Rick: Good afternoon, and welcome to the Tuesday webinar series, “Chiropractic Economics Webinar for Doctors of Chiropractic.” I’m Rick Vach, Editor-in-Chief of Chiropractic Economics. Today’s webinar concepts on spinal bracing is sponsored by Aspen Medical Products. And as always, our program is being recorded and will be archived at Chiropractic Economics website for one year.
Our expert is on board here today to speak with you and, when this presentation is complete, we’ll follow with a Q&A period. You can submit questions throughout the presentation by clicking on the appropriate icon on the right side of your screen. Our presenter today is Brantley Stricker, PT, DPT, who has a doctorate degree, physical therapy from Maryville University. Brantley spent several years in clinical roles in both inpatient and outpatient settings. He was hired by Aspen Medical Products in January, 2017, as a product specialist and was responsible for the Kansas, Missouri, Southern Illinois territory.
Brantley has had immediate success with both surgical and non-surgical specialists because of his background in physical therapy and his understanding of spinal bracing concepts. Dr. Stricker, thank you for taking the time to participate in our webinar and for sharing your expertise with concepts and spinal bracing and helping clear up some of the common myths and misconceptions. Before we get started, Dr. Stricker, can you please give us a brief background of your work with spinal bracing and Aspen Medical Products?
Brantley: Yeah, Rick. I’ve been with Aspen for 4 years as a product specialist or a local field rep. I work primarily in the non-operative marketplace, which is kind of a growing trend in our company. Prior to that, I spent 5 years working in an outpatient orthopedic physical-therapy clinic, and I worked a little part-time inpatient at a local hospital as well.
Rick: Thank you, Dr Stricker. And now, well, I’ll hand it over to you and we’ll begin the presentation.
Brantley: Thanks, Rick. Yeah. So, before I jump in, just to expand on my background a little bit. So, during those 5 years that I was in clinical practice as a physical therapist, outpatient setting, I spent a lot of time treating low-back pain patients, I think about 50% of the physical therapist’s time in the clinic is spent on spine pain. And in those 5 years, I never once generated an order for a lumbar brace for pain or anything, quite frankly.
So, whenever I began working for Aspen and noting the non-operative, you know, pain-relief market that Aspen works in, it was intriguing to me that I never really understood or knew about this device and its therapeutic applications, as a treatment device for conservative low-back pain management. So, that’s just a little bit about my background. We’ll just get right into the seminar.
There is a picture of me in a suit, that’s real nice. So, to overview current spine-pain research, we’re gonna look at trunk musculature, spine kinematics, and then review some spinal-bracing biomechanical research, and then, some spinal-bracing outcome-related studies.
This very first slide is probably our most important piece of information that we can share today, and it’s one of our biggest objections whenever we’re trying to find new users or to advocate for using bracing for low-back pain management. As you guys can see, there’s a misconception shared by about 50% of physicians, therapists, and nurses. And I would say that that 50% that spine bracing to be useful for back-pain care don’t really understand what type of brace is really relevant. If I were asked by a patient, you know, prior to work for Aspen, “Hey, Brantley, what do you think about me getting a brace?” I probably would’ve talked them out of it or I probably would’ve referred them to a retail shop like a Walgreens, or a Target, or a Walmart to just get a brace from the shelf. Which is not really supported by science or any kind of outcome studies, and we’ll review that here toward the end of the seminar. But that was just my clinical behavior and that’s something that I’ve kind of witnessed over the 4 years of working in the clinics and, you know, presenting on this, educating, and marketing these devices to clinicians.
So, more recently, or in 2017, a systematic review was published by Azadinia that reviewed all of the literature on the subject of bracing related to trunk-muscle function. And this particular author found no evidence that bracing of any type resulted in muscle atrophy of the trunk muscles. So, that was profound. When I started in 2017, that was a very important piece of literature for me whenever I was trying to sell this concept to new users.
To follow up on that literature review, Azadinia…she produced a randomized control trial on the same subject, she wanted to tease out if…she actually designed a study, and they used a particular brace throughout their day for 7.5 hours, if it resulted in, not just trunk-muscle weakness, but very important muscles, the lumbar multifidus, transversus abdominis, and obliquus internus, you know, your core stabilizing muscles. And the brace had no effect on that musculature. So, we can conclude that bracing doesn’t have a negative side effect in regard to creating or inducing muscle atrophy as many of us maybe have believed or were taught in school through traditional, you know, medical teachings.
