Chronic Pain Chronicles with Dr Karmy
Join Dr. Grigory Karmy M.D., a distinguished chronic pain management physician with over 20 years of experience, on a captivating journey through the world of pain relief in his podcast series. Delving into the latest regenerative medical treatments like PRP, stem cell injections, and prolozone therapy, alongside educational discussions on pain transmission and the latest medical innovations, Dr. Karmy shares invaluable insights and real-life stories, empowering listeners to find relief and regain control over their chronic pain.
Chronic Pain Chronicles with Dr Karmy
Episode 28: Is Permanent Nerve Block Possible Featuring Dr. Cornish?
Most of the patients who get nerve blocks experience complete pain relief for the first few hours after the block, but the effect becomes weaker after that.
Wouldn't it be wonderful if that effect could last forever?
Join Dr Karmy for an in-depth interview with Dr. Cornish, who developed a brand new treatment that may just do that.
If you have any questions for Dr. Karmy, feel free to email us at karmychronicpain@gmail.com
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Again, my practice it's been whoever's walked through the door, but in those who've been referred with fibromyalgia, I've managed to demonstrate that in fact, they have a series of different issues. How do I know that? They're implanted, they've got several sets of leads in. They're all medication and pain free. So it raises a question about that diagnosis. Hello, this is Dr. Karmy for Chronic Pain Chronicles. And today with us we have Dr. Cornish. He is a pain physician from Australia, and he's developed a very innovative approach to managing chronic pain. Hello, Dr. Cornish. Hello. Now, I don't know physicians are very much guideline guided. Let's just say. Uh, there isn't really a lot of incentive to do something new or different from what everybody else is doing because everything else follow a specific guideline that this society or that society put together. In other words, I don't think of medicine as a place where individual physicians are, allowed to be particularly innovative often organizations are innovative like universities and pharmaceutical companies, but not necessarily physicians. So how did you, decide of get to the point where you tried to develop something new? That started in approximately 2013 within the chronic pain domain that is. When I was referred a patient who had terrible phantom limb pain and the surgeon had no idea what to do and asked if I could be involved. He was specifically interested in getting my input related to skills I had in regional anesthesia. An anesthesiologist as a baseline qualification. I've published quite extensively within regional anesthesia, which ironically comes back to the same issue of what we might call innovation. But I'll come back to this. I've got a different way of describing that process. So to come back to the amputee, I'd noticed for many years that I could completely control phantom limb pain temporarily using a peripheral nerve block that was regarded as controversial by my colleagues. It was not regarded as controversial by the nursing staff looking after the patients because they saw this happen. That's why the difference my colleagues never came along to see. Which says something else, of course. The question that then was in my mind, if I can get them pain free temporarily, and it's really important, pain-free. Pain-free is not some relief. Pain-free is literally no pain. And the question was, how do I make this last forever? Mm-hmm. Can I make this last forever? And that would be a guiding principle, right? Through this work. And it, it's a question of curiosity, really. If I have pain free, then surely I have found where this comes from. Mm-hmm. And if I can make it last forever, then haven't I found something really quite important. Finding something important has no relevance other than what it does for the patient. The patient being at the very center of this story. And I think that it's really important to underline that, that the patient has actually at the center. Why pain-free? Why would I focus on that? Well, part of my reasoning there was that we need a decent endpoint. If we are going to be doing something to somebody, we need to have a decent outcome endpoint that's meaningful. And I would suggest that 50% pain relief, which is a currently accepted standard in chronic pain for interventions is hopeless. Now that using the word hopeless, of course, puts me somewhat in the firing line. But the reality is that if I said that 50% of the patients under my care were not asleep when I thought they were, or that 50% of the spinals weren't working or whatever, 50% of my intravenous cannula weren't in the vein. There would be an outcry. And yet we quite calmly say, well, it's all very well to come along and have an injection and you'll get 50% relief. Isn't that wonderful? In my experience, it's not wonderful. It's actually 50%. And then they say within the field of neuromodulation, 50% get 50% relief and the rest get less. So we're kind of degrading the standards. So I came back and said how do we copy cardiology and oncology? Who did something really interesting years ago when they made the one year, five year and 10 year survival? And the point was death. And very few people argue over whether somebody is dead or not. Now that sounds horrible, but it did mean that cardiology and oncology sped ahead and their research is wonderful. And the original placebo paper by Beecher from Boston is very worrying to read now. I got into reading old references through a friend