Lower back pain is very common, whether it's from injuries, degeneration, or just a lifetime of lifting things, playing sports, and at some point it's likely to be a pain we all experience. While not all back pain means a serious problem, when it is, it's good to look at a variety of treatments that avoid the use of addictive pain killers/opioid. One such treatment is the use of nerve and/or spinal stimulation.
In this 2 part episode Dr. Gurtej Singh discusses a new form of restorative therapy that stimulates the nerves of the muscle directly responsible for stabilizing the lumbar spine, called ReActiv8 Restorative Neurostimulation system, along with colleague Dr. Chris Gilligan.
A Deep Dive into Restorative Therapy for Back Pain
Featured Speakers:
Gurtej Singh, MD | Chris Gilligan, MD
Dr. Singh was born and raised in Philadelphia, Pennsylvania. After attending William Penn Charter School, he earned his BS in biology at Elizabethtown College and his medical degree at Penn State University College of Medicine. He completed his residency in physical medicine and rehabilitation at the Rehabilitation Medical Institute of Michigan. He was chief fellow in the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City. Most recently Dr. Singh developed the physical medicine and rehabilitation - pain program at Greater Baltimore Medical Center (GBMC) before joining Orthopaedic Associates of Central Maryland Division (OACM) of the Centers for Advanced Orthopaedics (CAO). During his residency, Dr. Singh also served as the team physician for the Warren Mott Varsity and JV football teams, as well as president of the Resident Council at the Detroit Medical Center. Over the past six years, he has been part of two different boards - one serving philanthropic initiatives for the Towson community and the other, the Board of Trustees, for his undergraduate school. Dr. Singh has also lectured on multiple occasions to residents in the Department of Neurosurgery at the University of Maryland Medical Center. Dr. Singh is a fellow of the American Board of Physical Medicine and Rehabilitation and a member of the American Society of Interventional Pain Physicians, North American Neuromodulation Society, North American Spine Society, and American Academy of Anti-Aging Medicine. He is a speaker and instructor for Medtronic where he teaches physicians how to perform spinal cord stimulation, utilize intrathecal pumps, and treat spinal fractures with kyphoplasty. Transcription:
A Deep Dive into Restorative Therapy for Back Pain
One such treatment is the use of nerve and/or spinal stimulation. In this podcast, Dr. Gurtej Singh discusses a new form of restorative therapy that stimulates the nerves of the muscle directly responsible for stabilizing the lumbar spine called ReActiv8 Restorative Neurostimulation System, along with colleague Dr. Chris Gilligan.
Hi, I'm Scott Webb and I've got a bone to fix with you. Doctors, thanks so much for joining me for part one of this series on the ReActiv8 system. In part two, we'll speak with Damian Salgado, a veteran and ReActiv8 patient. But for today, the two of you, a couple of experts, are going to kind of chop it up a little bit. Tell us about ReActiv8, all the benefits for patients and doctors and everybody involved. And Dr. Singh, I'm going to hand you the keys and let you drive.
Gurtej Singh, MD (Guest): Well, thank you so much, and thanks to all of the listeners who are out there tuning in. I am Dr. Gurtej Singh, the Director of Spine Intervention and Pain Management for the Centers for Advanced Orthopedics. I am more than honored to be joined by one of my esteemed colleagues, Dr. Chris Gilligan. Chris?
Chris Gilligan, MD: Thanks so much. I'm Chris Gilligan. I'm the Associate Chief Medical Officer of Brigham and Women's Hospital and Director of the Brigham and Women's Spine Center. Most relevant to this conversation, I've been the principal investigator for the research on a new therapy for treating low back pain, which is obviously what we're going to discuss today.
Gurtej Singh, MD (Guest): Chris, you and I have been in practice for so many years. We've seen thousands of patients with low back pain and, unfortunately, many of them go on to become chronic low back pain patients. This is a new device, this is a new therapy. So, some patients may not fully understand how this works. We're going to get into all of that. You know, in your day-to-day practice, how many chronic back pain patients, you know, do you see? And how frustrated do some of them get when our traditional therapies don't help them?
