Outcomes Rocket Podcast_Dr. Gilligan: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Saul Marquez:
Hey everybody! Saul Marquez with the Outcomes Rocket Podcast. Such a pleasure to have you tune in to the podcast once again. You know, we have an incredible opportunity today to chat with a very talented and well-known individual. His name is Dr. Chris Gilligan. He’s the Chief Division of Pain Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine at Brigham and Women’s Hospital, also an assistant professor of anesthesia at Harvard Medical School. Dr. Gilligan’s original training is in emergency medicine with a subspecialty training in pain medicine where he has focused on pain of spinal origin. Dr. Gilligan’s clinical expertise is focused on the treatment of pain-related disorders of the spine. He also treats patients with a wide range of pain conditions, including cancer-related pain, complex regional pain syndrome, and post-herpetic neuralgia. Dr. Gilligan’s research focuses on clinical trials of new interventions and devices and medications for the treatment of pain. Dr. Gilligan, such a pleasure to have you here today, thanks for joining us.
Dr. Chris Gilligan:
Thanks so much for having me, glad to be here.
Saul Marquez:
So can you help set the stage for chronic low back pain? And let’s talk about its causes, different types, possible treatments.
Dr. Chris Gilligan:
I’d be happy to. So when we are treating a patient with or evaluating a patient with low back pain, we divide it into four categories and they’re pretty simple. The first is, is it acute or is it chronic? And that cutoff is at 12 weeks. The reason for that is that natural history, the chances the patient’s just going to get better on their own are higher, general when it, when it’s acute. The other way that we divide it is is it reticular, meaning going down a nerve route, shooting down your leg sciatica, in common terminology, or is it axial? My back’s hurting, it’s not sciatica, it’s not shooting down my leg. And based off of that, that will inform a lot of how we’re going to evaluate the patient, what we’re going to expect, which treatments we’re going to offer. So just to give you a quick example, if someone comes in with acute axial back pain, you know, my back’s been hurting me, killing me for one or two weeks, in the absence of red flags, a history of cancer, or signs of infection or trauma, in the absence of those, we can typically be very reassuring to that patient. Chances are you’re going to get better are extremely high, treatments will tend to be things like non-steroidal anti-inflammatory drugs, ibuprofen, etc., muscle relaxants, and reassurance that there is unlikely to be any need for diagnostic tests, interventions, or anything of that sort. On the other hand, we have things like chronic low back pain. So if a patient has had severe low back pain and it’s gone on for two years or more, the chances that’s going to get better on its own, for example, are extremely low, and our whole evaluation paradigm and treatment paradigm is going to be very different.
Saul Marquez:
No, thank you for that. This could be pretty complex, right? And so when you think about chronic low back pain, it seems to be kind of that pain, that nuisance that we really don’t have solutions for. Can you talk about what lasting relief looks like and ways that we could help people with this?
Dr. Chris Gilligan:
Absolutely, and then to be clear, those other distinctions matter a lot in terms of outcomes. So, for example, if somebody does come in and they have sciatica, many times that can be treated very, very effectively with surgery, with other interventions, etc. But you’re exactly right that if we’re talking about patients who have chronic, just axial low back pain that’s measured in terms of time frame in years, some of them have conditions that have been amenable to good treatment for a long time. But too many of them, either there isn’t a treatment option for them or there might be a treatment option for them but it’s not going to give sustained relief, it’ll give transient release. And that is, when it’s really severe, limiting function, limiting quality of life, not responding to therapies, it’s a brutal condition. So it’s important for people to understand that we’re not talking about a little backache, a minor backache. We’re not talking about my back’s sore because I’ve been sitting in meetings too much. We’re talking about the kind of back pain where you can’t do your job, where you can’t exercise, debilitating, and that, I would even say to a certain extent, starts to take a person’s life away from them or their identity away from them. Because after all, we tend to identify ourselves in part from the kind of work we do, from being active in our communities, with our families, etc, and so if a person loses those abilities, it’s really a devastating situation.
Saul Marquez:
Yeah, for sure, and so that’s a great distinction Dr. Gilligan, the non-surgical candidates, right? So we will treat patients with pain meds with surgery, but what do you do with the non-surgical candidates that pain meds aren’t working for? What types of solutions are available?