And then, this is an important…maybe even the second most important thing that we have going for us right now, but we were fortunate enough to meet with the chief medical officer for the Health and Human Services department last year. They were developing a pain-management best-practices report to combat the opioid epidemic and they were looking for, you know, non-opioid type tools and devices to manage pain. And we met with the CMO and discussed some of the evidence that I’m gonna review here in just a little bit, and she agreed that it should be part of their toolbox. And the task force included bracing for the first time in a pain-management practice guideline. So we’re really happy with that and it’s a great guideline throughout, but this section is in the restorative-therapy section, so it’s part of like the physical therapy, you know, manual therapy, [inaudible 00:07:32], all those types of modalities, bracing is now included in that section for the first time, like I said, a guideline supporting bracing for back-pain management.
So, as we all know, back pain has high incidence and prevalence. If you look at these numbers, when prevalence starts to overcome the incidence, you know that there’s a chronic or recurrent nature of the condition, which we all know this but I just wanted to cite some epidemiologies for statistics’ sake.
Low-back pain, the most common type of spine pain, it’s the second most common reason to visit a doctor. And you can see all the functional impairments and disabilities related to back pain and suffering from it.
So, I’m going to jump into trunk-muscle function and some of the biomechanics. So, looking at trunk-muscle flexion, we’re thinking about rectus abdominis, some of the stability muscles, transverse ab, and the obliques. Trunk-extension muscles, we think about the erector spinae, the big strap muscles, the prime movers of the spine.
This next slide is far more important to me, we’re looking at this transverse cut of the lumbar vertebrae. And the muscle that we’re gonna talk about mostly today is the multifidus, which is tucked in there next to the spinous process and the facet joint, and it is a vital muscle for lumbar stability. It compromises about 70% of your spinal stiffness in the neutral zone. So it’s a very important muscle, and unfortunately, when there’s a back injury, it becomes dysfunctional quite quickly. So…
So, moving forward, when we’re talking about bracing, I think a lot of folks think about rigid braces or trying to lock somebody in a particular range of motion, trying to hold them in neutral or something like that. But that’s really not what the braces we’re talking about today are trying to accomplish. They’re semi-rigid, or they’re flexible by design, so they’re not really trying to block a whole lot of motion. So, whenever we think about what the brace is doing, it’s more important to think about not so much the quantity or a certain range of motion, flexion, extension, side bending, rotation but to think about the arthrokinematic motion, or the slide and the glide that’s going on, that quality of motion that occurs in the vertebrae as you move.
So, from a practical perspective, think about a patient that may have normal range of motion, full range of motion bending forward but they have pain. So something’s not quite right there. And another way to kind of think about this quality of motion or what we’re really trying to treat with the braces, say, a patient has flexion to 20 degrees, and then, they have severe pain which limits their full range of motion. We put them in a brace, an Aspen brace, a semi-rigid brace, and the patient may be able to flex 40-50-60 degrees without pain. So we’re not really trying to block, you know, quantity of motion, we’re trying to treat the quality of motion or improve some of the arthrokinematics. And we’ll get into why maybe those arthrokinematics are dysfunctional here in just a little bit. But if you’re looking up common medical terminology on this kind of concept, painful arc is one term that describes it, or aberrant spinal motion, or functional instability. These are all common terms kind of describing a poor quality of motion that we’re hoping to improve with our brace.
So, just to confuse you guys…no, I’m just kidding, this is a picture of a shoulder, just because it’s a little bit easier to illustrate poor arthrokinematics and then proper or normal arthrokinematics. So, in the top-left picture, you can see the the humerus head is seated nicely and you have your subacromial space. In the bottom-right picture, you can see that the humeral head is navigated a little superiorly and it’s creating some shoulder impingement. So, why that’s happening I’m not quite sure but we can all guess that there’s likely a rotator-cuff muscle dysfunction and that’s what’s allowing that humeral head to translate superior. So when we look at the spine, you know, we’re thinking about stabilizing muscles a lot here today, or that’s what we’re gonna discuss primarily. Rotator-cuff muscles are stabilizers of the shoulder. The multifidus muscle is the stabilizer of the spine. So looking at lumbar instability or poor quality of motion, poor arthrokinematics, this is a picture of a flexion-extension test, but you can see it’s a little bit harder to really illustrate this instability in the spine, even with a good picture like we have here. But you guys are probably familiar with this test. Patients in neutral picture, flexion picture, you can see that anterior translation. I’m not sure if they have a pars fracture or spondylolisthesis or if this is a case of, you know, muscular dysfunction and functional instability, it doesn’t matter. It’s just illustrating this poor arthrokinematics or quality of motion that we would, hopefully, try to be able to treat with a brace.
