger point injections. And so we're going to allow them to talk, have a rebuttal for each of them. And then we're going to have a brief Q&A so you guys can send your questions via the chat function on Zoom. And then I'll try to just filter through the questions and pass them along. And then what we wanted to do was spend about 10 minutes in a breakout room. We'll try to split up everyone in here into smaller groups and just get to know each other. Because again, the main idea of this community session is also to network. And I realize that is difficult when we're doing this virtually. So we'll try to utilize the breakout room function. And then we're going to spend the last 30 minutes with Dr. Zach McCormick, who's going to be talking about assessing the literature for the spine physiatrist. So you have two main learning objectives. The first is to discuss the rationale for and against trigger point injections for spine pain based on the current available evidence. And then second objective is to develop a systematic method for reading, interpreting, and critically evaluating spine literature. So why do I pick these two topics? One, no one responded if there was anything particular they wanted to go over. So I just came up with them. But two, we know that it differs based on practice pattern, whether or not people perform trigger point injections for spine pain. So I really thought it would be interesting to hear two sides of the coin and also to just hear the evidence regarding the use of trigger point injections. Then also we can realize that whether you're in academics or private practice, you can really be busy to keep up with the current literature and also to just go through all the different studies that are coming out and knowing which studies can truly impact your practice. And so I thought it would be good to hear from someone who's definitely knows a lot about publishing and going through lots of different studies as a reviewer. And so I think that'll also be helpful for our practice. So before we get into it, I wanted to hear from the audience, how many of you currently perform trigger point injections for axial spine pain? So we're going to get this poll up here and just see where everyone stands before we get into it. Wow, these are almost like election results. We're right at the line here, 51, 49. So we're about almost 50, 50 in this room. So this'll be great. We'll sort of, I'll be really interested to see how the breakout rooms go and after people hear the point counterpoint arguments. All right. So, let's see if I can, without further ado, we're gonna get into the speakers. I can move on. Before, I just wanted to just put a case example out here. Not really relevant to this specific talk, but just wanted to make something here. But, you know, a 45-year-old gentleman comes to your clinic presenting with neck pain for the past six months. There's pain located along the bilateral upper trap muscles without any associated neurological findings into the extremities or radiation to the extremities. Patient works as an attorney and spends about eight to nine hours sitting at work, about five days a week. A primary care doctor prescribed muscle relaxers and referred to physical therapy and also ordered x-rays without any significant findings seen on imaging. So patient comes to your clinic and is wondering if they can have any type of injection performed for them. So I'm gonna get into our debate. I didn't have a specific person that we were gonna start first, but I'll have Dr. Nagpal present first, and then we'll circle back afterwards after we hear rebuttal, we'll go back and forth. So Dr. Nagpal, if you wanna share your screen and we'll have you start off. Good evening, everybody. Hope we're all doing well. Let me get my screen shared here. All right, let's see how that works. This is not the right thing. All right, here we go. So hope everybody's doing well and having a good meeting so far. This is a wildly different experience for all of us. And I think it's been nice to have people like Aaron and who've really taken the bull by the horn, so to speak, and put things together so we can still have a really educational meeting. And so I'm Amit Nagpal, I'm at UT Health San Antonio, and I'm Associate Professor in the Department of Anesthesiology and the Division Chief of Pain Medicine. I'm gonna be talking to you guys today about trigger point injections for spine pain. I have really no disclosures that are relevant to this particular talk. So here's some facts about trigger points and facts in general about pain. It's almost impossible to figure out what's causing somebody's pain. There are people in this audience who have done studies that have set forward diagnostic certainty for the diagnosis of certain conditions or are better yet are well-versed in that because we've studied these things over and over. For example, how to determine whether somebody's pain is being, is generated by the third occipital nerve or by facet joints. That's been elucidated to the point that we understand how dual diagnostic or prognostic medial branch blocks work. And we know that with a certain degree of sensitivity and specificity and a certain degree of awareness that we are able to predict whether somebody will improve with radiofrequency ablation due to those medial branch blocks. But here's the thing about that. It's very common for interventionalists to claim that it's easy to know what's the cause of someone's pain. That's because interventionalists frequently ignore pain that they don't understand. And my counterpart, Dr. Schneider today will tell you that trigger point injections should not be done in the axial spine because they don't exist. I know he's gonna say that and I haven't seen his slides but I know he's gonna say that. And I'm gonna tell you that then he'll tell you, well, if that patient walks into his office and has something that vaguely feels like myofascial pain, he doesn't know what to do about it because he's an interventionalist and he's going to ignore anything that he doesn't know how to treat. And the reality of that, it comes from the fact that, hey, all these years we've been telling people that we know that we can diagnose facet pain with a certain sensitivity and specificity with dual diagnostic or maybe even triple diagnostic blocks. And now there are people in our field who are very intelligent, who have written evidence-based guidelines to show that, you know what, maybe we shouldn't even be calling these things diagnostic blocks. Maybe we should call them prognostic because all they tell us is whether people will get better with radiofrequency ablation. We even have prevalence data to say that facet pain is probably X amount of percent of back pain, probably in the range of five to 10%. And 30 to 40% of neck pain is facet pain. But geez, that's based on data that comes from meal branch blocks because interventionalists like to put needles in things and that's how they decide whether