who'd done his PhD in history of Science through Princeton, and he said, you need to read the original references. Forget the current literature.'cause it may be based on fallacies and mistakes and errors in the original literature. And it's amazing how often the original work has not been read properly. There was a mistake in the original work. So I've been reading back and back, and back, so we have this issue over, do we have a solid foundation in science before we start doing things. So part of that is if we are running on 50% pain relief and placebo leaps into view when you're going for 50% mm-hmm. Are we comparing a placebo treatment to a placebo treatment? Mm-hmm. And I'm not brave enough to say, oh no, no. That's ridiculous. I actually think there's a very serious issue there, leaping away from that back to the amputee. I tried every single thing that was within the accepted domain as you talk about guideline based practice. Mm-hmm. So she had some, an infusion of calcitonin and she had a trial of epidural placed electrodes with neuromodulation. And that was an interesting experience for other reasons. One is I managed to get her other leg tingling. Oh. I could not get the amputated side tingling at all. But I had the company representative strongly encouraging me to keep going. Keep trying. You're nearly there. You are nearly there. I've got an electrode array in the epidural space and I'm a very experienced anesthesiologist. I'm only too well aware of the risks of the epidural space. I actually pulled the electrode array out and said, no, I can't do this. It's not going to work. Now, a less experienced person might have said, oh gosh, yes, let's keep on going. And then we might have ended up with a disaster in there and no effect. So I moved from there thinking, what on earth am I going to do with this person who is still crippled with pain and thought if my nerve block's been so effective, why don't I put the leads in her stomach? Just try it. And I had a very honest chat with her about this. And she said, look, if you think it might work, let's try it. Even if I get 10% relief, I'll be happy. And so I put the leads in her lead in her stump as a trial. Being very conservative and I'm not being silly about it. And that becomes funny having done a trial, 'cause she was pain-free the next morning. Wow. But she was not only pain-free, something else had happened. Her amputated foot in her pain state was turned around and split in half. So it was pointing backwards and split in half. And with the onset of this effect at that stage, I didn't know what it was. Her foot turned around, fused and then disappeared. And we turned it off and it do accept. So we could replicate this effect time and again so she ended up pain free off medication and her functional outcome score. It depends upon whether you have an agenda in this game or not, because if there's an agenda for atory disability indices, et cetera, you don't like what I'm going to say. But her outcome was that she's a triple world champion, double world record holder in her Paralympic event. So that's an extreme outcome for somebody who could not actually get out of bed because she was so sore. Now, was this a major fluke, huge placebo effect, and I'm just a snake oil merchant? I guess it's possible. Statistically we would say that, but I also think there's a responsibility here to say what on earth happened there. How does that work? The effect's been replicated, but it's gone a lot further than that. I then thought, well, if I can do this here, this is supposed to be impossible. If we follow the work of Herta floor, and her work on the alterations in the sensory homunculus, then what I was doing is impossible. Doesn't work. Now there's an interesting an error, in her work because when she did the original work, she'd done what's called an auxiliary brachial plexus block, was an upper extremity amputee. And just as a pure irony, my doctoral thesis is on the brachial plexus regional anesthesia of the brachial plexus, and she did not actually have a brachial plexus block performed. So her result that there was residual change, the residual sensation she didn't get complete relief. And if you block the plexus, you get complete relief of pain. So, there's a scientific mistake and the methodology of her original work. So can we replicate? We've got something that's supposed to be impossible. No peripheral techniques are said to work in that context. It's supposed to be a central issue. Yeah, it's supposed to be central. If we come way forward, we'll have to jump all the way back and we'll have to do this the whole way through to understand the threads of this work.'cause this is actually, this is a science project. It's not really a clinical study at all. It's about science. If we project way forwards, we are managing to stop something peripherally using a peripheral effect. And if we are wrong about that, then electromagnetic theory is wrong. And I think that would be a very brave call by somebody to say the Maxwell equations are incorrect. That's highly validated science. And this is where this is all founded. Did we have the answer back then? No. We simply had an observation. And, part of what happened was I was immediately isolated as being a little strange by my colleagues. So I get somebody with an impossible result and I'm immediately, I would suggest that within the history of science, that's actually quite a common thing. Similar devices, one of the wonderful example demonstrated that handwashing made a big difference to the incidence of infection in this hospital, and they hounded them out. So this has happened multiple