So, spine biomechanics, the key point is the multifidus contributes to nearly 70% of the stiffness on the lumbar spine by muscle contraction. And it’s active throughout the entire range of motion, so it doesn’t get to take a break.
And this is just a EMG picture of the multifidus not getting a chance to take a break and it just shows you how vital it is throughout the entire range of motion. This was a study produced by Jacek Cholewicki on just spine muscle function throughout the range of flexion and extension. So, if you look at this graph, you can see the dots on the left side, and we’ll just focus on the rectus abdominis, it’s the dot that’s the very highest on the left and goes down sharply. So, a patient is in trunk extension. As we go from left to right, patients and trunk extension, as you all can see and understand, the rectus abdominis is very active. And as the patient approaches neutral, the rectus abdominis silences a little bit. And as they go into flexion, the extensors the erectors spinae start to kick on and do their job. But hopefully you can appreciate that dark line, we have a pretty blue arrow pointing at it, that’s the multifidus muscle, so you can appreciate its function is vital throughout flexion, neutral zone, and extension. So it’s an important muscle and it’s vital to spine health.
So, I may mention the words stiffness and stability synonymously and I feel like that’s okay, I feel like, from a clinical perspective, we have the terminology of stability or core stabilization. We know what we’re talking about. But if you look up some of this research and you read into this a little bit after this discussion is over, you’ll see the word stiffness mentioned. And it’s not in a negative connotation, it’s simply the way to measure spine stability because stability doesn’t have an engineering calculation, you can’t measure stability. So the authors typically remark spine stiffness or trunk stiffness, where as a clinician would likely say, “Trunk stability,” or, “spine stability.” This particular research that I quoted here, “The Six Blind Men and the Elephant,” it’s interesting to me because these are some of the most prestigious spine biomechanical professors that have produced numerous articles on the subject and they don’t always quite agree on how they use stability as far as a term in their papers. So, when you’re reading this and you become confused, it’s for a reason. Their papers aren’t all produced in conjunction, so it can get a little bit confusing. And they even know that, so…
The next article I’m mentioning is just a negative connotation that’s associated with stiffness in the back. So this was a study that was produced a couple years back by a number of professors. But one in particular that I think is very a interesting speaker is Lorimer Moseley, he’s a neuroscientist and a physical therapist. But they were looking at is a complaint of stiffness from a patient, an actual mechanical change in the spine or is it perceptual, you know, inference, so, “Is it something that the mind creates?” And what they found in this paper is patients that reported stiffness in their back did not actually have stiffness or a mechanical stiffness in the spine, they had the opposite. So we may feel this consciously, the stiffness, but it’s not a true perception, it’s a false perception. So just different data points on stiffness and stability, just to kind of provide some clarification if you’re getting confused on me saying stiffness and stability and whatnot and how that relates to back-pain patients.
So, like I mentioned earlier, the multifidus muscle is kind of the key component of this discussion. But when we’re looking at a few pictures here in a minute, I wanted to cite these articles because it’s where we picked up these pictures. But this first article is probably the most relevant to understanding what’s going on in the spine, and the lumbar multifidus and atrophy concept. This author injected piglets, baby pigs, with an irritant solution to induce a back injury in the disc and in the nerve root. And what they observed was rapid multifidus atrophy within 48 hours. They saw 25% reduction in cross-sectional area, so a one-fourth of that muscle decomposed in 48 hours following that experimental injury to the disc or nerve root. That’s important for us to understand, an acute low-back injury could relate to the same thing, and we’ll review some patients here in just a minute. The “Muscle Control and Non-Specific Chronic Low-Back Pain” article, I decided it because a number of the photos that we’re gonna look at are from that article. And it’s an interesting article that discusses this lumbar-multifidus atrophy concept but it also talks about some neural-modulation techniques that some of the interventional pain-management doctors are doing. And it seems to be a novel idea and it makes sense but what they’re doing is they’re implanting basically NMES, or Russian stim units, implantable into that muscle belly, or the multifidus muscle, to try to stimulate it to recover its function through, you know, their stimulator. I don’t know that that product has moved forward in the market or whatnot but it’s a really good article on the concept, it was published back in 2017.