it's true or not. And now we have to backtrack on that and decide whether those prevalence data are even real. So I would venture to say that we have been too dogmatic and trigger points are real. And how do I know they're real? Well, I see it in my day-to-day operations, in my day-to-day clinic. I know that the American College of Rheumatology has created trigger point diagnostic criteria which are based upon the seminal work of Trevelle and Simon from decades ago. And that a trigger point has to be defined by a tender area of muscle with a predictable location, with a top band of myofascial tissue, with a characteristic referral pattern in which palpation reproduces pain. If it does not have all five of these characteristics, it's a tender point according to the ACR. And so we have diagnostic criteria. Now some might argue, well, geez, that's kind of made up. Okay, yeah, maybe it is, maybe it is made up, but you know what else then is made up? The diagnostic criteria of rheumatoid arthritis and lupus and every psychiatric disease because they're all diagnostic criteria just like this. We do not have a genetic test or a laboratory test or an imaging study that can give you the full definition or diagnosis of a rheumatologic disease. Sure, anti-CCP antibodies have been demonstrated to be high in patients with rheumatoid arthritis, but you have to have X-ray findings and or cardiac findings or lung findings and all. The diagnostic criteria are wide and far, but nobody ever calls into question whether rheumatoid arthritis is real. So I'm here to say that I think it's fair for us to say trigger points are real and it's okay to have anecdotal evidence-based, not evidence-based, anecdotal expert-based guidelines. And even to that point, we have a Delphi study. Okay, so I asked when we were supposed to, when we first started putting this together, should this be contentious? And Aaron said, no, we're all friends, we shouldn't do that. But I'm gonna be contentious here. And I'm gonna say that Dr. Schneider is on the editorial board of Pain Medicine. And this study is in fact, he's a section editor. And this study was published in Pain Medicine. It's a great journal. I think Dr. Schneider does excellent work and he'll tell you that, we shouldn't be doing trigger point injections, but I'm here to tell you why shouldn't we do, why shouldn't we first start with the premise that this is a real condition and then therefore decide if we can actually treat it. And so this is a Delphi study. A Delphi study is a consensus expert panel to decide a particular question. In this case, how do we define trigger points? And the first round of the Delphi study, it was determined that trigger point diagnosis by 70% or more of the experts was indicated by a top band of tissue with a hypersensitive spot and referred pain. So this post dates the ACRs diagnostic criteria. And this group has basically said that they come to this consensus that there's these three things. And then they do round two of their Delphi panel and 40 of the experts, and now around 66% stated that this should be the minimum criteria, top band, which we just said, top band, hypersensitive spot and referred pain. And the reason that it's only 66 is because there's a group that also thinks that the referral pain, particularly in something called a latent trigger point may not be profound during the examination. So therefore we don't know. But let's go with the premise that at least from this diagnostic criteria, it should be a top band with a hypersensitive spot with referred pain. Now let's be evidence-based. Fine, that's expert opinion. Where does that come from? But it's okay, because that's how a lot of our diagnostic criteria for diseases, we don't understand they come from. That's where the diagnostic criteria for fibromyalgia comes from. It's all expert opinion based in consensus statements and Delphi panels. So that's fine. So, but let's be expert based about treatment. At least that we should be able to do, right? And let's look at the evidence-based pyramid. We know that a well-designed meta-analysis and or systematic review is the pinnacle of evidence. And the second highest, second highest ranked would be an RCT and so on. But we also know that poorly designed studies do not trump well-designed studies. So for example, a well-designed non-randomized controlled trial is better than a poorly designed randomized controlled trial. We know that to be true. So I went and perused the literature for well-designed studies to determine whether or not we should be treating patients with trigger points, with trigger point injections in the axial spine. That's the actual, that's the question here today. And so this is a study from 2017, which studied the effects of dry needling, which is a form of trigger point injection on spinal mobility and trigger points in patients with fibromyalgia syndrome. Now I will give you, we should not equate trigger points in fibromyalgia because fibromyalgia is accompanied by tender points. But that doesn't, a fibromyalgia patient can have trigger points. Why not? So these patients were diagnosed with trigger points in the appropriate fashion. And algometry scores in those patients showed improvement with the dry needling and in the other group, which was the part of this controlled trial is not blinded of course, because the other group got cross tape, kinesio taping. And what we find is in many of these muscles, which we will all agree are in or near the axial spine, we saw improvement. Yes, in both groups, both groups. But that, I think it's important to note that that takeaway is that, hey, the dry needling, which is a trigger point injection did help some percentage of patients with trigger points in the spine, in the axial spine. And we're not talking about the appendicular skeleton, we're talking about the axial spine. That here we're looking at a T-test data to show significance with improvement in pain, one month post-treatment in the lat dorsi, in the axillary portion. Also true in the mid portion of latissimus dorsi. Also true in the iliocostalis at the T6 level. Now we're really dealing with paraspinal muscles here. Also true with iliocostalis at the T11 level. Pay no attention to the fact that they're spelling iliocostalis incorrectly here. Okay, that's fine. We know they're going into the right muscle, almost certainly. At L1, that's also the case. Multifidus, okay, so this is a muscle. Who knows? All this time we've been saying that facet joint pain has this high prevalence and everybody is very excited about that. But maybe it's because we're denervating the multifidus that radiofrequency ablation really works. So I don't, but maybe it's trigger points. Maybe all these people who are saying have facet pain actually have trigger points and we could just go in and do a trigger point injection in their multifidus and maybe they're gonna get better. Or kinesiotaping. I'm not saying there's anything wrong with kinesiotaping. I'm