Flip Chart
Use the 2-sided presentation tool to walk your patients through LSS, their treatment options, and what to expect with the mild® Procedure.
We’re proud to highlight Ashley Comer, A.P.R.N., NP-C, on her educational Op-Ed article in the Charleston Gazette! As a member of our Advanced Practice Provider (APP) Advisory Board and as a nurse practitioner working within Interventional Pain Management (IPM), Ashley interacts daily with patients suffering from chronic low back pain (CLBP), many of whom are simply searching for relief.
Data from a recent Harris Poll survey found that nearly 3 out of every 10 US adults currently suffer from CLBP, and over a third of those surveyed rated their back pain as “severe.” Many of these individuals visited multiple doctors, and while their pain progressed, only then considered seeing an Interventional Pain Specialist.
Read Ashley’s insights below on why patients should consider IPM at the onset of pain treatment and potential treatment options outside of the often-prescribed opioids.
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As an Advanced Practice Provider (APP), you are an integral part in helping patients with lumbar spinal stenosis (LSS) get on the path to lasting relief.
In this webinar workshop, led by our panel of mild® experts, APPs Ashley Comer, NP, Marie Zambelli, NP, Kelsey Kimball, PA, Lauren Cote, NP, Patrick McGinn, PA, Kristen Klein, NP, discuss how patient education and proper outcomes assessment play an important role in optimizing patient outcomes after the mild® Procedure.
Access the webinar here:
Looking for more info on mild® patient identification criteria?
Check out our blog: Identifying & Educating mild® Patients – APP Guidance
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Sign Up NowAccording to our Advanced Practice Provider (APP) Advisory Board, imaging review, a key aspect of mild® patient candidate identification, is often not included in initial schooling. To help APPs learn the basics of image review, become more familiar with identifying anatomical landmarks, and understand how to confirm if a patient is a candidate for the mild® Procedure, we asked James Lynch—an APP with the Pain Consultants of San Diego—to walk us through his tips and techniques for magnetic resonance imaging (MRI) review. In the following article, he shares pearls for becoming confident in imaging review and provides a series of videos so you can follow his step-by-step approach to determine if patients with lumbar spinal stenosis (LSS) should make the move to mild®.
As an APP in an Interventional Pain Medicine practice that offers the mild® Procedure, reviewing MRI images to determine the presence of hypertrophic ligamentum flavum (HLF) is a critical aspect of my role. Prior to joining this practice, I had very little experience reviewing MRI images. It was not part of the core curriculum while training to become an APP, and it was not an area that I felt very confident in. I’ve become more familiar and proficient with imaging review; however, I can say that it’s much more straightforward than it may initially seem. Through hands-on experience, by sharing clinical pearls among peers, and by watching step-by-step videos like those included in this article, I became competent, comfortable, and confident performing image reviews to identify mild® patient candidates—and I know other APPs can too.
We know that up to 85% of spinal canal narrowing is caused by thickened ligament. When we see patients with symptomatic LSS, if HLF is present, we will likely advance to mild® to provide patients long-term relief using a therapy that has a safety profile equivalent to an epidural steroid injection (ESI), but with lasting results. Being able to review a basic MRI empowers me to identify patients who may benefit from the mild® Procedure and confidently present my recommendations to them. This confidence helps build trust between me and my patients, and makes them feel more comfortable and assured prior to scheduling their mild® Procedure. Having more patients move to mild® means that I’m giving my patients a chance to achieve clinically meaningful, statistically significant improvements in mobility, Oswestry Disability Index (ODI), and pain reduction on the Numeric Pain Rating Scale (NPRS). It’s also incredibly rewarding to hear patients tell me about what they’re able to do now that they can walk further and do more activities than they could before.
LSS is highly recognizable by the signs and symptoms patients commonly exhibit, including pain, numbness, or heaviness when standing or walking, and finding relief by sitting, bending forward, or sleeping curled in the fetal position. When we see these signs in our patients, we’ll order an MRI to confirm the diagnosis and determine whether the patient is a good candidate for the mild® Procedure.
When we request an MRI, we’ll get a report and the imaging back for that patient. During my review of the report, I look line-by-line, specifically confirming whether the report notes central canal stenosis. It is also helpful to make note of other contributors to central canal stenosis (such as enlarged facets, disc bulge, etc.) in order to properly prepare a patient for potential follow-up expectations.
Tip: As you gain comfort with image review, practice reviewing the MRI first and report second to confirm their diagnoses.
In the example shown here, I would note the following:
Reminder: You can also request that the radiology report include a measurement of the HLF, which can make it easier to review.
Because I have confirmed the presence of central canal stenosis in the report, I’ll then review the imaging to determine whether the patient is a candidate for the mild® Procedure. You can also take the reverse approach and review the imaging first, and then use the radiology report as a confirmation of your own findings.
A note on software: While the specific software demonstrated in this blog is Ambra Health, much of the imaging software used today is similar in function and review procedures. Whether you’re using Ambra Health, Sharp, or another software option, the tips and tricks demonstrated in this blog should be consistent, regardless of the software you’re using.
In pulling up the images, I typically begin setting up the images to facilitate a clear and efficient review process. Begin by adjusting the layout of the software to show 2 images at the same time.
On the left-hand side, we will show the sagittal view, or vertical cross-section of the patient. On the right-hand side, the axial view, or horizontal cross-section of the patient, will be displayed.
Press the “Link” command in the system software to correlate the images together and select the STIR images (T2 weighted images).
Tip: The reason I use the T2 image is because the cerebral spinal fluid actually brightens up, making it a lot easier to assess the spinal canal.
My specific area of interest in evaluating the mild® patient candidate is the small black area, which is the ligamentum flavum, highlighted in the image here.
In the small white area, we can see the central canal where the nerves are housed. In this image, we can see that the canal is very small, with very little white showing. This is consistent with central canal stenosis, and in this case, we can see clearly that the hypertrophic ligamentum flavum is compressing the nerves.