So, we’ll start on the right side, that column on the right. You can see, I drew a little yellow line just to show where the multifidus is in relation to the erector spinae. But the patient on the top, they have a healthy muscle mass and obviously they’re not in any kind of pain or have any sort of dysfunction. But as you move down to kind of a subacute, and then, a chronic state of low-back pain, you can see how much that muscle composition changes. Not only is it atrophying or its cross-sectional area is reduced but there’s also fat infiltrating the area, so the body is changing that space into just fat. And then, across the bottom, there’s some studies that are grading the amount of fatty infiltration in the musculature, so you can see Grade 0,1 and 2, just depending on how much fat is infiltrating where the lumbar multifidus muscle should be or was.
And this is another concept, this is just kind of discussing this point in a little more specific nature unilaterally. You can see on the top, there is a posterior lateral disc bulge. So, on the left side, top left, there is a posterior lateral left disc bulge. And you can see, in slide C and D, that the decomposition, or the lumbar-multifidus atrophy and fatty infiltration, is occurring more on the left than the right, which is something that researchers have started to notice in general as well. And then, on the other side or on the right side of the slide, you can see these cross-sectional areas. B level looks decent. There’s a little bit of fatty infiltration. Obviously C is very pathological and degenerative in nature. And you can tell, you know, on the cross-sectional image on C, that there is significant lumbar-multifidus atrophy and fatty infiltration.
I just wanted you guys to maybe visualize some of this. I know that you probably have maybe seen this before but I wanted to kind of show you all, and then, discuss a few scenarios where I was in different medical practices, interventional pain practices, where I was discussing…there’s one in particular. I was with a nurse practitioner and we were reviewing the slide, I was showing her what I was talking about, trying to get her to start using bracing for conservative low-back pain management. And just had a patient in with an MRI, and I asked her if she could pull it up so we could do some splicing and slicing and work our way down through the spine. This patient had a very obvious deteriorated segment and it looked just like the slide, it looked decent, healthy, until we got to the vertebral level that degenerated significantly and she had literally no multifidus muscle left and it was all pretty much fat at that point. So, it was convincing to that nurse practitioner that, you know, bracing that patient would make sense, the use of bracing for pain relief. But that’s just one story. I don’t think there’s a whole lot of surgeons that really appreciate this concept either. And, you know, you guys know what I’m talking about there. But…moving forward.
So, looking at some of the kind of common medical procedures to treat low-back pain or low-back injury or conditions, the top left is a radiofrequency ablation. And this is a treatment that is pretty common in interventional pain-management practices. Essentially, they’re introducing a hot or a cold needle to the medial branch of the dorsal rami, which innervates the facet-joint capsule. We all know that it carries the afferent nerve or the pain signals up into the brain which causes suffering and whatnot, but that nerve also carries motor control and output to the multifidus muscle. So, if you ablate that nerve, you’re gonna experience muscle dysfunction and atrophy and fatty infiltration which could lead to degenerative changes in the facet joint and the vertebrae, the disc, at that level.
So, moving forward, retractor-related muscle damage, obviously this is just mechanically- [inaudible 00:25:01] and the muscle tissue is did not survive the surgery. And implications for this is, you know, if the patient is undergoing an L4 L5 surgery and they have retractor-related muscle damage, you know, we know that the deep multifidus muscle, it transverses one segment or it connects, you know, adjacent vertebrae, but some of the more intermediate and superficial fibers transverse two, three, four, and five lumbar vertebrae. So that could relate to some of the, you know, degenerative changes in adjacent level disease that you see with lumbar-fusion surgeries. But those are just a few outcomes or treatments that we may be able to avoid if we can get proper conservative care in time.