Chris Gilligan, MD: So frankly, of all of the diagnoses that we treat, low back pain is the most common. And for the patients who have severe, refractory disabling low back, it's incredibly frustrating. And frankly, that's what motivated me to do the research to try to develop better therapy for it, was that it was frustrating for them, it was frustrating for me. If they came with their partner, their partner was frustrated. And the sense that we can do lung transplants and heart transplants, but we had many patients with disabling low back pain and, in too many cases, we couldn't help them. That was just hard to swallow, frankly.
Gurtej Singh, MD (Guest): I would certainly echo the same thing in my experience. And once I had learned about the ReActiv8 system, how the device works, I went back and I thought, over the years when I would see these patients, and we would try various things, right? From simple to complex medications. Unfortunately, some, you know, would get onto opiates and narcotics. There are so many different injections that you and I have offered these patients epidurals, cortisone shots, even nerve burns. Some of these patients would see some of our surgical colleagues and end up with even spinal fusion.
What struck me was looking back at their MRI and seeing-- you talked about how other areas of medicine can help to fix an organ. And all of a sudden, I began to really appreciate how much wasting away or atrophy patients had in the muscles of their lower back. Was that as surprising to you?
Chris Gilligan, MD: It was, it was. And then, so with this therapy, of course, we target the multifidus muscle, which is a muscle that most people and, frankly, many doctors haven't heard about, haven't thought about. But it's the strongest stabilizing muscle of the lumbar spine. And as you alluded to, it's a muscle that is heavily implicated in that scenario where a patient develops severe low back pain and it just stays chronic and refractory and goes on for years and years, and doesn't respond to simple medications, doesn't respond to physical therapy. And this therapy in a nutshell is about restoring that muscular or that neuromuscular control, restoring this functional stability of the patient's spine. And then, as a consequence of that, helping the patient to get pain relief.
Gurtej Singh, MD (Guest): One of the things, you know, with this podcast that we should also help our audience understand, you know, there are two different sort of types of chronic low back pain. One, we call radicular and this is a type of low back pain that may start in the back in the buttocks, but ends up going all the way down the leg and usually involves numbness, tingling, burning, sometimes pins and needles. Many times, we refer to that as something being like sciatica. So, this particular procedure, its intended treatment is not going to be geared to somebody with a sciatica.
But the second type, which is where ReActiv8 comes into play, is what we call more of a mechanical low back pain, right? So, I've noticed with a lot of my patients in terms of bending and twisting, getting up from the chair, where they kind of struggle with that sort of almost at times like a vice-like grip. Do you feel patients describe it that way? Or any other experiences?
Chris Gilligan, MD: Very much so. The other things that I'm hearing frequently from this group of patients is that some activities may be something that involves the external muscles, big muscles, like carrying in the groceries, that may or may not be okay. But activities like brushing their teeth; if they shave, shaving; doing the dishes, cooking, leaning over. So, activities that just involve more micromovements or microstability, those will just be excruciating and, in fact, impossible to do for them. So, we'll have some patients who will say, "Well, in terms of my muscles, I've done a huge amount of physical therapy. I've done a huge amount of exercise programs. And my core muscles from the outside feel strong." That will be true for them, but they may have dysfunction, that atrophy and wasting that you referred to, of the multifidus muscle, one of the deeper muscles and the stabilizing muscle that they don't fire voluntarily. And that leaves them with debilitating, disabling, severe pain, provoked in many cases by the more minor movements.
Gurtej Singh, MD (Guest): It was eye-opening for me as I became more educated with this device, that strengthening those deepest multifidi muscles, really it's the hardest thing to do, right? We can go to the gym, we can go to physical therapy, we can be a really good patient and do our home exercises every day, and yet still have a lot of difficulty in targeting that lowest muscle.