times. If you're close to the answer, that's what's gonna happen. So this evolved from the amputee and what else can we use this for? And then can we answer the question how. So this is how it's it's evolved. And , is there any other way of doing this? Kind of, not really. It's in the ideal world or everything would be done A, B, C, D, but in reality , there are multiple examples of the same thing. In Australia, Kathy Freeman is known for her brilliant running at the Sydney Olympics with this wonderful running suit. And I was reading an account of how it was discovered. The actual suit was invented at 11:30 PM late on a Friday or weekend evening by the physicist who was playing in the laboratory and just switching panels around. And came up with the solution. So this is not a we did this in a totally systematic, logical way. No, , I think science often moves in this just people observing and being curious. So if we fast track a little bit forward in the development of this, the next thing was really we were continuing to get pain free and I was continuing to use regional anesthesia to find the target to identify where this came from. It gets trickier here. One of the problems in regional anesthesia is that anatomy and an anesthesiologist don't really go together. Anesthesiologists know lots of pharmacology and physiology. Tend to know relatively little anatomy that's not being rude. Surgeons know lots of anatomy and that's their territory really. There are lots of mistakes made within regional anesthesia in terms of anatomy, and so I was correcting things as I went and keeping this eye on, am I getting PainFREE? Not, you can't invent PainFREE. But saying that had to be, we were trying to translate pain short-term PainFREE to long-term PainFREE. The next part of this was that the thing giving us pain free long term was the neuromodulation unit. Now the industry says the current stimulates nerves. There's a big problem. Because it's pulsed current, it's not direct current. The industry has assumed it's direct current, and that's an error in science. And that a friend of mine is a physicist at the University of Adelaide, and he suggested that we do a simulation study just to demonstrate that, but also to have a look at how this might behave within the body, which is quite different to a vacuum. And first of all, we were able to demonstrate that it is indeed. That the pulsed current of the device, and this isn't us making it up, they actually call it an implantable pulse generator. They freely admit that it's pulses. Mm-hmm. So how on earth did they jump to direct current? Now this has absolutely spectacular implications. Probably most away people with chronic pain and I am by the way, also a pain physician. So it sounds to me it's just happened by, in some ways luck. You were desperate, you wanted to try something because the traditional guideline based things just were not working for an individual patient. And you did something and it worked far beyond your expectations and you felt there was something there and you just started to dig deeper into it. From what I'm hearing is that a lot of conversation in science and maybe in medicine is about the role of electricity. So electricity is used by spinal cord stimulators, which are basically what happens with that. I did an episode on spinal cord stimulators, but basically they put a probe around the spinal cord in the epidural space, and then they stimulated, which they felt was with electricity. And then electricity is also felt to be involved in conduction of impulses down the nerves sodium channels, which are probably the most important channels in conducting signals from body part up to the brain is conducted through sodium channels, which again, I felt to be controlled by voltage. And what you're trying to say is that a lot of these effects are not because of electricity per se, but because of the electromagnetic field. And electromagnetic field is, is what is generated during spinal cord stimulation. And the reason it doesn't work very well is because electromagnetic field is not very strong at the level of spinal cord because cerebral spinal fluid dampens it. And perhaps it is stronger if you put electrode closer to the nerve. Where there's no cerebral spinal fluid. So fundamentally it's the importance of electromagnetic field. And the way that electromagnetic field works with the nerves is it actually stops the sodium channels from transmitting the information up to the brain. So that was one angle. The other angle was just the discussion of what part of the body should you treat with chronic pain. There's a lot of ideas that actually pain is central force at many congestions, and so if you just treat the nerves. It shouldn't really help patients with chronic pain. You should maybe treat the spinal cord or maybe the brain, but not the nerves. And what you're telling me is that in, at least in this case, treating the nerves actually treats chronic pain. Is that about right? Let me come to a few of the points.'Cause there are some nuances here, which are very important. The electricity used by spinal cord stimulators, I know you didn't actually say this, but that whole paradigm is I'm afraid wrong. Spinal cord stimulation is not that they're using the wrong words. Right from the get go Norman Sheley, who first placed an electrode on the, he didn't place it in the epidural space. He placed it on the spinal cord itself. So he took CSF out of the equation, which is kind of interesting. They didn't assume that spinal cord either. The epidural space, which is around, it's, it's outside the fluid. It's a, a potential space between