Symptomatic Reactions, Clinical Outcomes and Patient Satisfaction Associated with Upper Cervical Safety in Chiropractic Care
Upper Cervical Chiropractic Research Show #1 – Chiropractic Deep Dive Podcast – Symptomatic Reactions, Clinical Outcomes and Patient Satisfaction. Upper Cervical Safety in the Research.
Safety & Chiropractic has been questioned in the past, and we are here to address Upper Cervical Safety with the 1st Research Podcast of The Deep Dive Podcast. Clinical Outcomes and Patient Satisfaction are also addressed. Here is the transcription below if you’d rather read instead. Let us know if you have any questions!!
– To Your Health
Dr. Kevin Leach
Dr. Leach: Dr. Tyler Evans, How are you sir?
Dr. Evans: I’m doing great, Dr. Kevin Leach, How are you?
Dr. Kevin: Doing well, thank you sir. So we’re going over a research paper today called “Symptomatic Reactions, Clinical Outcomes and Patient Satisfaction associated with Upper Cervical Chiropractic Care: A Prospective Multicenter Cohort Study. This is by Dr. Kirk Eriksen, Roderick Rochester and Eric L Hurwitz. Published in the BioMed Central Musculoskeletal Disorders Journal. If you would Dr. Evans, will you just do a quick overview , just do a 50,000 foot overview of the paper and what it’s showing, what were they trying to answer, what did they accomplish?
Dr. Evans: So an overview of this paper is that it was a was a 1,000 (1,090) patient study with over 83 different Upper Cervical Chiropractic offices, of all of the different types of Upper Cervical Chiropractic [techniques]. What they found was after two weeks of care, they tested before and after, and roughly 4.5 patient office visits ,requiring 2.4 adjustments over those 4.5 visits, (only half the time they needed an adjustment, which is kind of cool), thirty one percent of patients had what we call a “symptomatic reaction”. Intense symptomatic reactions, which are a level higher, occurred in just 5% of patients. The satisfaction level on a numerical rating scale from 0 to 10 was scored a 9.1 on average across the board for all the people. Out of 5 million career upper cervical adjustments, they never once had an “Adverse Reaction”, which is the highest kind of reaction. That would be a time or situation where the person needed to go to the hospital or there was a death or something very, very serious. So out of 5 million career Upper Cervical Corrections (Adjustments), not once did they have a problem in which in which something like that occurred. This is a first time ever paper, and it was a really great paper. Let’s get into.
Dr. Leach: Awesome. I’m just going to explain a little bit, for the people listening, what the difference between Upper Cervical Chiropractic is, and what that actually means compared to traditional Chiropractic. A lot of people hear the word “Cervical” and they think something else. What we’re talking about, “Cervical” means “the Neck”. So Upper Cervical Chiropractic, being different than traditional meaning we focus on the neck and that’s because of the Anatomy, the Neurology, and just how complex that area is compared to the rest of the spine. So we’re doing techniques that adjust and align that area that aren’t your traditional spinal manipulative therapy techniques, with the rotation and the popping and the typical cracking sounds that you would hear with that. There are specific techniques I would say maybe eight, nine or ten, that only addressed the Upper Neck. In doing so, it actually addresses the entire spine. But that’s a lot of Neurology that maybe we won’t get into at this point. Maybe we can do another show on that. So that’s a good overview for anybody that just wants the cliff notes. Any other 50,000 foot perspectives just to take home for anybody listening? Like the value of this study? How they can use it in their practice? How could sharing it with family members help?
Dr. Evans: There’s just a couple interesting quick takeaways. One is that this paper actually showed a 57 percent improvement in their Oswestry Disability Index, which is for Low Back Pain. It actually compared on par if not better than other general Chiropractic guidelines in terms of Low Back Care improvements. So it’s something you may not expect to hear coming from an Upper Cervical Safety [Chiropractic] study. But, what we found is that when we balance that head over the neck properly, the lower back actually had quite a great benefit. A lot of people wouldn’t think that or know that, which was a side effect of them studying everything in this paper.