Chris Gilligan, MD: Yes. And that's true for a couple of reasons. One is that it's a muscle that we typically don't fire voluntarily. Typically, the multifidus muscle fires in an automatic or a reflex fashion in order to stabilize us as we move through the world. And the other thing is that when patients have pain from one of their discs, the intervertebral discs in their back or from one of the joints in their back, the facet joints, having pain from that structure will lead to an inhibition of the multifidus. So that adjacent pain, it's called arthrogenic inhibition, where it will cause a reflex blocking of the multifidus muscle, preventing it from firing. And much of the logic of this therapy is to have a device to help them overcome that inhibition, to get the multifidus firing again, restore their neuromuscular control, get their spine functionally stable again, such that they'll be able to get out of this cycle of severe, disabling, chronic low back pain.
Gurtej Singh, MD (Guest): To help give our audience another sort of example, when an individual will suffer from a stroke and maybe their foot doesn't work as well, a lot of physical therapists will use an external stimulating system, it's called electrical stimulation. And they'll place a pad on one of the muscles in the front of the shin. And when you activate it, you'll see the foot lift up off the ground. And I think that's a great example that our listeners can think of. We're placing a stimulator on the nerve to help that deepest muscle, the one that we can't get to, help strengthen.
You know, a lot of physicians in the pain management space are very familiar with neuromodulation, you know, where we would do like a spinal stimulator for chronic pain. This is actually restorative neurostimulation. When you became involved with this device, can you tell us how you guys came up with restorative neurostimulation? It's a completely new term.
Chris Gilligan, MD: Yeah, it was a completely new term and it's frankly a completely new approach. So, other spinal cord stimulators and similar peripheral nerve stimulators, those have traditionally stimulated sensory nerves in order to block the sensation of pain to just relieve pain by blocking the sensation. This therapy is a completely different mechanism. This is not blocking the sensation of pain. This is restoring the function of the multifidus muscle, restoring the functional stability of the spine, restoring the neuromuscular control. Such that as a consequence, the patient doesn't have pain, but it's not covering up the pain. And so, that's where we really frankly felt the only accurate way to describe it was with that term, restorative neurostimulation.
Gurtej Singh, MD (Guest): One of the things that patients come to us and ask so many times, they'll say, "Well, how can we fix this as opposed to masking it? How can we improve my situation instead of putting just another bandaid on it?" And I have experience in both discussing this procedure with patients as well as talking to other colleagues. This is one of the first times in the field of back pain management where we can actually improve something and actually show it improve year over year. We can actually enhance a patient's quality of life, to say that I'm energized to discuss this with patients is sort of putting it lightly.
Chris Gilligan, MD: Yeah, I think that concept that you pointed to, that it's restoring, that it's getting to the root of a problem and fixing a problem rather than covering it up. I think that's very powerful for all of us. It's very powerful for the patients whom I treat, I'm personally very motivated by it. And I think it's an important point that you made that with this restorative therapy, what we're seeing over time is patients do well at six months. They do even better at 12 months. They do even better at 24 months, and they do even better at 36 months. In other words, the longer we treat them with the restorative therapy, the better they do. And that's in terms of how they're doing in terms of improvement in their pain, improvement in their function and improvement in their healthcare-related quality of life. So, all of the outcomes that we follow in back pain patients are getting better and better the longer we treat them with restorative neurostimulation. And that's incredibly important for our patients and, frankly, incredibly rewarding for you and me and everyone who treats back pain patients.
Gurtej Singh, MD (Guest): That's right. You mentioned this and I was sort of alluding to the published data. You know, so with something that is fairly new both in our field, but also to patients here in the US, if I understand right, the longest patient has been implanted out almost eight plus years. But the data has been quite robust. Does it go out past four years now?
Chris Gilligan, MD: The longest data that we've published so far is four years. that's from a trial that we did in Australia and Europe. We just published from the biggest trial that we did, which was Australia, Europe, and the US. We just published our three-year outcomes and we're getting ready to prepare the four-year data from that.