the bone of the spinal canal and the membrane, the dura that surrounds the spinal cord. This information isn't for Dr. Karmy'cause he knows that as well as I do. It's for all the listeners. Is it impossible to get an effect with spinal cord stimulation? I think the answer is nothing's impossible. It's just unlikely. And all the results would point to it being unlikely. And in the event that the epidural space is not the safest part of the body to be in we should be careful about actually ever placing an electrode array in the epidural space. Now, given that probably 98% of the world's use of these devices is in the epidural space, you'll see that there's a real issue there. Now, what we've gone and done, we're not closer to the nerve. We are more like a cell phone tower transmitting to cell phones at distance. And we've just worked out how it works, not in a. Yes, we've reverse engineered it, not completely without problems along the way, trying to work out why did we get this brilliant result in the first 20 or so. I think we revised 50% of them 'cause we had brilliant pain relief in some and I couldn't understand why we didn't have brilliant pain relief in the others having done roughly the same thing and then worked it out. And then we simulated what we'd done. And when the electrode array is placed very close to the skin, to the dermis, you get electromagnetic scatter and the skin that the outside of the skin acts like a a parabolic reflector. So you focus the electromagnetic field. Towards your target. So it's just x-rays. It's the way the electromagnetic spectrum is managed. So see, I guess you'd have to say the technology has been completely misunderstood. And that's how we have got this remarkable result. Up to the brain, we probably misunderstand the role of the brain in all of this. Because if I put my hand on a hot plate, I'll pull it away in a reflex withdrawal long before I say ouch. So the reflex is that we have reflex patterns all over the body that occur long before we say anything will turn our head towards the sound. Long before we say, what was that? We are sensory motor reflex beams and we are closing off one side of that loop.. And your feeling is that maybe the brain is overrated as a source of chronic pain. We have to change the language here to understand the papers. The scientists are unanimous. It's just the doctors who are struggling.' This is according to the science . the pain comes from activation of these sodium channels. Let's talk a little bit about practicalities. Now, maybe let's go maybe one other direction. You started with specific condition, which is incredibly hard to treat, and frankly I think majority of chronic pain physicians don't have a good result with these patients. Yes. And that's phantom limb pain. Very difficult. So maybe, first of all, staying with that diagnosis what percent of your phantom limb patients respond to this approach? All of them. All of them. A hundred percent. Okay.. Around that the paradigm shift is such that the structures are not in place to look after the patients and one of them pain free at three weeks, and then quite bizarrely as an Australian phenomenon. And this guy had to fight a bush fire to save his home and pulled his legs out of place. Very Australian thing to happen. But it so there's a, it is allowing recovery. If you do not allow enough time for recovery and they don't comply, they'll pull their leads out of place and you lose the effect. It's just like tuning your TV or your radio or not, or having, this is, that's the way electromagnetic principles work and so it's a vulnerability and there've been people where we really needed to put them into a managed environment for six weeks to give it any chance at all. I think one of the things, the only time I haven't had any effect from leads is when the diagnosis wasn't secure to begin with and the diagnosis being pain-free, they were not pain-free when I got a little over enthusiastic or the patient was really keen to proceed. And that was a long time ago now. Like for phantom linkage, do you screen them by doing blocks first? Yes. Yes. I think it's a mistake not to take them through a systematic approach. And that comes down to are your regional anesthesia skills good enough? And does that mean I'm saying I don't miss No, of course. I miss not very often and I'm prepared to say, I've missed, I need to repeat this. I need to redo it. I haven't quite got what I wanted. Can I make it up like that? No, no. We're talking important stuff. There's a real cost when you are aiming for pain free, there is an enormous cost to getting it wrong. You're denying that, potentially denying the patient a brilliant outcome. That's phantom limb and that's honestly amazing. I've seen some patients that were able to manage better with phantom limb pain. Yes. But I've never seen pain free with phantom limb pain. They talk about that mirror therapy. But last, I guess maybe it's selection bias, but vast majority of patients that I've seen, they don't respond to mirror therapy. On that one. The selection bias, I think you'd probably agree with me. It's possible that my results reflect selection bias. Yeah. It is possible. It'd be an extraordinary thing if it was. I mean, I, like I said, I've never seen pain-free phantom limb pain patients. Yeah. I've seen partial responders to ketamine infusions. I actually have done some peripheral nerve blocks for phantom limb. They got about four days of improved pain. Not gone, but improved. But, uh, yeah, of course, people on all kinds of medications also don't work very well. Yeah. So, but the broadening from there, you didn't just they