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Daniel: Okay. Very good. Good afternoon everybody. And welcome to the Tuesday webinar series, “Chiropractic Economics Webinar for Doctors and Chiropractic.” I’m Daniel Sosnoski, Editor-in-Chief of Chiropractic Economics. And today’s webinar, “Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial,” is sponsored by Foot Levelers. And, as always, our program is being recorded and will be archived at Chiropractic Economics’ website, chiroeco.com/webinar, for one year. Our expert is on-board here today to speak with you. And when his presentation is complete, we’ll follow with a question and answer period. You can submit questions throughout the presentation by clicking on the appropriate icon on the right side or bottom of your screen. We’ll do our very best to get to all of your questions. But if we run out of time, we’ll forward the remaining questions to our expert and then notify you via email when the answers are posted on our website, chiroeco.com/webinar.
Our presenter today is Manuel Duarte, DC, who maintains a private practice specializing in athletic training. Dr. Duarte has been a full-time faculty member at National University of Health Sciences for 19 years. And he is now Chair of Clinical Practice and Chief Clinician for the DC program at NUHS. Dr. Duarte, thank you for taking the time to participate in our webinar and for sharing your insights regarding your work on a ground-breaking study regarding the interaction of chiropractic and shoe orthotics. Arguably, one of the most rigorous investigations ever taken in this area. Before we get started, Dr. Duarte, please give us a brief background on yourself and your work with the study.
Dr. Duarte: Well, thank you, Dan. I appreciate that wonderful introduction. And I am Dr. Duarte. And I have practiced body fitness, physical medicine. I’ve been in study practice for over 30 years. And I am the Chair of Clinical Practices at National University at Lombard Campus. My job is to oversee the clinicians in all of our departments, DC, AOM, as well as naturopathic, and make sure that the interns at National receive a great clinical experience and receive a good education. My interest in shoe orthotics for the treatment of chronic low back pain actually started several years ago. I was preparing for a class and I was researching the use of orthotics for chronic low back pain. And much to my surprise, when I did a literature search, little to nothing came up that was useful for me. And I was surprised because so many chiropractors and other types of physicians use orthotics to treat back pain. And I was just shocked that there was no evidence to support the use of orthotics for the use of back pain.
So this was back in 2011. We did a pilot study with Dr. Cambron, myself, and did a study on shoe orthotics for the treatment of chronic low back pain. It was a randomized control, but it was a pilot study. We only had about 50 patients. And we had a control group. And then we had a group that received orthotics. The results were promising. So the conclusion was that a larger clinical trial was needed to verify the results. And this was published in JMPT in 2011. So fast forward a few years. And we were able to get funding. And we were able to put a larger program together for shoe orthotics, and this is this study, for the treatment of chronic low back pain. And this study now had 225 patients in it. So this is a much more viable study. But it comes from the pilot. So, you know, what prompted this is we were looking at, you know, so many people…you read “National Institute of Neurologic Disorders,” and we see that, you know, 80% of adults experience low back pain at some point in their lifetimes. And what we know about back pain is that it tends to be chronic. It tends to be progressive and degenerative. So people just keep getting worse. The condition gets worse, unless we intervene at some point to break that chronicity and slow down the progression.
We combined that amount of patients with chronic low back pain with the treatment, which when you look at the medical treatment, the medical treatment tends to be use of opioids for pain. According to a 2014 study, statistics on opioids from the Department of Health and Human Services, we found that over 650,000 opioid prescriptions were dispensed within a year. Almost 4,000 people began nonmedical use of prescribed opioids. And this use tends to initiate heroin use. So something needs to be done. In 2017, we’re at a crisis. I work with some people in the VA. And there was a directive set forth to decrease the number of opioid prescriptions for veterans. Also, in hospitals, physicians on staff were given a directive to reduce the number of opioid prescriptions given. If we look at some of the electronic health records, meaningful use has provided the physicians with a list of medications that the patients receive. This is a pre-populated list. Even if it’s a new patient, you will have a list of all of their prescriptions and the physicians who provided so we can, you know, do something to prevent people from doctor shopping for opioids.
And as you can see from this current slide on the National Institute of Drug Abuse, you can see how the use of opioids has increased from 2002 to 2015 among males and females. And the total use is just phenomenal. And it’s unacceptable. And it’s become a crisis in the United States. So if you think that 91 Americans die every day from an opioid overuse and that opioid addiction many times possibly could have started from the use of opioids for chronic low back pain, well, it just makes good sense to think, “What can chiropractic as a profession do to impact that number and decrease it?” So hence, the study. And the study was published, as you can see, in the “Archives of Physical Medicine and Rehabilitation” in 2008. This journal was ranked 9th among the top 27 physical medicine and rehabilitation journals and 12th among the top 72 sports science journals in the world. So this is a very reputable journal. It is a medical journal. And here it is carrying chiropractic conservative care modalities. So we’re trying to impact and reduce the impact of chronic low back pain on patients and reduce the need for opioids in the treatment of that chronic low back pain. So I’m hoping that this study helps in that fashion.
So it’s our contribution and chiropractic contribution, Foot Leveler’s contribution, to having an impact on the opioid epidemic in this country. And you could see, I want to thank Dr. Cambron and Dr. Dexheimer and Sally Freels. Without a team effort, this would have never come off. And I just want to thank my colleagues for their help and their initiative in getting this article published in such a prestigious journal.
