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In December 2023, Jim from Mentor, OH, was suffering pain related to lumbar spinal stenosis (LSS). At the time, Jim’s mobility was limited. “Standing was minimal,” Jim recalls. “I could hardly walk.” 

Recommending the mild® Procedure for LSS with Neurogenic Claudication 

To address Jim’s pain and mobility challenges, Dr. Hassan Aboumerhi with UH Hospitals recommended the mild® Procedure. 

According to Jim, Dr. Aboumerhi described the procedure as simple and similar to receiving an epidural steroid injection. Jim confirms that the procedure was short. “The mild® Procedure was perfect for me,” he says. 

In the immediate aftermath of the procedure, he noticed an improvement in his symptoms: “Every day after that for about two weeks, the pain was less and less.” 

Jim’s mild® Outcome: Improved Mobility and Functionality 

Jim’s recovery time after mild® was brief. By 2 weeks post-procedure, Jim says, “I was walking. I was standing. I was pain-free.” 

Today, Jim reports that he’s “back to normal,” feeling fine, and can walk and stand with “no problems at all.” 

Jim encourages his fellow LSS patients to “absolutely […] not be afraid to have it done.”  

“If you ever want to be able to tie your shoes again,” he says, “I’d suggest the mild® Procedure.” 

Interested in speaking to a doctor who performs the mild® Procedure for spinal stenosis? Check out our mild® physician finder to locate a healthcare provider near you! 

Watch Jim’s Story 

mild® Procedure Patient Testimonial Transcript: Jim from Mentor, OH 

Hi, my name is Jim and I had the mild® Procedure done by Dr. Aboumerhi.

Standing was minimal, walking, I could hardly walk anywhere. Across the room was tough because you couldn’t lift your leg. It was hard to even put your leg down onto the ground. So it was tough, so that was all minimal. And the mild® Procedure was perfect for me. I mean, we were done in half hour, 45 minutes. And I would say about two weeks later, like Dr. Aboumerhi told me, I was fine, I was walking, I was standing, and I’ll say pain free.

Absolutely do not be afraid of having it done. It’s absolutely like the name says—mild, simple. Go in and out. It was good. It was done. And I’m feeling fine.

Listen to More Patient Stories Find a mild® Doctor

Disclaimer – Patient stories reflect the results experienced by individuals who have undergone the mild® Procedure. Patients are not compensated for their testimonial. 

The mild® Procedure is intended to treat lumbar spinal stenosis (LSS) caused by ligamentum flavum hypertrophy. Although patients may experience relief from the procedure, individual results may vary. Individuals may have symptoms persist or evolve or other conditions that require ongoing medication or additional treatments. 

Please consult with your doctor to determine if this procedure is right for you. 

Overview

At the American Society of Pain and Neuroscience (ASPN) Annual Conference in Miami, FL in July 2024, we were pleased to host a symposium with a panel of leading interventional pain management (IPM) providers from around the nation.

The panelists explored how they are elevating their practices with mild® and shared practical insights on how to:

  • integrate mild® into care pathways and busy OR schedules.
  • collaborate with surgeons and APPs to identify patients.
  • build new bridges to referring specialties.
  • become the go-to provider for all pain interventional care.

For more information on how mild® is elevating IPM practices and patients, visit ELEVATEwithmild.com.

Watch the Symposium

Chapter 1 – Intro & the mild® Procedure

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(00:00) I’m Dr. David Dickerson. I’m an anesthesiologist and pain specialist in Chicago. I’m here with some esteemed colleagues that’ll introduce themselves. But first we’re going to click over and as we talk about the new era for interventional pain management. We’re going to talk about these specific objectives today. I think we’ll accomplish these, specifically we’re going to look at how we bridge this gap between our beloved epidural steroid injections for treating spinal stenosis and the mild® Procedure, and really how in many practices now we’re seeing that the role of epidural steroid injections and the efficacy of those is something that we can talk about because we have something to offer when it’s not working.

(00:47) We’re going to talk about how you integrate this procedure, this treatment, into your busy practice and how it enhances and elevates the work that you’re already doing. Now, these patients are already there and we’re going to talk about how you bring the patients in from your community that aren’t already there, and how we do that with both our surgical partners and our non-surgical partners that currently have forgotten about these patients or perhaps aren’t aware that there are treatments to change the symptoms these patients have. We’re going to want to really have everyone leave here excited to be involved in this pipeline in delivering this care, this evidence-based treatment. And what do I mean, excited? I mean willing to recognize that a mild® clinician or a mild®-aware clinician is able to grant access to patients that needs something that’s not just about movement, mobility and relief, but also can drive things like their brain health through better socialization and more steps.

(01:47) So what we’re talking about downstream of this, while we’re talking about better walking, better relief, what that amounts to is effectively dementia risk for many patients when we look at the data around the importance of socialization and steps. So if that doesn’t get us all interested as people who, if we’re all lucky enough will be aged, we need to normalize this therapy as soon as possible. Otherwise, it’s not going to be something that’s around for us when we’re looking to keep going. So my colleagues are going to introduce themselves, and I can promise you based on the conversations leading here, this will be a very valuable part of your day. And if it’s not, come find me afterwards because I want to be held accountable for that as the moderator.

(02:32) Hello, good afternoon. My name is Zohra Hussaini. I am a nurse practitioner working in Kansas City at the University of Kansas Health System, and I’ve been there for a little over 10 years. Hi everyone. I’m Rebecca Sanders. I’m her neighbor to the south in Joplin, Missouri. I’m a hospital employee, but anesthesia, interventional pain is my background. And I’m Dr. Peter Pryzbylkowski. I’m anesthesia-boarded interventional spine based in the Philadelphia area. Did my first mild® and fellowship in 2012.

(03:04) Excellent. A lot of experience up here, and I think that that will come through very quickly. But first we want to understand where we’re starting as a group because you’re all a part of this. We’re not here to talk at you. We really want to have some interaction during this talk. So we’re going to do some surveys and we’re going to get a sense of really where our audience is in regards to their amount of exposure to the mild® Procedure. So if you’re not someone who performs the mild® Procedure, answer this as if you’re someone who schedules, refers, evaluates, or is participating in identifying candidates. So on average in a month, how many patients are you recommending for the mild® Procedure? And there’s a QR code, you’ll click that it’ll allow you to put the answer in and we’ll be able to see those right up here.

(4:00) Alright. And it looks like folks are having a couple. And if you’re a provider or a physician that performs these, how many do you do in a month? Alright, we see some heavy hitters in there. Five plus, I mean, and again, part of this is it’s a pipeline. We’re going to refer in, we’re going to select, we’re going to perform the treatment. So there’s going to be some range here, but I’m glad to see that there’s a lot of experience in the room. And so even around your table, while we want you interacting with us, by all means have a little bit of side conversation about–is what they’re saying true? Do you believe that? Is that what you see? It’s a great way to put us to the test. So let’s talk a little bit about why this matters. We’re going to set the stage from an evidence-based standpoint and talk a little bit about first, what is this treatment? Dr. Sanders.

(4:51): All right, I think that’s my cue. Hi everybody. We’re going to talk about the mild® Procedure. I’m going to go over to some of the basic science, and this is a wonderful procedure that’s changed all of our practices and we really stand on a very solid foundation of evidence. And I’ll review that a little bit today with you guys. Oh, thank you.

(05:11) Alright, so you’re all here because you probably see neurogenic claudication in your clinics on a daily basis. These patients typically are on the older side. So if you look at this 60-year-old population and older 20% of them are actually going to have neurogenic claudication, and a lot of times they’ll present to our clinic with back pain. And when you start to talk to ’em, you’ll realize, oh, this patient has really changed how they live and it’s actually their stenosis. We might see arthritic changes in their spine for sure, but it all started with that stenosis, they’re sitting more, they’re not able to walk as much, they’re not going on trips because they’re afraid they’re going to have to walk and there might not be a bench. So very, very common problem. And the studies show that when you see stenosis on an MRI, more than 90% of those patients are going to be symptomatic.

(06:03) So if you think about our diagnostic codes, we have lumbar spinal stenosis with or without neurogenic claudication. So that means with or without symptoms, more than 90% of your patients are going to be symptomatic. And it’s kind of our job to ask them the right questions to see if indeed they are symptomatic and that’s something we can treat. If indeed they have symptoms, a lot of times they’re going to describe some numbness in their back, their buttock or their legs, and that’s going to improve when they sit down. Or a lot of times they will say bending forward like on a shopping cart that will relieve their symptoms. They’re like, oh yeah, I’m always looking for that shopping cart. The reason this procedure works so well is because ligamentum flavum hypertrophy is a huge player in spinal stenosis. A lot of times patients will have multifactorial stenosis, but in 85% of the cases of stenosis, the ligamentum flavum is a large player. That’s why this can be broadly used for a lot of patients with stenosis. So this is for patients who have neurogenic claudication and then their ligament has hypertrophied up to 2.5 millimeters or more.

(07:09) So when we do the mild® Procedure, what we’re doing is we’re debulking the ligament, we’re removing the attachments of where the ligament attaches to the lamina, and that makes it more pliable and that basically will remove that kink where the stenosis occurs. The advantages is it’s a very short outpatient procedure. It has a safety profile that’s equivalent to an epidural steroid injection. So a lot of these patients have already had an epidural. They understand it’s a very low risk procedure. This has actually been proven to have the exact same safety profile as a lumbar epidural steroid injection. It can be performed with local anesthesia and or light sedation. So it’s an excellent option for patients who might not be good surgical candidates and are not good candidates for general anesthesia. Very light sedation is all that’s needed. You don’t have any suturing or anything that you need more than just a small incision the size of a baby aspirin.

(08:06)* Let’s talk a little bit about the evidence. So one of my favorite things about the mild® Procedure, why I used it so readily as a new pain physician was the level of evidence. So there’s actually Level 1A guideline evidence for the mild® Procedure. There’s now three randomized control trials with long-term data to support the use of the mild® as both a functional and pain improvement procedure that is also durable. So we’re seeing studies that are now out to three years actually showing both ODI improvement that are pretty dramatic improvements in ODI as well as standing time, walking time. And of course VAS pain scores have improved as well.

*Speaker comments; please review publications/references for accuracy.

(08:50) Lastly, there’s five-year durability data. So a common question patients ask us is, doctor, how long is this epidural going to last? How often am I going to have to have this? And so a lot of times they’ll say, how often am I going to have to have the mild® Procedure? Well, I love telling them that we now have five-year durability data saying that the vast majority, over 80% of these patients have avoided surgery. So that’s very attractive to say this is not only short-term fix, but we’re actually going to where the root of the problem is and fixing that problem.

 

References:

(06:27) 1. Jain S, Deer TR, Sayed D, et al. Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety. Pain Manag. 2020;10(5). https://doi.org/10.2217/pmt-2020-0037. Accessed June 1, 2020.

(06:27) 2. Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009;18(5):679-686. doi:10.1007/s00586-009-0919-7.

(07:22) 1. Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009;18(5):679-686. doi:10.1007/s00586-009-0919-7.

(07:22) 2. Benyamin RM, Staats PS, MiDAS ENCORE Investigators. mild® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016;19(4):229-242.

(08:19) 1. Staats PS, Chafin TB, Golvac S, et al. Long-term safety and efficacy of minimally invasive lumbar decompression procedure for the treatment of lumbar spinal stenosis with neurogenic claudication: 2-year results of MiDAS ENCORE. Reg Anesth Pain Med. 2018;43:789-794. doi:10.1097/AAP.0000000000000868.

(08:19) 2. Mekhail N, Costandi S, Nageeb G, Ekladios C, Saied O. The durability of minimally invasive lumbar decompression procedure in patients with symptomatic lumbar spinal stenosis: Long-term follow-up [published online ahead of print, 2021 May 4]. Pain Pract. 2021;10.1111/papr.13020. doi:10.1111/papr.13020

(08:19) 3. Benyamin RM, Staats PS, MiDAS ENCORE Investigators. mild® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016;19(4):229-242.

(08:34) 1. Benyamin RM, Staats PS, MiDAS ENCORE Investigators. mild® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016;19(4):229-242.

(08:34) 2. Mekhail N, Costandi S, Abraham B, Samuel SW. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract. 2012;12(6):417-425. doi:10.1111/j.1533-2500.2012.00565.x.

(08:34) 3. Mekhail N, Costandi S, Nageeb G, Ekladios C, Saied O. The durability of minimally invasive lumbar decompression procedure in patients with symptomatic lumbar spinal stenosis: Long-term follow-up [published online ahead of print, 2021 May 4]. Pain Pract. 2021;10.1111/papr.13020. doi:10.1111/papr.13020

Chapter 2 – Bridging the Gap Between ESIs and Surgery

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(00:00) Once again, my name is Peter Pryzbylkowski. I’m an interventional spine doctor in Philadelphia. I’ve been doing the mild® since 2012. When I came back to market 2017, 2018, I got heavily involved. Again, I deal with an elderly patient population. I’m at the Jersey Shore. I have patients who live in Florida for six months, come back up to see me for six months. And what I found is a lot of my older patients Medicare beneficiaries were getting in a rut where they were just wanting epidural after epidural after epidural. So I’ll go over some things later on in the presentation to how I’ve really introduced mild® to that patient population to kind of get you out of the rut of just doing repeated serial epidurals on Medicare beneficiaries. One of the things that has helped, if you aren’t already aware, is CMS only allows you to do an epidural once every 90 days now.

