Expert Opinions: Consider Moving to mild^® Directly or the Next Step After Initial ESI Failure

In case you missed the American Society of Pain and Neuroscience (ASPN) March Madness Debates, Dr. Jason Pope and Dr. Jackie Weisbein discussed how many epidural steroid injections (ESIs) they administer prior to the mild^® Procedure in patients suffering from Lumbar Spinal Stenosis (LSS). Listen to these mild^® experts and challenge your own thinking – are you ready to #MoveToMild?

Jason E. Pope, MD (04:51)
I approach this the way that I try to approach most things in medicine which is an evidence-based strategy looking at common sense applications, and so the real question becomes how long do you give an epidural to work in order to say that it’s not working in the management and treatment of spinal stenosis? And there is, thankfully, a randomized prospective study looking at spinal stenosis treatment with local anesthetic alone or local anesthetic plus steroid in treating spinal stenosis. What is interesting about this paper is that it essentially was done in a way where patients had an opportunity to crossover, either getting local anesthetic alone or steroid at a six-week crossover. Essentially what it said was that at six weeks, if someone got relief with an epidural, it’s very likely that they would have that enduring relief profile out to twelve months. If they did not get relief after one or two injections between a 0–6-week application, then they likely will not get benefit from an epidural and they would have to move on to other interventions including decompressive surgery. So, when we look at how many epidurals, when we look at this paper, people had access to anywhere between one and three epidurals within a six-week period. If they got enduring relief at that six-week period, then that relief is maintained to twelve months. If they didn’t get that period of six weeks, then you need to move on to do something else. So, I guess when we’re talking about a debate, I would say follow the data. This was a study that was published in 2017. I was turned on to it by a good friend and colleague, Dr. Fishman, and I think that it has helped shape my practice and my physician partner’s practice and how we apply epidural steroid injections treating spinal stenosis prior to mild^®. We have data on mild^®, right? Comparing mild^® to epidural injection, it appears that mild^® was superior in the enduring relief profile.

Jackie Weisbein, DO (07:34)
I think that it’s hard to give a counterpoint to basically Jason saying there’s not a real answer and I think the reality is that it’s because everybody’s different, right? So, I would say that there is not a set rule. I think that patients that come in, if they have pretty significant lumbar stenosis, the most important thing that I’m telling my patients is that their response to an epidural is not predictive of their outcomes for mild^®. They may or may not have already seen my spine surgeon partner and had one to six, to 10 epidurals whose longevity of efficacy was waning over time and at that point, I don’t think there’s any reason for me to come in and say “hey, let me do another epidural just to prove to you that you’re going to have a good outcome from a procedure”. Realistically, I think it’s patient-centric and it’s great to have the data of the fact that someone might be a good responder to a long-term response from an epidural if they’ve had just local only or local with steroid. Up until a few years ago, I think we didn’t really have a lot of strong studies that supported epidural use, although we’ve all been doing them for patients with lumbar stenosis. The reality is that in the last few years, I think there have been a number of studies from Asia and Korea showing that there are patients who do well with lumbar epidural steroid injections, whether it’s interlaminar, transforaminal and when they have central stenosis or foraminal stenosis. But realistically the issue is just knowing that it’s not a predictor of their outcome with mild^®. I think that is the most important thing. Whether the answer is that patients should have one or six or whatever, at the end of the day, I think when they stop responding to epidurals that someone else is doing, it doesn’t help for the provider, physician, who’s seeing them now to say, “well, let me just do one more because that person might not have done a good job”. The reality is at that point, I think the person who’s had epidurals done and no longer getting efficacy, that’s the time to move forward. Now someone comes in and their back’s pretty messed up and they have pretty significant stenosis, I’m going to also be realistic with them about saying, you know, even something like mild^®, if you have really severe stenosis may not be a home run, like they’re going to be running a marathon after, but for someone who may not be a candidate for a more invasive procedure like a wide-open surgical procedure that my partner might be doing, it still might be a great option for them. So, I think the reality is there’s probably not a said answer, but I would say that whether it’s one or six, no matter how many epidurals they’ve had, I don’t think that means that they’re going to have a bad response or a great response to mild^®. I think that’s the main thing that is important and probably Jason and I could agree with, which is probably going to be a difficult thing for us to counterpoint on.