What's very reassuring to me, frankly, is that for all of those data sets, we see the same pattern that the longer we treat the patients, the better they do in terms of pain, in terms of function, and in terms of healthcare-related quality of life. And that's so important because, as you well know, this is a very chronic condition. So, we need therapies that give patients good outcomes that are durable, that last for years and ideally get better year after year. And, fortunately, that's what we're seeing so far with this therapy.
Gurtej Singh, MD (Guest): One of the things our listeners should know is maybe the two biggest take-home points when it comes to the research behind this device is that, for so many of the other things that we do for pain management, the data typically goes out only about two years. It's not frequent that you see three-year or even five-year data. So, the fact that mainstay medical is making the commitment to keep showing all of us that these patients continue to do better is really important.
The second is a lot of times when companies put out two-year data, that's usually when things start to peter off. And to be able to show that you can continue to get better year after year, use less of a resource, right? So, you won't need as much physical therapy. You won't need as much medication management. You can get back to working out, watching your kids play sports. You don't have to come and see the two of us in our offices every few months. I think our listeners should know just how important that is going forward.
We had briefly mentioned a few moments ago about, you know, what kind of a patient would be an ideal candidate. Could you give us some insight into who might be the right patient?
Chris Gilligan, MD: It's a patient where the pain is it's my back that hurts, that it's not shooting down my leg and it's not sciatica, you know, that you referenced earlier in the conversation. It's just my back hurts. I've tried whatever medications made sense and unfortunately didn't get relief. I've tried physical therapy, but unfortunately that didn't help. If it made sense for anybody to do any injections or things like that, I didn't get adequate, sustained relief from those. The pain should be relatively severe, relatively limiting in terms of the patient's function. It shouldn't be a mild pain. And it should have been going on for more than a year. When they're assessed by qualified clinicians, surgeons, et cetera, they should be hearing, "We don't see a good indication for surgery. We don't see something clearly surgical that should be fixed here." those are the main things.
The other things that we have to see in order to be identifying a patient who's really a good candidate for this therapy is we have to be seeing some sign of dysfunction of that multifidus muscle. And that can be either that we're seeing atrophy, and other degenerative changes on an MRI, a fatty infiltration of the muscle, atrophy of the muscle, et cetera, and/or that we're seeing dysfunction of the muscle when we do physical exam tests that assess the function of the multifidus and some of the adjacent muscles, physical exam tests like the prone instability test or the multifidus lift test. So, we do have to see some signs of multifidus dysfunction in addition to the other things that I mentioned.
Gurtej Singh, MD (Guest): When patients are well-identified, you know, the next big question, they certainly ask you and I, "What's the procedure like? And how long will I be incapacitated for afterwards?" For me, what I've been able to reassure patients is that because we are stimulating a nerve that is on the outside of the spine, we don't have to risk some of the more complications that we see with other procedures. So by placing this wire on the outside of the spine, laying it on the outside of the bone and adjacent to one of the muscles, we're able to secure the lead. So a lot of times, you know, the patients ask questions, "Well, what about in the future, will it move? And what are those complications?" And the long-term data has shown that it's actually a very safe procedure in terms of not harming the patient as well as in terms of staying where it's been surgically placed. And I let patients know that we make two small incisions, one in the middle of the lower back, so that we can place those two wires and secure them safely. And then, make a second incision either on the right or the left of their love handles or the flanks. And that's where we can tuck the battery under the skin. And so once those two incisions heal, usually it's, I would say, about two to three weeks. And then, we're able to activate the patient and get them to start using the device. Would you say your experience has been roughly the same or...?
Chris Gilligan, MD: Yeah, very much so. And I'll often talk to patients about the similarities that these devices have with pacemakers, just because that's something that most folks are familiar with. I'd make sure folks understand that this is typically a day surgery, that they typically don't have to stay over in the hospital.