stay with phantom limb pain. You looked at the other conditions. Yep. So what was your experience with other chronic pain conditions? I've yet to strike one where I didn't get the same effect. Now, have I done everything? No. Where we're a little limited now because, there's been some pushback , and we no longer have any operating space. we've been denied operating space in spite of what's been published . And we've of course got a large database that we can refer to and we can still publish, but is this a pushback because it's felt that we're doing something bad and we've had major problems and have medicolegal consequences? No. No. Not at all. And that would be it. It's really an expected thing that would happen. But we have simply been going on based upon this, as you quite rightly say, this extraordinary result. When I had her pain free, this first patient, it's a jaw dropping moment. Goodness me. Didn't quite hoped I'd get it, but didn't really expect it. Wow. And you move from there. This has to be curiosity. We all have our moments of curiosity and now it gets very unfair because there'll be people listening thinking, well, how do I get access to this? And that's one of the big deals for us. Mm-hmm. We are being stopped in our tracks. And different agendas. I was talking to a statistician recently who said it's very difficult to work statistically with pain, with a binary pain score.'cause I've been using a binary pain score for a long time now. Pain-free or not.. So for example, with the recent publication the complete relief of chronic pain in the group who weren't pain free, we have a confounder. The confounder is that one of those patients came back to me recently and I was really not looking forward to the consultation. Because that's going to have to say to her, I can't do anything at the moment. And she said, I'm pain free, thank you for saving my life. And I, that wasn't prompted. I almost fell off my chair. But she was still in the not pain-free group when I counted that. And there was another one who was 98% pain-free. She was at the end of her trial and she still wanted the implant. Mm-hmm. And breaking the rules. But do you say to somebody who gets really, very profound, but not complete relief, now I'm not going to implant you'cause that's not good enough for me. Or do you say we'll try it. So just to go down the list there is mechanical back pain, be it from facet joints or maybe even discogenic or muscle. The ligaments, there is radiculopathy, there is fibromyalgia, So you can treat fibromyalgia with this? Again, my practice it's been whoever's walked through the door, but in those who've been referred with fibromyalgia, I've managed to demonstrate that in fact, they have a series of different issues. How do I know that? They're implanted, they've got several sets of leads in. They're all medication and pain free. So it raises a question about that diagnosis. Fibromyalgia, you're getting results. What about the other back conditions? You're getting results with them? Based on those results that were published, just over 80% of the implanted patients were pain free and off all medication. Now, if we take a slightly longer view of more recent patients of at 10 days, everybody has been pain-free, which makes me way outside the guidelines. I no longer recognize the current classification which won't surprise you, but I call it channel apathic pain because that's what it is. This is a sodium channelopathy. Ultimately I'm a big believer in results over theory. But what about upper body? So, headache, neck, shoulder pain radiculopathy from an yes neck disc. Works absolutely in the same principle . the same approach. And I think it leads into recognizing the body as being a bioelectromagnetic phenomenon and therefore we are actually having to adapt to that science. There's an interesting issue here. Does that mean we treat everybody like this? Initially, we are physicians. We're trying to make a diagnosis as accurately as possible and then trying to institute a treatment pathway that will be effective for that patient. And therefore the answer has to be no. Not everybody gets implanted. Not everybody has opioids. Not everybody has gabapentinoids, tri Cycl, antidepressants, et cetera. We have to think of who's the person, and it's one of the harder things I thought at the beginning that everybody could be implanted, but they could all be pain free. It's amazing the way people will undo your best therapy. Again, I think fundamentally there's always risk reward ratio with any intervention. Absolutely. And so if somebody can recover and is making good improvement with physiotherapy, for instance, there's probably no compelling reason to implant them with electrodes. And so let's go back to maybe just the actual process. So it looks like you're using a lot of the same technology that was developed for spinal cord stimulator. Yes, exactly the same. Less invasive because you are not putting those electrodes in the epidural space where a lot of things can go wrong. You're just tunneling under the skin into subcutaneous tissue and using almost the skin as an antenna to basically spread the signal farther. The electrode. Yeah, the electrode array, the antenna. The skin. The skin is the parabolic reflex. Okay. Parabolic reflex.. Okay . and but then of course, so safety wise, at least to me, it sounds like it's safe than spinal cord stimulators. Uh, but then there's of course, that inconvenient tissue, and that is that you have electrodes just under the skin. So each time you move that part of the body, presumably you are bending the electrode. And then the other part is the