Moderator Timothy Deer, MD (10:05)
Wow, so far, we don’t have a great vote yet because you guys are being too nice and agreeing with each other. So, Jason I’m going to try to shake things up a bit in the rebuttal. You know, I had a patient today come into the office and she’s a very intelligent person and she had been walking every day and is very fit for her age, about 70, but she looked much younger, and she had a large ligamentum flavum on her MRI, about four millimeters compressing her spine – great candidate for mild^® – and we talked about an epidural. The question is, is it transforaminal or is it interlaminar? We can debate that, but then, the other thing she said is, “why would I go through that? Those don’t work in my condition”. She’d done research herself; she was a PhD before she retired. So, do you need to do an epidural at all? You know, we know that for radiculitis it works but for stenosis the data is certainly mixed. Do you need to do an epidural at all? And if so, why?

Jason E. Pope, MD (10:58)
You know, that’s a good question. I think when we approach the spine, we have to be mindful that we are performing a procedure. And, so the question is, is an epidural safer inherently than a mild^® procedure when we look at enduring outcomes? I would say I always will do an epidural injection first. Looking at the data, this randomized study that I was describing from 2017, if people are going to get relief, they’re going to within the first six weeks. So, you’re not sacrificing a tremendous amount of time doing a 60 second procedure for someone that could give them an enduring outcome. If we do the injection and again after the six-week mark, they’re not getting any better, I very quickly move to a minimally invasive decompressive strategy with a percutaneous decompression and outcomes are very good, especially with the candidate that you described. When we think about safety associated with the mild^® procedure, we’re actually posterior to the epidural space, we’re debulking a ligament; I still approach it very similarly with other neuraxial procedures. All that being said, I would typically do a 60 second treatment to see if there is an enduring outcome before I proceed with mild^®.

Moderator Timothy Deer, MD (12:14)
Dawood, you get the last question of the session…

Moderator Dawood Sayed, MD (12:16)
I think this question is kind of hard to answer but I was going to ask Jackie… I think you guys both seem to agree that mild^® should be done after epidurals stop working. So, in your practice, what’s the definition of an epidural working or not working?

Jackie Weisbein, DO (12:32)
Let me just say this to the point that Jason just made… I agree that if something like an epidural would help, but I think the reality is, I look at some of the insurance guidelines, right? If patients can get a certain number through Medicare, for example, in my MAC locality, a certain number of epidurals in a certain amount of time and they’re not actually able to get the relief sustained to meet the next benchmark of their insurance coverage, for me, that would be an unsuccessful procedure. But realistically, when we talk about the safety of mild^®, considering the safety profile of mild^® from the MiDAS ENCORE Study, demonstrates the similar efficacy to epidural. I don’t necessarily think that the patient coming in would be someone to be like, “oh, let’s just try an epidural first” if they’ve already done their research and they’re ready to move forward. Similarly, someone comes in and they’re interested in a procedure, I think having an educated discussion with that patient and explaining to them the risks and benefits and with a similar risk, benefit profile to an epidural, I don’t think that offering a patient mild^® sooner rather than later is something negative. So, Dawood, in a perfect world, I think the reality is we don’t have strict guidelines of how much steroid someone should get over the course of the year and we have more guidelines about how many procedures they can have, according to their insurance, and that unfortunately dictates our medical decision making, sometimes more often than not. Realistically, I think what percent efficacy is a patient going to get from an epidural, not necessarily duration because if they only got 40% efficacy for eight months, is that successful? I don’t know because, it’s such a unique thing. I don’t think there’s a clear benchmark for me. I think 80% really, for six months, I would say is a home run – for me, but that might not be enough success for another patient.

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