Dr. Leach: Right. Great. Let’s get into the background, methods, discussion and conclusion. Let’s start with the background. If we compare just Upper Cervical with traditional Chiropractic and just the overall research, what’s available? I believe this is actually the first study that’s been done showing the safety [Upper Cervical Safety] of exclusively Upper Cervical Techniques. But I’ve also heard someone else say that there was a lot more. Do you know anything about the details of that? if there’s any other specific studies like this one? Or is this a breakthrough, one-of-a-kind study here .
Dr. Evans: I’ll just break down the title real quick because it might be a little bit hard to understand. First on Symptomatic Reactions are reactions in which there is a slight increase in a symptom. Either neck soreness or back soreness or some sort of symptom. So they wanted to study that, because a lot of times Chiropractors, or at least in general the guidelines in terms of research, there’s some negative information that’s put out there. And they wanted to show Upper Cervical’s power in how it works. And that the symptomatic reactions are often quite short and low in severity and frequency. Then clinical outcomes.. so that would be the Neck Pain Disability Index, the Oswestry Disability Index. Two questionnaires that people did before and after [treatment] that actually breakdown out of a hundred point scale, specifically how their neck pain affected their ability to do their life. The patient satisfaction was rated as a numerical rating system from 0 to 10. Then a “Prospective Study”.. that’s why this study is unique. Prospective means it was planned in advance. They laid out the terms of the study to 110 chiropractors, they only chose to work with 83. Then they applied the parameters to these two weeks of care, and it was a “multicenter” meaning multiple chiropractic offices across the country and there were four different countries actually involved in this study. It was Spain, England, United States, and Canada, which is kind of cool. That’s an amazing thing that we can do that in our Upper Cervical profession. Then a “cohort” just meaning a group. So it was the first large group study across many different Upper Cervical techniques that had ever been done. I think it’s still the only one that’s ever been done like that. So Dr. Eriksen and Dr. Rochester.. they’re our mentors, Dr. Leach and me. Dr. Leach and I were lucky to know these guys because they they did something for our profession that hopefully we can continue to do. But they laid a great foundation and a great way to move forward with some great statistics. That’s why it’s so special.
Dr. Leach: I’d like to go into a little bit more detail about Symptomatic Reactions as opposed to “Adverse Events”. They chose in the study to use “Symptomatic Reactions” because in actuality, some of those Symptomatic Reactions are expected, so they didn’t call them “Side Effects” or “Adverse events”, which would imply that there’s there’s a negative connotation to what’s happening with the body. Because some of the symptomatic reactions that were recorded, for example breathing easier, was a symptomatic reaction. Which some would say is a very welcome “side effect”. Also digestive improvements, things like that. They recorded all of these even if it was positive or perceived as negative, like maybe some soreness or even some headache afterwards. So they defined it as symptomatic reactions. I think that’s an important point to make.
Dr. Evans: Yeah, absolutely. Kevin, if I can add to that. There are terms that we use in our office sometimes, like “retracing” and “restructuring” and I’m not going to go into that here. But the point is that healing is not always linear, and the research in PubMed is designed to study a thing over time, and take out the variables and it’s really hard to do that in the human body. Especially when you’re talking about manual therapy, which is what we do. Symptomatic reactions happen, and they’re a good thing at times. They can be very important to the healing process, and that’s because it’s not linear. So that’s an important thing for people to remember. That these symptomatic reactions are short in time and duration. Mostly less than 24 hours.
Dr. Leach: Right. That’s huge. Maybe we’ll get into a little bit of that at the very end as far as discussing how we see this in our own practices. I think that’s important and there’s some ways that I definitely explain to my patients about what’s going on with the body and that it’s just a healing process. For example, someone hasn’t gone to the gym in a year, they go to the gym, they work out, they’re sore the next day. It’s not that that’s a bad thing. It’s uncomfortable, but in the end it’s going to be beneficial. And so there’s some parallels there to what we do in practice.