By moving our image up to L2-L3, we can see an excellent comparison of the healthy central canal. The large white area shows that at this level, the thin black ligament is not compressing the nerves.
In the sagittal view, you’ll be able to see clearly where the spinal canal narrows, and this is helpful in identifying all levels where the central canal is stenosed.
We can also see here that the patient has a disc bulge, indicative of multi-factorial central canal stenosis.
It’s important to remember that comorbidities are common among LSS patients—in fact, a Level-1 clinical study of mild® patients demonstrated that just 5% of patients presented with central canal stenosis only. The presence of comorbidities, such as foraminal narrowing, lateral recess narrowing, or facet hypertrophy DO NOT RULE OUT patients as mild® Procedure candidates. Indeed, the same clinical study found that the majority of patients with comorbidities achieved an ODI improvement of ≥10 points at 2-year follow-up.
Using the length tool in the software, I can draw a line across the ligament (the dark area indicated in the image below) to obtain the ligament measurement.
Here, the measurement clearly shows an HLF of 6.38 mm. I will then repeat this measurement process at each of the levels that are affected by central stenosis (per the report, and as seen in the sagittal view).
Tip: As a reminder, any patients with HLF ≥2.5 mm may be considered a candidate for the mild® Procedure.
Once you become familiar with imaging review, you’ll develop your own tips and tricks that make the process easier and more efficient for you. Here are a few things that I suggest that can help when you’re just getting started:
In this video, you can see an end-to-end example of the imaging review for an ideal mild® case. In under 5 minutes, you can see how I:
When a patient can’t have an MRI, we will instead send them in for a computed tomography (CT), ideally with a myelogram. A myelogram will highlight these relevant anatomical structures, so you can see the ligament and determine the patient’s candidacy. Even if a myelogram is not an option, be sure to indicate a primary diagnosis for lumbar stenosis when you order the CT, and the radiologist will then assess that patient for lumbar stenosis and HLF.
When patients are in the office, I’ll often bring my laptop into the exam room and show them their imaging on screen. Being able to see their own anatomy, and specifically the hypertrophic ligament pressing on the nerves, is incredibly helpful to demonstrate this root cause of their LSS.
Then, I can also use the imaging to clearly point out how mild® addresses a major root cause of LSS by removing excess ligament tissue and leaving no implants behind. I’ll also show them where the nerves are being compressed and educate them about how mild® restores space in the spinal canal, which reduces the compression of the nerves. Most patients understand how the mild® Procedure works much more easily when they can see the images themselves, and it also helps them realize how the mild® Procedure can provide long-term relief and restore mobility.
When I first started with imaging review, I was much less comfortable and confident than I am today. Knowing that our practice is committed to helping more patients move to mild®, I recognized that becoming comfortable with imaging review was a critical aspect of my role. Even though MRI review was not something included in my initial APP education, I realized that becoming proficient gave me an opportunity to bring additional value to our patients and practice.
The best way I found to get comfortable with imaging review was to dive in and review previous cases so I could become familiar with the anatomy and structures. Beyond hands-on experience, there are resources that offer additional support, including:
With additional practice and experience, you’ll quickly become much more comfortable with imaging review. You’ll also notice how many of your patients with LSS have HLF and are candidates for the mild® Procedure. By putting more patients on the path to lasting relief with mild®, you’ll get to see first-hand how regaining mobility can be a life-changing improvement for the patients in your care.
Advanced Practice Providers (APPs) play a vital role in helping patients understand their lumbar spinal stenosis (LSS) diagnosis and treatment recommendations. By developing strong provider-patient communication, you’re taking the first step towards achieving positive outcomes and enhancing the patient experience.
Why is patient education so important?
Based on the data above, it is clear that patients over 65 years of age–the group most likely to suffer from LSS–may need more support to understand their condition and treatment plan. With the recognition that both lumbar spinal stenosis and poor health literacy can increase your patients’ susceptibility to poor physical functioning, pain, and limitations in activities of daily living, APPs should feel especially empowered to engage patients. This includes helpful education and dialogue that supports their understanding and helps them feel more comfortable taking the next step on their path to lasting relief.
In the following article, you will find step-by-step guidance and pragmatic suggestions that you can start using today, to help you ensure that your patients leave their consultation feeling confident and excited about their opportunity to make the move to mild®.
Watch: See APP Ashley Comer’s complete talk track for presenting mild® to her LSS patients.
Use the mild® patient brochure as a tool and follow these simple steps to help your patients better understand their lumbar spinal stenosis diagnosis and the benefits of the mild® Procedure.
Instead of using complex medical terms or acronyms, simplify your explanation with common words, phrases, and analogies to help patients understand their diagnosis and treatment options.
According to the CDC, nearly 9 out of 10 adults struggle to understand and use personal health information when it’s filled with unfamiliar or complex terms. (Source)
On the first page of the mild® patient brochure, you’ll find helpful illustrations that demonstrate the anatomical changes associated with LSS and the symptoms patients typically experience. During your patient consultation, be sure to highlight:
Many APPs and physicians use common, real-life analogies to help patients identify and understand their LSS symptoms. A common analogy that many patients may relate to is the “shopping cart syndrome.” Explaining that patients with lumbar spinal stenosis often feel relief when bending over a shopping cart (because it reduces pressure on the compressed nerves) can help patients recognize how this condition impacts their daily life.
Once you’ve established the common signs and symptoms of LSS, demonstrate what the MRI shows for that specific patient. Turn to the last page of the mild® patient brochure, where you can use the diagrams provided. Drawing directly on the patient brochure, indicate the following:
Watch: See how APP Ashley Comer uses the illustrations in the mild® patient brochure to demonstrate her patients’ specific areas of stenosis.