actual stimulator proportion. The device, traditionally, they inserted under the skin as well. Is it basically the same process and what is it like on day to day basis to actually live with it? Very important topic. They don't complain about it. There's somewhere between a two and a half and 5% incidence of pocket pain related to the pulse generator. And my jury is somewhat out about where it's best placed. Okay. I usually put it in the buttock that's related to what's been done. Traditionally, I put them in the abdomen. It's amazing. I've seen where others put 'em. Mm-hmm. And I'm not sure, a lot of thought, went into where they put them. They put them in just over the erector spani muscles. I put them in the thigh for amputees . if you like, on a level, this is just starting where, where all these things are really good questions that I've had myself. How are we best to organize if we say, yeah, this is what we want to do, how do we best organize? For example, it takes me 20 minutes, maybe 25 minutes to make a an IPG pocket. I've worked because I have the privilege of working in anesthesiology as well. I've worked with a breast surgeon who took 10 minutes to make a pocket. So you might say, why doesn't a general trained general surgeon make your pocket? Or a plastic surgeon quickly make the pocket somewhere and then you do the rest of it. Again, these are questions really for the future over how is it best organized? And how do we the electrode arrays people, they don't find it being under the skin disconcerting. They actually find it quite reassuring and they usually turn it up so they can feel a bit of a buzz.' cause they say, I know it's working now. So the danger of course, and I'm not sure if you can see me moving my hand, but skin moves. So you make a very good point about if we were designing a place anatomically to place the electrode array, it's a pretty dumb place to put it. Mm-hmm. But you're not putting it there for anatomic reasons. You're putting it there for reasons of physics. The physics says that's where it should be placed and we secure it as well as we can. And there is an incidence of migration of leads. People forget, do things they get on with their lives. We've had, we've got lots of stories of people forgetting their problem. They just forgot they had an issue. They and they pull the leads. So I think phantom limb is a little bit easy. Yeah. Because a lot of people, phantom limb don't use their leg very much except for an example you gave us. Yeah. But other areas like people without amputations for example, are there certain restrictions? Are there certain things they would not be allowed to do anymore once they have the implant? For the neck? For a cervicogenic headache where the leads go up the neck they can't really put their chin down to their chest without, they can't do that push down. They've gotta remember, I can still have that lean occipital movement, but I've gotta be careful when I flex my neck for low back pain. With current technology, I don't encourage people to try and touch their toes. Okay. I think that's just going to put pressure on there to pull them out. And for thoracic leads, thoracic had probably been it's been an interesting exercise in working out how skin moves when we move, when the skeleton moves. I didn't know any of that. And so you raise your arms above your head . in your back moves up. So how do we design and I used to put the thoracic leads up. Now I hang them as an attempt to allow gravity to keep 'em down. And so this is saying we haven't quite got the technology. We now understand the science of this. And if the patient has autonomy, has self autonomy and can make a decision that they're okay to live with a pain score of one or two or three, should we push them to have an implant and your point comes up? No. No. We shouldn't. We should give them the opportunity.'cause as you say, quite rightly. Every single procedure we do comes with a risk. I cannulate people for anesthesiology. I'm one of the unusual ones I can cannulate with both hands. There's a risk of death from cannulation, from infection. Never cannulate anybody if you don't need to. And I need to all the time. So I do that in a certain fashion. Your point though is it's a fundamental principle first do no harm. So it sounds like limitations are there, but they're very minor. People can still walk, they can still run. Are they able to lift heavy things? Are they able to do most of day-to-day activities? I think probably yes, because for a long time we didn't hear from anybody. We didn't know if that was because it had all fallen apart and they'd just gone to somebody else and saying, Dr. Corn is a crack pot. We're not going to go back there. And then we had a steady trickle of people coming back for new batteries. And they were doing brilliantly and they were just on with life. Okay. And so you end up saying, I would probably discourage somebody from going bungee jumping. Okay. That crazy New Zealand activity of jumping off, maybe not parachute jumping, but as things evolve, maybe all of those things are fine if the leads will stay in place. And I don't know the answer there, but your point, you know they can move. And, we can damage nerves while we're putting things in. It's cutaneous nerves. So, we're operating in a part, a space of the body, which is, it's all within the first three centimeters of the skin surface. So it's actually well away and the risks are really infection of the unit and pocket pain and movement of the leads and the benefit. Complete relief. I, now, I don't know if the leads can break as well? I've seen one . occipital lead that broke. And