(00:49) So some of these patients come in, maybe they’re again, epidurals in the 90’s, early 2000’s, they would get a series of three. I tell them now the series of three is gone. We have to think about other options now to treat your spinal stenosis. And I’m going to go out on a limb here and say, no one’s curing spinal stenosis with a lumbar epidural steroid injection. This is one of the few procedures we have in interventional spine where you can fix one of the root causes of spinal stenosis. Not many things we have in our field can fix a pain generator. This is one of ’em. We’re very good at putting Band-Aids on things. So this is one of the more durable procedures I do for my patient population. So we’re going to kind of go over here some evidence we have in terms of just epidural steroid injections. How many are you doing in your practice typically for lumbar spinal stenosis with neurogenic claudication, once again, have a QR code up there. If you scan it, we’ll be able to look live, see what some of these numbers are.

(01:47) So I say for my own practice I do in-office epidurals every other Friday, I do about 30 lumbar epidural steroid injections every other Friday in the office under local. So it’s a decent amount. I have a large Medicare patient population, so we can see the numbers here. They’re pretty high over 15, about 60% over 15. So it’s a lot. So this is where we can make some headway with the conference today. And our panel presentation is how do you change going from serial repeated epidurals to explaining to the patient you have a therapy available to you that’s as safe as an epidural steroid injection that requires no suturing and is truly minimally invasive without burning any bridges. So we see a lot of the newer things on market. You have large posterior constructs that are put in between spinous processes. That’s not this procedure, right? My opinion is you need to jump through a mild® before you do a posterior fusion device. Why? This is a lot easier procedure to do prior to putting a posterior fusion device in. So you want to make it look easy, make it look simple. So that’s why you want to do the most conservative thing first and work your way up that algorithm for treating spinal stenosis patients.

(03:02) So how many of you find serial epidurals for stenosis patients with neurogenic claudication to be effective? Sometimes I’d agree it does provide benefit, but the benefit tends to be transient. The question I get asked repeatedly in my office is, how long is this going to help me? And I’m honest, I say everyone’s different. I don’t have a magic crystal ball. You might have relief for a few weeks, a month, maybe two or three months, but on average, I’d say stenosis patients, when we do a lumbar epidural steroid injection or maybe getting four to six weeks of relief, they come back into the office, they want another injection. I say, Medicare’s not going to approve another injection. We have to wait 90 days from your last epidural to do another epidural. Why not think about fixing the root cause for your stenosis with a procedure? Then the next question I get asked is, I don’t want surgery on my back. So you have to explain to the patient, this is not surgery on their spine. It’s an outpatient minimally invasive procedure, same day procedure, minimal sedation you could do under local like Dr. Sanders said with a small Band-Aid you put on the back before they leave.

(04:11) So we have some data here. Just going over epidural steroid injections. So we had a couple clinics I was involved with one of them. And does the use of multiple epidural steroid injections prior to the minimally invasive lumbar decompression, does it affect outcomes? Long-term, meaning if you do one epidural versus five epidurals prior to a mild®, is there any difference in terms of the VAS score after a mild® Procedure? And what we found was that there is no difference. It doesn’t matter if you do one, do zero, do multiple, five or more, the outcomes are still there for this procedure. Patients will be able to stand and walk longer than they can prior to doing a mild® Procedure, which is great. So we encourage physicians who do epidurals to think about this sooner in your algorithm, try to get out of the rut of doing repeated epidurals. I can tell you I’ve had to really train my APPs to get out of the rut of just ordering the same procedure over and over again. We know what the benefit of that procedure is, and it’s not long lasting to think about this more sooner in the algorithm.

(05:19) So this is a chart I do like to show my patients in the office. So obviously we do conservative care therapies first, physical therapy, chiropractic care, acupuncture, plus or minus conservative care with medications, they tend to not work as we know for stenosis patients. So then we’re heading towards an epidural. What’s next after an epidural? So I set my patients up from the first visit with me so they know what step A, step B, step C is. Why is that important? If you do an epidural and that patient does not have any relief whatsoever, you don’t want to lose that patient. So they need to know that you have a game plan in place as an interventional spine doctor to treat stenosis. So I go over step A, step B, step C, and let me tell you, you look like a hero when you say we’ll do an epidural, it’s going to help you for a few weeks and the pain’s going to come back.

(06:09) Then you have someone who’s engaged and wants to listen to you about the next steps in care to treat their stenosis. Most patients, almost all my patients want to avoid the major open operations. Even patients that need a decompressive laminectomy, when I look at their MRI, they have severe stenosis. They can’t walk one city block. They still do not want a laminectomy. They want whatever option you have, doc, I trust you, I believe in you. Whatever you can do for me to help with these symptoms, please do it. And then if patients do go on to these more invasive procedures, they know they’ve done everything they can with an interventional spine doctor before they got into the OR with a scalpel to the back.

(06:53) That’s great. I want to build a little bit on this practical experience. I think that all of us have put this into our ecosystem, and like I said, it really has elevated what we’re offering our patients and it really differentiates our practice from peer practices in the communities. Building a little bit on what you said, Dr. Pryzbylkowski, you mentioned sort of the talk track you have, how’s your practice set up in order to really support that process? Doing a whole lot of stuff and patients are coming and going. It sounds like you have a really big first meeting, but what’s the setup that then happens as people are having the care that you described?

(07:30) Yeah, so good question. So definitely tell them step A, B and C at the consult. Anyone that’s a Medicare beneficiary who I do an epidural steroid injection on when they’re checking out of my office, they get a pamphlet. Vertos has a really nice index card with a QR code on it and it says, injection stop working, think about mild®. So I give that to everyone 65 and older who I do a lumbar epidural steroid injection on in the office, not at the ASC, but in the office. I do most of my lumbar epidurals in the office under local. So that just reiterates that if you don’t have durable benefit from what I just did for you two, three minutes ago, this would be the next option. So they scan the QR code, they learn more about the procedure when they come back into the office, you’re already discussing this as the next step in care. If the epidural you did, which more likely than not, did not provide any long-term benefit,

(08:22) That’s great. I think that’s such a practical tool. Patients need to hold onto something and tell ’em, put it on your fridge, give it to a family member, don’t lose it. But if you lose it, we got more. We actually do the same, but we have ’em take the picture of it so that they can walk with that. And the packets are great. Also, the people in the Vertos packets I will say, look very, very happy. So I sometimes make light of that. I say, I don’t know if you’re much of a dancer, but this procedure might get you back on the dance floor because on the front cover of one of the packets is people doing things that I can’t do well even without stenosis, Dr. Sanders. So tell me a little bit about when we were talking getting ready for this, you had mentioned that there are instances where you might go straight to mild® and not doing epidural surgery. Can you tell me about that sort of patient-centered approach you’ve developed? Right.

(09:13) I never thought of myself as an aggressive person, but I’m like this person that’s like sometimes just don’t even do an epidural. I feel like I’m aggressive. And some of that’s because I think we see our patients and literally I had a guy I did three years ago and he brought back his new girlfriend. He wants me to do the same procedure for her. So we see these great results and I think it gets us excited about this procedure and it gives us satisfaction as a physician. So with that foundation of these good results, sometimes she’ll have patients in your office that they’ve had a stroke, maybe they’ve had a heart attack, maybe they have peripheral vascular disease, maybe they have all three and they really need their anticoagulant. And to me, I mean we’re somewhat putting them at a risk if three times a year, year after a year we’re stopping their anticoagulants.

(10:01) And if I have the alternative of the mild® Procedure and I say, let’s stop your anticoagulant one time, let’s do this procedure and then you might not need more invasive treatments. I think we’ve done them a tremendous service. I think we sometimes forget how important it’s to treat neurogenic claudication from the standpoint of longevity for these patients, like you said, their mental health and their cardiovascular health. So if I see a clear diagnosis of neurogenic claudication, when you start to measure these ligaments, you’re going to see, wow, this is 6, 8, 10 millimeters. You’re seeing some very large ligaments. And like you said, if we go to the problem and we treat it, we feel like we’ve actually fixed something long-term for these people.

(10:41) So I’ll throw this out based on Dr. Pryzbylkowski’s data, that epidurals are a delay of game to real outcomes. Could the best epidural you ever do for spinal stenosis be one that also has a mild® with it? For the first one. That’s your favorite way to do it. That’s why, and that’s what I’ll a shared conversation with the patient, of course. So a lot of times I’ll say we can start with an epidural. That would be the least invasive thing to do. Or we can do a mild® Procedure and we could even do the epidural at the time of the procedure. And a lot of times when you present that safety profile as the equivalent to an epidural, I think patients are very excited about it.

(11:16) We’re going to get back to that a little bit later when we talk about long-term outcomes with this procedure and really circle back on is this the end of epidurals or not or is it the way to make epidurals work better than they ever have? And I think as I look around the audience, I’ve had a lot of conversations with folks that this doesn’t kill epidurals, but as we get to long-term outcome data, we’ll talk a little bit about life after mild®. Zohra, a couple of questions for you. I think in my practice, my PAs and nurse practitioners really are this missing link in terms of making sure that the patient moves from that great talk track and planning stage to actually delivering the care. Can you talk a little bit about how you interact and follow up with the patients that are receiving epidural steroid injections for spinal stenosis and how you chat through those next steps versus really pivoting towards it doesn’t sound like we’re meeting your needs and what that conversation looks like.

(12:09) Sure. So I mean obviously I think a lot of practices apps are really doing the follow-up to procedures, assessing patients for procedures. And that’s really key to understand how you’re going to progress to the next step with whatever your physician and collaborative is doing. So it’s important to understand when is the patient exhausted in what you’re offering or you come on as an APP and you’re seeing a patient that the physician has seen for many years and maybe has gone through multiple treatments with epidurals. At what point do you have a discussion that says, okay, maybe there’s other things we can offer for you. We have other tools. Is this really working? And I think the key thing for me when I’m assessing a patient is really understanding what their goals are. What are we trying to accomplish for you? If you’re just looking at the pain score, that pain score may never change, but their function might be better even though you’ve tried a treatment and they come and they say, well, I’m still at a 10, but I’m walking to the mailbox or I’m able to play with my kids.

(13:06) So I try to establish what are your goals? What are you here for and what are you trying to accomplish? And then that helps me know, well, here’s what this treatment can do, here’s what this treatment is not going to do for you. And be able to then elicit that pathway to say this is an option. We can start with epidurals being one of them, but if this is not working well for you, if you’re not reaching those goals, if you’re not able to come off your pain medications as you would like to or increase that functionality, there are other things that we might be able to do to supplement that that don’t require the same three month step process that might actually not even be working for three months. But again, it’s identifying to the patient that there are things available so they don’t feel like they give up and not come back because you didn’t give them another option that they think that they could have. So I think that’s one aspect that can help.

(13:55) That’s great. It’s really nice to see the variance and practice, but also there’s a lot of similarities between the way we’re building our ecosystems to deliver this.

References:

(04:20) 1.Pryzbylkowski, Pain Manag., 2021.

(04:42) 1. Pryzbylkowski P, Bux A, Chandwani K, et al. Minimally invasive direct decompression for lumbar spinal stenosis: impact of multiple prior epidural steroid injections [published online ahead of print, 2021 Aug 4]. Pain Manag. 2021;10.2217/pmt-2021-0056. doi:10.2217/pmt-2021-0056

(05:21) 1. Deer TR, Grider JS, Pope JE, et al. The MIST Guidelines: the Lumbar Spinal Stenosis Consensus Group guidelines for minimally invasive spine treatment. Pain Pract. 2019;19(3)250-274. doi:10.1111/papr.12744.

Chapter 3 – How to Empower Your Team to Integrate mild® Into the Practice

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(00:00) So we’re going to talk about bringing the patients in that maybe aren’t in our practice and how we are going to bring this into our team-based approach. And one of the elephants in the room is, a lot of us are, people talk about practicing at top of license. What’s that look like for interventional spine specialists? It means we were in the procedure suite as much as we can be while still making sure that everything is running the way as if we were in all of the rooms doing the exams, doing the talk tracks. Sometimes he’s even better by having other people there doing it who maybe have those softer skills. How much of your time are you spending in the procedure room?

(00:37) So I’d say I spend 60 to 70% of my time in the procedure room. But like you said, it’s about getting your APPs, knowing what your talk track is, knowing what your algorithm is. And that might be difficult. I’m going to practice with 12 other pain doctors who don’t all think and act the same way I do. So I give kudos to my APPs because if they’re seeing one of my patients versus one of my colleagues, the talk tracks might be different. And it’s a lot for them to keep in their head of what is the doctor that this is the patient of willing to do and not willing to do.

(01:10) So, let’s drill down on that because clearly you and I and Rebecca are not the people we’ll be talking about this. Will you talk a little bit about APP education for us? Because I think APP preparation education makes that 60 to 70% not a disaster makes it a success. And so tell us a little bit about how we can educate our APPs.

(01:28) Yeah, absolutely. I mean, I think education is a passion of mine. When I started the practice, we are not well-trained in pain management to begin with as APPs. Obviously we have limited training and we don’t have fellowship in pain and we don’t get much pain management education under the belt training. So what does empowerment mean when you ask how can you empower a team member or an APP? It’s support, right? It’s support. It’s providing tools, it’s being there to help grow that individual, to train them in a way that fits and aligns with the way you practice and sharing that philosophy of how you work. So the training is really key. So do you offer educational videos, are you providing them access to conferences or networking opportunities with other peers or with yourself in a way that the APP can learn what it is they need to understand to identify the patient?

(02:27) Are they watching you do the procedure? Can you show them how to do the procedure in the way that they see it? Not for the APP to do it, but to at least identify an understanding of how to talk to the patient about what to expect with the procedure. Because if I can’t help the patient understand that it’s not a major surgical spinal procedure, they may never agree to go to the next step. And if I’ve never seen it be done and I don’t understand the process of it, I’m not going to be able to educate, help the patient understand post-op or expectations in any way. So being able to empower someone I think all comes down to the support. What tools are you providing? Are you helping that APP learn how to read an MRI enough to get the idea of whether they’re going to be a candidate in the first place to then refer to the physician to say, Hey, I want you to further look at this patient. I think they’re a candidate. And all of these are essential to be able to work collaboratively and effectively with someone in your team, whether it’s your APP, the nurse or another physician colleague. I think you have to really be able to support each other in that way.