You can also accompany the spinal illustrations in the mild® patient brochure with an added tool, such as a spine model or the patient’s MRI to reinforce the anatomical positioning of the problem or validate the diagnosis, respectively.
Once patients fully understand their condition, walk them through all of the reasons why you recommend they make the move to mild®. If you turn back to the beginning of the brochure (or access the same information in the mild® patient flip chart) and review the remaining pages, you can quickly cover the advantages of mild® relative to other treatment options, and prepare your patients for what to expect during and after their mild® Procedure.
Because epidural steroid injections (ESIs) were historically the standard of care for lumbar spinal stenosis patients, your patient may be expecting you to recommend another injection. You can explain that the data shows that there is no benefit to giving more than one ESI before mild®, and that giving more than one ESI delays the patient from receiving the longer-lasting, more effective mild® Procedure.
Every year, thousands of lumbar spinal stenosis patients are able to stand longer and walk farther with less pain thanks to the mild® Procedure, but those results aren’t achieved overnight. Improvements in patient functionality are typically achieved over time, with patients gradually increasing standing time and walking distance. If you set expectations in advance, patients may be more excited and satisfied to see their own functional improvements over time.
LSS patients rely on APPs as critical members of their care team. Across the patient journey from diagnosing your patients’ LSS to finding relief with the mild® Procedure, APPs are key in supporting patients, helping them understand their condition, and feeling confident about their decision to make the move to mild®.
At Vertos, we recognize and support the role of APPs and are committed to providing education and resources that help you put more LSS patients on the path to lasting relief.
Don’t miss out on the latest and greatest tips and tools from Vertos.
mild® is often referred to as a “simple little procedure” that can make a major impact on the quality of life and mobility for lumbar spinal stenosis (LSS) patients. Minimally invasive lumbar decompression (mild®) removes the problem and leaves nothing behind—no implants, no stitches—allowing patients to stand longer and walk farther with less pain. A short, outpatient procedure, it is performed through a single 5.1mm incision in the patient’s lower back, addressing a major root cause of lumbar spinal stenosis by removing excess ligament tissue. Patients typically resume normal activity within 24 hours with no restrictions.
So, how do practices describe this “simple little procedure” to their patients? We like to say the mild® Procedure is similar to “removing a kink in a drinking straw,” reducing the compression on the nerves in the lower back to restore mobility and relieve pain.
We asked a group of mild® physicians how they describe the mild® Procedure and its big, life-changing potential to their patients and referring physicians. We heard a lot of fun analogies—here are a few of our favorites.
I describe mild® to my patients as a “quality-of-life procedure.”
I walk them through my algorithm and I say, “Listen: I can put a temporary Band-Aid [solution] on this for you with an epidural steroid injection (ESI), or I have a tool in my toolkit that could hopefully fix this for you where it’s not just a Band-Aid. It really improves your quality of life.”
Once you frame it this way for patients—as an epidural being a Band-Aid, with mild® being more of a definitive procedure—you have a captive audience that typically wants to go ahead and get a percutaneous decompression.
Our patients are generally familiar with cardiology procedures. So, I tell them lumbar spinal stenosis treatment options are similar to the options available for patients with coronary artery stenosis. You can either treat them with meds to improve blood flow or put in a stent to open it up more permanently. The mild® Procedure restores space around the spinal cord, just like a stent restores space in your blood vessels.
I tell patients: “Your spinal canal is kind of like your sink when it gets clogged. If your sink is really clogged, you can pour Drano down it all you want. But that’s a temporary fix, and it doesn’t work long-term. At some point, you’ve got to get in and unclog the drain.”
I describe how mild® works like fixing a room that is overcrowded with furniture. I tell them:
“Imagine a room full of tables and chairs, and you just can’t move around. What I am going to do today is just take a couple of chairs out to make some more space, so your anatomical structures can move around easily.”
“When I describe what stenosis/LSS does to a patient’s spinal canal, I compare it to having too many people in an elevator. What we do with mild® is open the door and let a few people out so that the folks remaining have more room to move freely for the ride.”
How do you describe mild® to your patients? If you have an effective analogy you use to talk about the benefits of mild® or its approach, we’d love to hear about it. Email us today. If you need additional patient resources, please contact your Vertos representative.
As a mild® provider, it’s important to brand yourself as a mild® practice to attract new patients and educate people in your community who are searching for relief from lower back pain and mobility issues. By presenting the mild® Procedure as part of your treatment offerings, you can highlight that your practice provides advanced lumbar spinal stenosis (LSS) treatment options for potential patients searching for alternative solutions to epidural steroid injections (ESIs), pain medication, or back surgery.
The following patient education, healthcare professional, and digital (web/social) resources will help ensure your practice is well-equipped in identifying and educating the community and your referral networks about LSS, and how mild® can play an effective role in a patient’s care path.
Outfit your practice so patients know you offer the mild® Procedure.
Add information about mild® to your website to help educate patients about the procedure.
Additional content and tools designed specifically for APPs to help identify and educate patients.
Build connections with referring physicians to help attract more patients to your practice.
Word-of-mouth can be one of the most powerful tools to grow your mild® practice. Encourage patients to help advocate on your behalf.
We’re here to help! Team Vertos is committed to ensuring your practice has a strong foundation of tools to educate your community about the mild® Procedure and how its benefits are transforming the lives of patients. Please reach out if you need further assistance in optimizing these resources.
To order patient education marketing materials (brochures, posters, etc.) or to schedule a staff training, please contact your local Vertos representative.
For additional marketing-related questions, please email us at mild@vertosmed.com.
Interventional Pain Management is a fast-growing specialty. As new lumbar spinal stenosis (LSS) procedures become available, practices are evolving the way they collaborate and work together to optimize patient care. The mild® Procedure’s patient selection process is quite simple, but requires imaging review, which is often not a part of Advanced Practice Providers’ (APP) traditional education.
