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Member May: Evidence-Based Assessment of Platelet- ...
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Good evening, everyone. My name is Christina Ganam. I am the member engagement coordinator at the Academy. We're just going to get started with a few housekeeping notes before we get started. The views expressed during this session are those of the individual presenters and participants do not necessarily and participants and do not necessarily reflect the positions of AAPMNR. AAPNR is committed to maintaining a respectful, inclusive, and safe environment in accordance with our code of conduct and anti-harassment policy, which is available at aapnr.org. All participants are expected to engage professionally and constructively. This activity is being recorded and will be made available on the Academy's online learning portal. An email will be sent after this activity with a link to bring you to the recording and evaluation for the best attendee experience. During this activity, please mute your microphone and when you are not speaking to ask a question at the end of the session, please use the raise your hand feature or use the chat feature to type in your question. Note, time may not permit panels to field the question. Before we begin, I'd like to introduce tonight's speaker, Dr. Mary Ambach, who holds a double certification in physical medicine and rehabilitation and pain medicine, along with dual fellowship training in orthopedic sports and spine and orthobiologic and regenerative medicine as a clinical instructor and voluntary assistant clinical professor at the University of California, San Diego School of Medicine and the Department of Orthopedic Surgery. She is dedicated to educating and inspiring others to contribute and advance the field of orthobiologics. She is also the founder of BioEvolve San Diego Orthobiologics and Sports Center, a premier destination for cutting edge orthopedic regenerative treatments. As a leader in orthobiologics, Dr. Ambach has educated and mentored physicians worldwide on advanced autologous cell therapies, if I'll just mispronounce that. Her contributions to medical journals and textbooks underscore her commitment to research and clinical excellence. She is a current board member of the 2026 President-Elect for Interventional Orthobiologic Foundation, which provides the gold standard orthobiologic education, providing structured image guided injection training, and provides a strong foundation and evidence based practice. As the host of Orthobiologics Now, IOF's regular webinar series, she leads discussions on current research and clinical applications. And without further ado, Dr. Ambach. Thank you, Christina. So I would like to ask you if you could just turn off your videos when you log in. That way, we can have the full screen here. Christina, can you do that for me? Yes. Okay, so I'm going to share my screen and see. Okay. Sounds good. Okay. Good evening, everyone. Thank you for joining us. I'm Mary Ambach. I'm a physical medicine and rehab physician. I'm also board certified in pain medicine, and I have a private practice in San Diego that's predominantly musculoskeletal. I've been in practice for about 18 years. And about seven years into my practice, I just got tired of shooting my patients cortisone shots, and they keep coming back after three months. And that's when I realized there must be something more that I can do for this patient. So I started researching other treatment options. And that's when I came into regenerative medicine orthobiologics. And so I joined OrthoHealing Center in LA, got further training in regenerative medicine, and I have now a predominantly orthopedic regenerative medicine practice in San Diego. So this evening, our topic is on the use of platelet-rich plasma for lumbar spine conditions. So why orthobiologics? As we all know, spine pain is a complex condition. A majority of the patients that I see in clinic have already tried and failed multiple standard treatment options. These are patients that are seeking natural alternative treatment options that are non-surgical, that has the potential to improve their condition, restore their tissue injury, and they also wanted to avoid chronic opioid therapy. And so there has been many mechanisms, potential mechanisms of how PRP helps with low back pain that are published in literature. And so I just listed the key ones here. But there's thousands of growth factors that are in our platelets, and they have the ability or at least have shown the potential for these growth factors to stimulate tissue proliferation, whether it's collagen or myoblasts or myelin sheath or cartilage. It does stimulate the proliferation of extracellular matrix. It modulates inflammation. It does recruit other cells into the damaged tissues. It does have some analgesic effects. And so those are just some of the mechanisms by which PRP helps. So back in 2018, there was this systematic review and meta-analysis that was published that has become the foundation for the American Society of Interventional Pain Physicians, basically, recommendations on how to use orthobiologics for low back pain. And at the time, they found that PRP had level three evidence for lumbar disc injections and level four evidence for lumbar facet and epidural injections. Fast forward five years. In 2023, we published this systematic review of PRP for low back pain. We included 40 studies, 13 of which are randomized controlled clinical trials, and they included