just saying the trigger point injections helped this group too. Multifidus at L2 as well. And there were many other muscles that you can certainly go in there and look at and get the same impression that I did. Okay, here's a randomized trial and it's sham controlled of paraspinal stimulation combined with trigger point needling and needle rotation for the treatment of myofascial pain. And what this study really did was it combined, this is from 2014 from the Clinical Journal of Pain. And the authors, the scientists in the study compared trigger point injections to sham. And they also compared MD-IMST, which essentially when you read the paper is electroacupuncture. They put needles into acupuncture points in the muscles that were defined as having trigger points and then electrically activated them. And so essentially it's electroacupuncture. And what we see is that both groups did superior to in terms of pain improvement than the sham where the needle was taped to the skin. So at least, but now I will give you that the electroacupuncture seemingly did better in each of the timeframes at one week, two weeks, three weeks and four weeks than trigger point injections did. But hey, electroacupuncture is probably just a version of a trigger point injection. Maybe it's a modernization or an improvement of a trigger point injection in and of itself. So I firmly believe that this data shows us that at least four weeks out, which granted I'd love to see eight week, 10 week, three months, six month data, but at least a month out from the trigger point injections and from the electroacupuncture, there's improvement. And therefore it works. And this is the table summary of their data indicating that the trigger point injection with just lidocaine versus the electroacupuncture group, both were superior than to the placebo sham group. And there was an improvement in sleep, by the way, for us to indicate. Not an improvement in SF-10 and SF-12, excuse me, neither group, but hey, there's something here. We're talking about pain, right? Okay, so now I went back to 1989. It was a fairly well done study, though the diagnostic criteria they used to determine what's a trigger point is different. But this is a perspective randomized double-blind evaluation of trigger point injections where it's comparing different groups that different injectates and, or acupressure. And what we see, and there's only a two week follow-up. I understand, I get it. And this is from 1989, okay? So they were in a different timeframe when they were trying to focus on what myofascial pain is. But this is a study that people call attention to quite often to say that trigger points don't work. Because if you see the percent of people who improved in the vapo-coolant and acupressure group, which is absolutely not a trigger point, right? Whereas A, B, and C, lidocaine, lidocaine plus steroid and acupuncture are all injections of some, the needle penetrates the skin and he doesn't. The group that did the best was the vapo-coolant and acupressure groups. But there's responders in the trigger point group, right? 40% of people got better. There's no significant difference between these groups. It wasn't well-powered probably. I mean, certainly it wasn't well-powered. And acupuncture is a single dry needle stick in the painful area, which makes it a trigger point injection. And therefore I would argue that if you add this data in, you would say that, okay, this type of trigger point injection, 61% of people got better, that's not bad. We take that in a lot of pain medicine and a lot of our interventional procedures. We can get 61% improvement. And lastly, as we mentioned, systematic review, a well-designed systematic review and meta-analysis is the pinnacle of the evidence-based pyramid. It's the apex. And so this is a really well done systematic review and meta-analysis comparing dry needling and trigger point manual therapy in patients with neck and upper back myofascial pain syndrome. So again, we're talking about the axial spine. And what we see here is they did a great job of really looking at the available extent data at the time of the available studies that compared these things. And they looked at each of the very important components of a well-designed randomized control trial like random allocation concealment, baseline comparability, blinding, et cetera. And they gave us a total score of how rigid and well-designed the original RCT was. So we see that we have a range. This one's eight, this one's five. But then also we look at the different versions, amounts of bias, and we see a lot of lows, right? So there are some concerns in many of the studies and there's one that's high risk. So this study has a high risk of bias but the rest of these are good. So therefore it's good data. Good data goes in, hopefully good data comes out. And their conclusion without going too deep into the details of their meta-analysis was that what they found was both dry needling and trigger point injections, I'm sorry, trigger point manual therapy which is not an injection, right? Improved pain and function in the short to medium term with patients with myofascial pain syndrome. Neither intervention appeared to be superior to the other. Okay, and that's fine, that's fine. I'm not saying that we have to do trigger point injections in the spine in lieu of other treatments but what we're saying is that, hey, trigger point injections in the spine seems to help in this systematic review and meta-analysis of some good data that went into the study. So in summary, if you want home runs, go watch baseball. Interventional pain management is not a game of home runs. We don't throw Hail Mary touchdowns all the time. There are incremental improvements in our patients. We are excited when something gives us 50% responder rates. We're excited when our new technology comes out and the responder rate is 30 or 40% because that's giving us going the right direction. This isn't hypertension, this isn't diabetes. We are excited to have small victories. And so trigger points themselves are real and for some percent of the population, the injections work. Now, if you, the other issue that I didn't talk about here is safety. If you avoid the known risks of these procedures, it's pretty safe to do. And I think in the hands of a competent physiatrist, there's no reason to worry too much about this. Pneumothorax is a big deal. It's a big deal. If you get a pneumothorax doing a trigger point injection, it's a problem, but there are ways to decrease the incidence of that, like use utilization of ultrasound to perform the procedure and visualization of the pleura. You can clearly, the possibility exists for you to use the smaller needle. So even if you get a pneumothorax, it's less clinically relevant. And so there's a lot of things you can do to mitigate this risk, but they're pretty safe procedures. The last thing I'll say is that my mentor, Dr. Ramamurthy, who taught me most of what I know, used to call