Although image review can be intimidating, APPs report that the learning curve is relatively short and there are resources available to help you get started. Below are some tips from mild® APPs on how they quickly established comfort with imaging review in their practice, allowing them to “look for the ligament,” identify hypertrophic ligamentum flavum (HLF), and educate mild® patients independently. You can access a CME webinar on the topic below as well.
In this American Society of Pain & Neuroscience (ASPN) webinar, moderators Timothy Deer, MD; Dawood Sayed, MD and faculty members Navdeep Jassal, MD; Eugene Paik, MD; Ashley Comer, NP-C; Christine Christensen, APRN; and Zohra Hussaini, MSN, FNP-BC, MBA, APRN discuss how physicians and APPs can match more patients with the right treatments sooner by working together.
Access the WebinarEducational activity is jointly provided by Evolve Medical Education, LLC and Mantra Meetings, and is available for CME credit until its expiration date of June 23, 2022.
Looking for more info on mild® patient identification criteria? Check out our blog: Identifying & Educating mild® Patients – APP Guidance. Interested in APP-focused education and events? Sign up to stay informed and receive the latest updates!
Sign Up NowWe know that mild® is a great option for the lumbar spinal stenosis (LSS) patients in your practice—but it’s also a great way to differentiate your offering and attract more referrals from the community.
As mild® has gained more and more momentum—demonstrating a safety profile equivalent to epidural steroid injections, positive patient outcomes, and 5-year durability of results—our practice has made mild® a cornerstone of our LSS treatment algorithm. It’s certainly rewarding to see patients regain mobility and get back on their feet. Importantly, when these cases become success stories, mild® patients, their family members, referring physicians, or physical therapists become powerful advocates in the community, driving referrals and offering compelling testimonials that build credibility, motivate new patients, and improve your community’s access to this meaningful treatment.
It’s important to recognize that today, many people in our communities still think about pain management in terms of medications and epidurals. As interventionalists, we have an opportunity to educate them on the wide range of services we provide and how we can not only help manage symptoms, but also restore function, improve overall health, and enhance overall quality of life. If the mild® Procedure has yet to become part of your management of lumbar spinal stenosis (LSS), my colleagues share in a recent blog post how to integrate the procedure into an LSS treatment algorithm. Here are a few steps you should consider taking to reach and attract more patients:
As clinicians, we are often tasked with making complex concepts accessible to our patients and other clinicians, many of whom only know LSS as “chronic low back pain” or who believe options are limited to serial epidural steroid injections or surgery.
To introduce mild®, we utilize the patient education tools to emphasize several key points:
If they ask why our practice moves to mild® early in the treatment algorithm, we can reference this recent clinical study, published in Pain Management, which found that:
To help patients and caregivers access and engage with this information, I like to share a plain language summary document. It helps patients better understand how mild® can reduce the treatment burdens associated with frequent injections, provide lasting therapeutic results, and help our practice meet our primary goal of restoring function and achieving sustained improvement in quality of life.
We also use the summary to educate and build relationships with referring clinicians, many of whom are unfamiliar with minimally invasive lumbar decompression, the procedure, and its impact on care protocols. The summary is written using simple language but is very detail-rich, making it a valuable resource for health stakeholders involved in collaborative care. When we send this to practices in our network, we like to strengthen the referring relationship by:
In addition to sharing the plain language summary, it can be helpful to leverage educational videos on your website to further inform patients about the benefits of mild® for lumbar spinal stenosis.
To help patients find the information they’re looking for, create a video summary that describes the information the patient is about to see. The shorter and more concise the description, the better. You can include specific details on the benefits of mild® leading with the key points patients care most about:
Success stories from patients who have benefited from your spinal stenosis treatment offer a powerful and influential tool for creating patient awareness and should form a cornerstone of your outreach efforts. When a patient finally finds relief, they usually want to help other people who are suffering get back on their feet.
Document your lumbar spinal stenosis patients’ treatment journeys and capture testimonials so you can share them on your website and social media platforms. Teach them how to recognize the signs of LSS in their friends and family members and encourage them to share their story.
Additionally, when working with referring care providers, implement strong post-procedure communication strategies to cultivate active, engaged partnerships. Following a mild® Procedure, we inform referring providers of their patients’ results, and help them understand what the patient can expect over time.
When APPs understand that patient functionality continues to improve as time progresses, they can help manage patient expectations. APPs working within our referring clinicians’ offices also appreciate frequent status updates. This often translates into additional patient referrals and better care partnerships.
At the end of the day, our primary goal is to offer meaningful outcomes that restore function and reduce pain for patients in our community. To capture attention and positively impact more lives, it is fundamentally important that we make our communities aware of the full range of services we offer for lumbar spinal stenosis patients.
Taking this approach takes a little work but yields considerable reward. Successfully treating with mild®, using those successes to build lasting community relationships, and helping patients finally get on the path to relief, has brought our practice immense satisfaction, as well as steady increases in patients coming in to see what options we may have to treat their pain and increase their activity.
If your lumbar spinal stenosis (LSS) treatment algorithm relies on serial epidural steroid injections (ESIs) to relieve chronic lower back and leg pain associated with neurogenic claudication, data supports a different approach—performing the mild® Procedure immediately upon diagnosis of LSS or moving to mild® after the first ESI fails may help your patients avoid “ESI Exhaustion.”
We already know that epidurals are not capable of “curing” neurogenic claudication, a major root cause of lumbar spinal stenosis which is present in 94% of patients. The steroids in the injection are believed to reduce inflammation to relieve pain; however, injections are only treating the symptoms of LSS. For long lasting relief, debulking the ligament is required. Injections results typically last less than six months. To provide ongoing relief, patients often require 2-3 injections on average per year.
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. Once you start recognizing the signs of ESI Exhaustion in your lumbar spinal stenosis patients, you’ll see why so many leading clinicians are moving to mild® earlier in their treatment algorithm.