various target structures, including the discs, the facets, the epidural, muscles, ligaments. It's a multi-target injection. The studies that were included had a high compliance rate with regards to the minimum information that's required for the studies to report whenever they're reporting biologics for orthopedics. And this time, we found level two evidence for the use of PRP for low back pain. So definitely improving, moving in the right direction. Not quite there yet, but it's positive movement forward. So let's talk about intradiscal PRP. This was the first RCT that was published, and it was by Greg Lutz, the late Greg Lutz at HSS, who published a double-blind randomized controlled clinical trial comparing PRP with contrast control injection. And they found a statistically significant improvement in the pain and functional outcome in these patients at the eight-week mark and also up to the one year compared to baseline. They then published a two-year follow-up study and a five- to nine-year follow-up study, and still showing statistically significant improvement in the pain and function for these patients that received PRP injections. And less than half of them required pain medications, less than a third of them required additional spine injections, and these procedures were found to be safe. So we also published a randomized controlled clinical trial using PRP and bone marrow concentrate. PRP for the less degenerated discs and bone marrow concentrate for the more degenerated discs. And it was a multi-center trial, 60 patients, 15 at each site, and it was a crossover design wherein the control and the treatment groups were able to cross over to another treatment group or in the control group to a treatment group at various times, three months and six months, if they pass certain criteria. Which was 50% improvement, more than baseline. And so our 12-month results showed a statistically significant improvement in the pain scores and Oswestern Disability Index of both the PRP and bone marrow concentrate group at 12 months compared to baseline. We found that both the PRP and the bone marrow concentrate were equally effective in treating discogenic low back pain and leg pain with a single PRP injection or a single bone marrow concentrate injection. There was not enough power in the study to show a significant difference between the two, although the raw data for the bone marrow concentrate were slightly better. And all the patients who crossed over to the treatment group showed significant improvements in their pain score and functional outcome score at 12 months compared to baseline. No complications were found. Not all of the RCTs that are published showed positive outcomes. There were two that did not show any significant difference. However, if you look further into these studies, there's some limitations into their studies. So this was one study that was published recently. This was an RCT comparing intradiscal PRP with saline and antibiotics. There was a very small whole blood draw of 32 cc, which most likely resulted to a small concentration of platelets that were injected. As we all know, MODIC changes correlates highly with passive discogram and discogenic pain. And these were excluded from the study. There's also several data on C. acnes or cutic bacterium acnes, which is a ground positive anaerobic bacteria that can possibly contribute to the pathogenesis of degenerative disc disease. And also several data that shows that maybe a disc biosis in the natural disc environment, i.e. overgrowth of some bacterias, can contribute to degeneration. And so using an antibiotic as a control may have affected their results along with the other factors that I just described. So they found no significant difference between the two. So moving on to epidural PRP, there's actually more RCTs in epidural PRP for discogenic pain, degenerative disc disease, compared to PRP and autologous bone marrow concentrate for low back pain. So let's go over some of those. This was an RCT, one of the earlier RCT studies on epidural PRP by Ruiz Lopez. And this was a study comparing epidural PRP, and they used a caudal approach, versus an epidural steroid injection. They did a six-month follow-up period, and they found that initially the steroid group did well up to one month, after which the PRP did better and had significant improvement in pain and function up to their follow-up of six months with no complications. Another study, again, comparing epidural PRP with epidural steroids. This time it was a transforaminal epidural approach. And again, same trend, or in the steroid group did better at first for up to about a month. And after one month, the PRP continued to show significant improvement in the numeric pain rating and the global perceived effect up to their six-month follow-up period. So it would be interesting to see how this translates in the longer-term follow-up studies of, you know, one to two years or even longer. Due to the interest of time, I'm not going to go over all these other studies, but there's four other randomized controlled clinical trials, also comparing epidural PRP with epidural steroid injections. These were studies with an N of 30 to 124 patients, a six to 12-month follow-up period. Again, showing the same trend of consistent decline in the steroid effects, starting at about one month, and that PRP offering superior, more sustained benefits up to six months, and in some studies, up to 12 months. So moving on to facet joint PRP, there's not a lot of RCTs on this. In fact, there's