(03:29) That’s great. And Vertos has a lot of opportunities to create those bridges as well. So if you’re not as creative as Zohra, then please reach out to the Vertos team because there are a lot of opportunities to bring durable education opportunities to the team and then also to the care environment.

Chapter 4 – Collaborate with Surgeons and APPs to Identify Patients

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(00:00) Yeah, so the initial talk track with me four or five years ago with the spine friend, so I’m good friends with I golf with these guys, is give me your patient that has AFib, has a COP date, has all these comorbid conditions you don’t want to operate on anyway. They might need a laminectomy, but you don’t know if they’re going to get off the table. So I worked my way up from the sickest patients now to healthy patients who they’ll to me now they know a laminectomy is a big procedure, so it takes time. It’s that initial explanation of what you’re doing is not burning bridges for them. I’m not putting in an implant that they have to remove, that there’s going to be evidence that I did something in the spine. When you see these patients back three months and you look at their scar, it’s barely visible.

(00:52) It’s the size of a baby aspirin like Rebecca said. So the talk track was different at first. I’m not burning any bridges. Give me your sickest patients talk track is different now. So all the patients that did well who are sick, I fax all my results back to my referring colleagues. I’m a big believer in the more times they see my name on their desk, even when they’re on Facebook or social media, I like all their posts. They know I’m thinking in the back of their head if Oh, I’m going to send a patient to Pryz, man, I’m going to send a patient to Pryz. I keep seeing his name on my desk all the time and the patients are doing well. So in big believer, when you have good outcomes, you got to send ’em back to your referral source, know whoever it is, chiropractor, family doctor, spine surgeon. So the talking tracks gotten easier where now I have colleagues of mine who are now on board, but I’m not going to lie, when I first started doing these heavily again in 2017, 2018, I was worried about burning bridges because these are the guys who are referring me on my stim trials and implants. So it took some time, but it does get better once you show them the outcome and you’re not really burning any bridges for ’em.

(01:56) Absolutely. I think that’s a great answer. Great. So I think setting this landscape of this two year data was presented last year by Dr. Staatz as a data release at this meeting. And I remember sitting and listening to it and at first I was like, okay, this is really interesting. And I was a little disappointed. I was like, man, I wanted mild® to just smoke laminectomy. I wanted it to be this thing that all of a sudden all of us that were out there that weren’t saying it, but the elephant in the room is like, is this better than laminectomy? Is it better than laminectomy? Then I thought, man, I would have a hard conversation back at the office if all of a sudden I had this thing that was better than laminectomy that I was because I’ve never said it right. But if the data then brought that, so this non-inferiority data that shows that effectively between patients and the mild® Procedure, which think about that, those are different patients.

(02:49) They had access to a treatment that had no more harms than laminectomy in this large data set of Medicare patients. So that access is a big part of this story that you don’t get when you just look at the table and see that the harms were similar, the re-operations were similar, what happened after mild® versus laminectomy was very similar. It really levels of playing field and it puts us in a position to pick the right treatment for the right patient at the right time. And I think that that’s what this Medicare data shows me. Knowing that a hundred thousand Medicare patients have received this treatment says a lot. It says a ton. It means that in our communities, people receiving these therapies and the interventional spine specialists for the most part haven’t been run out of town with pitchforks and torches, but so it’s happening. It’s happened and it’s been a decade of development here that leads to this data and the Medicare dataset, but I think this is very important.

(03:39) We’ll go to the next slide. And I think that to me disarms this conversation of like, well, what happens when there are studies shows that this is better than laminectomy, we should stop doing laminectomy. What it says is pick the right patient for the right treatment. And that data shows that as we’re doing that we’re actually not inducing more harms and we’re creating access to people that have decompression. I think that’s really great. So we’re going to talk about, I think something that I’m hinting at throughout this talk track, which is interventional pain anxiety with our surgeons. And I think that data helps pacify some events says, look, it’s all about picking the right treatment for our patients. I totally agree with you. The first place that I start is mild® is always an option for patients without other spine surgical options. It’s always an option.

(04:29) Build your practice there, celebrate your wins, show that it works even in those challenging patients that didn’t have another option, I think initially we wanted to say, look, it’s not just for that part of the Venn diagram, it’s for everybody true statement, but how do you actually implement change? And change management can come through comfort, data, relationships and time. And I think that if you lean into that and you build a practice, that anxiety starts to go away because you then start to be able to treat people like one of my spine surgeon’s grandfathers who was a paratrooper and needed a mild® Procedure. And it’s interesting because he actually was a fellow at Rush and wasn’t practicing, but I spoke to him because his dad was a primary care physician. The grandfather was getting the mild® Procedure and they said, would you talk to my son?

(05:16) He’s a spine fellow. I said, absolutely. I talked to him two years later, he’s now working as one of my partners. He’s building a spine practice. It’s very interesting the conversation that we have around this treatment for his grandfather had no other options. And you know what he says? I would be happy to take every patient who still needs something after a mild® Procedure and offer them whatever their spine surgery is that they need. He’s one of the only surgeons in my practice, in our integrated group that has a wide open door that says, I’m not going to send this case for a quality review. I understand the treatment, what it is and what it isn’t. And I am glad to be your first surgical resource because when those patients walk in the door, they leave scheduled for surgery. So maybe the question is finding the right team members that are at a different point in their career that are building that can understand what the mild® Procedure is and isn’t, which is the first step, and I use the important term, understand in my community, I hear a lot of surgeons come back to me and say, I don’t believe in the procedure, is what we do about belief or is about understanding.

(06:21) And that’s where evidence and science set this apart. So while I don’t throw that back in their face and say, I think what you mean to say is you don’t understand the procedure, I go ahead and have a conversation with someone who is ready to understand it. And that’s just important. And that’s about change management as well is let’s not waste our time. We have treatments that we could be doing. And that’s my little pearl for dealing with the anxiety is sometimes don’t provoke it. Find where it’s not happening. Lean in there. Dr. Sanders, you want to talk a little bit about some experience with the surgeon referral-APP dynamic and really how you report back to them with how the patients are doing?

(06:56) Right. I think that’s a great point. So first of all, I think it’s important. We talked a lot about our team model in our office. We just have a kind of almost like an understanding that nerve pain, radicular pain, that’s going to be our first priority. We’re going to treat that first because that’s going to help the patient. And in many ways then we’ll address their mechanical issues thereafter. So that goes from literally my receptionist, to my nurses, to my nurse practitioner. And we all in terms of the providers are looking at imaging. And I think when our surgeons see that we are really doing our due diligence to give patients a true adequate diagnosis. And when I see a surgical lesion or a surgical need, I’m going to be the first to recognize it and refer them to you. I think that gives us a lot of credibility.

(07:48) And then like you said, I mean it’s collaborative. Patients are literally being marketed medical treatments and patients are oftentimes looking for a minimally invasive treatment to their back pain or their urgent claudication. You want to be the center that offers the gamut of treatments and what you’re going to capture. If I do a mild® Procedure, I’m also going to capture their friends who maybe aren’t a candidate for the mild® Procedure and they’re going to ask me for it. I’m going to review their imaging and I’m going to give them to the surgeon. So really you’re going to be building adequate spinal care in your community and that’s everybody wins in that case.

(08:32) Zohra, I think that you’ve described for me how bridges that you build to surgeon’s offices with their APPs have been a untapped resource to really socialize and normalize what we’re talking about here. Can you talk a little bit about some of the success there?

(08:47) Sure. I’ll share actually an example of opportunity that we had where one of our past fellows, we’ve had multiple fellows come through our program over the years, went on to his own practice and in their community, I believe there was like seven miles done per year by a particular person that was trained in it. So obviously compared to Dr P. over here, that’s like nothing but over the course of the development of this particular provider within that institution, and he was trained in mild®, brought that to the facility, majority of the conflict was the surgical team that they were working with who it was a little bit of a, can we do this and are we burning bridges? Are we building them? And they had a very large practice of APPs who in the surgical area would assess their patients and then move them onto the surgical schedule.

(09:44) But a lot of these patients weren’t candidates for surgery and they started to reach out to the pain team and said, Hey, we can’t do surgery on this patient. Can you guys at least offer some pain management, some injections or whatever you guys do. So there was a very large gap, or not a connective, cohesive relationship of what the pain docs could do and what the surgeons didn’t understand were available. And so I was actually asked to come out and have a conversation with that team of APPs in the surgical area because all of those referrals to pain management were coming from the physicians on the surgical side and their colleagues in the APP world to where are we going to send them. So sometimes they weren’t sent anywhere and they’re like, sorry, you’ve got a bad spine, there’s not a surgical option and there’s not much else we can do.

(10:31) And so we were able to work together to say, if that’s the case where you are not wanting to operate, what is it that we on this site can do? And we work in the same facility, let’s collaborate. So physician to APP dynamic is one where we build that capacity to learn and grow and be efficient. But APP to APP collaboration is key as well. So I might learn or be able to connect to another APP in a practice better than I can to a physician. Our physicians might be able to connect to the physicians better than an APP, but who’s assessing and who’s referring. And if you can kind of create that pathway, it really helps to build the bridge and make those opportunities available.

References:

(03:01) Staats P, Dorsi M, Reece D, Strand N, Poree L, Hagedorn J, Percutaneous image-guided lumbar decompression and outpatient laminectomy for the treatment of lumbar spinal stenosis: a 2-year Medicare claims benchmark study, Interventional Pain Medicine, Volume 3, Issue 2, 2024, 100412, ISSN 2772-5944, https://doi.org/10.1016/j.inpm.2024.100412.

Chapter 5 – Building Bridges To Referring Specialties

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(00:00) Bridge building. This is one of my favorite things to talk about with mild®. And let’s see who can be creative. What are, give me one or two referring specialties that have been surprising sources that aren’t surgeons or aren’t spine surgeons.

(00:22) So for me it’s been chiropractors. I’ve had a lot of chiropractors in my area take interest in this and want me to actually educate them on this procedure, which was profound to me. I mean, I come from academics. I never worked with chiropractors until I went to private practice seven years ago, but they’re a large referral source for me now. And the more I can explain the different types of things I do that just aren’t facet blocks and epidurals, the more engaged they’ve been. So that’s been a huge win-win for me.

(00:50) That’s great. Rebecca? Good one. Good. I’m sorry I already gave you the mailman. I think word of mouth. I mean I think of all the procedures I do, this is the one that patients come in the most just asking me for this procedure by name. So I think like you said these, I mean I have been so surprised how much we help people’s mental health because they’re able to do more. They’re traveling. Someone told me last week I was able to go to Alaska because of this. Thank you. So I think people like to talk about it. So I would say word of mouth,

(01:22) I would have to agree with patients themselves. We actually leave the pamphlets and the booklets out in the clinical area. So when patients are waiting for their half hour sometimes to BC that they’ve got some resources to look at and not everyone’s a candidate. So you have to take caution and not telling patients about things that’s not for them. But having that there and having the patient advocate to go to their colleagues or their physicians that they’re seeing and say, Hey, I heard about this. Can you offer this? And sometimes that’s what comes to us, whether it’s by a surgeon or another doctor or somewhere that they heard by a friend that had it that, Hey, I heard about this option, can I do that? So I think that goes a long way even when patients themselves have knowledge about it.

(02:05) That’s great. So you mentioned these patients that the surgeons decide were too sick and they can’t have it and they just go somewhere. Well, I found where one of those places is they’re too sick because they usually have cardiopulmonary disease. So I go to my pulmonologist, I go to my cardiologist because what they’re tracking on is walking tolerance testing for a lot of these patients and they’re not doing it in the office, but that’s what they ask. And these patients can’t do cardiac rehab. So I went to the cardiac rehab PTs as well and I said, what do people complain about when they don’t have dyspnea but they can’t walk and it’s claudication, but they’re not candidates for spine surgery. What are you talking about? And that’s been a massive referral source for me being able to take those patients and knowing also that I’m not going into the epidural space.

(02:45) Those patients, I’m not doing this on blood thinners, but I keep them on their baby aspirin. I still perform the procedure less than a hundred milligrams. And they say, wait, they can stay on the baby aspirin. That’s not something that’s happening in the rest of the decompression world. It shouldn’t happen. And so I throw that out as those are my two. And then those patients tell all their other friends that have orthopnea and dyspnea about me. Go to the next slide.

Chapter 6 – Become the Go-to Provider for All Interventional Pain Care

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(00:00) So the go-to provider for interventional pain care, that’s the goal here. This is something that is like that center of excellence, that plaque on the wall, we do mild® here. And what does that tell you about these practices? Well, it tells you they think differently and that perhaps they’ve, they’re willing to make mobility matter above lots of other things that we’re thinking about on a daily basis.

(00:28) So we’re going to talk a little bit about how this word of mouth concept and differentiation, and I’m just going to throw out one idea that as I went and talked to my surgical colleagues about nonsurgical back pain with all the data that came out around spinal cord stimulation, they said, great, now you’re going to be doing stim for all these patients who need spine surgery. And we went over those studies and what I said was, we’re not talking about the super sick patients that do have spinal pathology. Those are the patients I want to offer a mild® for. So while I’m talking about nonsurgical back pain stim, and they’re like, wow, you think about things really differently. Maybe you aren’t trying to take my business. Maybe you’re trying to take care of the patients that I can’t help and my team can’t help. So to me, that was the biggest differentiator.