When patients experience short-term relief for a condition as challenging as LSS, it can be easy for them to become frustrated and lose hope. Patients can become tired from needing to return for repeat injections. Other patients may start to feel hopeless if the injection is not effective or if it is only effective for a very short time. It’s important to remember that LSS patients often experience debilitating pain and loss of mobility that can have a devastating impact on their quality of life.
To help your patients remain optimistic and aligned to your treatment plan, educate your new and existing LSS patients about your treatment options early. Make sure they know that there is a procedure that offers the safety equivalence of an ESI, but with lasting results. If you are starting their treatment plan with a single epidural, inform them about the mild® Procedure during that first visit, so they know that if the ESI is not effective, there are other options that can help restore mobility by addressing a major root cause of LSS.
One of the more common questions patients have about a steroid injection is “how long will the results last?” Unfortunately, with ESIs, efficacy can vary by patient, and it can be difficult to predict the degree of relief or durability of effect for each. While studies have shown pain relief for up to six months in some lumbar spinal stenosis patients receiving steroid injections, other studies have demonstrated limited effectiveness.
Even more vexing for some patients is that the durability of effect of an initial ESI may not be experienced with subsequent injections. To achieve effectiveness over two to three years, five or more injections per year may be required.
Rather than offering patients a series of injection after injection with short-term results, move to mild® after the first ESI fails. The mild® Procedure offers a clinically proven safety profile equivalent to ESIs, but with lasting results. A 5-year study completed by the Cleveland Clinic showed that mild® helped 88% of patients avoid back surgery for at least 5 years while providing lasting relief.
If patients are dissatisfied with their results and feel they’ve run out of options in your practice, they may start to search for another solution. By offering mild® as an early intervention, you can avoid losing patients and actually increase productivity in your practice. Upon diagnosis of LSS, inform patients that you offer mild®, a minimally invasive treatment option that offers durable relief.
If you have already treated a patient with an ESI and it failed, or the patient received an injection in another practice, there is no reason to continue to offer another injection. Most patients I’ve seen are excited to learn that there is another option. Moving to mild® gives them new hope in finding lasting relief.
While “ESI Exhaustion” is highly common among LSS patients, it is also completely avoidable. Recognizing that serial injections are often the standard of care when conservative care methods like exercise and physical therapy have failed to provide relief, we published a study in Pain Management that evaluated whether LSS patients benefit from multiple ESIs prior to mild®.
The article, ‘Minimally invasive direct decompression for lumbar spinal stenosis: impact of multiple prior epidural steroid injections’ compares outcomes between 145 patients receiving either 0/1 injections or 2+ injections at 6 centers in the United States. In reviewing results between the two groups, we concluded that there is no benefit to performing multiple epidural steroid injections before the mild® Procedure and that doing so delays the patient from receiving a longer-lasting, more effective mild® treatment.
Based on this study and other favorable data, we recommend performing the mild® Procedure for lumbar spinal stenosis patients immediately upon diagnosis of neurogenic claudication with hypertrophic ligamentum flavum, or after the first ESI fails.
Does your practice offer the mild® Procedure? Do you manage patient identification and education? Follow these 3 steps to optimize your practice routine:
Shopping Cart Syndrome – lumbar spinal stenosis (LSS) with neurogenic claudication (NC). These patients will often be the first ones to find chairs in your waiting room or use the walking aids, such as a shopping cart, to establish a flexed position. The flexed posture is a common sign of NC because it opens up the spinal canal to alleviate the pressure on the central canal to avoid pain that comes with being straight, upright, or mobile.
Ask patients the following questions to better understand how LSS with neurogenic claudication is limiting their mobility and when they experience symptom onset. Patients commonly report pain, so it is essential to talk about their functional limitations (eg, desire to walk the dog, get the mail, play with their grandchildren, etc.).
Consider incorporating these questions into your EMR or intake process so patients are routinely screened for neurogenic claudication.
Ask patients the following questions to better understand how LSS with neurogenic claudication is limiting their mobility and when they experience symptom onset. Patients commonly report pain, so it is essential to talk about their functional limitations (eg, desire to walk the dog, get the mail, play with their grandchildren, etc.).
Consider incorporating these questions into your EMR or intake process so patients are routinely screened for neurogenic claudication.
Hypertrophic ligamentum flavum (HLF) contributes up to 85% of spinal canal narrowing
mild® is covered by Medicare (all ages, all plan types, including Medicare Advantage), the VA, U.S. Military, and IHS. Commercial coverage varies.
mild® helps patients stand longer and walk farther with less pain.
If you would like a mild® Quick Reference Card for your office or to learn more about APP-specific educational opportunities, please contact us and let us know what you need.
What was the biggest news at the ASPN 2021 Conference? New mild® data! Five poster presentations highlight the reasons more practices are moving to mild® as a first-line therapy for lumbar spinal stenosis (LSS).
View Dr. Pryzbylkowski’s poster presentation here.
View Dr. Sayed’s poster presentation here.
View Dr. Jassal and Ms. Christensen’s poster presentation here.
Physicians and practices treating lumbar spinal stenosis (LSS) patients with epidural steroid injections (ESIs) will likely recognize a common “condition” among serial ESI patients that our practice typically refers to as “Epidural Exhaustion.” Epidural Exhaustion is typically seen in patients who have tried multiple injections but have experienced only short-term functional improvements with little to no pain relief. Many times, LSS patients who do not improve after a single ESI or series of ESIs can become frustrated, or begin to lose hope in ever feeling relief from their spinal stenosis symptoms.