some of these procedures, he used to say that what he was doing was developing a therapeutic relationship with the needle. Now we know a lot of these people, what they need quite a bit of is biomechanical improvement, physical therapy, exercise processes, ergonomic evaluations, and restoring their muscles to their usual length because of contraction, because of the type of work that we all do at computers and so on. But a lot of patients don't wanna do that. But if they get even short-term relief from a trigger point injection you did, now they believe you because you're working hard for them. That placebo effect that they might get, or frankly, just a real effect that might, because you numbed up the muscle that hurts for one day or two days, might lead them to do the physical therapy that's important for what they actually need. And so I think trigger point injections in the spine work for long-term, but the data gives us about a month from what I've shown you here. But I also think it's probably helpful even in people where it may not help as an injection, just to help you develop a relationship with that patient. All right, so that's it. I'm sure Byron's got something himself that may make you disagree with me, but I don't think so. I don't think he'll be able to do that. Thank you. Thanks, Amit. I like the mic drop right there. So next up will be Dr. Byron Schneider giving the con argument for trigger point injections. So again, I'll mute off and Byron will share his PowerPoint and we'll go from there. Brian, just make sure to unmute your mic. Technicalities. All right. I'm screen sharing. Let me just pull it back up. All right. Thanks for having me. Sorry, my lighting kind of sucks. Nicely done, Dr. Nagpal, and thanks for inviting me, Dr. Yang, and thanks for everyone joining. I see a lot of names I recognize, both faculty and a lot of residents and fellows. And it's not quite the same as going to a meeting in San Diego, as signing into your computer at 7 at night. So we appreciate everyone joining. So I don't have any relevant disclosures to this. I do think it's fair to point out where I'm coming from. So I would contest I'm not a needle jockey. In fact, arguing against doing injections I think would say I'm pro-noninjection therapy. But I don't do a lot of injections. I inject probably a quarter of the patients I see. I will freely grant you. I don't know what causes everyone's pain. But I'm also grounded in science and reality. And so for those of you that recognize this picture, we'll come back to this. So the outline of what I'm going to go through is what are we treating? Does it work? And if it does, clinically, what does this look like? So Dr. Nagpal said myofascial pain and trigger points are real. So I would like to think I'm not presenting a con argument today. I'm just going to present a critical appraisal of what I would argue are very pro-trigger point articles. So here's a nice review article from five years ago in our PM&R journal about what are we treating? What are trigger points? What's myofascial pain? So here they say unfortunately much of the terminology, theories, concepts, and diagnostic criteria are inconsistent, incomplete, or controversial. They acknowledge that for many clinicians the finding of one or more myofascial trigger points is required to have the diagnosis of myofascial pain. And yet, speaking a little bit out of both sides of the mouse, they also acknowledge that the pathogenesis and pathophysiology of trigger points and their role in myofascial pain is unknown. So this seems like a lot of unknowns to me. We also want to know, well, what are these? This is a perfect marriage in a world that likes to say low back pain is nonspecific. If you find something that everyone has, well, maybe put two and two together and nonspecific low back pain is myofascial pain. And therefore by default they have trigger points because that's part of myofascial pain and so we should treat it. But in this article here they acknowledge, although it's a little dated, that the prevalence of myofascial pain is actually unknown. But what I think much more importantly here is that they state that central sensitization is an important factor in the development of both tenderness, referred pain, the conversion of acute pain syndromes to chronic ones, and maybe an important factor in the pathogenesis of both fibromyalgia and myofascial pain. Which again, trigger points and myofascial pain go hand in hand. So here I would argue, if we are saying nonspecific low back pain is myofascial pain, but then at the same time saying myofascial pain is centralized pain, why do we keep coming back to the muscles when, as Dr. Negg-Paul acknowledged, many of these patients probably need therapeutic exercise or other non-interventional treatments to treat their quote-unquote muscle pain. If we are going to look at this from a scientific perspective, we're physician scientists, we need to know what trigger points are. They must be defined. There must be a validated way to diagnose these. We must know the prevalence and incidence of these, so how many people have it. And then what's the natural history of this? So for example, if you look at an acute disc herniation, and we know most people get better within six months or a year, and you do a study that follows them out to a year, if there's no difference between the treatment and the control group at a year, well, that might just mean that everyone eventually gets better. And maybe that means you don't treat them. I don't know. It depends how bad they hurt. So if you look at a natural history of something that has a poor course, then you would think a treatment that has true treatment effect will actually show benefit throughout the study because you know they're not getting better spontaneously. So if you went over this or Dr. Nagpal did, what is the definition? Well, this is pretty consistent throughout the literature. A trigger point is a hyper irritable spot, a palpable nodule, top bands, direct compression, contraction can elicit a jump, there's tenderness, there's local response, there's referred pain, and it responds in a specific pattern distant from the spot. So what we're saying trigger points are is that when you push on the muscle, it hurts. And I like to think that our jobs are hard, and they are. And if it was really this easy, if every patient you could just say, hey, point to where it hurts, our lives would be a lot easier, but that's just not how it works. So if we're going to study this, and we're going to accept that the definition is just that you push on it, that causes some difficulties, right? And when you look at other studies, again, this review from 2015, they acknowledge this, that there is no objective way to say what a trigger point is. And they also state in a very pro trigger point article that besides the use of palpation, there are no accepted criteria for identifying or quantitatively describing muscle trigger points. So while I