(01:09) And it’s really great to see that things that don’t seem related are actually a part of the same conversation around advancing and advanced procedures. So I use nonsurgical back pain as a great way for me to build the world of mouth amongst the surgeons that I still want to win over because they are my partners and they do great work. They do great work to help many of our patients. And when I trained, you wouldn’t do half the stuff we would do without knowing that surgeon was going to back you up and speak highly of the care you delivered. We can’t let go of that. It is a team. So what would you say, Pryz, in terms of the differentiating factors and how you preserve that or deliver it?

(01:46) Yeah, I mean it’s meeting with these physicians. It’s having the one-to-one dinners with them. It’s building the relationships. And like Rebecca said earlier, when you see a surgical candidate, don’t pretend to do something that you think is going to help when it’s not. So get ’em in front of the provider. I like to text the surgeon I work with all the time, a picture of the MRI and the demographics and say, here you go. And it goes both ways. When they see people, they can’t help. They’re referring to me when I see people, when I know it’s surgical right away, I’m referring back to them.

(02:18) Love that. Clear boundaries and also speaking out loud things that maybe they don’t know as part of your process. Just getting that out there. Dr. Sanders.

(02:30) So very similar to what you said when it comes to seeing these patients, our goal is to get the adequate diagnosis. And I’m always, I’m very honest with my patients. I like to show ’em their MRI and sometimes a trick is to have ’em come here, stand up and look at your MRI and then go see if they’re looking for their chair to sit back down. And I’ll show them and I’ll say, you have a lot of things causing your stenosis. I’m not going to fix all of that. I’m not going to necessarily make your MRI look pretty, but my goal is to make you more functional and it’s going to happen in a very minimally invasive way where the risks are small. So I don’t promise something, I don’t promise a new MRI. I’m certainly looking for dynamic instability or other things that would maybe exclude the patient.

(03:21) And I think doing that due diligence is what’s going to keep our outcomes looking good. And then I tell patients, this is not a hundred percent success rate. If you look at the studies, it’s 80%, which is phenomenal. I think that is remarkable that we get 80% success rate from such a minimally invasive procedure. But I say if I do five of these on one person, unfortunately it’s not going to work. And that’s why I do the epidural at the same time. So at least they feel better for a little while while we’re getting them to the surgeon.

(03:49) And in terms of practices that have made these leaps, made these developments, Zohra, I’ll ask how are APPs the differentiator in delivering this care?

(04:04) Dr. Sanders mentioned a point about patients looking at their MRI, and it’s funny, and I always give my docs a hard time that my patients said that I was the best care provider because I actually took the time to go over their MRI with them. And it was the first time anybody ever explained to me what was going on. And I think that really, I mean in and of itself helps the individual, the patient to really feel empowered about their care, to understand what the next steps could provide. But it comes down to just, again, empowerment of your team to be able to work at the best of their scope so that you can work as a physician to the best of your capacity, doing the procedures that you need to do and having the right team to be able to help facilitate those patients to come through to you through proper training. Obviously ASPN has an APP track, so I’ll throw that plug out there starting at one o’clock if anybody in the room wants to join to learn about the various new advances in all the different spaces of pain. And so just being there to support them, to advocate, to help them learn so that they can eventually help you learn and get the patients the care that they need.

Meet the Panelists

Headshot Dr David Dickerson David Dickerson, MD is a board-certified physician in Anesthesiology and Pain Medicine. He received his medical degree from the University of Chicago – Pritzker School of Medicine and completed his residency at the University of Chicago Hospitals and a fellowship at the University of California, San Francisco. He currently practices at the NorthShore University Health System in the greater Chicago area.
Headshot Zohra Hussaini Zohra Hussaini, MSN, FNP-BC, MBA is a board-certified family nurse practitioner specializing in pain management at the University of Kansas Pain Clinic in Overland Park, Kansas. She is the lead coordinator of the advanced practice providers in the Interventional Pain Clinic. She serves on the board of her local chapter of the American Association of Nurse Practitioners (AANP) and participates in shared governance in her institution as a member of the Opioid Stewardship Committee and past-Chair and current member of the Advanced Practice Provider Council.
Headshot Dr. Peter Pryzbylkowski Peter Pryzbylkowski, MD currently practices at Relievus Pain Management in Haddon Heights, New Jersey, and is board certified in Anesthesiology and Interventional Pain Medicine. He received his medical degree from UMDNJ – Robert Wood Johnson Medical School. He is fellowship trained and a former resident at the University of Pennsylvania.
Headshot Dr. Rebecca Sanders Rebecca Sanders, MD is board certified in Anesthesiology and Pain Medicine. She earned a medical degree from the University of Arkansas for the Medical Sciences with a residency and fellowship at the Mayo Clinic. She now practices at the Freeman Institute for Pain Management in Joplin, Missouri.

 

Dr. Dickerson, APP Hussaini, Dr. Pryzbylkowski, and Dr. Sanders are paid consultants of Vertos Medical.

The views and opinions expressed in this symposium, videos, and article are those of the speakers and do not necessarily reflect the official policy or position of Vertos Medical.

Overview

The MOTION Study, a prospective multicenter randomized controlled study, was designed to evaluate the safety and effectiveness of the mild® Procedure alongside with conventional medical management (CMM) as a first-line therapy in contrast to patients treated with CMM-Alone.

In July 2024, Sherif Costandi, MD, from the Cleveland Clinic shared new MOTION Study data at the American Society of Pain and Neuroscience (ASPN) Annual Conference in Miami, FL. This update compared the 2-year functional outcomes of the CMM-Alone patients who crossed over to mild® with the mild®+CMM as first line treatment group.

Data on subjective and objective measures demonstrate that improvements in patients who received the mild® Procedure after first receiving CMM for up to 1 year are comparable to those in the first-line therapy group (mild®+CMM).

Overview

The MOTION Study, a prospective multicenter randomized controlled study, was designed to evaluate the safety and effectiveness of the mild® Procedure alongside with conventional medical management (CMM) as a first-line therapy in contrast to patients treated with CMM-Alone.

In July 2024, Sherif Costandi, MD, from the Cleveland Clinic shared new MOTION Study data at the American Society of Pain and Neuroscience (ASPN) Annual Conference in Miami, FL. This update compared the 2-year functional outcomes of the CMM-Alone patients who crossed over to mild® with the mild®+CMM as first line treatment group.

Data on subjective and objective measures demonstrate that improvements in patients receiving the mild® Procedure after first receiving CMM up to 1 year are comparable to those in the first-line therapy group (mild®+CMM).

Dr. Costandi Explores “Two-Year Follow-Up of Crossover Patients Treated with the mild® Procedure”

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Author: Sherif Costandi, MD, Cleveland Clinic 

Abstract - Dr Costandi - Motion Study 2 year follow up of crossover patients treated with the Mild Procedure

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Dr. Costandi Explores “Two-Year Follow-Up of Crossover Patients Treated with the mild® Procedure”

Video Transcript: Dr. Costandi Explores “Two-Year Follow-Up of Crossover Patients Treated with the mild® Procedure”

(00:00) Hello everyone. This is Sherif Costandi. I’m the Pain Medicine Fellowship Director of the Cleveland Clinic. I’m very excited to share with everyone the results of the two years results of the crossover group of MOTION study. Historically, symptomatic spinal stenosis has been treated first with conservative measures that included oral medications, physical therapy, and possible interventions like epidural steroid injections. Those who failed conservative measures were considered for

(00:30) open surgery decompression. With the inception of mild® for the percutaneous image guided lumbar decompression procedure, this algorithm has been challenged and the mild® positioned itself in the middle for those patients who have failed conservative care measures. However, they’re not really candidates for the open surgical decompression or are not willing to proceed for the surgical decompression surgeries. MOTION study is a level one, RCT, multicentric, five year study.

(01:00) The goal of the study was to evaluate mild® as a first line therapy. The design was to randomly assign patients into two cohorts. A group would be receive conservative medical management alone versus another cohort who would receive mild® as a first line therapy, along with conservative medical measures. We had 72 who were enrolled in the mild®,

(01:30) along with CMM versus 76 patients who were enrolled in the CMM alone. After one year, patients were allowed to crossover from the CMM alone and receive the mild®. What we did in this analysis is we looked at the two years outcomes of those patients who crossed over, and then we compared them to the years outcomes of the patients who had mild® with a CMM as a first line therapy. The outcomes that were measured included numeric pain scores.

(02:00) Patient reported measures like as Oswestry Disability Index, Zurich Claudication questionnaire specific to spinal stenosis and walking tolerance test where patients are asked to walk for 15 minutes at their own pace until they either feel hurt or they start to develop some symptoms, they have to stop or they would stop at the 15 minutes. When we looked at the measures, there was no

(02:30) statistical significance between the CMM alone group and the mild®, the patients that received the mild® as a first line therapy. We look at the median improvement of the ODI in the crossover group as 14.3 versus 16.4 in the mild®, along with the CMM. We look at the Zurich Claudication questionnaires. The symptom severity was 0.8 in the crossover versus 0.8 in the mild®, along with the CMM measures. Same thing with the physical function.

(03:00) It was 0.5 versus 0.5 in the mild® and CMM alone. The walking tolerance test was 209% for the crossover versus 222% for the mild® plus the CMM alone. So there was no statistical significance in any of the means improvements in any of the measures that were assessed. Therefore, the patients that had the conservative measures and then received the mild® procedure had similar outcomes to the patients

(03:30) who received the mild® procedure as a first line therapy. With the safety profile of mild® procedure that’s comparable to epidural steroid injections and the plethora of the studies that showed the effectiveness of the mild®, the algorithm of care for symptomatic spinal stenosis is really challenged and we wonder if the mild® could be considered as a first-line therapy. Thank you everyone, and hope you enjoy a great conference. Thank you.

The views and opinions expressed in this article are those of the authors/speakers and do not necessarily reflect the official policy or position of Vertos Medical.

Overview

The MOTION Study is a 5-year prospective, multi-center, randomized controlled study designed to assess the safety and effectiveness of the mild® Procedure alongside with conventional medical management (CMM) as a first-line therapy (treatment group) compared to CMM-Alone (control group).

At the American Society of Pain and Neuroscience (ASPN) Annual Conference in Miami, FL in July 2024, Timothy R. Deer, MD, from The Spine & Nerve Centers of the Virginias shared 3-year follow-up results of the MOTION Study. Data included subjective and objective measures of the group receiving the mild® Procedure (mild® + CMM).

The data provides additional evidence of the durability and safety of mild® as a first-line treatment in a real-world setting, suggesting that while CMM manages symptoms, mild® addresses a primary cause of lumbar spinal stenosis (LSS) by debulking the thickened ligamentum flavum and reducing the compression of neural elements.

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Author: Timothy R. Deer, MD, The Spine & Nerve Centers of the Virginias 

Abstract - Dr Deer - Mild Motion Study 3 year follow up in a multicenter randomized controlled study. Concluding level 1 evidence and use as an early first line therapy.

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Dr. Deer on the Data: “mild® at 3-Year Follow-Up in a Multicenter Randomized Controlled Study”

Video Transcript: Dr. Deer on the Data

(00:00) Hello friends, Tim Deer. The MOTION study is a five-year prospective, randomized controlled trial comparing minimally invasive lumbar decompression where we go in with a small portal and remove pieces of ligament of the ligamentum flavum, that compresses the spinal sac and causes pain with spinal stenosis versus comprehensive medical management, which includes things like physical therapy, injections, medication, ablations, things we normally do in our spine clinic.

(00:30) The 3-year mark we have 40 patients who really are doing quite well. If you look at the data, the outcome measures we’re looking at, things like ODI, things like numeric rating scale, the Zurich claudication scale, and the really, the walking test of how far you can walk, how far you can stand for 15 minutes. All those tests are statistically positive in favor of minimally invasive lumbar decompression. *Statistically positive compared to baseline.

(00:57) In addition, 92% of patients were able to avoid a larger lumbar opened surgery. And I think that’s phenomenal because the other option for these patients have always been open decompression or fusion or both. And I think to see a reduction and large surgery that often are needed, but in this case we found they often aren’t needed and we’re showing that people are doing quite well without bigger interventions.

(01:20) We’ll be presenting this at the ASPN 6th annual meeting. Hope you can join us. If not look for a publication of the three-year data and we’ll be back again, hopefully reporting the four and five-year data to follow. Thank you very much again. Look for the MOTION study. Look for the ligament when you’re treating patients. I’ll see you in Miami.

The views and opinions expressed in this article are those of the authors/speakers and do not necessarily reflect the official policy or position of Vertos Medical. The data is only for the study group receiving the mild® Procedure (mild®+CMM).

mild® Provider, Dr. Youssef Josephson | Double Board-Certified PM&R and Pain Management Physician | Modern Spine and Pain

This case study explores the successful treatment of a patient, age 87, by Dr. Youssef Josephson. After he decided to move this patient to the mild® Procedure for lumbar spinal stenosis (LSS), Dr. Josephson found the procedure not only helped her avoid major surgery but also improve quality of life, regain functional ability, and discontinue use of opioids.

Patient History: Pre-mild®

An 87-year-old female patient presented with the following complaints during her consultation: 

  • Poor quality of life marked by an inability to walk and stand for prolonged periods due to significant pain. 
  • Heavy reliance on pain medication despite disliking the side effects, which left her feeling tired and unable to engage in daily activities. 

Although she had undergone multiple interventions, her desired level of function remained unaddressed.

Dr. Josephson observed that despite her age, she exhibited considerable vitality and potential for functional improvement.

Past Treatments

The multiple and unsuccessful interventions included physical therapy, epidural injections, and extensive dependency on medication.

She consulted with a spine surgeon, who proposed a significant open surgery involving fusion. After discussing this route with her physician, she opted to pass on open surgery due to concerns regarding recovery time and extensive anesthesia requirements.

Despite her overall good health, she preferred minimal levels of general anesthesia.