This is just reiterating the same point but just in a functional EMG. So, this study was just using electromyography to measure muscle function compared to pain intensity and resting muscle thickness, so cross-sectional area in relation to pain duration. So, when we look at that muscle composition and its cross-sectional area, you can see, on this left chart, as the years go by, patients result in less and less and less resting thickness or cross-sectional area. So the muscle is deteriorating slowly and gradually over time. This other slide on the right is important because it shows pain intensity relates to that muscle function. So, if a patient is in, you know, 4, or 5, or 6 visual-analog-scale pain, you can predict that muscle function is going down accordingly. So, as a patient’s pain intensity increases, the muscle function reduces. So, from a clinical perspective, if a patient, you know, is going to therapy and they have five, six pain on a visual-analog scale and you’re trying to provide them some sort of core-strengthening program or whatnot, if the pain is not mitigated or the pain is not relieved, the muscle can’t recover, it can’t function, you can’t retrain it when it is inhibited or it’s not functioning due to this pain. So, from a clinical perspective, a patient comes in, 5 out of 10 pain is there throughout the treatment session, that therapeutic exercise dosage is not facilitating the multifidus muscle. So, first reduce the pain and then try to restore and rehabilitate the muscle. It’s kind of the take away from that, [inaudible 00:27:57] that chart for me.
So, in conclusion, in general, low-back pain, facet-joint, disc, nerve-root genic pain conditions contribute immediately to multifidus atrophy. So, from a takeaway message, spine pain induces multiple atrophy, which results in spine instability or a loss of stiffness. In an environment of spine-system dysfunction, there’s a cascade of events following spine injury that makes bracing for pain relevant.
Just one other data point. So, as far as prevalence or the incidence of lumbar-multifidus atrophy and fatty infiltration, it correlates to about 80% of patients that have low-back pain. So, you say, “Well, it’s not 100%,” but you have to also include the amount of patients that maybe don’t have a mechanical-type back pain, maybe you’re having a psychosomatic-type of back pain condition. So, if you conclude that, you know, those patients are in this survey, it’s probably one for one when you’re actually looking at true mechanical low-back pain conditions correlated with lumbar-multifidus atrophy.
So, just to review on with the little illustration, I like this chart, hopefully, it makes sense to you all as well. The top left is a normal loop, it’s a happy loop. So, if we’re looking at this Neuromuscular Control Unit, Brain and Spinal Column, it provides signaling to your muscles, and then, the muscles provide motion and stability to your spine. When the spine is happy, it provides proper proprioceptive feedback and it is a complete loop, so you have good normal fluid motion. Whenever there’s an injury to the spinal column, be it a disc, facet joint, nerve root, something of that nature, a true mechanical pain, the proprioceptive feedback is joined by a nociceptive pain signal. When that pain signal reaches the neuromuscular system, there is a loss of neural drive or there’s an inhibition to the musculature, primarily the multifidus. So then the spine loses stability and it loses proper fluid qualitative movements. So you have this self-perpetuating situation where there’s an injury, and then, you have a neuromuscular reflex that creates an inhibition of the musculature. So, there’s a few different terms in the literature, pain inhibition, reflexive inhibition, arthrogenic muscle inhibition, all describing that same muscle shut down due to pain. I think arthrogenic muscle inhibition is the term that’s probably catching on, I see it most often. But I believe the other two were some of the traditional terms from back in the 1980s and 1990s when they were witnessing this situation with the VMO and the vastus medialis leak that shuts down when there’s a knee injury. So, arthrogenic muscle inhibition, I think that’s the most current medical term to describe this process.
So, we already talked about this, but correlation between lumbar multifidus atrophy and low-back pain…unilateral back pain, we saw that with that posterior lateral left disc bulge, you know, there’s more muscle asymmetry and there’s more fatty infiltration on that same side. I think I’m repeating myself here a little bit, so, we already reviewed all these data points earlier.