then the other thing is how often what percentage of the patients end up with leads that move? And can you even just, do you have to remove it completely then or can you just reposition it? What happens if the leads move? They come back saying, I'm sore, doctor, what's going on? And so I was saying to them, look, we don't get funded to put you under if I get an X-ray, they never get quite the right projection for me to tell where they are Exactly. So I'd say to them, let me take you back and we will do the diagnostic injections again. But that gives us a perfect opportunity to see where the leads are. And in all in the public that we've published the numbers who came back in all bar one, I was able to prove that the leads had moved. And they all chose to have them recited mainly because they'd all been pain free beforehand. And I would suggest that had they not been pain free, because they're going to have to be limited in what they do for eight weeks post reciting of leave. If they were had 20, 30% worth of pain relief, they would say, I'm not doing that again. No, take it out. It's useless. They all say, please put it back. So we put it back according to the framework, the mathematical framework, and they're pain free again. So that's happened in all but one case. And in that case I thought, there's something really quite odd here. And has he got another source of back pain? And I managed to demonstrate it. And this has gone on to be quite odd. Cause I'm taking his unit out in a week's time and what's happened, he's no longer sore. Mm-hmm. He's pain free. Okay. Pain's gone. We've got a group who had been cured. That their pain has disappeared and we implanted him, the pain went was controlled and then all of a sudden he noticed he wasn't sore and he wants his unit out quite reasonably. So he had two sources of back pain and we only really found one when we got the other completely controlled. And we've got a number of back pain patients who have got two units in related to two sources of low back pain. Only visible when we had complete control of the other. So it's a more questions come the further into this you go. Some of the papers that you published, they didn't quite have a hundred percent response rates for various conditions, but that's because you were still early on and still refining the technique. Is that right? The most accurate set of data is the latest one. It divides off into the ones where we were secure. We defined diagnosis of pain as you're either you're pain free after injections, diagnostic blocks, you're pain free for 24 hours or longer. So less than 24 hours that didn't meet. Now early on, what do you do if somebody comes along and they've had to pay money?'cause this is not well funded in Australia. They've had to pay a good chunk of money to have some injections come in, get anaesthetized, get a whole lot of injections sometimes, and they are pain free for 20 hours. Do you say I'm not happy with that. I'm gonna repeat them. There'll be another chunk of money. And they say, you're wrong. You're full of it. So there was that pressure and then we had the primary care physician saying no I'll send you to somebody much better than him. And so they go. So we have this other set of pressure. So what do you do in that circumstance? And there's a group of patients in that, in the data set, who I treated successfully, but who definitely did not meet the diagnostic criteria. But I was under pressure. One of them is a spectacular patient for another reason she wasn't pain free. She had about 18 hours worth of complete relief and then it came back. Then she came to see me and said, I'm pregnant. And I'm thinking, I'm in so much pain, I'm thinking of terminating. And I implanted her under ultrasound. Pain free. Had the baby baby's now growing up nicely. She's delighted. Took the unit out sometime later because she was pain free again. And if people say you're over treating, you weren't there. And that's a really important result. So we've got now with a trial of neuromodulation, they have to be pain free at day 10. And we get them to turn their device off on day seven. And then turn it back on. And by day seven they've all been paying all B one, we're pain free. Again, it's, if you're not getting pain free, I would suggest you've got the diagnosis wrong. And so you've gotta go, where have we gone wrong? Here it comes back to history and examination. What am I missing that gave me this result? Bearing in mind that I failed to work out 5% of the back pain patients just the published result was 5% failed to find their source. Mm-hmm. Part of that is early days got a lot better over time but now part of it is also if I told you the exact profiles of the patients then you'd go, if you thought you could diagnose that you are dreaming. But we know we're trying to get pain free. And that's where we, I had to have a point at which I said, no, I'm not gonna try any longer. So we're going from pain free. And it divides off into those who were pain free at day 18 and implanted all of them. Say my chronic pain's gone. Over time there were two or three who progressed beyond this six week period where I had they couldn't mobilize well. And again, on the same model that we have pain-free, and we have some people who have more than one source, are we dealing with another source? Now my co-investigator Anne Cornish, and we, a husband and wife team, and Annie commented that one of the patients never interacted with this unit at all. And if you're not willing to turn it up or turn it down, then how, this is not a textbook. You need certain amount. And , when he was very uncomfortable