acknowledge that some things like psychiatric syndromes have expert opinion or a set list of symptoms that correspond with the diagnosis, that's not where we're going in today's world. So we're looking at functional MRIs to look at things like neuroplasticity that develop or involve CNS processes. And in every other thing we do, we are searching for these reliable, quantitative, validated ways to diagnose things, like in rheumatology, where we have specific biomarkers for most of these diseases. So we're going to look at this. And for this disease, if it exists, the gold standard is simply that it hurts when you push on them. And again, acknowledging there is no test. This isn't a syndrome of clinical diagnosis and exam and some imaging and some lab work. There's nothing. There's no test. There's no imaging. This is relying on it hurts when I push you, therefore you have trigger points. So we are way behind in the science on this. What about the prevalence? The citation here should be from the slide before again. But the prevalence of myofascial pain in the general population is unknown. And again, many people make the unfounded jump that nonspecific quote unquote low back pain equals myofascial pain. And that is not a correct assumption. I don't know what causes people to hurt sometimes. But then what makes it logical for me to then just assume it's myofascial pain? Because I don't really have a good way to diagnose myofascial pain either. So therefore, your back hurts. I don't know why you hurt. I can push on you. You say it hurt. Therefore, it's trigger points. I mean, come on. That's not what we do in 2020. Now, this article I love because we also need to understand that, all right, I'll freely grant you or I'll grant you the argument. All right, if you hurt and you push on it, maybe it's a trigger point. Well, if that's real, you would expect for people that don't hurt to not have trigger points, right? Otherwise, it's completely nonspecific. And yet in this article, although it's looking at lower limb muscles, they looked at what they call latent trigger points in asymptomatic patients. So they pushed in people that don't hurt to see if they could find a trigger point. And of the 206 patients that they evaluated, almost 80% had trigger points. So you don't even need to hurt to have a trigger point, which again, why are we treating these? What is an asymptomatic trigger point? So they looked at people that don't hurt to see what that is. And then even more so in asymptomatic people, they have seven of them or eight. So I could do a trigger point injection on every single person that walks into my clinic based on these clinical criteria. So what we know about other causes of axial pain. So this study is, it's pretty good. It's not perfect, but they looked at 156 patients of 358. So maybe the other 150 or 200 had myofascial pain. I don't know. But they looked at patients who weren't getting better with conservative care. They needed more definitive treatment. And we said, all right, can we figure out the problem? And they essentially underwent diagnostic injections, which are validated, which have known sensitivity, which have known specificity, which you can get false positives, but you can't get a positive diagnostic block in an asymptomatic patient. You can't have someone's pain go from zero to zero with a block. And just with these criteria, just looking at discs and facet joints and SI joints, those numbers at the bottom of the screen add up to 91%. And even if you say this is favorable, maybe you say this is 91% of half of the patients. I think this shows that in other parts of the spine, when we know we define the problem, we have a validated way to treat it, we can find these people. And we can do it reliably. And on top of this, if we're saying people with nonspecific pain have myofascial pain, well, this flies in the argument because this shows most people don't have nonspecific pain. It means they just have undiagnosed pain. And then lastly, if we're going to look at it again from a scientific perspective, we need to know what the natural history is. Because again, if chronic myofascial trigger point pain doesn't get better, if you have a treatment that works, there should be separation between the natural history and the intervention in the group. And here we see that people with quote unquote chronic myofascial pain, this is a study of people with fibromyalgia and myofascial pain, that on average, they had pain for at least five years, with pain extending up to 15 years. So again, do we really buy if the average person with myofascial slash trigger point pain hurts for five years that their muscles just hurt for five years and that's the cause of their pain? So again, if you have someone that tears their biceps, strains their hamstring, if you have all of these other muscle type pains, they don't last for five or six years. I think this argues to show that indeed, this isn't muscle pain, that chronic myofascial pain is central pain. How about tomorrow? You need it. No, it's never needed. I know. All right, everybody, well, hopefully, we're back into the main room, I appreciate you guys taking the time just to get to know each other as well. So we're going to keep moving on to our last speaker, Dr. Zach McCormick. And before we start, we're going to send out another poll question to see what people have to say. I realized I didn't keep a put up an option for all of the above, and I just realized that. But just pick one that is probably one of the more common ways you keep up with the literature. So Sean, could you put up the poll whenever you're ready, because I know people are still coming back in. All right. Okay. All right, so we've got a nice mix, annual meetings, monthly journals. There's some who don't have time, which is totally understandable. Time's a very valuable commodity. So thanks, Sean, for that. We're gonna move on to our last section. Again, appreciate everyone's patience through this. So Dr. Zach McCormick, who is an associate professor at the University of Utah, who has published extensively, has been on multiple editorial boards, is going to go over the Mint Trials. And so he's gonna introduce that study, go over it. And again, you can access this online for free. Here's the website link, or you can just go online and look that up. And so without further ado, I'm gonna stop my screen share and let Dr. McCormick get on and share his screen and unmute. All right. All right, good evening to everyone. So yeah, thank you so much for having us here. I'm really big thanks to Aaron Yang for organizing this session. And it's always fun and a pleasure to be a part of any session with Dr. Schneider and Dr. Nagpal. So I was quite impressed by both arguments, a lot of passion that came out there. And I only wish I had someone that I could debate this with. But I know that one of the hopes was I could talk a little bit about kind of how to stay on top of the literature. I don't have a special