So, we’re gonna jump into some of the research that Aspen’s produced over the years in conjunction with some very prestigious researchers. But first, we’re gonna look at the old-style or the more traditional commonly depicted back braces that are in medical textbooks still. These braces, obviously, I don’t have to subscribe to you all, but these are for motion restriction, these are some of the most traditional devices for the spine. They’re largely obsolete, we don’t see them very much anymore. A lot of, you know, trauma surgeons and neurosurgeons are using Aspen motion-restricted devices that are much more comfortable than these products. But these are your old-style motion-restrictive type devices, which is not what we’re talking about today. These are your old common clinical indications for those types of devices, which we are not really talking about today but I wanted to include them just to get them out of the way. But think about a compression fracture, spondylolisthesis, those are just traditional clinical indications for, you know, rigid bracing products. So, once again, I think I am repeating myself with these two citations, which we reviewed those images earlier.
So, jumping into the Aspen research, this is a picture of Dr. Greg Kawchuk. The picture of him is not really important but the device that is in the background, with a patient laying on their belly, is important. So, this is a device that I believe he invented and uses to measure spine stiffness during research and whatnot. It’s just one of the great links that Aspen has gone through to kind of prove the biomechanical effect of our product. And then, these other equations and this other illustration is just from other research that we’ve used to prove the biomechanical effect of the brace when it’s applied. Findings of all of these things is our LSOs, they increase spine stiffness 14%.
So, what does that stiffness mean and why it’s important and whatnot? So, how does a back brace help? So LSOs increase spine stiffness or stability through targeted compression. The Aspen brace is different than any other brace on the market because it has two compressive mechanisms in the posterior panel, one for the upper and one for the lower half of the brace. So, the best way for me to describe this is you think about a patient that is shaped like a pear. They may need a little more tightening superiorly. A patient that’s shaped like an apple or a beer belly may need a little more compression inferiorly. So that’s just one mechanical advantage of using this particular style brace. We call it “targeted compression” because the patient can kind of target the compression with the little pull tabs on their own and dictate where they need the most support. If you look at this wine, or this wine barrel, this is just a nice little depiction that I like to think of. If you think about the hoops that are around the barrel, the top hoop is a little bit thinner than the middle hoops, think about if those hoops were not on there. All the wine would leak out. So, think about our braces. You know, it has to have a congruent fit for that particular area, just like these hoops on this barrel need to be congruent to that particular area. Patients aren’t shaped like a cylinder, so there’s definitely an advantage to having that targeted compression mechanism that’s in the back of the Aspen.
Characteristics of different design braces. So, when I was talking about when I first started referring patients maybe to Walgreens or Target or Walmart to get a brace, those braces are elastic in nature, so they stretch when the patient tightens them. Therefore, they lose any sort of biomechanical effect on the spine or the trunk whatsoever. The differentiator with the Aspen product is using a non-stretchy, we call it an inelastic or non-elastic material. So, when the patient tightens that slick track mechanism and tries to target the compression to their spine, the brace doesn’t stretch, it stays tight and congruent to their trunk.
The bottom study is just an EMG study that we have mentioned earlier but it just proves the same thing. One other part or one other concept, on the first study…I’m sorry, I’m going backward a notch. this study included also an Aspen brace with rigid paneling. So we had an Aspen brace, a semi-rigid brace, an Aspen brace with rigid paneling, and then, the stretchy-type brace. What we saw was, or what we thought we would see would would be that the rigid paneling brace would induce or create more trunk stability. And that was not the case. And the way that the author described that is there was likely an incongruence in the fit due to the rigid paneling, so there wasn’t an enhancement of the trunk stiffness in the patient. So, if the panels are overly rigid, you can think of that as they’re not gonna get that good congruent squeeze with a good hug on the patient, so it’s not gonna lead to any increase in trunk stability or trunk stiffness. And it’s certainly not comfortable to wear rigid paneling braces.
So, to put all this information and review an outcome study, first, we’ll look at kind of what’s going on or what we observe in the spine. So, like I said earlier, within 48 hours, you see about a 25% reduction in multifidus cross-sectional area in 48 hours resulting in a gross spine instability of 16%. So if this patient visits a clinic within a couple days, you can kind of presume…and I know that we’re not treating math equations here but just humor me, the patient has a predictable gross spine instability of 16%. If they’re given a brace, we can get their spine stability enhanced 14% to 27%, just depending on which Aspen product you’re using. So, we believe, and the research supports that that introduction of the stability through the LSO can reduce pain and provide stability, which promotes an environment in which the spine can recover.