While “Epidural Exhaustion” is remarkably common among lumbar spinal stenosis (LSS) patients, it is avoidable. In our practice, we have found that moving to mild® (Minimally Invasive Lumbar Decompression) earlier in the patient journey helps drive positive long-term clinical outcomes and stronger patient satisfaction. Today, we have changed our practice workflows to move more patients to mild® after their first failed ESI. We proactively communicate the benefits of the mild® Procedure to our patients at the time of diagnosis or before they begin their treatment journey in our practice, so that they understand the breadth of their treatment options. With the availability of mild® as an early treatment option for more spinal stenosis patients, we can reduce incidences of ESI exhaustion and put more of our LSS patients on the path to long-term relief.
Although repetitive epidural steroid injections are still the standard of care in many practices and instilled during our training, the data show that serial ESIs offer little benefit to long-term patient outcomes.
As noted by Heidi Younan, Director of Patient Marketing & Practice Integration at Vertos Medical, we already know that epidurals are not capable of “curing” neurogenic claudication, which is present in 94% of patients with lumbar spinal stenosis. While repetitive ESIs deliver some chemical benefit and can offer transient, temporary relief for radicular components, ESIs do not address a major root cause of stenosis. Decompression is required to reduce narrowing/triangulation and relieve pressure in the central canal.
A 2016 study conducted by Janna L. Friedly et al., studied the overall long-term effectiveness of treatment with epidural corticosteroid injections for lumbar central spinal stenosis and the effect of repeat injections on LSS patient outcomes through 12 months. The multicenter, double-blind, randomized, controlled trial with 400 patients concluded that repeated epidural injections offer no additional benefit if injections in the first 6 weeks did not improve pain. Therefore, performing multiple ESIs on patients who did not benefit from the initial injection is essentially delaying treatment that can provide beneficial and long-term outcomes.
Because of its effectiveness and safety profile, I strongly recommend moving to mild® earlier in the patient journey, after the first failed ESI. Recognizing that up to 85% of spinal canal narrowing is the result of hypertrophic ligamentum flavum (HLF), there is tremendous benefit in being able to debulk the HLF and restore space in the spinal canal, thus reducing compression of the nerves. The minimally invasive mild® Procedure enables our practice to offer a treatment option that is a step up from ESIs with the same low complication rate, but with excellent effectiveness and lasting results.
Ms. Younan also highlights that clinical studies of mild® have demonstrated clinically meaningful, statistically significant improvements in mobility, Oswestry Disability Index (ODI), and pain reduction on the numeric pain rating scale (NPRS). More recent 5-year data shows that after undergoing the mild® Procedure, only 12% of patients required surgical decompression at the same level over 5 years. Stated differently, mild® gives the potential to help 88% of patients avoid surgical decompression surgery for at least 5 years, while providing symptomatic relief during that time.
Beyond the individual clinical benefits, I also advise other pain specialists that there are many practice-driven reasons to offer mild® in lieu of serial epidural steroid injections. The MiDAS ENCORE level 1 data demonstrated an exceptionally high 85% patient satisfaction rate among patients who received the mild® Procedure. Patient satisfaction is a key benchmark in our practice. With the mild® Procedure, we have seen tremendous patient satisfaction, and we know that those patients tell their friends, relatives, and neighbors about their positive results, which increases word-of-mouth to our practice.
My goal as a physician is always to assess where the patient is in their treatment journey, the impact of lumbar spinal stenosis symptoms on their lifestyle, their priorities for the procedure (such as a minimally invasive approach or a short recovery time), and their treatment history to determine the best path forward for that individual.
This purpose of this article is certainly not to challenge any and all use of ESIs within the modern pain or spine practice. ESIs can be an effective tool and are a critical part of our practice armamentarium. For some patients, ESIs offer significant benefits; however, evidence and experience demonstrate that ESIs are not a one-size-fits-all solution. Many patients with LSS fail to achieve significant pain reduction, while others who do experience pain reduction or functional improvements find those benefits to have limited durability.
In our practice, we still commonly begin a lumbar spinal stenosis treatment plan with a conservative approach to determine if an ESI will effectively reduce the symptoms of LSS. Once we understand how our patient responds to an ESI, we can determine the best treatment plan for the patient. If they have a good result with an ESI, we suggest that they resume normal activities and self-monitor for changes over time. On the other hand, if they do not see significant benefit from the initial ESI, I will strongly consider them as a candidate for mild®, and barring any contraindications, we typically schedule their mild® Procedure within a few weeks.
A powerful message for patients looking for significant relief is that we will start their LSS treatment with an ESI, but we’ll also be able to know very quickly if the epidural steroid injection is going to be successful for them. When patients understand that they have other minimally invasive, nonsurgical options, they may be less concerned if they experience limited relief from their first ESI.
The key question is, “At what point can we reliably assess whether an individual patient will benefit from serial ESIs?” Here again, we can look to the Friedly data showing that repeated epidural injections offered no additional long-term benefit if injections in the first 6 weeks did not improve pain. Based on this data and the results we’ve seen first-hand in our own practice, we know that we can assess our LSS patient results post-ESI and determine whether we should move them to mild® earlier in their treatment journey.
(Graphic courtesy of Vertos Medical)
One of the most significant ways our practice has shifted after the adoption of mild® is that we now evaluate most patients as potential mild® candidates. If we suspect LSS, we present mild® as a treatment option from the start. In making this shift, we have discovered a few clinical and workflow pearls that optimize success across the practice.
1. Train staff to recognize patient symptoms
Because LSS is especially common among adults over 60 years of age, and our practice treats a high volume of senior patients, we have found that many of our existing and new patients are excellent candidates for mild®.
Our practice trains our APPs and other support staff so they can immediately recognize the signs and symptoms of LSS independently. Of course, we ultimately diagnose LSS and neurogenic claudication with the support of imaging, but I always remind our staff and patients that imaging can’t show pain. As a healthcare team, we need to be proactively asking questions like, “Does hunching forward significantly relieve the pain you’re feeling?” or “Do you feel pain in your back and legs when standing or walking?” If the answer to either question is yes, we know there’s a good chance that patient may be candidate for mild®.