We really try to make sure that patients have a very, very good feel for seeing the device. We try to make sure that they see an example of both the battery and the leads, just so they have a full sense of what the therapy is and to prompt to make sure that we're figuring out what questions the patient has and trying to address all of those questions. And you're right about the question about lead migration. We've tried to be very disciplined in looking for that and reporting that. And, fortunately so far, in our biggest trial where we just published the three-year data, we had zero lead migrations. So, 204 patients and zero lead migrations. And I think that's a tribute to the engineers who are involved in developing the device.
Scott Webb: Well, it certainly seems like if the ReActiv8 system isn't the gold standard yet, that it probably will be sometime soon. I certainly look forward to speaking with Damian in episode two about his journey, you know, from being injured on the battlefield to finally getting the ReActiv8 system and how it's changed his life. Dr. Singh, thanks so much for driving today. Dr. Gilligan, thanks for your expertise. And you both stay well.
Gurtej Singh, MD (Guest): Thank you, Scott.
Chris Gilligan, MD: Thanks again. Be well.
Scott Webb: Find out more about us online at mdbonedocs.com. And please remember to share and subscribe to this podcast. And that's all for today. I'm Scott Webb. And that was a Bone That's Fixed.
A Deep Dive into Restorative Therapy for Back Pain
One such treatment is the use of nerve and/or spinal stimulation. In this podcast, Dr. Gurtej Singh discusses a new form of restorative therapy that stimulates the nerves of the muscle directly responsible for stabilizing the lumbar spine called ReActiv8 Restorative Neurostimulation System, along with colleague Dr. Chris Gilligan.
Hi, I'm Scott Webb and I've got a bone to fix with you. Doctors, thanks so much for joining me for part one of this series on the ReActiv8 system. In part two, we'll speak with Damian Salgado, a veteran and ReActiv8 patient. But for today, the two of you, a couple of experts, are going to kind of chop it up a little bit. Tell us about ReActiv8, all the benefits for patients and doctors and everybody involved. And Dr. Singh, I'm going to hand you the keys and let you drive.
Gurtej Singh, MD (Guest): Well, thank you so much, and thanks to all of the listeners who are out there tuning in. I am Dr. Gurtej Singh, the Director of Spine Intervention and Pain Management for the Centers for Advanced Orthopedics. I am more than honored to be joined by one of my esteemed colleagues, Dr. Chris Gilligan. Chris?
Chris Gilligan, MD: Thanks so much. I'm Chris Gilligan. I'm the Associate Chief Medical Officer of Brigham and Women's Hospital and Director of the Brigham and Women's Spine Center. Most relevant to this conversation, I've been the principal investigator for the research on a new therapy for treating low back pain, which is obviously what we're going to discuss today.
Gurtej Singh, MD (Guest): Chris, you and I have been in practice for so many years. We've seen thousands of patients with low back pain and, unfortunately, many of them go on to become chronic low back pain patients. This is a new device, this is a new therapy. So, some patients may not fully understand how this works. We're going to get into all of that. You know, in your day-to-day practice, how many chronic back pain patients, you know, do you see? And how frustrated do some of them get when our traditional therapies don't help them?
Chris Gilligan, MD: So frankly, of all of the diagnoses that we treat, low back pain is the most common. And for the patients who have severe, refractory disabling low back, it's incredibly frustrating. And frankly, that's what motivated me to do the research to try to develop better therapy for it, was that it was frustrating for them, it was frustrating for me. If they came with their partner, their partner was frustrated. And the sense that we can do lung transplants and heart transplants, but we had many patients with disabling low back pain and, in too many cases, we couldn't help them. That was just hard to swallow, frankly.
Gurtej Singh, MD (Guest): I would certainly echo the same thing in my experience. And once I had learned about the ReActiv8 system, how the device works, I went back and I thought, over the years when I would see these patients, and we would try various things, right? From simple to complex medications. Unfortunately, some, you know, would get onto opiates and narcotics. There are so many different injections that you and I have offered these patients epidurals, cortisone shots, even nerve burns. Some of these patients would see some of our surgical colleagues and end up with even spinal fusion.