Dr. Chris Gilligan:
So previously one of the things that we’ve had as we’ve looked to see, dissipation of the pain coming from their … joints, and in those cases, we’ve done diagnostic injections called Diagnostic Medial Branch Blocks, and then if those were positive, nerve deadening procedures, radiofrequency ablations. The challenge with those is that even in a best-case scenario, they tend to give transient relief and they don’t always even give transient relief. So our treatment options for those patients, frankly, were too limited. There’s a therapy that we’ve done a lot of research on that’s been now FDA approved and available in the United States, which is restorative neurostimulation to treat this refractory severe disabling chronic low back pain that’s no susceptible. In other words, an ache not a nerve injury. And we’ve been very, very pleased with the outcomes that we’re seeing with those patients. We now just recently, in the last couple of weeks, published our three-year outcomes on those patients, and I’m pleased to tell you that what we’re seeing is that for a very large number of those patients, we’re getting excellent outcomes, meaning taking their pain from severe to mild on average, taking their disability from being right where moderate-severe disability to mild on average and taking their healthcare-related quality of life from being subpar to getting close to the US population norm for healthcare-related quality of life. We’ve also seen that almost half of those patients, if they’re on opioids, are able to voluntarily eliminate their opioids and another 20 to 22% are able to reduce their opioids, so we’ve seen benefits that way, so we’re frankly very pleased. Now, this isn’t like all therapies. There are criteria that make somebody appropriate for it, and there are criteria that make somebody inappropriate. So it’s not the panacea for all patients with severe chronic low back pain. But for a significant number of them, we now feel like we have a safe, and in many cases highly effective, treatment option that we can consider for them, and that’s a huge relief. That’s a huge relief to the patients, of course, it’s a relief to those of us who spend our dedicate our lives to trying to help them.
Saul Marquez:
Yeah, no, I appreciate that. So there is, sounds like, robust clinical data to support the effectiveness of the therapy. And so how does the data compare to other clinical data in the field?
Dr. Chris Gilligan:
I would argue favorably. No, I’m involved in the research, so you can decide if you think that I’m objective or not, of course, but I would argue favorably, both in terms of the scale of the improvement that patients are getting a really clinically substantial improvement, not a marginal, and that they’re, like I mentioned, that their pain and their disability after three years of stimulation is mild. So they’re doing well that way that their healthcare-related quality of life is approximating the population norm. I think that’s very important. The other thing that I think is very important is frankly that the outcomes that we just published are three-year outcomes, and that’s really important with the chronic condition. It’s one thing if you show that patients get better for six months, but do they then revert back to being severely affected or they get better for one year? Do they then go on, is it then they go back to baseline so it’s not sustained? So I think it’s very important that we’re showing three-year improvements. And then the other thing that I personally find very reassuring in the data is that essentially all of the measures are moving in the right direction. So what I mean by that is that their pain is getting better, but also their function is getting better and also their healthcare-related quality of life is getting better. So when you see that all of the measures are moving in the right direction and in a substantial way, I find that very reassuring.
Saul Marquez:
That’s fantastic, thank you for sharing that. And so as a treating physician and even from the perspective of a healthcare administrator or a payer plan seeking to help these patients, or even an employer, like let’s just be real, right, employers out there have a ton of employees that suffer from this. How should this treatment be used? Should it be used as a last resort for these patients or could it be used earlier in the care continuum?
Dr. Chris Gilligan:
So the first phase for these patients should be trying to get them better with conservative therapies, physical therapy, and appropriate medications, okay? If they get better with those beautiful, terrific. This should be for patients who, their symptoms have gone on for one year or longer, where the symptoms are limiting their function, where their chronic low back pain is accompanied by signs of dysfunction of the multifidus muscle, which is the strongest stabilizing muscle of the lumbar spine, and those can be signs of dysfunction, non-physical examination by a clinician or on imaging studies, or both; but when that’s the case, on the other hand, this is a quite a safe procedure, frankly our data show good safety, and it is an implantation, but it’s an implantation, the analogy that I’ll make to patients is it’s a little bit like having a pacemaker put in in terms of how big of a surgery, the recovery is, fortunately relatively quick. So I don’t think that’s something that should just be held in reserve for the worst of the worst or left at the end of the treatment algorithm. I think it should come into play for patients who really need a therapy and on the other hand, have not gotten relief with conservative things like physical therapy and appropriate medications.
Saul Marquez:
Got it, thank you so much for that. And are these procedures being done in the OR? Are they being done in ambulatory surgery centers, the office, all the above? Can you share a little more on that?
Dr. Chris Gilligan:
They’re being done in ambulatory surgery centers. They’re being done in conventional operating rooms. They’re not done in the office because you do want that level of sterility that you have in an ambulatory surgery center, but it’s a day surgery commonly done just under a sedation anesthetic.
Saul Marquez:
Very cool, very cool. And so you’ve been studying this for a while now. So what’s been a surprising finding from your studies of this problem and therapy?