Younan also notes that the Vertos team has developed resources and training to support APPs. All resources are available through your Vertos sales representative.
2. Look for the ligament
When reviewing a patient’s MRIs/CTs, a simple rule we use is “look for the ligament.” Hypertrophic ligamentum flavum is a common problem that contributes up to 85% of spinal canal narrowing. We have trained our APPs to apply this rule while reviewing images to help identify patients who may benefit from the mild® Procedure.
In the image, the thickened ligament can be seen clearly, resulting in compression of the spinal cord nerves.
3. Present mild® in your initial LSS treatment plan
When we work with patients, we make sure they know that our focus is on improving their functionality and reducing pain. We are clear from the start that we’re going to evaluate their symptoms, treatment history, and goals to determine their best treatment pathway based on the latest evidence and techniques.
Patients are generally open to the idea that a therapy that works for one patient might not work for them. So, I typically tell the patient, “We are going to start with a single epidural, and we’ll be able to know quickly if the epidural is going to be effective for you.” I also let them know that if they do not experience a significant improvement after the epidural, or if those results wear off after a short period, we can still help them with proven, minimally invasive options. Then, I tell them about the mild® Procedure, and how it offers a safety profile similar to an epidural, but with lasting results.
By presenting mild® as part of the treatment plan from the start, patients have more confidence that we are going to be proactive in their care and make sure they have the opportunity to access advanced LSS treatment options that offer excellent outcomes.
Overall, the addition of mild® has been a real game-changer in our practice. We see mild® as a safe and effective alternative to serial ESIs that drive long-term patient improvements and high patient satisfaction—a treatment we make available to as many patients as possible, as early as possible. I regularly tell other interventional pain specialists to incorporate mild® in their practice, and once they see the impact it has on their patients, they understand why we are so passionate about moving to mild® after failure of the first ESI.
About Dr. Jason Pope
Jason Pope, MD, is an Interventional Pain Physician trained in Pain Medicine at the Cleveland Clinic with board certifications in Anesthesia and Pain Medicine. He completed an Anesthesiology Residency at Vanderbilt University Medical Center and received his medical degree from the Indiana University School of Medicine. Dr. Pope is the Founder and CEO of Evolve Restorative Center in Northern California and serves as an expert reviewer for the Medical Board of California. Dr. Pope also serves as President Emeritus and Chairman for the Pacific Spine & Pain Society (PSPS), President Elect for the American Society of Pain & Neuroscience (ASPN), Director at Large and Chairman for the International Neuromodulation Society (INS), and Chairman for the North American Neuromodulation Society (NANS).
About Heidi Younan
Heidi Younan is the Director of Patient Marketing & Practice Integration at Vertos Medical. A critical member of the Vertos team for over a decade, Ms. Younan works with clinicians, APPs, and patients to support the successful integration of the mild® Procedure in pain practices and help more patients experience the life-changing benefits of mild®. Ms. Younan also contributed portions of the clinical content within this article.
The objective of the study “Use of Epidurogram is Not Necessary for Safe, Minimally Invasive Direct Lumbar Decompression” was to investigate the safety of using osteal landmarks vs an epidurogram to establish a visual safety barrier prior to decompression with the mild® Procedure. A retrospective data analysis was performed on 147 patients that compared those receiving an epidurogram with performance of the mild® Procedure versus those that did not. View the abstract poster below to learn more about the outcomes.
Watch Dr. Jason Pope present his abstract from the American Society of Pain and Neuroscience’s (ASPN) Third Annual Conference where he shares why the use of an epidurogram is not necessary for safe decompression with the mild® Procedure.
Eager to further understand the mild® Procedure and how it can put your lumbar spinal stenosis patients on the path to long-term relief? Contact Vertos Medical and discover why leading interventionalists offer mild® in their practice.
This study was recently published in the Journal of Pain Research, click here to view.
Jason Pope, MD (00:00)
Well, welcome everyone. My name is Dr. Jason Pope. I have a practice in Northern California serving Napa, Sonoma, Mendocino counties and I’m here today to talk a little bit about an innovative strategy that we had in performing the mild® Procedure. And the question that we were trying to answer with this was essentially, “Is the epidurogram necessary when executing the mild® Procedure on patients, whether you’re going to perform a single level or a multilevel strategy?” And so we retrospectively looked at 147 patients. So we can see here the female to male breakdown along with a median age of around 77. And we looked at patients that either got the epidurogram with performance of the mild® [Procedure] versus those that did not. And we did so equitably across the patient population that we were serving. And as we can see with a stenotic level, clearly the most common areas that were performed were at L3-4 and L4-5 and that’s no surprise. And then we looked at patients whether they were done as a single level or a multilevel. And we can see here that the breakdown of these patients where 54 patients received contrast, 42 non-contrast, in a single level. And the most common level that was performed was at L4-5. But what was also very interesting was in this retrospective review, again, of about 147 patients, about 80% of them had the procedure done bilaterally if it was at a single level. And interestingly enough, when we did a multilevel mild®, and in this cohort, it represented at least two levels, the most common level that was the index level of where it was treated was at L3-4 and bilaterally, this was performed nearly 50% of the time. So when people do multiple levels of [the] mild® Procedure, the unilateral reality based on symptoms changes a little bit as compared to if you were doing a single level.
(02:27) And again, this was done over a total cohort of 147 patients. And the way that this came about and again, we highlighted the fact that when we looked at the use of epidurogram in managing patients with spinal stenosis symptomatically, with the mild® Procedure, it wasn’t clear that it really offered an increase in safety. And it wasn’t clear that it highlighted when the decompression was completed because epidural flow after decompression doesn’t necessarily increase after the ligament is trimmed or resected. So we looked at trying to simplify the procedure, and this was done just by using the osteal landmarks. And we can see the facet line and the laminar line in the middle section of the abstract presentation here. And I can say with confidence, using osteal landmarks alone as compared to the epidurogram, and we use the midline incision, the refined Streamlined Technique that you all have come to know and love, that in performing this, there were zero complications, as defined as problems with infection, nerve injury, allergy to contrast, which is something that can happen, but clearly in this cohort, it did not.