What struck me was looking back at their MRI and seeing-- you talked about how other areas of medicine can help to fix an organ. And all of a sudden, I began to really appreciate how much wasting away or atrophy patients had in the muscles of their lower back. Was that as surprising to you?
Chris Gilligan, MD: It was, it was. And then, so with this therapy, of course, we target the multifidus muscle, which is a muscle that most people and, frankly, many doctors haven't heard about, haven't thought about. But it's the strongest stabilizing muscle of the lumbar spine. And as you alluded to, it's a muscle that is heavily implicated in that scenario where a patient develops severe low back pain and it just stays chronic and refractory and goes on for years and years, and doesn't respond to simple medications, doesn't respond to physical therapy. And this therapy in a nutshell is about restoring that muscular or that neuromuscular control, restoring this functional stability of the patient's spine. And then, as a consequence of that, helping the patient to get pain relief.
Gurtej Singh, MD (Guest): One of the things, you know, with this podcast that we should also help our audience understand, you know, there are two different sort of types of chronic low back pain. One, we call radicular and this is a type of low back pain that may start in the back in the buttocks, but ends up going all the way down the leg and usually involves numbness, tingling, burning, sometimes pins and needles. Many times, we refer to that as something being like sciatica. So, this particular procedure, its intended treatment is not going to be geared to somebody with a sciatica.
But the second type, which is where ReActiv8 comes into play, is what we call more of a mechanical low back pain, right? So, I've noticed with a lot of my patients in terms of bending and twisting, getting up from the chair, where they kind of struggle with that sort of almost at times like a vice-like grip. Do you feel patients describe it that way? Or any other experiences?
Chris Gilligan, MD: Very much so. The other things that I'm hearing frequently from this group of patients is that some activities may be something that involves the external muscles, big muscles, like carrying in the groceries, that may or may not be okay. But activities like brushing their teeth; if they shave, shaving; doing the dishes, cooking, leaning over. So, activities that just involve more micromovements or microstability, those will just be excruciating and, in fact, impossible to do for them. So, we'll have some patients who will say, "Well, in terms of my muscles, I've done a huge amount of physical therapy. I've done a huge amount of exercise programs. And my core muscles from the outside feel strong." That will be true for them, but they may have dysfunction, that atrophy and wasting that you referred to, of the multifidus muscle, one of the deeper muscles and the stabilizing muscle that they don't fire voluntarily. And that leaves them with debilitating, disabling, severe pain, provoked in many cases by the more minor movements.
Gurtej Singh, MD (Guest): It was eye-opening for me as I became more educated with this device, that strengthening those deepest multifidi muscles, really it's the hardest thing to do, right? We can go to the gym, we can go to physical therapy, we can be a really good patient and do our home exercises every day, and yet still have a lot of difficulty in targeting that lowest muscle.
Chris Gilligan, MD: Yes. And that's true for a couple of reasons. One is that it's a muscle that we typically don't fire voluntarily. Typically, the multifidus muscle fires in an automatic or a reflex fashion in order to stabilize us as we move through the world. And the other thing is that when patients have pain from one of their discs, the intervertebral discs in their back or from one of the joints in their back, the facet joints, having pain from that structure will lead to an inhibition of the multifidus. So that adjacent pain, it's called arthrogenic inhibition, where it will cause a reflex blocking of the multifidus muscle, preventing it from firing. And much of the logic of this therapy is to have a device to help them overcome that inhibition, to get the multifidus firing again, restore their neuromuscular control, get their spine functionally stable again, such that they'll be able to get out of this cycle of severe, disabling, chronic low back pain.
Gurtej Singh, MD (Guest): To help give our audience another sort of example, when an individual will suffer from a stroke and maybe their foot doesn't work as well, a lot of physical therapists will use an external stimulating system, it's called electrical stimulation. And they'll place a pad on one of the muscles in the front of the shin. And when you activate it, you'll see the foot lift up off the ground. And I think that's a great example that our listeners can think of. We're placing a stimulator on the nerve to help that deepest muscle, the one that we can't get to, help strengthen.