at the time and he was completely pain free when he was sitting down, and so you go just what is the issue there? But in the early phase, yeah, all of them. So we also know from some other data, which I've yet to get published that this is not a placebo.'Cause that's the other question, could I have produced this population entirely with a placebo effect pain-free? We're replacing batteries now between five and 10 years old. They've all been pain free. They all want their batteries. They're all fine. But we've got a natural experiment within that group. It's not a placebo. So does it continue to be effective or does it lose effectiveness over time? Assuming the leads stay in place, and second of all, as some patients have a cure to the point that you can remove the unit, remove the leads, and the pain stays down. The answer to both questions is, yes, it stays and some patients are cured. And my greatest disappointment is that it's not all of them. So they could take the units out after a couple of years and say, that was clever. The other side of the coin is that for those who say you're over treating and these patients would've got better anyway my answer is that if you had a therapy like this and withheld it because you said you're going to get better anyway that's immoral and unethical. That these patients were desperate. And I took one out two year, two and a half years after I put it in. She was pain free and back running around the field. When I put it in, she was on a lot of medication and couldn't get outta bed. So it's a hard-hearted person who says, no, don't do that. That's ridiculous. Again, I think there's lots of studies that chance some, once someone develops chronic pain, chances of them becoming a hundred percent cured as vanishingly wall.. But I think honestly the resistance would mostly come from the fact that you are not doing it the traditional way, traditional way as you start with mice. Then there's some kind of a startup company, university based does stuff based on the my studies that then gets approved by, or gets endorsement by academic community. Within the university. And it's that sort of top down approach is what I think our medical system loves. Yes. And then anything that doesn't look that way, there's always a question why didn't you start with mice? And who are you to tell us how to practice when we're supposed to be the experts in the field? That's turf for honestly very common. But so let's maybe talk a little bit then about access to this. Presumably, the spinal cord stimulators are not cheap. The electrodes are not cheap. Then there's codes that I mean, in Ontario we have OHIP which is our provincial insurer that covers procedures. It certainly pay a code for spinal cord stimulator, but obviously there isn't a code designed for subcutaneous insertion of the leads for something totally different. And then you are on top of it all. You're mentioning that you might have difficulty accessing facility where you can actually insert the leads. So what the obstacles to care here at present time? Have to choose my words carefully here. I, I actually think ultimately that the public should start demanding a change in thinking. There's lots of literature to describing the problem and then this, oh, this doesn't work very well, and oh this doesn't work very well. One of the great dilemmas of course, is that we are the only ones who know how to do this. And there are millions affected. And this isn't a matter of me saying I'm much better than everybody else. We're physicians. We're trying to do our best for patients. So if somebody in Australia, let's suppose, or even in Canada that wanted to access your treatment right now, what does that look like? They can't. We are being stopped. And that's because a lack of facility or there's more obstacles than that? I think this is a battle of ideology versus science. And the only reason I still remain in the game is I see our patients and their outcomes. I'm not silly around this. If I wasn't getting the result, I say we , give up. It's become too hostile, go away, do something else. But ironically, I've struck the same issue in my other work. The scientist in me says, oh, that's exciting. This, the huge number of questions. Any decent project always generates questions. And , how do we develop something like this? Into an available modality. I don't think really that the device itself is the key here. I think the understanding of pain and then the way the pathway develops from there is far more important. Which feeds into what you were saying that the patient does well having physiotherapy, and there are lots of patients I've only treated I think it's of those I diagnosed quarter were implanted. Now, there are various reasons why the others weren't, but it still says there's a drop off. You're not, you're not operating on everybody. And there are several amputees. I haven't even cons. We've talked about implants and they've, we've decided no, together. No, it's just not worth it. So yeah, that's all. I hope that's been of interest. That was absolutely fascinating. Thank you, Dr. Cornish. It looks like there is finally a possibility to bring the pain down to zero which is for an interventional pain management. It wasn't something that I ever thought would happen. Thank you. You're very welcome. Disclaimer, when it comes to your health, always consult with your own physician or healthcare provider for personalized advice and guidance. The information provided in this podcast is for educational and informational purposes only and should not be considered medical advice or a substitute for professional medical care.