MRI Findings, Neurogenic Claudication and MOVE2mild®

An MRI revealed buckling at the L4-L5 level along with ligamentum flavum hypertrophy.

Based on this imaging, the patient was diagnosed with spinal stenosis accompanied by intermittent neurogenic claudication, attributed to various risk factors and underlying health concerns.

Dr. Josephson determined the most appropriate treatment for her condition and desired outcome was mild®, with a focus on treating levels L4-L5.

Images submitted by Dr. Josephson

Imaging provided by Dr. Youssef Josephson that shows buckling at the L4-L5 level along with ligamentum flavum hypertrophy - first image Imaging provided by Dr. Youssef Josephson that shows buckling at the L4-L5 level along with ligamentum flavum hypertrophy - second image

Procedure Details 

The procedure was performed utilizing fluoroscopic guidance. The patient was treated at the L4-L5 segment to address the hypertrophic ligamentum flavum which was compressing the space in the spinal canal and putting pressure on the nerves in the lower back. A mild® Tissue Sculpter was utilized to extract excess ligamentum flavum. Once satisfactory decompression was achieved, small amounts of dye and cortisone were injected to visualize improved flow and overall results.

The case concluded with a small incision closure using glue and one Steri-strip, which minimized recovery time.

The Results 

At the one-week postoperative follow-up, the patient reported feeling significantly better. 

At the one-month follow-up, the patient handed over her pill bag, indicating she no longer needed the medication. This is notable given that, at 87 years old, she had been reliant on opioid medication.

Dr. Josephson described this moment as the “Holy Grail” of pain management, being able to help his patient regain their quality of life and functional abilities without medication. 

Key Takeaway from Dr. Josephson:

“I call it the Holy Grail of pain management and that is when a patient who has been maintained on medications, walks in and hands you their pill bag and says ‘Doc, I don’t need this this anymore. I now have my quality of life back. I have my ability to function back,’ and that to me that is a slam dunk.” 

Key Takeaways from Dr. Josephson on Why He Continues to Advocate for mild®

Dr. Josephson continues to treat spinal stenosis with mild® because the procedure provides outcomes that address both pain relief and structural issues without resorting to major surgery, interventions, or lengthy recovery periods.

As a minimally invasive procedure, mild® requires a short recovery time as well as a very minimal postoperative course. Usually within a matter of days, patients are back to themselves—indeed, a better version of themselves.

Read More Case StudiesGet Trained on the mild® Procedure

Make the move to mild® and evolve your practice’s standard of care. Learn more about how mild® can be a valuable part of your practice.

In February 2024, Marlene from Willoughby, Ohio, decided with her doctor that she would undergo the mild® Procedure for lumbar spinal stenosis (LSS). Her pain before the procedure was a stabbing sensation, “probably close to a 9 or 10,” when she was standing, putting weight on her left side, or sitting on a hard surface.  

Her condition was very limiting, preventing her from walking without pain. She was unable to stand upright while walking upstairs and couldn’t walk more than 10 feet at a time. 

Undergoing the mild® Procedure for Back Pain 

Marlene recalls the day of her procedure as “wonderful” because she was looking forward to it, and she trusted her doctor.  

The procedure itself was simple for Marlene: “They took me into the operating room, and I went gently to sleep. And when I woke up, I was pain-free.” 

Recovery Time for the mild® Procedure 

The first day after the procedure, Marlene was given no restrictions for the recovery period. Her doctor only advised that she should take it easy and let her body be her guide. 

Because she cares for her elderly husband, she had quite a bit of work to do at home. She was tired and made sure to rest, but by the second day, she was “back to doing everything fairly normal.” 

Marlene’s Advice on mild® as a Spinal Stenosis Treatment Option 

Surgery wasn’t an option for Marlene due to her age—she’s 86 years old—but she couldn’t live with the pain she was experiencing. That made choosing mild® an easy decision. 

Even so, she wouldn’t hesitate to tell someone else to have mild®. “I would recommend it,” she said, “Don’t hesitate if your doctor is recommending it. I say go ahead with it.”  

 

Watch Marlene's Story

Expand to view transcript

Okay, my name is Marlene. I had the mild® Procedure done in February of this year.  

How are the symptoms before the mild® Procedure?  

Very bad, very high pain level. Probably close to a 9 or 10.  

What was your pain? Like and where was it located?  

The pain was like I was being stabbed with knives when I would stand and put weight on my left side. And if I tried to sit down on a hard surface, it would feel like somebody was stabbing me, and I was very limited to what I can do.  

How could you stand for and how long could you walk for before the mild® Procedure?  

Well, standing was a different story because you can put your weight on your other side. I put my weight more on my right side, but I still felt I still felt a lot of pain when I stood up. But walking was almost impossible. I would take one step at a time. I went upstairs on my hands and knees. I didn’t stand upright to go upstairs, and I would say I couldn’t walk more than 10 feet at a time.  

What was your procedure day like when you were about to have the mild® Procedure?  

Well, it was a wonderful day for me because I was looking forward to it, praying for the procedure to work, and I trust my doctor.  

So I was up in there bright and early morning. It was very simple. They took me into the operating room, and I went gently to sleep. And when I woke up, I was pain-free.  

After the procedure, what was the recovery like? Did you have any restrictions?  

No, I had no restrictions on the first day. He [the doctor] said just take it easy and just let my body be my guide. 

Since I have an elderly husband that I care for, I had to do quite a bit of work around the house. So by the next day, I was back to doing everything fairly normal. I rested a lot. I was tired. But by the second day, I felt like it was a miracle.  

How long can you walk and stand now after the mild® Procedure?  

Well, on my left side, which is where I had the procedure, I have no pain. I can walk, I can do anything, but I do have the same symptoms on the right side—not quite as bad on the right side now. 

What would you tell others who are considering this procedure? 

Don’t hesitate if your doctor is recommending it. I say go ahead with it.  

I’m 86 years old, and they wouldn’t do surgery. So surgery wasn’t an option, and I couldn’t live with that pain. So it was it was easy for me to make the decision. But I wouldn’t hesitate to tell somebody to go ahead and do it. I would recommend it.

Listen to More Patient Stories Find a mild® Doctor

Disclaimer – Patient stories reflect the results experienced by individuals who have undergone the mild® Procedure. Patients are not compensated for their testimonial.

The mild® Procedure is intended to treat lumbar spinal stenosis (LSS) caused by ligamentum flavum hypertrophy. Although patients may experience relief from the procedure, individual results may vary. Individuals may have symptoms persist or evolve or other conditions that require ongoing medication or additional treatments.

Please consult with your doctor to determine if this procedure is right for you.

“My mantra is challenge directly, care compassionately”

Air Date: 5/13/24

 

The Medical Sales Accelerator Podcast welcomed Vertos Medical’s Kris Krustangel, Vice President of Sales, for a conversation on leadership, authenticity, and personal growth. Kris shared his journey in becoming less ego-driven and more authentic as a professional in the device and medical sales field.

Lessons on Ego and Authenticity

In his path from clinical specialist to sales executive, one seminal moment helped shaped Kris’s approach towards his work and life: while serving in his first leadership role, an executive pulled him aside after a quarterly business review and gave him some tough and insightful feedback. The executive told him his presentation “looked good and it sounded good” but it didn’t address the questions and concerns that it should have.

This was the moment when Kris realized that he’d been “so focused on really how [he] looked, how the slides looked, how [his] answer sounded.”

“I was kind of void of the authenticity of driving the real solution to the problem. And I was just too focused on looking good, I’ll be honest,” Kris recalls.

He remains grateful he received such challenging feedback early in his leadership career: “I still to this moment remember that individual and thank him all the time when I see him at conferences.”

Learning to Focus on What Matters Most

This realization that he’d been focused too much on appearance and not enough on impact set Kris on an iterative process of growth. “I think I was able to firstly kind of refocus on what matters most,” he recalls. “And a lot of times, it’s not what matters to you. It’s what matters to those that are around you.”

He began to realize to see how easy it is to “overcompensate with movements and actions and even volume, just how loud you are versus substance,” but “the challenge is, how quickly can you realize that’s not the most important thing? And then how can you elevate yourself to put yourself in a position where you’re really delivering value in whatever you’re doing?”

 

Engaging with Obstacles and Confronting with Kindness

Kris has worked in a variety of organizations throughout his career, from large corporations to very small startups where he was the first commercial employee. When he considered joining Vertos Medical, which he calls a mid-sized startup, he applied a critical lens to determine how decisions are made, asking questions like “What is the mission of the organization and how ultimately are the resources aligned?”

Essentially, he looks for signs of ego, because “that ends up being an obstacle.” And when he sees ego in an organization, his approach is to “make a decision about not engaging.”

“You have to ask, is it worth it? So there’s an engagement decision to make,” he says, and “once you’ve made that decision to engage, how are you going to adapt in a way that’s still meaningful to move forward, whatever that mission or that purpose is?”

Now, when he does decide to engage with an ego-driven organization or individual, he points it out with directness. “Granted, I do it in a very compassionate way,” he says. “My mantra is challenge directly, care compassionately.” He approaches the conversation with kindness because he cares about the people he’s connected with. “I can just basically go to you and say, ‘Is this the best decision for the business? Or do you like this decision because you came up with it? And be honest about it. I’ve been there, too. We all have.’”

Finding Purpose in Helping Others

As a leader, Kris is “trying to drive an environment where we remove ego and really focus on the best decisions for the business—to help the patients and physicians we work with.”

However, “if you’re going to function at the highest level possible, if you’re going to show up for others like you do, you really have to have some boundaries,” says Kris.

He urges others to invest in themselves so they can continue to perform at a high level: “invest in your energy, invest in your mindset so you can do the hard work when you need to.”

In his relationships with colleagues and team members, he is “overtly focused on being authentic and being really kind in a way that matches what [others are] trying to do.”

“I just feel deeply passionate and purpose driven around the idea that I can help people do better at what they want to do,” he says. “That’s the best possible thing I could ever do. As a parent, as a professional, there’s nothing more important to me.”

Listen to the Podcast


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Expand to view transcript

02:40
Kris Krustangel
Yeah, thanks for having me. I feel really lucky to be a part of this conversation today.

02:44
Podcast Host
So you’ve been in med device a long time, a lot of different roles, a lot of different responsibilities. And kind of, to my statement earlier, I know some conversations we’ve had before that you’ve realized at times that ego could be an obstacle and were talking about The Obstacle is the Way and things of that nature, along with stoic philosophy. Was there a moment in time throughout your career that you sort of had that revelation? Did you just walk out of an opportunity or what was that?

03:14
Kris Krustangel
Yeah, just give a little context: so it’s been 20 years of medical device. I started as a clinical specialist and kind of grown from that role into now leadership for the last 12 or 13 years. But to answer your question specifically, it was about like year into my first leadership role where I can just remember, you know, coming out of a QBR (quarterly business review) and being so focused on really, you know, how I looked, how the slides looked, how my answer sounded. I was kind of void of really the authenticity of driving the real solution to the problem. And I remember coming out of the meeting, and I’m sure you guys have been in these meetings, right? You got like 20 managers and a couple of VPs, and they’re grilling you and you come out…

03:51
Kris Krustangel
At that moment, my pride was pretty high, and I had kind of an adjacent leader who wasn’t my VP, who was a VP in there. He’s like, “you kind of crapped the bed in there.”

04:00
Kris Krustangel
What? What do you mean I crapped the bed? He’s like, I’m not really sure you answered many of the questions that were being asked. I mean, yeah, it looked good and it sounded good, but I’m not sure it really delivered in the way. And man, I still to this moment, remember that individual and thank him all the time when I see him at conference because it was kind of a seminal moment when I realized like what were my priorities as a leader specifically? Like what was I trying to show up and do and most importantly, how to be effective. So, yeah, that one to this day, I remember were like in Huntington Beach. I remember the room. I remember he grabbed me on that thing, you know, the awning right outside. And I was just too focused on looking good, I’ll be honest.

04:34
Kris Krustangel
And it was a mistake at a time in my career. I’m really grateful that happened early in my leadership career, for sure.

04:38
Podcast Host
That’s awesome, man. I love to hear that someone cared enough to pull you aside because that means they didn’t care how they looked, right?

04:49
Kris Krustangel
Yeah. Isn’t that true? That’s true. So, so true.

04:52
Podcast Host
That’s awesome. So you experienced that and you remember the room, probably the smell, everything about that day. What did you do about it?

05:01
Kris Krustangel
That’s a great question, and I think it’s iterative. Like, I didn’t wake up the next day and become my best version of myself. You know how it is. Just like you said in the beginning of this podcast, it’s about growing yourself and growing thoughts. So it takes time. But I think I was able to firstly kind of refocus on what matters most. And a lot of times, it’s not what matters to you. It’s what matters to those that are around you, right? So being kind of selfless first. And so you take the example of the questions that I was tasked with answering. I wasn’t really paying attention to the core of those questions, which are just like some business foundational things.

05:34
Kris Krustangel
And so I went back and I dug back in with my team and really tried to come up with better answers that were focused, that maybe didn’t look good. Right. Maybe weren’t doing the things were supposed to be doing, but they got up before the answer. And then I actually went back and took it back and had a sidebar with my VP at the time to kind of fill in those answers. And it felt, I don’t know, kind of invigorating because after that conversation, you know, sometimes the world gives you feedback right away. There’s real tactical, practical feedback with also resources to actually solve the problems versus me just, again, looking good. So it was iterative. Like I said, I came back, I tried to internalize it.

06:06
Kris Krustangel
I talked to my team, and then I tried to present something just as that kind of like, first step to “am I back on the right path or am I back on the correct path?” And I got some pretty quick feedback to say, yeah, this is the way at least you should think about leading in the medical device world. And it’s been pretty consistent since that.