only one RCT comparing inter-articular PRP versus lidocaine and steroids into the facet joint. And they have found a statistically significant improvement in the VASCORs, ODI, Roland Moore's disability questionnaire in both groups at one month. So they both had the same response at the first month, but the PRP group had the more sustained improvement up to their six-month follow-up period. So ever since the introduction of orthobiologics with the potential for it to strengthen and repair, there has been a renewed interest in the concept of the functional spine unit, meaning that there are multiple subsystems in the spine that actually creates stability, and that the spine behaves as a function of all its parts. And so the thinking was that, why not treat all the symptomatic structures that contribute to the stability of the spine to have a better outcome? And so we tested this hypothesis, and we published a prospective case series of 46 patients. And this was the first study on using multi-target injections simultaneously on the use of PRP for low back pain. We established some clinical criteria on how to identify the target structures. So it was a personalized treatment based on clinical presentation and imaging studies. And we found that using this approach, patients showed statistically significant improvements in their VAS and disability questionnaire up to one year compared to baseline. There was almost a 66% reduction in number of patients that were taking opioid medications, and their satisfaction scores were good to excellent. 82% of them would repeat the injections if necessary. And there was no adverse events with using this approach. So we do follow our patients in our orthobiologic registry. And using this multi-target treatment approach, this was my data from last year. Out of the 101 patients that participated in the ODI survey, 61% of them had an improvement in the average ODI at 12 months. And out of the 84 patients that participated in the pain survey, there was 43% improvement in the average pain score at 12 months. There's one RCT on using a multi-target PRP injection for low back pain. This one was PRP versus lidocaine injection, but they coupled this with prolotherapy. So basically what they did is they did the PRP injection and then followed this with prolotherapy, a series of injections after two weeks, and the same thing with their other treatment group, which was the control group, which was lidocaine. And they found that the PRP plus the prolotherapy group had better pain improvement at six months compared to the lidocaine and prolotherapy group, but there was no significant difference between the two in terms of functional outcome at six months. And so this is where we are right now. For intradiscal PRP, we've got four RCTs that has favorable outcomes. Two RCTs, again, as I mentioned, with non-favorable outcomes. There's five RCTs on epidural PRP with favorable outcomes, two on facet PRP, and one on multi-target PRP injections. So not a lot of studies, but it's a positive start, and I think we're moving in the right direction. Oops. How do I go back? So this is slide is. Okay. Doesn't want to go to this slide for some reason. Christina Can you help with this one. It doesn't want to say, huh, in between saying the arrow keys, like go back. Oh, see. 23. Let's try it out. Sorry guys. Go. Oh, for a moment. So basically that slide was showing the clinical decision algorithm on how to decide what structures to inject and basically that slide is a whole lecture on its own, but it was showing that you know how do you decide. If you're going to inject just the discs or how do you decide if you're going to inject the whole functional spine unit, including the discs, or the functional spine unit, without the discs. And with the first group were in. So, for example, if you're going to do interdisciple injections. That is the group that has the most support in literature in terms of studies that were published. And these are patients that have high discogenic pain. These are patients that has HIZ on their MRIs, modic changes, annular fissures, clinical symptoms that are consistent with discogenic pain. These are the ones that has the Furman two, three lower Furman scores and their degenerative discs, a rating. And these are the ones that at least there was six randomized controlled clinical trials showing that it does work really well. If you're injecting the discs alone. The middle group is the one that where most of our patients fall into and these are the patients that has multiple multi level structures that are involved, meaning there's a multi level degenerative disc disease. There's a spondylosis, there's spinal stenosis, some of them would have instability. There's few case series that has been published on using multi target injection, including the discs. And these are the patients that would do well with basically including all the structures that are contributing to that stability of the functional spine unit to inject with biologics. And then there's that third group who are in, you do a functional spine unit approach, but do not include the discs. And so there's three factors that I enumerated here that would determine when not to include the discs. So there's discs factors, and that includes patients that are too far gone in the disc. So these are the Furman's five wherein there's almost none and maybe the severe force, almost no space to inject the discs. If you look at the studies, more than 50% disc height loss is kind of our guide on when to say