Dr. Chris Gilligan:
Well, I think there have been a few. I would say the first is it’s been a pleasant surprise that we’ve had such good outcomes, that such a high percentage of the patients have gotten these clinically substantial improvements, these big improvements. And in all, like I mentioned before, I mean, all the different measures and the elimination of opioids on a voluntary basis, etc. The scale of the good outcomes in the patients, that’s been a pleasant surprise. The other thing I would say is that there have been some subgroups of patients who have done quite well with this, that also, I think what one might have thought would be quite challenging. For example, some patients with scoliosis, we had 12 patients with scoliosis, in our biggest trial. There was a limit on how severe their scoliosis could be, their … angle had to be less than 25 degrees, but those patients did equally as well as the rest of the population. And I think that also could show that this could help patients with some significant scoliosis and help them quite well. That was another pleasant surprise. We had some patients who have low-grade spondylolisthesis where one vertebral body isn’t lined up on the other, grade-one spondylolisthesis, and that group were 18% of our patients in our trial and they did extremely well. And again, I think that for me that falls into the category also of pleasant surprise with this therapy. And one last pleasant surprise, I would say is there, for a long time there have been spinal cord stimulators used to treat nerve pain, neuropathic pain related to the spine, and with those, one of the most common complications has often been lead migration, that the leads that are doing the stimulation can move and that can be a real problem, might create a need for a revision surgery. In our trials, we’ve so far had zero lead migrations, so that also was it was a very happy finding.
Saul Marquez:
Wow, a lot of surprises and good ones, so that’s great. You know, and it’s great when you’re able to land on something like this where you have an answer to something that really a lot of people haven’t had answers to, both clinicians and patients, so appreciate you sharing that.
Dr. Chris Gilligan:
Thank you, I can tell you, quite frankly, that was why I’ve been working on this topic, on this therapy for 14 years, from the idea, when it was, from the stage when it was really just an idea on the back of a napkin truly through till now. And the reason that I’ve put all those years into this topic is that for these patients, it was abundantly clear that they needed better treatment options, so that was the motivation.
Saul Marquez:
That’s great, and frankly, you think about this from an economic perspective, there could be significant savings for, societal savings if you’re able to give somebody relief without the need of, for non-surgical people, the relief that they need without the, cascading things like adjacent level, etc., right?
Dr. Chris Gilligan:
Absolutely, if we can get these patients healthy, get them back to work, help make it so they don’t need other interventions, they don’t go and get themselves a surgery, etc. I think the benefits in terms of the benefits to the human being who needs that improvement in their life, that’s huge. But also, I think the economic savings associated with this. I think the benefits from this therapy, both on the human level of helping that person get some pain relief, get their function back at their quality of life back, that’s incredibly valuable. But also the economic implications both in terms of healthcare expenditure and avoiding interventions, diagnostic modalities for some patients, even surgeries, and also the general economic benefits of getting that person so they can go back to work, do their thing, are tremendous.
Saul Marquez:
Love that, well, listen, Dr. Gilligan, this has been fascinating and it’s only the tip of the iceberg. I mean, you have fascinating work that you do here. What call to action would you leave our listeners with and what’s the best place for them to follow you and get to know your work better, all of the things you’ve published, what’s the best place for them to do that?
Dr. Chris Gilligan:
Well, I would say there’s a company that makes the stimulator. They’re called Mainstay Medical, M A I N S T A Y, and I think they’re a good starting point for people who want to want to look at some material to go into more detail, obviously, on how the therapy works, what it is, some of the outcomes data, safety data, etc. I think that’s a good starting point.
Saul Marquez:
Excellent, well, thank you for that. We’ll leave the link to Mainstay Medical inside of the show notes of our talk with Dr. Gilligan today. So make sure you check that out, and Dr. Gilligan, what call to action would you leave folks with?
Dr. Chris Gilligan:
So the call to action that I would say for folks is if they are suffering from this sort of refractory severe chronic low back pain or if they have a friend, a loved one who’s suffering with it, I think it’s important to know that there are some new developments, there are some new therapies. Like we talked about, they’re not panaceas, so it’s not for every single case, but that it is worth looking into it. And that this is relatively new stuff, you know, it’s been out, FDA-approved, in the last year or two. So it’s worth revisiting for a situation where somebody may think there’s nothing that can be done. I think it’s worth looking into it and seeing whether there could be some benefit from this therapy or that sort of individual.
Saul Marquez:
Fantastic, well, Dr. Gilligan, thank you so much. I appreciate that and definitely appreciate you spending some time with us here on the podcast.
Dr. Chris Gilligan:
It’s a pleasure, thanks so much for having me.
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