06:22
Podcast Host
Yeah, I’m curious. This might be a strange question, but if you look back on the idea of wanting to look good, do you have a sense of what that was a symptom of that led you to that point at that time?

06:38
Kris Krustangel
That’s a deep question. You know, one, I’m not a good-looking guy here watching this on the camera. [Laughs] So it’s not that, you know, I think it comes down to earlier in careers and maybe earlier in tenures of positions. We’re all kind of feeling our purpose and our way out, and with the ways that we’re seeing, if that makes sense. And sometimes I think it’s easy to overcompensate with movements and actions and even volume, like just how loud you are versus substance. And I don’t think it’s anybody’s fault. I mean, for those of the people that are listening, that are in medical device, we see it every day. I see it with doctors, I see it with reps, I see it with other leaders.

07:14
Kris Krustangel
But I tend to realize that it’s those people that can have either someone stop them to point out the gap or someone to really self-actualize as life just goes on, you’re more comfortable. That’s not the most important thing to think about. But to answer your question again, it feels circumstantial. You know what I mean? Like, it’s just a way. Sometimes you start in a position, and I think it’s totally normal. I bet you people on the call right now feel the same way, and it’s totally normal. Not that you’re asking me this, but I think the challenge is like, how quickly can you realize that’s not the most important thing? And then how can you elevate yourself to put yourself in a position where you’re really delivering value, whatever you’re doing, right?

07:50
Podcast Host
Yeah, it’s pretty fascinating because I could almost see it turning into like a Pavlov’s dog scenario. Like we experience the success around something and so we associate these things, but maybe it’s correlation, not causation, but then our brain goes, well, I gotta be this way. So, yeah, it’s great for you to identify how has it changed how you look at business today. Does it impact your conversations with the team hiring? How does that look?

08:20
Kris Krustangel
It 100% does. And I won’t go too far back into my story, but, you know, I’ve had a series of different experiences with large strategics as well as, you know, very small startups, being commercial employee number one. Now, Vertos Medical, where I call it a middle-sized startup, but, you know, as I went through my due diligence before I had the opportunity to really join here. I mean, I looked through a pretty critical lens about how decisions are made, right? What the mission of the organization is and how ultimately the resources align up with those things. And I think what you learn if you start to get a real eye for ego, is that that ends up being an obstacle. To your point at the beginning, that ego is the enemy.

08:58
Kris Krustangel
And so when you see those things, I think you’re able to either do one of two things. You can make a decision about just not engaging, right? Like, I’m not gonna go down this path. Like, and again, for people listening, with all due respect, I’m sure there’s a physician, you know, that has a certain bravado or whatever, and you just realize the amount of resource and time you’re gonna have to spend to convert or get to that position. You have to ask, is it worth it? So there’s an engagement decision to make. And then the second part is, once you’ve made that decision to engage, how are you going to adapt in a way that’s still meaningful to move forward, whatever that mission or that purpose is.

09:30
Kris Krustangel
And I think in everything that I do, I’m looking for it to a fault or to a betterment because it allows me to be more functional, more fluid. Now, what I just pointed out where situations where I’m relying on, like a physician, right, or a sale. Only as my team, it makes it a little bit easier because I can just point it out, you know what I mean? Like, granted, I do it in a very compassionate way. I mean, my mantra is challenge directly, care compassionately. So I’m definitely direct. But I’m also, I would like to say, do it have a kind heart because I care about the people I’m connected with. But in the team that I work on, obviously the rules are a little bit different.

10:02
Kris Krustangel
I can just basically go to you and say, like, is this the best decision for the business? Or do you like this decision because you came up with it and be honest about it too? Like, and I’ve been there, too. We all have. And I think being able to see that environment in business play out in real time, there’s no question in my mind the better that we get at that last version of what I just explained to you, we come up with faster, better solutions to deliver value to our patients and physicians—with no doubt in my mind. So not only do I look at it, not only am I conscious of do I engage with it? But professionally, now I’m trying to drive it.

10:34
Kris Krustangel
I’m trying to drive an environment where we remove ego and really focus on the best decisions for the business to help the patients and physicians we work with. So great question.

08:02
Podcast Host
Have you noticed this mindset? I guess first, let me ask this. Let’s say someone is listening and they’re interested in this concept, this idea. It maybe rings familiar to them, but maybe they never put words to it or a structure. You mentioned Ryan Holiday. Are there any other sources of content that you have found yourself going to learn more about the actual operating system of what this looks like from a behavioral standpoint?

11:11
Kris Krustangel
I could give you a bunch of recommendations, but truthfully, if you’re looking to start with Ryan Holiday, he has a book called Ego is the Enemy. There’s another one called The Obstacle is the Way. They’re very closely aligned. It’s based on stoic philosophy, which sounds way smarter than a state school-graduated guy like me. But the foundational principles are all there. And if you start with either of those books, or even just the blogs or the podcasts he does, it’ll give you a taste of what he’s talking about. And a lot of it is what I like to think is just air that we breathe already. You know what I mean? Be kind, be honest. Like, these aren’t new concepts. But I think the way he talks about it, and he gives experiences or descriptions of how it fits in everyday life…

11:48
Kris Krustangel
Like, he does it for being a father, he does it for being a friend, he does it for being a professional. You actually start to see the architecture, right? The beams of the building in front of you in different places, and that’s really helpful. And then he does go on and there’s other kind of step offs from him to talk about how it applies to business. So I’d definitely just start there. It’s too good to go anywhere else, honestly. He’s kind of the mecca on this topic, on modern day stoicism, for sure.

12:12
Podcast Host
Yeah. He’s got a lot of study behind it. He frames stoic philosophies in a lot of modern terminology or ways that we communicate today. I’ve read The Obstacle is the Way. I have not read Ego is the Enemy. I definitely need to. He’s also a great writer.

12:27
Kris Krustangel
Totally. Yeah.

12:30
Podcast Host
So I’m curious. You had that shift, and you named it as a seminal shift. You started to pay attention. It was iterative. So over time, you’re recognizing more and more how these changes in your behavior are not only better for the business, but I’m assuming better on the communication with your team, the relationships you built. Did you get any feedback over that course of iteration from direct reports, people that were adjacent to you? Any of those team members?

12:56
Kris Krustangel
Yeah, that’s a great question. I definitely did. I mean, to be really honest with you, I think authenticity is hard. You know what I mean? It feels hard to. Especially. You have almost like, there’s so much noise right now, in the environment, it’s hard to even know when to be authentic versus when you’re being buzzed at by social media or, you know, your phone’s ringing or your dog. Like, when are these moments to be really clear and present? I would say. And wherever you’re doing. And so, to answer your question, it’s like there’s certain situations, whether it be leaders or reps, where at the end of the day, they’re pausing and they’re kind of re-churning all that we talked about—a lot of authentic, challenging, right? A lot of, “Hey, is this the best decision? Is this the right customer?”

13:33
Kris Krustangel
“Have you thought about it?” And again, a kind of compassionate way. And at the end of the day, I do tend to get pretty good feedback. Like, this is a super powerful day. I’m really glad you said this. Nobody’s framed it that way. And I don’t think the way that I say it is special, but I will say that I am overtly focused on being authentic and being really kind about it in a way that matches what they’re trying to do, right? And what matters to them—not just what matters to me, what matters to them. And so I think I tend to get a lot of feedback over time where it’s, you know, the different VPs that I work with now or my CCO or, you know, the reps, like, they appreciate it.

14:08
Kris Krustangel
I think at times I’d be lying if I don’t wear people down a little bit. I mean, they don’t want to hear it, and maybe I don’t want to hear it. I’ll be honest with you. But I just feel deeply passionate and purpose driven around the idea that I can help people do better at what they want to do when I’m not around them especially, that’s the best possible thing I could ever do. For what? In my life, yeah. As a parent, as a professional, like, there’s nothing more important to me than doing that thing. So I’m going to value the time that I have to have those conversations. And generally, yeah, I mean, I get some feedback in the discussion that, like, it’s positive. I’m starting to get—I’ll be very clear—the reps ride with me…

14:47
Kris Krustangel
Like, they don’t want to hear me, but it’s not for everybody, and it’s the price you pay for the space you occupy. But the feedback has been good, and that’s why I continue to kind of double and triple down on being really authentic and direct with my approach and things.

15:00
Podcast Host
What framework are you walking through when you’re not in a good headspace? Or things seem to be crashing around. Right. Which happens frequently for everybody. What framework do you walk through mentally to say, hey, am I staying authentic? Am I being authentic? Like, what does that define that? And then what framework do you use to kind of check yourself? I think that’d be helpful for everybody that’s also looking to do the same thing.

15:22
Kris Krustangel
It’s hard because, you know, I don’t know how I’m coming across right now. People usually say high energy, passionate. I’m not always like this. I have bad days, like, I have bad minutes. I think, to answer your question, it’s okay. First off, just be okay with that. Like, some people feel guilty or they try to avoid it, but, like, just be okay that you’re not your best self. I think that’s the first step of that kind of recovery mindset of what you’re describing. But the second thing is, I do try to spend a little bit of time, whether it be journaling or just discussing with an adjacent peer or mentor, like, what’s really getting at me. Like, I’ll throw out all the practical pieces and say, hey, this is what I think about this thing. What do you think about?

15:55
Podcast Host
And generally, you know, nine times out of ten, eight times out of ten. And again, PSA public service announcement: surround yourself with good people that you can trust, that are better than you, that are going to say stuff to you that you don’t want to always hear because it works. But I have those conversations eight times out of ten, nine times out of ten that give me that perspective of why I’m maybe not feeling authentic or I’m not feeling as connected with the things that I do. And then I try to get back on track. And even to be more practical than that, sometimes it’s just a mood, you know what I mean? You just don’t wake up and you don’t have the best sleep.

13:47
Kris Krustangel
Or I’ve got a teenage son who, you know, wants to talk to me until 02:00 in the morning, which, you know, I really appreciate. Because he’s gonna graduate eventually. But it makes it hard the next day. Maybe I’m not my best self. So I also try to think about things that give me quick boost, which, you know, one of my mentors, Alan Meacham, he’s the chief revenue officer for Nalo Medical. You know, practice gratitude. Just take a quick stock of what you’re thankful for in a moment. Music. Work it out. Even a quick ten-minute set of something like, and maybe that’s a little shallower than you’re looking for, but those are just quick blips to get you kind of back to where you need. And we all need them. I mean, we just, we all need them.

14:22
Kris Krustangel
I think the trick is recognizing how far you’ve gone before you actually realize: oh, I need that thing. And that’s why I go back to the first piece is like, pick up the phone. Hopefully you can talk to somebody that can kind of give you perspective that’s outside of your head.

14:34
Podcast Host
Yeah, I mean, look, we all know this, generally speaking, the med device community is a pretty active, very competitive, pretty fit (generally speaking) community. But this isn’t going to be a shock to anybody. Moving your body, getting a sweat and doing something hard, even if it is for ten minutes—the physical will affect the mental, right? And help clear the headspace. And so you ask, hey, maybe this is a little more, or you made the statement, maybe this is more shallow. Not at all. Those things have real physiological differences when we do them specifically, routinely. And that’s why I was asking. I was curious, what do you do, man? Because anybody in a leadership role, you’re catching the—somebody told me this once, right? one of my own mentors—you never come to me with the good things.

15:17
Podcast Host
You only come to me with the problems. They’re catching everybody’s problems. And so you’ve got to be able to wear that. And still, to your point or to what you’re talking about, remain authentically optimistic, positive, all of those things. So that’s why I was curious, how do you juggle it? Because everybody’s always looking for those little pearls so that they can let the water roll off their back like a duck, right?

15:41
Kris Krustangel
Yeah, totally. Well said. And again, it’s an iterative process. You know, as I learn new things or new tricks and tips, I’m always trying to put it in. But I think what you’re asking around mindset as well as energy management, because I think that’s a part of it, it’s really important. I think it’s under clubbed golf analogy, right. Kind of under invested in medical device. Could we just like go, go? Which don’t get me wrong, I’m guessing the three of us and the vast majority of your listeners, because they’re listening to this, are constantly going and going. But when you’re on that airplane, and they tell you put on the air mask before assisting others—I always believe that there’s something to be said about that.

16:17
Kris Krustangel
If you’re going to function at the highest level possible, if you’re going to show up for others like you do, you really have to show some boundaries to invest in yourself, to provide that energy and mindset so you can stay at that level all the time. And that’s, again, I’m just some medical device leader. I mean, you talk to, like, the Kobe’s and, like, the real performers, they’re the same way, right? They know down to the fraction of the second how to invest their time to recover.

16:39
Podcast Host
Right?

16:39
Kris Krustangel
And that’s what we’re talking about. And so I can’t go by this part of the conversation without throwing out another PSA. Invest in yourself, invest in your energy, invest in your mindset so you can do the hard work when you need to, do the hard work and move whatever you’re trying to do, move forward. So, great fallout.

16:54
Podcast Host
I appreciate that, because the same potential level of ego that could tell us that we need to be able to sleep less, we need to be able to get up earlier, we need to be able to work harder. That same thing hurts your ability to actually be that person. And the brain is really interesting. Humans, everything about us is pretty interesting. But there’s a really pretty simple concept is if we’re low on gas, then it takes more horsepower. Or we get worse gas mileage in the things we need to do. And so if you run yourself dry, and then you expect to be a leader in a position where you’re not driven by ego, that’s going to be hard because you’re going to default to that because your brain’s going to think you are under some level of attack.

17:42
Podcast Host
So I love that you call that out because we do have to put the mask on ourselves first.