Dr. Leach: Let’s talk about research in chiropractic in general real quick before we head to the methods. For example, when people look at research and they say, “well who funded the research?” and who did it? Are there biases? Are there complications? I think it’s really important to know, (not really making excuses for the profession, but to really make it clear) that there’s no “National Institute of Health” There’s no huge conglomerations that are paying for this research. So when research is being done in Chiropractic, if anybody wants to get research done, we have to do it ourselves. So, Yes, we see results in our office and we see amazing things, and we want to prove the efficacy and the benefits of research, but we’re the ones who have to fund it. Typically it’s doctors who are taking time out of their own practices that may or may not be getting paid for it. And, if they are it’s not very much. They’re doing it to advance the profession and to just create more research to ultimately help more people. I think that’s a really important point, because a lot of people will say, “it’s chiropractic and it’s funded by chiropractic. Of course you’re gonna have good results, and you’re gonna see good things.” I mean that’s where we are right now. Do you know if there’s any advancements or any newer situations happening where we are going to have any funding from people like the NIH or any other big studies that are going to happen that come from outside funding?
Dr. Evans: So in terms of the NIH, I do know a paper. The Dickholtz study done at Palmer at some point after 2008. That paper was so foundational and groundbreaking in terms of studying one thing, High Blood Pressure. Actually blood pressure changes as a result of the Atlas correction. The NIH did grant them like a million dollars or something like that, to do a study that has not been taken to full completion yet. And I’m not certain as to why. But that’s part of the problem is that in Chiropractic we just don’t have the infrastructure and we need more infrastructure. We need more people doing research. One person in general that I know that is out there doing this, that’s not an Upper Cervical Chiropractor, but a lot of her stuff points to the Upper Cervical Spine as a place of a big input into the body. Her name is Heidi Haavik, and she’s down in New Zealand. She is doing some amazing research. I think she does get grants, I just don’t know where they’re from. If they’re from NIH or what. But she is a legit clinical researcher down there making cool stuff happen. At some point we could review her stuff. But this paper was done, like you said, by people that took time out of their practice and that’s a rough spot. That most of our stuff is just case studies and a lot of times people don’t take that as a burden of proof. That’s why we’re in a tight spot there.
Dr. Leach: So the conflict of interest is in the methods, which is just what you went over. I think it was funded from the Orthospinology Association. Is that who did it? The IRB of Life University Chiropractic School.
Dr. Evans: So every Chiropractic College has an Institutional Review Board. Every Chiropractic College has to get this IRB approval before doing a study, especially with humans. Because you don’t want to be doing things to people without having it reviewed, published and tested. So the IRB thing is a big deal in getting papers approved. It’s actually quite hard, so that’s an important piece of doing research.
Dr. Leach: As far as breaking down the methods, there was eight different techniques that were used in the study. Seven maybe? Do you think we should break that down and explain them? Or do you think maybe it might be too much? How about just maybe the difference between the Orthogonal and Segmental. You want to just break that down real quick?
Dr. Evans: Yeah. So when we talk about Upper Cervical, we always discuss Orthogonal and Articular because segmental would be false. By in Articular, meaning we’re specifically looking at the articulation between C0 and C1. Orthogonal meaning we’re looking at the orthogonal relationship between the head and the Atlas and the cervical spine. To break it down really quickly, in the 1930s there were two guys, BJ Palmer and Alec August Wernsung that developed this style and idea of correcting the upper cervical spine, to balance the head because of its specific relationship to the rest of the spine. The fact that it doesn’t have a disc above or below. They developed a whole new science in Chiropractic and really in Health. Understanding how the neck can affect the whole body. So we have all these techniques that branched off but it’s really broken down into two specific types. Orthogonal and Articular types. Orthogonal types being Atlas Orthogonal, Advanced Orthogonal, Epic was not in this paper because they weren’t in technique yet. Also Grostic, Orthospinology and NUCCA. I don’t think I’m leaving anyone out there. Then the articular types are the Toggle group, the Blair group, and the Knee Chest group. So there’s really three groups in the articular group.
Dr. Leach: Just for the listeners out there that might not be completely familiar, when Dr. Evans said C0/C1, he’s talking about the relationship between the head and how that sits on the very top bone of the neck. The word “orthogonal”.. if you think about crosshairs on a rifle, and you think about the head straight up and down in relation to the top bone in the neck, and then the rest of the neck as well everything being nice and aligned. No head tilt, neck deviation or things like that. In “Articular” meaning related to what’s going on with the joints and looking at the joints and seeing if they’re aligned and seeing if it’s maybe right or left or slips in certain different ways. Again these are slight nuances, and as Dr. Brooks would say it’s just a box with a bunch of different holes and you’re just looking into the box from different perspectives. These techniques have developed and we want the end goal being the proper function of the upper neck, but these different techniques are just different ways to get to it based on slightly different analysis. If you would, talk about all the methods with inclusion criteria, and go from there?