And so there were zero complications performing either one level or multilevel [mild®], either unilaterally or bilaterally with contrast or without contrast. So this underscores the importance and the strategy that if one chooses or elects to not use the epidurogram in performance of the mild® [Procedure] you can do so safely, based on this patient cohort. So again, appreciate your time. I want to also thank my co-authors associated with this project, Dr. Timothy Deer and Dr. Steven Falowski. And I want to also thank the Vertos team for helping with the assembly of the abstract. So with that, thank you.
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.
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.
2012 data from Health Market Sciences report for Vertos Medical 2013.
Data on file with Vertos Medical.
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.
Based on mild® Procedure data collected in all clinical studies. Major complications are defined as dural tear and blood loss requiring transfusion.
MiDAS ENCORE responder data. On file with Vertos Medical.
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.
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.
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.
Treatment options shown are commonly offered once conservative therapies (e.g., physical therapy, pain medications, chiropractic) are not providing adequate relief. This is not intended to be a complete list of all treatments available. Doctors typically recommend treatments based on their safety profile, typically prioritizing low risk/less aggressive procedures before higher risk/more aggressive procedures, but will determine which treatments are appropriate for their patients.
Although the complication rate for the mild® Procedure is low, as with most surgical procedures, serious adverse events, some of which can be fatal, can occur, including heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood or fat that migrates to the lungs or heart). Other risks include infection and bleeding, spinal cord and nerve injury that can, in rare instances, cause paralysis. This procedure is not for everyone. Physicians should discuss potential risks with patients. For complete information regarding indications for use, warnings, precautions, and methods of use, please reference the devices’ Instructions for Use.
Patient stories on this website 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.
Reimbursement, especially coding, is dynamic and changes every year. Laws and regulations involving reimbursement are also complex and change frequently. Providers are responsible for determining medical necessity and reporting the codes that accurately describe the work that is done and the products and procedures that are furnished to patients. For this reason, Vertos Medical strongly recommends that you consult with your payers, your specialty society, or the AMA CPT regarding coding, coverage and payment.
Vertos Medical cannot guarantee coding, coverage, or payment for products or procedures. View our Billing Guide.
Vertos is an equal employment opportunity workplace committed to pursuing and hiring a diverse workforce. We strive to grow our team with highly skilled people who share our culture and values. All qualified applicants will receive consideration for employment without regard to sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender identity, physical & mental disability, medical condition, genetic information, veteran status, or any other basis protected by federal, state or local law.
Hall S, Bartleson JD, Onofrio BM, Baker HL Jr, Okazaki H, O’Duffy JD. Lumbar spinal stenosis. Clinical features, diagnostic procedures, and results of surgical treatment in 68 patients. Ann Intern Med. 1985;103(2):271-275. doi:10.7326/0003-4819-103-2-271.
Kalichman L, Cole R, Kim DH, et al. Spinal stenosis prevalence & association with symptoms: The Framingham Study. Spine J. 2009;9(7):545-550. doi:10.1016/j.spinee.2009.03.005.
Fukusaki M, Kobayashi I, Hara T, Sumikawa K. Symptoms of spinal stenosis do not improve after epidural steroid injection. Clin J Pain. 1998;14(2):148-151. doi:10.1097/00002508-199806000-00010.
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
Friedly JL, Comstock BA, Turner JA, et al. Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial. Arch Phys Med Rehabil. 2017;98(8):1499-1507.e2. doi:10.1016/j.apmr.2017.02.029
Pope J, Deer TR, Falowski SM. A retrospective, single-center, quantitative analysis of adverse events in patients undergoing spinal stenosis with neurogenic claudication using a novel percutaneous direct lumbar decompression strategy. J Pain Res. 2021;14:1909-1913. doi: 10.2147/JPR.S304997
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
Abstract presented at: American Society of Pain and Neuroscience Annual Conference; July 22-25, 2021; Miami Beach, FL.
Mobility Matters: Low Back Pain in America, Harris Poll Survey, 2022. View data and full summary at knowyourbackstory.com.
Deer TR, Grider JS, Pope JE, et al. Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST): Consensus Guidance from the American Society of Pain and Neuroscience (ASPN). J Pain Res. 2022;15:1325-1354. Published 2022 May 5. doi:10.2147/JPR.S355285.
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Now Offering mild®
We are excited to announce that we offer the minimally invasive mild® Procedure for patients with lumbar spinal stenosis (LSS). This short, outpatient treatment removes a major root cause of lumbar spinal stenosis through an incision smaller than the size of a baby aspirin and has shown to significantly improve LSS pain and mobility.
Get in touch with [PRACTICE] to see if you may be a candidate for the mild® Procedure at [PHONE #] or [WEBSITE].
Symptoms of LSS
Pain, numbness, heaviness, and tingling in the lower back, legs, or buttocks when standing or walking are common symptoms of lumbar spinal stenosis (LSS) that can make doing everyday tasks unbearable. The minimally invasive mild® Procedure addresses a major root cause of stenosis, by restoring space in the spinal canal to help improve back and leg pain.
Find out if you may benefit from the mild® Procedure by contacting [PRACTICE] at [PHONE #] or [WEBSITE] today.
Patient Education Video
A common condition typically found in those over age 50, lumbar spinal stenosis (LSS) contributes to pain and mobility issues and may impact the ability to perform simple tasks. Watch this short patient education video to learn how the minimally invasive mild® Procedure may help those with LSS achieve lasting relief.
Find out if you may benefit from the mild® Procedure by contacting [PRACTICE] at [PHONE #] or [WEBSITE] today.
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