17:47
Kris Krustangel
It’s super hard to do again. I mean, we all live complex lives outside of work, I bet. So, you know, it’s hard to be that. But I would say that if I look back and I score myself right, the best work I’ve done, I’ve always done a better job of maintaining some self-investment along the way, you know, set calibration with the peers to get my mindset right, so then I can do the things I need to do both at home and at work to be successful. But again, I just want to say we’re all going to get off course, and it might be weeks, it might be months. Hopefully it’s just minutes. It’s just acknowledging where you’re at and trying to get practical about how to get back onto it.

18:21
Podcast Host
Kris, were you familiar with stoicism when you first kind of started this revelation around, hey, my ego’s in the way. I’m trying to look good. I’m trying to say the right things, but I’m talking right past the point that my superiors actually are asking me about. Were you familiar with stoicism at the time, or did you come across that along the way? And how did you interweave that into what you’re doing?

18:42
Kris Krustangel
I didn’t at the point. I mean, like a lot of things, it’s all just bravado and feeling early in the career. But, you know, I would say that there’s some input from my environment, my parents, my siblings. You know, you just kind of have a certain mind frame. But I didn’t understand it. Here’s what I did know. I did know that I had a growth mindset. I love to learn. I just do work, everything, random stuff. And it was like one of those things you get on a podcast, you listen to it, and they mention something, and you listen to another podcast and they mention the same thing. You’re like, wait a minute. I like these podcasts. They’re mentioning something, and then you dive into it.

19:12
Kris Krustangel
And so that probably happened, I would say, in the early 2012-2013, kind of just a couple years, 3, 4 years into my leadership roles, which I can’t believe was a decade ago, but, like, it was just the perfect time to then understand. The first off, we’re talking about thousands of years old, right? Philosophy. This isn’t decades. And just to hear that problems are still the same. I mean, from a societal standpoint, from a relational standpoint, they’re all still the same. And here’s these core tenets to help you better yourself as it relates to your environment, to deliver more value. And so then I kind of really dive in and I read the books, and I tend to go pretty deep, pretty quickly on the material, and then I come back up for air.

19:51
Kris Krustangel
And so now I just maintain what I would say is some refreshers, whether it be podcasts or blogs, et cetera, as well as just talking about it. I think we become better learners when we educate others about how it fits in foundationally in the work that we do, in the way that we act. So I wish I would have known it. I mean, I would have gone to it right after that meeting, you know, where my superior pulled me aside and said, you crapped the bed. But luckily, I stayed curious, and eventually I found the real pillars of the material to help me make it more clear in my head today.

20:21
Podcast Host
All right, so from a pure headcount perspective, there’s more sales reps in the organization, typically, than waiters, right. That’s just the way it is, and it’s an individual contributor role, and you’ve got a scoreboard, and the comp plans are set up for you to go. You go do. Ideally, if you’re winning, it’s good for the organization. If it’s a good comp plan, right. But it’s all about you driving your stuff. How do you talk to your team members? Or how do you advise people out there listening right now that are in that scenario? Or they’re only worried about their region because they want to make sure that their region isn’t the reason, say, maybe the country doesn’t hit right. How do they get out of that narrow lens? Or how do they marry that with the things that you’ve been discussing?

21:03
Podcast Host
Because that can be a challenge at times. You can be very tunnel focused and let everybody else worry about themselves or let the organization worry about what’s best. What’s your advice there?

21:12
Kris Krustangel
That’s an awesome question because I think about it a lot, you know, being fortunate. Like, I have to work across a couple organizations and work with some of the best reps I’ve ever seen in my career, up close and personal. There are two things that I like to convey to others. One is you kind of have to be a little selfish. And so I know I don’t want to contradict myself with the ego, but I think there has to be a certain sense of confidence and comfort in the plan or the approach or the knowledge that they have that maybe I don’t want to say average, but some of the parts rep may feel or look at things.

21:45
Kris Krustangel
And so it’s okay to challenge. It’s okay to feel passionate about how you’re gonna deliver success, because kind of that chip on the shoulder I always see is like, it’s like the gasoline in the engine. You can see this thing’s gonna go, it’s gonna fly. But the second thing that they do is really interesting. The best that I’ve seen, even though they may come off as, like, the funnest guy in the bar, gal in the bar, you know, they got the big energy, which I really do appreciate. I enjoy that, too. They’re very focused on delivering their success through other’s goals. Like, if you really ask them, if you really dig into them, they will tell you about their ten customers. They’ll tell you their whole lives, not just their personal stuff.

22:22
Kris Krustangel
They’ll tell you how they’re employed, how they care about patient flow, what the next board meeting is coming up. And they know all these really important motives to the physician and the physician supporters. And so what they’re doing is like, they’re providing that passion and that tenacity and that confidence, and they’re delivering success through what’s important to the customer, right? Regardless of what product, widget pill you sell. They are, like, locked into knowing in the most total version I’ve ever seen of all the information they could about what matters in that environment. And so kind of tying it back to the ego is the enemy: they’re not like, use my thing because I’m the greatest person ever. Even though some of them are just remarkable humans. Remarkable humans. They’re doing it because they know what they’re delivering…

23:08
Kris Krustangel
…helps all those motives and all those value drivers that the physician or the patient or the practice is looking for. And they may be obnoxious about it because maybe the physician doesn’t want to listen to them, but they will just, “I’m telling you, if you do x, we’ll get to y and you’ll be able to help, you know, this many more patients versus these patients.” Or if we do the procedures in the surgery center versus the hospital, look how that’s going to impact, you know, your work life balance. And it goes back to the idea again, the two things, having the passion and the tenacity and the confidence to know how to approach things, but then also having this just insisting, insane ability to analyze that opportunity and deliver success through the eyes of the customer and really value them.

23:48
Kris Krustangel
So that’s why I say it’s like, not ego driven. I mean, they’re utilizing the motives of others. And then they are the ones that are at peak club every year. They’re the ones that are making $500, 600, 700 million a year because they just, they know how to do that, and they have the passion to do it. I think it’s such an awesome question because it’s hard to do, and if it was easy, everybody would do it. But I think those two things just are none—and sorry to go a little long on this one—just separate the top of the top from everybody else. Those two things alone.

24:17
Podcast Host
So many visuals come to my mind when we’re talking about this and when we talk about in our business and asking questions. You need to understand not why someone should buy from you, but you need to understand what it is that impacts them about what you can bring to the table. It’s just like if you’re walking by and someone’s trying to cook the most delicious dish on the planet, and you can go sprinkle the perfect thing. Like, there’s no ego in that. If it turned that into the most delicious. But you need to understand the dish and you need to understand what flavor they think is delicious. Because you might think that ice cream is delicious, but if they’re cooking eggs and broccoli, well, probably not a good fit.

25:01
Podcast Host
So I love that you called that out, because I get really geeked out about this because basically what you’re talking about is you’re talking about constraint theory as it relates to behavior and decision making. Within surgeons or physicians who have been taught a very specific thing, they have a bounded rationality, a bounded knowledge of what they’re doing, which makes it hard for them to recognize how powerful your tool could be. And when you are non-ego driven, you can understand their perspective and come in and sprinkle in that perfect ingredient. I love how you just broke that down. That is every rep who just heard that. You need to go check yourself against that description. That was awesome.

25:47
Kris Krustangel
Yeah. And I appreciate it’s hard, again, and if you’re not willing to do that, the hard work, it’s not going to happen at the same level. You can still have success, right, with a few customers, et cetera. But if you’re not really going to dig in like we just discussed and deliver on a different level, you’re not going to be the person who sustains three, four, or five years of just high earnings, high impact factor potential. It’s just not going to work. And I just want to say one thing. There’s a nuance, what you just said about the constraint theory that we don’t talk about a ton generally. Like, I actually haven’t heard that in a while. But just think about how physician is trained, right. It’s all protocol, workflow based, UCX, UGY, etc. And I’m not trying to minimize for any physicians listening.

26:22
Kris Krustangel
I realize you’re far more dynamic than that, but generally you’re given a set of blueprints to kind of follow. The challenge—and I would argue being a frontline physician is where the hardest jobs are—is because: “Yeah, that’s great when I was taught it, and these are all therapies that I had.” Fast forward five or ten years with the dynamic shift of the payor, the dynamic shift of new entrants, the dynamic shift of reps, and so all of that is changing at incredibly rapid speed. But what’s the same? The physician still wants to do something. They still want to get something done for themselves or for their practice, for their patients. None of that has changed.

26:56
Kris Krustangel
So if you can come in as a rep and understand all those pieces of information they’re trying to sort through, all the things that they care about, then you see it more clearly than them sometimes and be like, oh, hey, it’s just this. Let’s do this one thing. And again, it’s not easy. It’s certainly not easy. It’s not for those that want to go fast, but it’s for those who want to set up long term success and create meaningful value, which I want to point out too oftentimes that the top reps, I think, get mislabeled as, you know, they just want to make a bunch of money. If you sit with and talk to them, that’s just like a part of it. They want to be meaningful. They want to help patients. They really want to help physicians.

27:32
Kris Krustangel
And they are more wound up passionately about that than even I am. You can sense I’m pretty passionate about it. Like, they want to drive impact. And so you got to remember that, too. In addition to the practical things we just talked about. You got to really want to help. You got to really want to help other people and mean it, and if you can put all those things together, back to, you know, your recipe, it’s going to taste amazing. And you’re going to have a ton of success, and people are going to be back for more, for sure.

27:58
Podcast Host
I probably shouldn’t mention it because I can’t even find it, but when I was looking down, I was trying to find, there’s a term that actually Matthew McConaughey has in his book Green Lights, because we throw a ton of books out there today, that literally describes this. I can’t remember what it’s called. I couldn’t find it.

28:10
Podcast Host
So we’ll have to drag it down and put it here.

28:12
Podcast Host
Yeah, we will.

28:13
Kris Krustangel
You have to get Matthew McConaughey on next.

28:15
Podcast Host
Yeah, there we go. But I love the description of it because it’s literally, it’s like, no, be selfish, but use the selfishness for the good of others around you. And that’s what you’re describing, right? Totally. To think that we’re not selfish or that you’re not out for your own interest is foolish because that’s part of our human nature. But just like the cell phone was amazing invention, right, piece of technology. It can be used for amazing things, like connecting us to our parents that don’t live here, you know, close to us with FaceTime, or to do something nefarious like set up a bomb somewhere. It’s all about how you leverage it. So I think that’s what the essence of what you were describing, and I wish I could come up with that term. I couldn’t find it.

28:52
Kris Krustangel
But you’re gonna find it an hour from now.

28:53
Podcast Host
That’s a great point. I’m glad you tied those two things together, too.

28:56
Podcast Host
That is awesome, Kris. I really appreciate you taking the time and spending it with us today. This has been a great episode. There’s so many little nuggets that people can take away and help with their own growth. We’ll put links to the books you mentioned, Ego is the Enemy and The Obstacle is the Way. I would second, and I’m sure Clark would third the recommendation on consuming those books 100%. We actually, just as a side note, because it was such an important book to me, The Obstacle is the Way is read by every employee in our organization when they onboard. So really appreciate it. If people want to connect with you, chat, ask questions, is it okay if they reach out to you through LinkedIn?

29:37
Kris Krustangel
Yep. That’s probably my best medium. I tend to try to be pretty active, both for the greater good of just our community, as well as just talking about what I do and what the products we sell do for the patients we work with.

Original Publish Date: April 17, 2024
Telegraph Herald Author: Maia Bond 

Article Excerpts:

As featured in the Telegraph Herald, the mild® Procedure has recently been adopted at UnityPoint Health – Finley Hospital in Dubuque, Iowa. 

Both the mild® Procedure and the Ion Endoluminal Robotic Bronchoscopy System were introduced at Finley to provide patients with additional options for minimally invasive procedures. 

The mild® option is targeted for patients with lumbar spinal stenosis (LSS), which occurs when the spinal canal narrows and compresses nerves, causing pain through the back and legs. 

Director of the UnityPoint Health-Finley Hospital Pain Clinic, Dr. Tim Miller, said that narrowing can be caused in part by the thickening of the joints and a ligament along the spine. The procedure removes ligament to help relieve pressure on the nerves, and patients typically go home after about two hours. 

Prior to the introduction of mild® at the hospital, patients had the options to receive physical therapy, be given epidural injections, or undergo open-spine surgery. 

Ruth Arlen underwent the procedure in December. Before the procedure, “I couldn’t stand to make a cake or stand to fry eggs on the stove,” she said. “I’d have to have a chair and sit in a chair.” 

Now, Arlen can do all that and more. Arlen said within a few hours of her appointment, she already felt relief. “I had walked into the place with a cane, and I walked out of the place not really needing the cane,” Arlen said.  

View the Full Article

Patient Testimonial

In the following video by UnityPoint Health – Dubuque, Ruth Arlen shared her experience with mild®, and Dr. Tim Miller explains how the procedure addresses LSS. Since the procedure, Ruth has been able to return to her typical daily activities pain-free.

The views and opinions expressed in this article and video are those of the authors/speakers and do not necessarily reflect the official policy or position of Vertos Medical. 

Original Publish Date: April 24, 2024 

Your Life Arizona recently partnered with Dr. Eric Church and Dr. Thomas Moshiri of Arizona Pain on an educational discussion about the mild® Procedure. 

In the segment, Dr. Thomas Moshiri, Medical Director and Interventional Pain Physician, explained that mild® is “a minimally invasive procedure” with a typical recovery time of 24 hours. Most commonly, patients go home the same day with a Band-Aid on their back. 

“It’s specifically geared towards patients who have been told they have spinal stenosis or […] can’t stand up straight, or have to lean on a shopping cart,” said Dr. Moshiri. 

“It’s really exciting to see these patients who have these symptoms […] and traditionally in the past they would go see a spine surgeon and have a major spine surgery. They don’t need to do that anymore,” said Dr. Eric Church, Chief Medical Officer and Interventional Pain Physician. 