Dr. Evans: OK. The inclusion criteria.. the patients were aged 18 to 85. There were ten cases per Chiropractic office. Some offices had less, just because, you know things happen in life. The data collection clinical outcome variables.. the way they studied the data, was they did a Neck Pain Disability Index and Oswestry Disability Index pre and then post two weeks of care. That is a limit to this paper, it was only two weeks. So a greater paper, would be to follow up on these these patients maybe six months or a year later and see how they’re progressing. The intervention was Upper Cervical Chiropractic only. The reason we do that is because what we find with the Upper Cervical Spine, it is very susceptible to movement lower down. So, if you are putting a force in somewhere else in the spine it can actually change what’s happening up top. So this was Upper Cervical Chiropractic technique only. That’s what the UCT stands for in the paper. That’s special to denote because this is the difference and what we do is we’re only working on the top bones. Really the top one or two and that’s what makes us different. The re-exam and clinical outcomes were two weeks later. They did a follow-up and they did the Neck Pain Disability and the Oswestry and the Numerical Rating Score. Patient satisfaction.. the way they tested Patient Satisfaction was by asking three questions. How satisfied were they on a scale 1 – 10. Sorry not three questions. Symptomatic Reactions.. they had thirteen specific areas that they looked at. So one was neck pain, one was radiating radiating pain like down a limb, arm or a leg, arm or leg weakness, tiredness or fatigue, headaches, dizziness, nausea, vomiting, tinnitus, blurred vision, confusion, depression or anxiety, fainting and low back pain. Then there was a space for other symptoms but that’s pretty all-encompassing there and those things might sound intense but oftentimes (Kevin, I don’t know if you feel this way, but I know that in my practice) patients come in with all that stuff. And so if we’re working with a patient they may have that just because that’s their symptomatology. Some of what we we’re trying to determine in this paper was did that increase? Did it stay the same? Did it get better? Their intensity was also graded on a scale of 0 to 10. Duration was graded from 0 to 30 minutes, that would be the symptomatic reaction happened over 0 to 30 minutes. It was either 30 minutes to 4 hours, 4 hours to 24 hours, and then more than 24 hours. So that’s actually when the symptoms started. So if a symptom started at 24 hours after the first correction(treatment) it was graded as that level. Then finally the patient was asked to indicate the impact on daily activities for each symptomatic reaction. Did it affect life not at all? a little? or a lot? Then the Rubenstein guidelines for how symptomatic reactions were defined was used. That was a new or related complaint that was not present at baseline or a worsening of the present complaint by greater than 30% compared with baseline, occurring 24 hours following care and any intense symptomatic reactions were identified as complaint fulfilling the score greater than or equal to a Numerical Rating Scale of 8, which was 5%. That’s not to be confused with an adverse effect which was a life-threatening situation meaning the admittance to a hospital.
Dr. Leach: Cool. So that’s the methods. So as far as Results are concerned.. like you said before, there was a hundred and fifteen doctors, eighty-three were included from the four different countries, the average number of years that they were in practice was thirteen. The average number of adjustments for each of those doctors was about eighty five point five adjustments per week. 49 weeks of practice per year. Average number of career adjustments was 60 thousand with a total of over five million for all the doctors that were involved in the study. I think they included this to show maybe the importance of their experience? Why was that included in the study?
Dr. Evans: The reason that was included into the study was because there have been a handful of papers in the past that were pointing at Chiropractic as a source of adverse events. Meaning stroke, or you know other crazy things that have been blamed on it. What they found was that with Upper Cervical Chiropractic care in 5 Million adjustments they didn’t have ANY. At a minimum within three hundred thousand adjustments, regular spinal manipulative therapy, had caused or possibly caused a stroke. So that’s a much deeper conversation. The Cassidy.. if you guys are out there listening you can go look up the Cassidy study. But what we find is that it’s not that Chiropractic or Spinal Manipulative Therapies cause the strokes, it’s that oftentimes people are in mist of a stroke and come in because they are complaining of numbness and tingling in the face, neck pain, head pain, weakness. These are the things that we see our patients for on a regular basis and so they go to the ER. If someone had been to a chiropractor oftentimes they place blame. We just want to put that out there, that this study showed that in 5 million visits, that there were no adverse events. and so it’s just a product of statistics.