sauce. So that poll presents a few options. I think that we all have limited time and some more than others. You may have kind of built in time to read, write, research if you're in an academic world. And you certainly may not. If you are primarily a clinician, private practice or other hospital systems, it's not really part of your day-to-day or built in, so to say. So if there's any advice that I can give, when you're strapped for time and there's just clearly way too much to read, where do you even start? I think there are some great digests that you can subscribe to out there. I do try to at least browse table of contents of four or five journals every month. And maybe that's too many, but pick maybe one or two, maybe three. And so you at least are, and then dig in and read where you see that something looks interesting or relevant to your practice. Aside from annual meetings, which obviously are great, and you're gonna get folks who hopefully are really on top of the literature in their area, you're gonna hear it from them. And they're gonna break it down for you and do a great job of summarizing what is tons of literature that takes a long time to actually read through. But the other one is just, I would just encourage everyone to just stay connected with your peers and discuss what's out and what's recent. So I feel like I read a lot and that I stay on top of literature the best I can, but I learn a ton from my partners and I miss things all the time. And they mention a paper that I hadn't seen before and, hey, this is great. So stay connected basically. So beyond that, I'm gonna talk more, I'm gonna dig in a little bit further on actually how to critically read a paper, a spine paper. And of course, we're gonna focus on a clinical paper and that is the mid-trials as Dr. Yang mentioned. And let me try to advance this, there we go. So these are my disclosures, probably relevant. I do have funding for radiofrequency ablation studies. Some of it is industry sponsored, some is investigator initiated. I'm really not gonna talk about technologies here, but really research principles. So there is so much that we can discuss as it relates to how to really pick apart a clinical outcome paper as you're choosing what to read and ultimately selecting papers that you do really wanna dig into and read word for word and critically appraise. I'm gonna focus on these five areas. So patient selection, procedure technique, control interventions, data analysis, and then interpreting results. There is so much more that we could talk about, there just isn't time. So this is the ClipNotes version. If you find this interesting, and if you wanna read more, and particularly more about the mid-trials, this is a paper that a group of us put together a couple of years ago. It's available in Pain Medicine. I just encourage you to take a look if it is interesting to you. So let's get to the mid-trials. All right, so this is a very large randomized control trial of three separate study arms conducted at 16 centers in the Netherlands, published in JAMA. So it received a ton of publicity and really affected the way that payers were looking at radiofrequency ablation, the way that other non-call it interventional specialists were looking at this as a treatment. It had a real ripple effect, right? So a lot of people pay close attention to this, and it was very much in the mass media as well. So this trial, three arms. So first was one arm where patients were allocated to, they were thought to have facet joint pain, and we'll talk more about this. The next, they were thought to have secret iliac joint pain or secret iliac complex pain. And then the third was some combination of secret iliac facet joint and discogenic pain. So as we start to take a careful look, among the many principles, here are two really major ones. And I'll take a moment, I'll go through several slides on this because Mitt provides an excellent example of sort of how not to do this or why we need to have a critical eye. So in any clinical trial where authors, investigators claim to be studying a certain patient with a certain diagnosis, we need to make sure we agree that this is actually the diagnosis of the patients who were enrolled and subsequently treated. In the same vein, if investigators say they administered a specific treatment, do we believe that that treatment was actually administered? Was it done according to methods that we would agree that it was a real treatment done in the proper way that it should be done to theoretically have effectiveness? So let's go through these, we'll go through these study arms in the Mitt trials. All right, so the facet joint first. So a ton of literature on this. You know, we know that the SIS guidelines, for example, for a diagnosis of true facet joint pain recommend dual comparative medial branch nerve blocks, low volume of anesthetic, and using contrast to rule out vascular flow and a potential false negative. And this is founded in science. So I know, you know, Amit and Byron talked quite a bit about how difficult it is to diagnose pain or, you know, anatomical sources of pain. Totally agree, couldn't agree more. But, you know, there is foundational science, right? That goes back decades. If you, Kaplan did this, you know, back in 1998, pressurize the facet joint, the study subject reports pain, then they go back and anesthetize the medial branch nerves that supply sensation to that facet joint, repressurize that joint, and now the patient doesn't report pain. So yes, we can go through the flaws in our interventional diagnosis, but there is foundational science for this. And, sorry, just trying to advance these slides. There we are. So, you know, more study here. So this is Schwarzer from Australia. So they looked at the false positive rates of single diagnostic medial branch nerve blocks with a 50% belief threshold, and they found it to be just under 40%. And you'll find other studies, and that number varies depending on the study. But at the end of the day, very high false positive rate when it's contingent on a single block with a 50% relief threshold. So next, what about procedure technique? Well, without getting into all the nitty gritty nuances, when conventional radiofrequency technology is used, it is very well established that it's important to lay the radiofrequency electrode in parallel to the medial branch nerve. That is gonna provide the greatest chance of lesioning the nerve and lesioning the greatest segment of that nerve. So, you know, really properly denervating the facet or facet joints in question, or rather they have been diagnosed as a source of pain. You know, perpendicular approaches have been studied. And if we look carefully at that literature, they are perhaps no better than sham. And that's fairly intuitive. If you think about the shape of a radiofrequency lesion with a conventional electrode, there really isn't much projection beyond the tip. So with a perpendicular approach, like what's shown