“How the procedure works is that we are removing extra tissue around the spinal cord. So once we remove it, it doesn’t grow back,” said Dr. Moshiri. 

According to Dr. Moshiri, the procedure allows for some patients to experience relief of pain almost immediately. Dr. Church noted that their practice has had many patients say that after receiving mild®, they are able to get back to activities they enjoy. These patients “are able to walk longer, stand longer, play with their grandkids, go on walks with their spouses or loved ones, with their dogs.”

The views and opinions expressed in the video are those of the authors/speakers and do not necessarily reflect the official policy or position of Vertos Medical. 

This prospective longitudinal study compares outcomes for Medicare beneficiaries receiving outpatient percutaneous image-guided lumbar decompression (PILD) using the mild® Procedure to patients undergoing outpatient laminectomy. All patients were diagnosed with lumbar spinal stenosis (LSS) with neurogenic claudication (NC).

The study included 2,197 mild® patients and 7,416 laminectomy patients. Several factors evaluated were age, gender, baseline comorbidities, subsequent surgical procedure rates, and rates of harms. Baseline data were extracted individually to allow for longitudinal analysis through a two-year follow-up.

Overall, the rate of harms and subsequent surgical procedures was similar between groups, suggesting that mild® should be considered as a treatment option, particularly for older patients with multiple comorbidities. At two-years, mild® patients experienced fewer harms and underwent more subsequent surgical procedures than laminectomy patients. The higher rate of subsequent surgical procedures for mild® may be attributable to its position earlier in the LSS treatment algorithm.

View the Full Publication

In a recent podcast from St. John’s Riverside Hospital in Yonkers, New York, Dr. Stephen Erosa discusses how the mild® Procedure can help to treat patients with lumbar spinal stenosis. Dual board-certified pain physician Dr. Erosa describes how a minimally invasive lumbar decompression, or mild®, is a relatively new procedure that may help patients when more conservative treatments don’t work.

Throughout the 15-minute podcast, Dr. Erosa discusses the typical symptoms of lumbar spinal stenosis (LSS) including the shopping cart sign, lists both traditional and current procedures for LSS, what patients can expect during and after mild®, and the research and clinical data behind the procedure.

An excerpt from the podcast includes:

“The procedure is minimally invasive and durable without needing extensive surgical time, hospital stay, or having implantable devices. So, it really is the best next step when conservative measures have not helped and injections have stopped helping, prior to moving on to a neurosurgical or an orthopedic surgical procedure.”

Listen to the podcast below:

Listen to the podcast on St. John’s Riverside Hospital’s website

The views and opinions expressed in this podcast are those of the authors/speakers and do not necessarily reflect the official policy or position of Vertos Medical.

Many providers are moving beyond epidural steroid injections (ESIs) for patients with chronic low back pain associated with lumbar spinal stenosis (LSS).

Instead of simply masking the pain caused by an enlarged ligament with epidural injections, which may only provide temporary pain relief, providers now opt for more innovative and durable spinal stenosis treatment options such as the mild® Procedure.

A Hispanic woman in her 60s, with the quote "The first epidural lasted about three months and then the pain was back. I went for the second epidural, and it didn't last two weeks. My physician said, "Well you can have one more," nd I said, "No, I'm finished with them." - mild® patient.

Managing LSS with ESIs

An epidural steroid injection, which is a medication that is injected into the epidural space in the lower spine to reduce swelling and offer pain relief, may be offered to patients with chronic low back pain from conditions such as lumbar spinal stenosis.

Recent data indicates that repeat epidural injections for patients who experience only short-term improvement may not be in the patient’s best interest in the long term. Alternative treatments, such as minimally invasive lumbar decompression, or the mild® Procedure, may be a better option for some patients.

Durability of Relief, Column 1: Epidural Steroid Injections - To achieve effectiveness over 2 to 3 years, 5 or more injections per year may be required. Column 2: mild Procedure - mild helped 88% of patients avoid back surgery for at least 5 years while providing lasting relief.

What is LSS?

Lumbar spinal stenosis, also called LSS, contributes to chronic low back pain and is prevalent in approximately 20 percent of patients over the age of 60.  LSS is often caused by an enlarged ligament in the back, which compresses the space around the spinal canal and puts pressure on the nerves in the lower back. This pressure around the spinal cord can cause pain, numbness, heaviness, or tingling in the low back, legs, and buttocks. A common visual cue is often referred to as the “shopping cart syndrome,” where the act of leaning over, often over a shopping cart, cane, or walker, helps to temporarily alleviate pressure felt in the lower back pain.

Two spinal vertebrae next to each other. Left shows a healthy spine. The right shows an aging spine with LSS (lumbar spinal stenosis). It includes a disc bulge, a thickened ligament, and bone overgrowth.

In addition to epidural steroid injections, some common conservative treatment options for LSS can include the mild® Procedure, medication, and/or physical therapy, with more invasive options including procedures such as spacer implants, spinal stenosis surgery, or other open surgery.

How exactly does an ESI work?

Epidural steroid injections are typically offered to LSS patients when more conservative treatment options, such as exercise and physical therapy, have failed to provide relief.

Steroid medication is injected directly into the epidural space, which may relieve pain by reducing inflammation around the spinal cord and nerves. The effects typically last for less than 6 months, after which additional injections may need to be administered.

How effective are ESIs for LSS?

Data shows that epidural steroid injections can effectively relieve pain for LSS patients—but the effects are not lasting, and pain may return, typically in months. ESIs treat the symptoms but do not address the root cause of pain associated with LSS.

The Dark Side of ESIs—The Downsides, Side Effects, and Risks

While ESIs are an effective form of early treatment for some patients, they may not provide reliable, lasting relief for all low back pain.

As mentioned in the Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST), certain payer guidelines, including Centers for Medicare and Medicaid Services (CMS), now stipulate that patients should have obtained a minimum of 3 months of pain relief with eventual recurrence of pain before it is reasonable to proceed with additional injection therapy.

This means that for patients exhibiting shorter-term relief of less than 3 months after receiving an ESI, clinicians should consider alternative treatment options.

ESI treatment may require repeat injections over time

Steroid medication reduces inflammation, which can temporarily relieve pain. However, epidural steroid injections only treat the symptoms of LSS—not the root causes of pain and inflammation. The effects of epidural steroid injections typically last less than 6 months, and patients often require an average of 2–3 injections per year to sustain long-term relief from low back pain associated with LSS.

A white man in his 60s contemplating the dark side of epidural steroid injections, with the quote "They gave me the first one and it worked for two weeks. I had to get a second shot, and within a week it had already worn off." - mild patient.

Repeat ESIs can have negative impacts on patient health

There are many patients for whom repeat epidural steroid injections may offer more risks than benefits. For instance, steroid medications have been linked to bone loss, or osteoporosis. ESIs may also introduce risks for patients with certain comorbidities such as diabetes, cardiovascular conditions, active infections, bleeding disorders, or those taking anticoagulant medications.

As an alternative, epidural injections without the use of steroids may be considered, as well as more advanced decompressive therapies such as the mild® Procedure.

ESI Exhaustion

In addition to the health concerns associated with repeat steroid injections, the mental and emotional effects experienced by many LSS patients can also reveal the dark side of repeat epidural steroid injection treatments.

Due to the temporary nature of epidural steroid injection relief and the requirement for repeat injections, many practices encounter patients with what is increasingly becoming known as “ESI Exhaustion.” ESI Exhaustion can be spotted in patients at any stage of LSS treatment or stenosis severity.

A woman of color, in her 60's with the quote, "I went through three rounds of injections. I had heard, 'we've had pretty good results with this.' But when you go through so many, it's like 'okay, I've heard this one before.'" - mild patient.

ESI Exhaustion Sign #1: Feelings of Hopelessness

When patients experience short-term relief for a condition as challenging as LSS, they can easily become frustrated and lose hope. LSS patients often experience debilitating pain and loss of mobility that can have a devastating impact on their outlook and optimism for the future. Losing additional time and energy to repeated appointments, procedures, and recovery times can also be detrimental to their quality of life, and some patients may start to feel hopeless if injections remain ineffective or lose their efficacy soon after receiving them.

ESI Exhaustion Sign #2: Decreased Durability of Relief

One of the more common questions patients have about a steroid injection is, “How long will the results last?” Unfortunately, with epidural steroid injections, efficacy can vary by patient, and it can be difficult to predict the degree of relief or durability of effect for the individual. While studies have shown symptom relief for up to 6 months in some lumbar spinal stenosis patients, other studies have demonstrated the limited effectiveness of epidural steroid injections.

ESI Exhaustion Sign #3: Solution Shopping

If patients are dissatisfied with their results and feel they have run out of options in your practice, they may search for another solution. By offering alternative treatments such as the mild® Procedure as an early intervention, you can retain the patients in your practice and increase productivity, while continuing to develop closer relationships and increase your reach within your community.

 

Avoiding repeat ESIs

Given the significant advances in minimally invasive spine technology, current research confirms that repeat epidural steroid injections should be reserved only for patients who experience significant and lasting relief after the injections, and/or those who are not candidates for higher-level interventions or surgical decompression.

For patients experiencing relief that lasts fewer than 3 months, clinicians may wish to consider more durable treatment options.

Move past injections and make the MOVE2mild®

While they may offer temporary relief, epidural steroid injections do not “cure” LSS. Without addressing the enlarged ligament, which contributes up to 85% of spinal canal narrowing , relief may only be experienced on a short-term or temporary basis.

Minimally invasive lumbar decompression may be the next step for long-lasting relief from LSS and to reduce pressure in the canal. By decreasing the amount of space taken up by the enlarged ligament, patients can experience decreased pressure on the spinal nerves, which may lead to decreased pain.

Performing multiple epidural steroid injections only delays patients from receiving treatment with more lasting results, such as minimally invasive lumbar decompression—the mild® Procedure.

Turning to mild® as the first line of therapy addresses the root cause of LSS by removing excess ligament tissue around the spine, proven to provide a 5-year durability of results.

The Evidence is Extensive. The Consensus is Clear. Level 1 data and real-world outcomes support mild as the gold standard of care for LSS. 5-year durability. >35 peer-reviewed publications. 16 clinical studies. Level 1 data: 2 multicenter RCT studies.

MOVE2mild® after the first ESI fails

The mild® Procedure is a short, outpatient procedure that can be performed using only local anesthetic and light sedation. The procedure is performed through a single incision in the low back smaller than the size of a baby aspirin, or the diameter of a drinking straw (5.1mm).

By removing excess ligament tissue that has built up around the spine, mild® restores space in the spinal canal. This reduces pressure on the nerves in the low back, addressing a major root cause of LSS, which can help reduce pain.

  • The mild® Procedure does not leave an implant behind, and patients typically resume normal activity in 24 hours with no restrictions
  • mild® does not require stitches, staples, or complex bandaging
    • Typically, patients leave the outpatient procedure facility with just a Band-Aid covering their incision and visit their doctor a few days post-procedure for a quick wound check to ensure healing is progressing normally
  • The safety profile of mild® is similar to epidural steroid injections, but with lasting results
  • mild® has been shown to provide lasting relief, with 88% of patients avoiding open back surgery for at least 5 years

The next step may be mild. Image outline of a woman in her 60s walking.

The mild® Difference

When Epidural Steroid Injections (ESIs) Don’t Provide Lasting Relief, mild® can improve patient outcomes across a variety of measures:

Walking/Standing

In a study performed at the Cleveland Clinic 1 year after the mild® Procedure, patients were able to:

  • increase their standing time from 8 minutes to 56 minutes with less pain.
  • increase their average walking distance from 246 feet (comparable to walking to the mailbox) to 3,956 feet (comparable to walking around the mall).

An illustration showing Increased mobility over time following the Mild® Procedure. Patient functionality continues to improve as time progresses. Stand 7x longer: Baseline at 8 minutes versus Month 12 at 56 minutes. Walk 16x farther: Baseline at 246 feet (example, walking to the mailbox) versus Month 12 at 3,956 feet (example, walking around the mall).

Pain Relief & Mobility

mild® demonstrated excellent long-term durability with significant improvements in both pain and mobility over 2 years. Clinical data from the MiDAS ENCORE 2-Year Study finds mild® provided patients with lasting pain relief and increased mobility.

Long-Term Durability

A 5-year study performed at the Cleveland Clinic demonstrated that mild® helped 88% of patients avoid back surgery for at least 5 years while providing lasting relief.  Use our Find a mild® Doctor tool to connect with an interventional pain management specialist in your local area to find out if mild® is right for you.

To learn more about mild® and how it can help people suffering from LSS get on the path to lasting relief, explore mildprocedure.com.

David Dembinski, MD, suffered from severe lower back pain for more than a decade. He was evaluated for chronic back pain and tried various prescription painkillers for years, but the medicines only went so far. He did physical therapy but didn’t experience any real improvement, and saw a chiropractor consistently for six weeks; still, nothing changed.

“About two years ago, it finally got to the point where I couldn’t do much,” Dr. Dembinski said. “I couldn’t walk very far without my back pain getting worse. I couldn’t golf. I was very functionally limited.”

He went to Saint Luke’s Pain Management Center in Overland Park, Kansas, to speak with his pain management specialist, Joel Ackerman, MD.

Dr. Ackerman told Dr. Dembinski about an innovative procedure called mild®, which stands for Minimally Invasive Lumbar Decompression. The mild® Procedure treats the root cause of spinal stenosis by restoring space in the spinal canal and has a quick recovery time.

A few weeks later, Dr. Dembinski underwent the mild® Procedure and went home the same day. After taking a couple days to rest, he said the difference was remarkable.

Read his physician-turned-patient full story on Saint Luke’s blog at the below link.

View the Full Article

The views and opinions expressed in this article are those of the authors/speakers and do not necessarily reflect the official policy or position of Vertos Medical.

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