Dr. Leach: Yeah I think that study is going to be one that we’re gonna review in the future because I think of how important that study is. It’s really important to show these studies that really show no Causation.. possible correlation but no causation. That’s the exact mechanism that’s thought of as far as how.. you know unfortunately because we see those conditions all the time, sometimes those slight nuances and those red flags of knowing that the patient is actually having a stroke before we adjust their neck to hopefully make it feel better, sometimes that’s not caught, they get adjusted, they go to the emergency room.. “where have you been? oh you went to the chiropractor? you know it caused a stroke.” and so I’m not sure if it’s the Cassidy study, but I know one of them shows that the risk of a patient having a stroke, whether it’s at that point or later on is the exact same as if the patient went to a medical doctor, who’s not adjusting or manipulating the neck. It’s literally the exact same with Cassidy. That’s why the thought process is.. if they had the same quote-unquote risk to go to the medical doctor and the chiropractor it’s most likely happening already, and the medical doctor refers to the ER, the chiropractor refers to the ER, or they go to the ER after, and they find that they’re having a stroke. But obviously they don’t say that the medical doctor caused it because they didn’t do anything to their neck. That’s a good study that we’ll get into. You talked a little bit before, it might confuse some people about how a certain amount of adjustments were done and there were a lot more visits than adjustments. So a lot of people that have been to a chiropractor or who know about chiropractic, they might wonder why, “would you ever go to a chiropractor and not get adjusted?” I think it’s a really important point that many chiropractors, but definitely most Upper Cervical Chiropractors.. our entire goal is to get you adjusted and get you aligned but not to do it every single time. Not as a treatment or symptomatic treatment but to kind of train your body to be in alignment. So these next percentages for example 31% required only one adjustment over those two-week periods. They might have gotten checked two times after but found that there was no treatment actually necessary. There was no adjustment actually necessary because they’ve actually held their alignment. 28% needed 2 adjustments, 19% needed 3, 11% needed 4, and then 9% possibly more than 4 adjustments. So that’s a really important point to understand is that there’s a lot of testing going on before actual adjustments are being made in Upper Cervical offices. 74% of the patients seen in the study were considered “chronic” so that’s important to understand especially when you think about sensitization of nerves, pain and chronic pain. 74% chronic complaints with mild to moderate disability and moderate pain. So fairly serious patients coming in for the study and with the satisfaction rate and the results that we got, I think we’re pretty happy about those results. You want to talk about the the outcomes?
Dr. Evans: Yeah. Over the course of treatment, neck pain improved 56.8% percent which is Clinically Statistically Significant. So when we talk about a result in a paper in PubMed we always want to find that it’s statistically significant, meaning that the procedure or the treatment that was used was then shown to have some effect that is repeatable and reliable. That’s what statistically significant means. So it just means that it brings some weight to obviously that an Upper Cervical Chiropractor has the ability to to help with neck pain. Headaches were also improved 62.8%. Mid and lower back pain were improved 58.6% and 57 percent respectively. That’s just showing that Upper Cervical Care is effective in this case in that way this study was done. And that it is statistically significant for helping with those issues. Disability from neck pain improved 47%. Oswestry Disability for the Low Back improved 45%. Which meet what is clinically and statistically significant. The big thing to take out of this is just that patients did these two weeks of care, it was a snapshot in time, we had a 9.1/10 rating in terms of satisfaction, and very low level of symptomatic reactions. They were common and quite frequent but they were low in duration and low in intensity. And actually great statistically significant outcomes in terms of headache, neck pain, mid-back pain and low back pain.
Dr. Kevin: So we’ve got all those high percentages of improvement, but then when we also compare that, to just other articles, again major complications are extremely rare and it’s actually common to have these slight symptomatic reactions but like you said they typically go away pretty quickly. There’s nothing that’s really long-standing so that’s important. Just because we might be running out of time here, what else about the discussion do you think might be good to talk about?