you're probably going to get poor outcomes from an intradiscal injection. These are also patients that has sequestered discs or prolapsed discs because there's no structural containment to keep the biologics so the regenerative potential is low. So those are the disc factors. And then there's patient factors. And these are patients that has multiple comorbidities. These are patients that have diabetes, for example, wherein they have a high, they are high risk for infection. And remember, these are procedures that are a little bit more invasive, especially if you're going to the discs. And so you have to basically choose the right patients and if you think that they can handle going through a procedure safely. And then the last factor is a physician factor wherein I enumerated this intradiscal injections has a high level of complexity and skills involved. And so make sure that you have the proper training to do this and please don't do this if you're not properly trained to do so. And so if that, if you have any of these factors, these are the ones that I enumerated in that third group we're in, it's reasonable to do a just a functional spine unit approach, not include the disc in the injections. There's one RCT showing that basically decision making, showing good response with just the functional spine unit approach, not including the discs. Okay, so got over that slide that we can't see. So take-home points, chronic low back pain, complex condition, which can make it challenging to create PRP treatment protocols and standardize the methodologies. So just like any other treatment, it would need a personalized approach, I think, especially more so for the spine. Nevertheless, there is increasing evidence of good quality data on the safety and efficacy of autologous PRP for degenerative disc disease, for facet joint and for radiculopathy. And more high quality studies are needed, along with real world evidence in order for us to move the field of orthobiologics forward. These are my references and you should have access to these slides. Feel free to email me if you have any questions. soundblackmd at bioevolvesports.com and thank you for having me. Okay, so stop share. Let's get to the Zoom. And so we will open this to the question and answer session and we're going to try to limit this to about 15 minutes or so, as long as we keep getting questions. All right. All right. Let's see what we have here. Can you provide general recommendations on what PRP formulations to use for different tissue types, joints versus ligament versus disc versus muscle? Very good question. So the studies have been mixing the different formulations. Let's start with the discs first. So for the discs, there has been a recent push on using leukocyte-rich PRP for the disc because of the possible benefit of the WBCs, specifically the granulocytes, maybe the monocytes and macrophages, with regards to killing the bacteria that they think is contributing to the pathogenesis of degenerative disc disease. So leukocyte-rich, however, you know, I've used leukocyte-poor in the past. I think the more important factor is the platelet count. As long as you get to 1 billion is the count now per ml. I think that's the one that gives great outcomes. Anything less than 500,000 per ml, I think, will not result to greater outcomes. So the platelet dose is more, I think, of an important factor rather than the formulation, although there's a recent push to use a leukocyte-rich PRP, especially if you look at Greg Lutz's data at HSS. With regards to the facet joint, if there's sinusitis or even epidurally, if there's an active radiculopathy, there's more benefit to using a leukocyte-poor formulation as long as, again, you have that good platelet count. Only because there's a potential to flare up these patients who have active sciatica or active radiculopathy with leukocyte-rich formulation. Having said that, there are some different formulations or kits of PRP where you can still have leukocyte-rich that doesn't really flare up the patient. So these are like theoretical recommendations based on experience. But that's how I would answer your question. Also, there are some patients that have some autoimmune stuff will come with sinusitis, for example, their facet joint, and those are patients that would be good to do a leukocyte-poor PRP formulation. With regards to muscle, the data now on muscle is using a very low count, almost PPP, very low count platelet. So I would stay with the leukocyte-poor on those. And for ligament and tendons, leukocyte-rich has been what the data has been showing to work better. There's a question with regards to volumes. Again, if you look at the data, they're all over the place. But if I want to summarize all the data for transforaminal epidural, the volumes have been anywhere from 1 to 3, and that's basically what I use as well. If there's severe stenosis, you want to keep it in the lower volume, usually 1, 1.5. Majority of my patients that has mild stenosis, they can get to 2, 3 cc without any issues. If you're using an interlaminar, you could have a bigger volume. If you're using a caudal, we inject up to 5 cc in the caudal, even more, depending on what level you're trying to target. And for the facet joints, that's typically 0.5 to 1 cc. And that includes peppering the PRP around the facet joint capsules. Facet discs is anywhere from 1 to 2 cc of volume. And the muscles, it's a very small volume, especially if you're using PPP. You can do maybe 0.5, maybe 1 cc in your paraspinal muscles. How many cc of