So, as far as measuring this in a patient population, there’s a study by Morrisettle, cited at the bottom of the slide. But we reviewed visual-analog scale and a number of other things, but I think the ODI score is the most relevant, as far as patient function, and the improvement was vast on that scale as well. So, the patients that received PT treatment alone for low-back pain management over a 2-week period improved 2.4 points. Patients that received PT and an Aspen brace improved 14 points on the ODI over that 2-week period. So these patients were told to use a brace as much as they needed to. And I believe their time that they used the brace, self-reported, was about 5 hours a day. So that is dictated, obviously, by the patient and the PT that was in the study. But that 14-point improvement is significant clinically to me. So that is one of our outcome studies on the subject.
Practical explanation just reiterate this reflexive biomechanical situation. The functional outcome of a low-back-pain patient can be attributed to a biomechanical effect. When we restore some stability, the patient’s pain is reduced, and therefore, that pain reflexive…or that inner pain inhibition, or arthrogenic muscle inhibition, can be controlled or completely resolved. So the patient’s muscle function can then be re-established voluntarily through exercise and daily function. So, what we’re saying is the bracing can make stabilization exercises more effective. And how that occurs is through reducing back pain and inhibiting pain inhibition. So it’s a double negative, it’s a positive. But that is kind of the main point that I’m trying to drive home and it’s relevant for acute, subacute, chronic pain conditions.
The study at the bottom is just another study that we sometimes cite, it just talks about pain medication, dosage, decrease whenever patients are braced with a low-back support. So, a study that was…it’s a little bit older, 2009, but it had a pretty positive outcome in regard to using lumbar bracing for low-back pain management.
So, to reiterate a couple concepts, bracing does not create muscle atrophy or dependency as some of you may have been taught. Bracing a spine-pain patient can aid in recovery of core strength through neurophysiological mechanisms.
So, back to the little loop. The top-left loop is obviously the happy loop, and then, the bottom-right loop is where we have pain and dysfunction. And whenever you’re looking at this bottom-right loop, spine column, pain, whatever it may be, facet disc, nerve root, genic pain, will have an inhibited neuromuscular control unit which shuts down or inhibits the multifidus muscle, which, in turn, reduces stability and movement in the spinal column. Whenever we think about the brace intervention or how our device impacts this hoop, you think about it as it’s restoring or improving that stability where there’s a loss due to the muscle function being inhibited. So it’s trying to get this patient out of this self-perpetuating cycle through relieving pain inhibition or reflex inhibition or reducing arthrogenic muscle inhibition, so, essentially increasing core strength or improving muscle facilitation.
Once again, we reviewed this earlier and I’m not gonna go over that again, but as HHS [inaudible 00:42:50], bracing should be part of the clinician toolbox, and we couldn’t agree more with that little blurb.
So, this next little section is no longer clinically-oriented, it’s more toward practice and economics and billing. So, all of our products…or not all of our products but the majority of Aspen products are coded and they are coded by Medicare. And chiropractors can bill Medicare for bracing if they have a DMEPOS number. So, that is a process that, if you reach out to your local Aspen rep, they can get you in touch with a consultant to help your practice go through that process. But essentially, you will become a supplier of DME products or Medicare patients.
The other blurb here is “DCs can prescribe and bill non-Medicare payers in most cases,” so we’re talking about private-insurance payers. So, same L-code is involved, they recognize that L-code that Medicare establishes for these particular products. And chiropractors, in most cases, can prescribe, fit, and bill their patients for these products.
So, reimbursement claims. These L-codes that I was mentioning that are signed by CMS, they have a particular reimbursement associated with a particular L-code. L-codes are assigned by CMS, non-Medicare care payers, I already said this, use the CMS L-codes as well. And then, January 1st of 2016, CMS implemented the split-code system which divided prefabricated braces into custom-fit and off-the-shelf. The majority of our products are prefabricated braces that are dual-coded, so they’re custom-fit-coded and off-the-shelf-coded. There’s gonna be a change in Medicare’s processes beginning of next year and it will be more relevant [inaudible 00:45:01] to understand, you know, the difference between using our product as custom-fit or as an off-the-shelf code, at that time. And I would recommend reaching out to your local Aspen rep for assistance and guidance on that process as well.