Dr. Evans: Yeah, I think the weaknesses of this study.. it’s always good to talk about the weaknesses. This study was done for two weeks, obviously we’d like to see a study that’s done over a longer period of time. That requires a lot of money, time and effort from guys like you and me. There are people like you and me out there just trying to help, so that pulls away from our practice, but it’s something that we need to do. It did not show a Risk Analysis. So there was no risk analysis necessarily in terms of a specific reaction. But it does show safety [Upper Cervical Safety] and efficacy which are important, and that’s a piece right there. All these pieces have to piece together in the Upper Cervical world to show that when we do this treatment, we get this outcome. But it’s just hard because we can’t do RCTs. You know, Randomized Clinical Trials in an Upper Cervical practice, are you kidding me? How do you do that? You can’t give a sham adjustment in an upper cervical office. It’s really hard because everything affects the upper cervical spine. So it’s tough. That’s our limitation and we need to keep doing more research.
Dr. Leach: When I read this studying when we were planning on doing, even with the mild symptomatic reactions that resolved less than 24 hours.. when I read that I was actually surprised. I’m not trying to say I’m better or blowing my head up, but I felt like it was actually pretty high. And it got me thinking as far as compared to my own practice, and it got me thinking that our patients may not be reporting what they’re feeling. Possibly because it’s less than 24 hours, I see them three days, four days later. So maybe they forget about it. Do you feel like those actually were a bit high compared to what you see or are those on par?
Dr. Evans: There’s times where I would say that some patients have some of that and then I would say there’s times when some patients just do amazing. So you know it’s hard for me to compare really. It’s such a changing, evolving thing. What I would say is that it’s surprising to me, really breaking it down, how effective Upper Cervical is at helping people, and having such little negative side effect. And how satisfied people are with it. You know 9.1 out of 10 in two weeks of are over a thousand different patients ? That’s incredible. I can think in my mind, I’ve had a couple of people that have had symptomatic reactions where they were concussed a few weeks before and we got them corrected and so they had a bit of a retracing cycle, where their headache got a little bit worse or their brain fog got a little bit worse. Then they felt the best they’d felt in years. There’s some of that.
Dr. Leach: Do you tell your patients after the first adjustment or maybe even the first week or two that, “hey, you might be sore.”, “hey, you might have some..”
Dr. Evans: Yeah and I do too
Dr. Leach: It’s interesting to think about the mechanism of that. I actually probably tend to tell and explain too much to patients because I’m passionate about what I do. And maybe they don’t want to know all the details. But I think it’s important and the mechanism being.. when you’re changing the structure and the biomechanics and the way that the bones inside of your head and your neck are moving and articulating.. that in and of itself, when you’re breaking up adhesions and scar tissue, that’s going to cause a little bit of inflammation. Any sort of inflammation in your joints, you’re going to get achy, you’re going to get pain. and because there’s a cervicogenic, a neck related headache that most have, you’re going to have that response. So I tell patients all the time, “Hey listen there’s a possibility you might feel these, but this is normal.” and unfortunately I think a lot of our colleagues might not actually tell their patients that. Because I’ve had several patients that I can remember say, “I went for a few visits and I was sore and it was painful afterward.” It’s like “well they should have told you that.” That’s going to happen because that’s part of the healing process. With the relationship of going to the gym and working out, it’s gonna hurt. It’s going to take a while before your body gets used to that, but it’s still beneficial in the long run. I think that’s really important for people to understand.
Dr. Evans: Absolutely.
Dr. Leach: Any other points that you want to hit on before we close it out?
Dr. Evans: No, I think we covered it really well. I think that was pretty all-encompassing. That was good.
Dr. Leach: Awesome. Well Dr. Tyler Evans, I really appreciate your time. I know you’re like five minutes away from some patients. We’ll be doing this again and thanks for your time
Dr. Evans: Yeah. Thank You, Dr. Leach. This was great. Let’s do it again.
That’s all for this episode. Leave some comments if you have anything to say contribute or have any questions!
Dr. Kevin