here in this slide, you really don't have a great chance at, it's very easy to miss the nerve. And even if you do capture a bit of the nerve within the territory of that radiofrequency lesion, it's unlikely to provide really extensive denervation, maybe just a very, very short segment of nerve. So getting back to, oh, excuse me. So when we look at the best studies where dual media branch blocks with a high relief threshold to consider a positive diagnosis of facet pain are used to select patients, and then parallel technique is used, these are the results we see. They're excellent. So, you know, Paul Dreyfus' work and then John McVicker from New Zealand, these are, you know, really excellent success rates. So Dreyfus' study, they reported 87% of patients with 60% relief or greater at one year after ablation. So keep that in mind when we look at the responder rates from the MINT trials. And then how about John McVicker's work? So 50, almost 60% of their subjects, participants reported complete pain relief, complete restoration of ADL. So talk about slam dunks or, you know, the successful Hill Mary Pass, that's it right there. So, and this is contingent on the diagnostic criteria or the selection protocol. And then appropriate procedure technique. So if we get back to the MINT trials, what did they do? Single medial branch nerve blocks. They did not do the dual comparative block paradigm. And then only 50% relief threshold. We know that there's a very high false positive rate. So probably in the realm of 40% of the patients that were enrolled didn't have true facet pain. And then they of course used perpendicular technique. So even though, so perhaps 60% of the patients they thought had facet pain truly did. And even then, the treatment they administered, highly unlikely to capture a meaningful segment of the medial branch nerve. So, you know, is this a sham intervention? Is it real? Does it have a real treatment effect? We can argue over that one, but it's certainly we know to be inferior to appropriate perpendicular technique with a conditional probe. So, you know, then moving on. So similar paradigm, you know, how do we diagnose sacroilateral, excuse me, sacroiliac joint and dorsal ligament complex pain? Interarticular blocks, lateral branch blocks. This is another one where we could kind of debate it ad nauseum. There's less literature on this, but we do know that if the goal is to provide denervation in the sacroilateral branches, we really should be anesthetizing sacroilateral branches. It just makes sense, right? When we talk about a prognostic block as a meat product. And so, you know, Dreyfus again, you know, a prolific group proved to us and validated that multi-site, multi-depth blocks can reliably anesthetize the dorsal ligaments and posterior capsule. And we do know that when certain radiofrequency ablation protocols are used in Cohen's study and in Nilesh Patel's study, the two sham controlled trials with CoolRF, we see high responder rates. It outperformed sham. And then in other clinical outcome literature, some of Allison Stout's work shows us that particular techniques with, you know, large gauge electrodes, whether it's cool or whether it's bipolar techniques with large gauge electrodes, these reliably, you know, provide denervation to the sacroilateral branch nerves. So what was done in the Mint trials? Well, single-site, single-depth blocks, which we know from Dreyfus's earlier work before the multi-site, multi-depth work doesn't work. It does not reliably anesthetize the sacroilateral branches. We don't even know what levels were blocked. It doesn't say in the protocols. And again, they use a low bar, 50% relief threshold. So I showed in the Cohen study, they use a 75% threshold. I want to talk to you about this concept. I'll give you a case study. I'll show you some of the benefits of a real case study. I'll ask you to mute your microphone. Thank you. Yep, thanks. So again, this is not a validated selection protocol. And when we look at the treatments received, so patients, it was provider preference. So some of the investigators used cooled RFA with the Epsilon and, you know, that's about, that technique, we know it works from the Cohen and Patel work. Palisade technique was used. That's not validated in a sham control trial, but we know from some of Stout's work that it should reliably capture the sacroilateral branches. We do have head-to-head data that says that the simplicity probe, the multi-electrode probe that's known as simplicity three is inferior to other modalities. Yet this was used and it was allowable in the trial. So heterogeneous techniques use one of which we know to be inferior to others. And then finally, I'll touch on the disc. So, you know, patients were allocated to the disc arm, or rather the disc arm was actually terminated early. They couldn't get enough patients, but within the sort of that multifactorial or the combination pain arm, disc, facet, and sacroiliac complex, patients were allocated based on history and physical. And then disc pain was confirmed by discography, but we don't know what standard was used. So we know that the bar, where the bar really is, is the SIS-ISP criteria for disc pain. And these are the operational criteria for diagnosing true disc pain. We also know that if discography is performed according to other standards, just if we take the literature out there, there's about a 29% false positive rate per disc, very high, so very poor tests if we're not using that SIS-ISP standard. Wolfer and colleagues actually took a look at the data that produced that 29% false positive rate. And if they apply the SIS-ISP criteria for diagnosing true discogenic pain, that false positive rate drops to 6%. So it matters. I mean, the means that we use to create these diagnoses, again, agree that there are flaws to interventional diagnosis, but still, if we're gonna do it, we might as well do it the right way. So then the treatments that were administered in the MIT trial, patients that were diagnosed with theoretical discogenic pain, at least as a part of their presentation, either underwent viculoplasty or IDEP. And many are probably familiar. There are sham-controlled trials for both of these that show efficacy compared to sham. And there may be a subset of patients who benefit from viculoplasty or IDEP, but these trials were incredibly restrictive. And the number of patients screened to get to those actually enrolled, these were highly selected populations, nothing like what we saw in MIT, where very few patients were frankly screened out. So it wouldn't be surprising that if you take kind of all comers, they're probably not gonna do well with viculoplasty and IDEP, most people don't use it. Frankly, I don't. But if it's gonna work, it's a very, very tightly selected, carefully selected subpopulation. So moving on to control intervention. So what are we comparing these RF treatments to? Well, the MIT trials looked at an exercise program. Interesting thing here