So, this is just a few bracing options and codes. On the right side, that’s what I was talking about today, are lumbar-support LSOs. You can see there’s a custom code, L0637, and off-the-shelf code, the L0650, you know, etc., etc. Moving over to a thoracic lumbar support, same thing, a different code that was assigned by Medicare, it has a custom and an off-the-shelf version of that product. And then, we have a cervical collar that’s pretty popular in the chiropractor community and, you know, it has just one code, so it doesn’t have an off-the-shelf code L0180.
So, in review, whenever we are billing or we’re documenting fitting and billing a patient for a particular brace, an LSO or a TLSO or…yes, LSOs and TLSOs only on this particular guideline, we’re trying to find medical necessity with one of the four following blurbs. And if you wee listening to me today, criteria Number 4 “To otherwise support weak spinal muscles” is relevant in a lot of cases for low-back pain muscle, or low-back pain cases. So, if you’re thinking about having to justify or determine medical necessity on low-back pain patients, I would say that a majority of them would fit into Criteria Number 4 “to otherwise support weak spinal muscles.”
And then, this is just an average of our L-code reimbursement per products. The top is the L-code for the collar, and then, the LSO, LSO, LSO. And then, the very bottom is the TLSO. So these are just general L-code reimbursables, the actual reimbursements are different on each date and it’s different for private payers as well. So don’t take these to heart, they’re just general figures.
All right, so that’s the conclusion of our talk here today. I wanted you guys to be aware that there’s aspenspinalbracingresources.com. So, it’s just a resource guide to review some of these abstracts and some of the research that we were discussing today. And our website has a nice little resource section to kind of review some more of the clinical research on the products for pain therapy, you know, the bracing products that I was talking about today but also there’s a lot of nice research on some of our acute-care-type products as well on our website.
Rick: Thank you, Dr. Stricker. This cleared up a lot of misconceptions. We’ve been collecting some questions from our audience we’re gonna get to. DTS, “Can spinal bracing be used for chronic pain? Because I’m under the impression that bracing is appropriate for acute injuries but not effective for chronic pain.”
Brantley: Yeah. The studies that I was citing earlier, specifically the Morrisettle study, it discusses patients in all stages of pain, acute, subacute, and chronic. If you kind of understand the clinical manifestations of a low-back injury, you know there is a rapid atrophy mechanism that occurs within a couple days. But if you notice on the slide, pain duration over many years, that muscle is losing cross-sectional area over a long period of time. So patients are slowly becoming more and more and more unstable or they’re losing more and more and more spine stiffness. So, the bracing products are certainly applicable in acute, subacute, and chronic stages of low-back pain.
Rick: Thank you. And another question, “Are you concerned about brace dependency for your patients?”
Brantley: Absolutely not. So, in review of, you know, kind of that pain [inaudible 00:50:01] arthrogenic muscle inhibition concept, if the brace can manage the pain, if it can reduce the patient’s pain, it will actually improve the patient’s ability to recover or rehabilitate their trunk musculature, specifically their core muscles and the multifidus. So, if the brace is reducing their pain, it’s gonna be improving their muscle strength. So dependency is not an issue.
From a clinical experience or from, you know, my times in the clinics, I see patients, you know, using the brace as much as possible acutely, and then they slowly start to discharge it and self lean and stop using the product quite as much as maybe they once did. But there isn’t any risk or negative side effects associated with using the brace for an extended period of time, you know, forever, as long as it improves their function, and they can get back to their daily living. You know, that is I think success.
Rick: Thank you. And we’ve got one more question, “Can chiropractic physicians prescribe bracing for Medicare patients? I was told that we cannot.”
Brantley: That is true, they cannot prescribe the brace. But what a lot of chiropractic clinics will do is partner with the patient’s primary-care physician to author the prescription. And then, therefore, the chiropractor can then supply, fit, and bill the patient’s insurance for the product. So, essentially there needs to be a physician, an MD, DO, NP, or PA that authors a prescription for the device, and then, the Medicare, or the chiropractor with a Medicare supplier number can then fit and bill the product. And…yeah.
Rick: Thank you. And at this time, we’d like to thank our sponsor, Aspen Medical Products and Dr. Brantley Stricker for today’s webinar. And thank you all for attending. Remember, this webinar, including our speaker’s Powerpoint presentation, has been recorded. We will alert you via email when the webinar is available online. Thank you again for attending and we look forward to seeing you next time. Have a good day.