You know, a lot of physicians in the pain management space are very familiar with neuromodulation, you know, where we would do like a spinal stimulator for chronic pain. This is actually restorative neurostimulation. When you became involved with this device, can you tell us how you guys came up with restorative neurostimulation? It's a completely new term.
Chris Gilligan, MD: Yeah, it was a completely new term and it's frankly a completely new approach. So, other spinal cord stimulators and similar peripheral nerve stimulators, those have traditionally stimulated sensory nerves in order to block the sensation of pain to just relieve pain by blocking the sensation. This therapy is a completely different mechanism. This is not blocking the sensation of pain. This is restoring the function of the multifidus muscle, restoring the functional stability of the spine, restoring the neuromuscular control. Such that as a consequence, the patient doesn't have pain, but it's not covering up the pain. And so, that's where we really frankly felt the only accurate way to describe it was with that term, restorative neurostimulation.
Gurtej Singh, MD (Guest): One of the things that patients come to us and ask so many times, they'll say, "Well, how can we fix this as opposed to masking it? How can we improve my situation instead of putting just another bandaid on it?" And I have experience in both discussing this procedure with patients as well as talking to other colleagues. This is one of the first times in the field of back pain management where we can actually improve something and actually show it improve year over year. We can actually enhance a patient's quality of life, to say that I'm energized to discuss this with patients is sort of putting it lightly.
Chris Gilligan, MD: Yeah, I think that concept that you pointed to, that it's restoring, that it's getting to the root of a problem and fixing a problem rather than covering it up. I think that's very powerful for all of us. It's very powerful for the patients whom I treat, I'm personally very motivated by it. And I think it's an important point that you made that with this restorative therapy, what we're seeing over time is patients do well at six months. They do even better at 12 months. They do even better at 24 months, and they do even better at 36 months. In other words, the longer we treat them with the restorative therapy, the better they do. And that's in terms of how they're doing in terms of improvement in their pain, improvement in their function and improvement in their healthcare-related quality of life. So, all of the outcomes that we follow in back pain patients are getting better and better the longer we treat them with restorative neurostimulation. And that's incredibly important for our patients and, frankly, incredibly rewarding for you and me and everyone who treats back pain patients.
Gurtej Singh, MD (Guest): That's right. You mentioned this and I was sort of alluding to the published data. You know, so with something that is fairly new both in our field, but also to patients here in the US, if I understand right, the longest patient has been implanted out almost eight plus years. But the data has been quite robust. Does it go out past four years now?
Chris Gilligan, MD: The longest data that we've published so far is four years. that's from a trial that we did in Australia and Europe. We just published from the biggest trial that we did, which was Australia, Europe, and the US. We just published our three-year outcomes and we're getting ready to prepare the four-year data from that.
What's very reassuring to me, frankly, is that for all of those data sets, we see the same pattern that the longer we treat the patients, the better they do in terms of pain, in terms of function, and in terms of healthcare-related quality of life. And that's so important because, as you well know, this is a very chronic condition. So, we need therapies that give patients good outcomes that are durable, that last for years and ideally get better year after year. And, fortunately, that's what we're seeing so far with this therapy.
Gurtej Singh, MD (Guest): One of the things our listeners should know is maybe the two biggest take-home points when it comes to the research behind this device is that, for so many of the other things that we do for pain management, the data typically goes out only about two years. It's not frequent that you see three-year or even five-year data. So, the fact that mainstay medical is making the commitment to keep showing all of us that these patients continue to do better is really important.
The second is a lot of times when companies put out two-year data, that's usually when things start to peter off. And to be able to show that you can continue to get better year after year, use less of a resource, right? So, you won't need as much physical therapy. You won't need as much medication management. You can get back to working out, watching your kids play sports. You don't have to come and see the two of us in our offices every few months. I think our listeners should know just how important that is going forward.