is that this really doesn't reflect clinical practice. So I hope that all of us wouldn't be doing radiofrequency neurotomy, using it as a treatment in patients who hadn't already failed an exercise program, and frankly, a formal physical therapy program. So it doesn't make a whole lot of sense to randomize patients to a treatment arm that they've already should have failed. And then furthermore, we really don't know what happened in this intervention group, the control intervention exercise group. We know nothing about the dose and the frequency essentially of the interventions provided, of the exercise intervention provided. There's a little bit in the methods, but it's slim pickings, or there's not much there. So it's hard to know, what is the intervention that was provided? And if I were to try to replicate it in my practice, I couldn't do it because I don't really know what was done. So then moving on to data analysis. So this is an important point that I'll spend a minute on. So mean data versus categorical data. So there's nothing wrong with mean data, but we really need it as a companion to categorical data. When we're looking at studies for the treatment of pain, whether it's spine pain or other. But one of the important principles of looking at mean data is calculating a minimally clinically important change. And there's a literature on this. We know that for low back pain, for the NRS scale, the MCIC would be two. And that's validated and it's been anchored against patient global oppression of change and then other means of anchoring to validate that. So interesting thing is, MCIC is not meant for intergroup comparisons, but that's how the authors treated this. So they said, well, the intergroup difference, you can see it here in the facet pain group was less than the MCIC, it's only 0.4. That's less than two, right? So one group is no better than the other. Well, Ostello, one of the authors within the MIT trials actually has written on this and said that MCIC shouldn't be an intergroup comparison. It's not a delta. It should be the effect within a group. So if we actually listen to what Ostello actually writes about, what he would say is that in the facet arm, or this is the radiofrequency group, I should say, in the facet cohort or arm of the trial, they actually surpassed MCIC for improvement in low back pain. Whereas in the exercise arm, it was less than MCIC at a 1.7 point change. And that carries across all three arms, facet pain, SI joint pain, or SI complex pain, and then the combination pain group. But then what about the categorical responder analysis? And this is important. So you look at the NIH impact guidelines for studying low back pain. It's been written about by many experts in spine researchers, pain researchers. When we talk to our patients about, what are the chances that you're gonna improve? They want a percentage, right? 50%, 50% chance that I'm gonna have at least a minimally clinically important change or a 50% reduction in pain, or a 10 point ODI reduction, 15 point ODI reduction. That's how we communicate with patients. And furthermore, all we do is look at group mean changes. It's gonna mask sub-cohorts that do very well with a treatment. If there's only a small bit of that cohort, treatment effects wash out when you look at group means. So we need them both. We need group means, we need a categorical responder analysis. And the other thing we have to pay careful attention to is how investigators treat their categorical data. How do they treat loss to follow-up? So in this case, in the original publication, they just throw it out. The patients that were lost to follow-up, they just disregard them. Well, that's okay. So you're just assuming, that's one way to treat missing data. And you can do that, but a very transparent way and conservative way to do it is to assume that those lost to follow-up aren't doing well, that they are lost because they don't wanna be part of the study anymore. They failed to respond to treatment. And that may not always be true, but it's the conservative way to handle data. And it's transparent to publish that. So we actually took a look, and this is in the paper that I mentioned, we actually just recalculated the numbers. And we said, what happens if we treat those lost to follow-up as non-responders? And then these are the numbers you see. So the first proportion is those that received a radiofrequency ablation treatment. Second is those who received exercise. And despite all the flaws in selection, in a procedure technique and appropriateness of the technique of the radiofrequency procedure, even despite all that, we still see intergroup differences, greater proportions, statistically significantly greater proportions that responded to RF. So I will leave it at that. I know we're running over time. Here are a few summary take-homes. I hope that some of that was interesting and thought-provoking and maybe gives you a few things to think about the next time you pick up a paper. And it might be a randomized control trial. It might be published in a prestigious journal, but it doesn't mean that it is a flawless study and certainly that the MINT trials are far from flawless. So thanks so much for everyone's attention. Really wish we could do this in person. I will turn it back over to Dr. Yang. Awesome. Thank you so much, Zach. And really thank you for all the speakers. I know taking the time out this evening to present some great content is not easy. So we put up a poll and we'll see where this shows up. Again, I think both sides had a really tough argument to present. And so it's pretty split here. I think everyone did a great job. No one's feelings should be hurt because I think everyone presented great evidence. And again, thank you, Zach, for your time. I'd say that's pretty close. All right. So I'm Trump in this, huh? Do you concede, Amit? No, I want to take this to the Supreme Court. Looks like some late votes are coming in. Yeah, the mail-in ballots are coming in my favor. Well, I know we're over time. We initially slotted to go till 8.15. I really appreciate everyone staying on here. So it looks like 50-50, there you go. This is great. Again, for those who are part of the spine community, please feel free to use the forum or message me if you have any other content that you'd like to see for the next annual meeting. I really hope that we can eventually get together and network, meet each other, see how, and appreciate each other's differences in practice patterns. And again, I really appreciate everyone being on here tonight and spending time to listen to some great content. So have a great evening, everybody. Thanks again for being a participant in this. Thank you, everybody. Yeah, thanks so much and good night. Yeah.

Spine Community Session

spine pain

poll

point-counterpoint session

trigger points

breakout room activity

literature assessment

controversy

evidence-based guidelines

myofascial pain

Mint Trials

treatment approaches