blood? Cc of blood depends really on what's your target PRP count, what kit you are using. So there's a lot that plays into that. But if you are wanting to get to the right platelet dose, at the very minimum, a 60 cc blood draw would probably get you to the right amount that will give you good outcomes. A patient with modic changes from 1 to 2, HIZ, flexion-based pain, what would make you lean towards? I don't have any experience on Intercept, so I can't comment on that. But the case series that we published, we used PRP that was at least 6 to 8 times concentration, then baseline, on our Furman 1 to 2. And our follow-up was one year, and we had 85% success rate for those patients. They did really well, especially with the ones with HIZ. Yeah, I don't usually filter for the discs or the joints when using PRP. Bone marrow is a different topic. Bone marrow, you filter whenever you're injecting to the spine. When I was first doing this in my first couple of years, I filtered my epidural PRPs. But in the past 3-5 years, I haven't been filtering my epidural PRPs, and I haven't had any issues. If you're doing a lysate formulation, lysate is that you're lysing the platelets, you're activating the platelets before you inject them to the epidural space. That's something that I would filter. I would recommend to filter because you just don't know what other kinds of platelet debris and fragments are left in there, so you want to filter those out. But for set joints, for the soft tissue, anything that's outside the spine, ligaments, muscles, there's no need to filter. PRP, proplaz. So this is a question about proplaz kit. Proplaz basically dehydrates the PRP, and when you do that, it clogs the kit up, and you can't further dry the PRP, only the PPP. I've used proplaz in the past. I haven't been using it only because I have really great responses to just traditional PRP, so I can't comment on that much. But we can talk about that, Sean, and sideline that with regards to proplaz itself, but there hasn't really been much data on that that I can think of. What else? Any other questions here? So there's not a lot of studies on cervical epidural, but everything holds true with regards to the formulations, like how to approach it. The volumes obviously will be smaller for a cervical epidural. The studies on cervical are all facets, maybe some on the epidural space as well. Not so much, but everything else would hold true for cervical spine injections. All right. I think that's it. I think we're done. One last question. What setup do you have for this intervention? Are you doing facet epidurals in the office? Yeah, so my setup, I have my own floor machine in the office, and so I have the ability to do all my spine injections in the office. I have been doing my intradiscal in the surgery center only because of the sedation aspect, but I'm going to start to try. The only problem with the surgery center is that you don't get the same people all the time, and so to train the nurses on how to process the biologics in the way that you want to is very, very hard. You basically end up processing your own if you're in a surgery center, and so I'm going to try to start doing these procedures in the clinic. I have an anesthesiologist that comes into the clinic and does basically an IV sedation, and so I'll let you know what happens, but I think it's very doable. I know some physicians who even use a sublingual MKO melt. I'm not endorsing anything, but they do basically MKO. It's a midazolam, zofran, which is ondansetron, and ketamine. I don't have any experience with that, but instead of having IV sedation, they just use this melt, and apparently it works, and it's very quick and obviously less cost to the patient because then they don't have to pay for the sedation aspect, but yeah, until this point, I've been doing all my procedures intradiscally in the surgery center because of the sedation aspect of it. Okay, well, you got my email. If you have any questions, feel free to contact me. I hope I can see you in one of the regenerative conferences, whether it's TOBI or IOF, and thank you for joining me.
Video Summary
Christina Ganam leads a session at the Academy, featuring Dr. Mary Ambach, a double certified expert in physical medicine, rehabilitation, and pain medicine. Dr. Ambach shares her journey into regenerative medicine, focusing on orthobiologics after feeling unsatisfied with the temporary relief provided by cortisone shots. The session's main topic is the use of platelet-rich plasma (PRP) for lumbar spine issues, aimed at offering non-surgical treatments to alleviate pain and potentially improve tissue regeneration. Dr. Ambach discusses various studies and evidence supporting different applications of PRP for spine conditions, such as discogenic pain and facet joint issues, highlighting the safety and efficacy found in systematic reviews and randomized clinical trials. She emphasizes the importance of tailoring treatments to individual patients based on several factors, including the nature of their spine issues and previous responses to other treatments. The talk concludes with potential clinical applications and recommendations for future studies, and Dr. Ambach answers questions related to PRP formulations, procedures, and outcomes, showcasing the promising directions of orthobiologics in spine care.
Keywords
regenerative medicine
platelet-rich plasma
lumbar spine treatment
orthobiologics
discogenic pain
facet joint issues
non-surgical treatments
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