We had briefly mentioned a few moments ago about, you know, what kind of a patient would be an ideal candidate. Could you give us some insight into who might be the right patient?
Chris Gilligan, MD: It's a patient where the pain is it's my back that hurts, that it's not shooting down my leg and it's not sciatica, you know, that you referenced earlier in the conversation. It's just my back hurts. I've tried whatever medications made sense and unfortunately didn't get relief. I've tried physical therapy, but unfortunately that didn't help. If it made sense for anybody to do any injections or things like that, I didn't get adequate, sustained relief from those. The pain should be relatively severe, relatively limiting in terms of the patient's function. It shouldn't be a mild pain. And it should have been going on for more than a year. When they're assessed by qualified clinicians, surgeons, et cetera, they should be hearing, "We don't see a good indication for surgery. We don't see something clearly surgical that should be fixed here." those are the main things.
The other things that we have to see in order to be identifying a patient who's really a good candidate for this therapy is we have to be seeing some sign of dysfunction of that multifidus muscle. And that can be either that we're seeing atrophy, and other degenerative changes on an MRI, a fatty infiltration of the muscle, atrophy of the muscle, et cetera, and/or that we're seeing dysfunction of the muscle when we do physical exam tests that assess the function of the multifidus and some of the adjacent muscles, physical exam tests like the prone instability test or the multifidus lift test. So, we do have to see some signs of multifidus dysfunction in addition to the other things that I mentioned.
Gurtej Singh, MD (Guest): When patients are well-identified, you know, the next big question, they certainly ask you and I, "What's the procedure like? And how long will I be incapacitated for afterwards?" For me, what I've been able to reassure patients is that because we are stimulating a nerve that is on the outside of the spine, we don't have to risk some of the more complications that we see with other procedures. So by placing this wire on the outside of the spine, laying it on the outside of the bone and adjacent to one of the muscles, we're able to secure the lead. So a lot of times, you know, the patients ask questions, "Well, what about in the future, will it move? And what are those complications?" And the long-term data has shown that it's actually a very safe procedure in terms of not harming the patient as well as in terms of staying where it's been surgically placed. And I let patients know that we make two small incisions, one in the middle of the lower back, so that we can place those two wires and secure them safely. And then, make a second incision either on the right or the left of their love handles or the flanks. And that's where we can tuck the battery under the skin. And so once those two incisions heal, usually it's, I would say, about two to three weeks. And then, we're able to activate the patient and get them to start using the device. Would you say your experience has been roughly the same or...?
Chris Gilligan, MD: Yeah, very much so. And I'll often talk to patients about the similarities that these devices have with pacemakers, just because that's something that most folks are familiar with. I'd make sure folks understand that this is typically a day surgery, that they typically don't have to stay over in the hospital.
We really try to make sure that patients have a very, very good feel for seeing the device. We try to make sure that they see an example of both the battery and the leads, just so they have a full sense of what the therapy is and to prompt to make sure that we're figuring out what questions the patient has and trying to address all of those questions. And you're right about the question about lead migration. We've tried to be very disciplined in looking for that and reporting that. And, fortunately so far, in our biggest trial where we just published the three-year data, we had zero lead migrations. So, 204 patients and zero lead migrations. And I think that's a tribute to the engineers who are involved in developing the device.
Scott Webb: Well, it certainly seems like if the ReActiv8 system isn't the gold standard yet, that it probably will be sometime soon. I certainly look forward to speaking with Damian in episode two about his journey, you know, from being injured on the battlefield to finally getting the ReActiv8 system and how it's changed his life. Dr. Singh, thanks so much for driving today. Dr. Gilligan, thanks for your expertise. And you both stay well.
Gurtej Singh, MD (Guest): Thank you, Scott.
Chris Gilligan, MD: Thanks again. Be well.
Scott Webb: Find out more about us online at mdbonedocs.com. And please remember to share and subscribe to this podcast. And that's all for today. I'm Scott Webb. And that was a Bone That's Fixed.