So the objectives of this articles were to investigate the efficacy of shoe orthotics with or without chiropractic treatment for chronic low back pain as compared with the control group, which received no treatment. So we had three groups. The first group received no treatment. The second group received orthotics. And the third group received orthotics and chiropractic care. This is a departure from our first study that was completed in 2011 where we only had two groups. We had a control group and we had a group that received orthotics, Foot Leveler orthotics, for chronic low back pain. This study included a third group that received Foot Leveler orthotics and chiropractic care. And the chiropractic care that they received was common chiropractic treatment, the high velocity, low-amplitude type of manipulation or flexion distraction. So we know that these are among the most common types of chiropractic manipulation used in practice today in the United States. So this was a first large-scale study, clinical trial, assessing orthotics for the treatment of chronic low back pain. We had 225 subjects with chronic low back pain that were randomized into one of three groups. We initially had calls from over 600 potential patients who called and went through the phone screen. And then we had patients come in for their baseline visit. And out of that 682 people who actually came in, we ended up randomizing 225. A lot of them, there were exclusion reasons why they could not. We had an exclusion criteria. That kept a lot of people out of the study. Some people didn’t want to make a commitment to the study. But we ended up with 225 adult subjects.
Pain and disability were assessed at baseline and then reassessed throughout the study. We used a numeric pain scale. And we used the Oswestry Disability Index for function. The outcome measures were basically changes in perceived pain. The numerical pain rating was used for that. And we used numerical because it’s easier to assess when a patient writes down a number from time to time as opposed to just putting a dot on a scale. So with the number, that’s a more valid way to assess perceived back pain. And then, of course, we used the Oswestry Disability Index, which is a well-known instrument to establish function. And after 6 weeks of study participation, then outcomes were assessed after 12 weeks, and then again after 3, 6, and 12 months.
So if you look at the results, what we see if that after six weeks, all three groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus group had significant group improvement in function. So that was a surprise to us. We didn’t really expect that. But we’re very happy to see that. We know today, with evidence-based research that yes, we’re very concerned with reducing pain. But we’re especially interested today with functional assessment and functional outcomes. And when we saw that there was an improvement in function of 40% when we combined chiropractic care with the use of custom-made Foot Levelers orthotics, we were just blown away by that. And then compared with the wait list, who waited when they waited to get their orthotics, and we found that their pain actually didn’t go down as much as the group with orthotics or the group with orthotics and chiropractic care.
So we can see by these numbers that these are significant. They’re statistically significant numbers in improvements in pain and function, and especially, with the addition of chiropractic to orthotic treatment, even greater improvement in function when compared with orthotics alone, but no significant difference in pain. And if you look at these P values, of course, we know that the lower the number, the more significant the findings. So what this tells us, in a nutshell, is that these findings were for real. They’re reproducible. They weren’t random. They weren’t just random results. So what we know is that after six weeks of prescription of shoe orthotics, Foot Leveler’s orthotics, we significantly improved back pain and dysfunction compared with no treatment. The addition of chiropractic care led to higher improvements in function. You know, the wait list, if you look at pain, there was significant improvement, but lower than the other groups. And function improved, but not at a significant level.
The Foot Leveler, the shoe orthotics group, when we looked at their pain, that improved 34.5%. And their function improved 18.5%. If we look at the Foot Leveler shoe orthotic plus chiropractic care, and, again, this was a diversified type of technique and it was also flexion distraction, their pain improved 40.4% and their function improved 32.3%. Amazingly significant findings for a study of this kind. Again, this is the largest study of this kind that we have today. So here we have some baseline characteristics of the patients that were randomized. And you can see the difference between men, married, Caucasian, with level of college, if they’re employed, if they had other types of pain in the lower extremity like the foot, the ankle, the hip. And this is something that I think we’re going to investigate further. We did collect quite a bit of data on these patients. And I know we’re going to have some spin-off or our research published on the findings of the effect of the orthotics, the effect of the orthotics in manipulation or the effect of the control group on hip, knee, leg, ankle, and foot pain. So this hasn’t ended for us. I’m excited to take a look at those numbers and crunch that data and see what the findings are.
So, you know, the level of back pain, all of these patients had chronic low back pain. And it was just amazing results that really blew us away here when we finally sat down and looked at the results. So we can see, if we look at this, that, you know, that Foot Levelers has put out this 40.4% better together, the idea that chiropractic treatment with Foot Leveler custom-made orthotics decreased low back pain by 40.4% and increased function 32.3%. So I think those are quite telling. And more research is certainly indicated in this area. Even though this was a significant study, I think there’s a lot more work that needs to be done. And I’m looking forward to future studies of this nature and looking at other areas of the use of the Foot Leveler orthotics with chronic low back pain and function.
Daniel: Okay. Well, thank you so much, Dr. Duarte. I just want to just comment on the fact that there is a link to footlevelers.com/proven and people can actually look at the study itself. And I would urge anybody attending this webinar, go ahead and take a look at it because it is really impressive to see this extremely unbiased research. It’s such a well-powered study compared to anything on this topic I’ve seen before, as I’ve often gone into the literature myself looking to see what research has been done on shoe orthotics. There’s been so little out there. This is really ground-breaking landmark research. And I wouldn’t be surprised if it winds up becoming a true landmark study.
Dr. Duarte: Thank you, Dan.
Daniel: You’re so welcome. If you’re ready, I’d like to just ask you a few questions from the audience. I think we got some good ones here. A listener is asking, how does this study impact the average chiropractor?
Dr. Duarte: Well, I think this study impacts the average chiropractor because, you know, we look at chiropractic care…You know, this is a world of evidence-based. Everybody Googles everything, you know. And we’re looking really at evidence. So how does this impact the average chiropractor? I think it would behoove chiropractors to, as you suggested, get a copy of this research. I think they should have it in their office and available to patients, and demonstrate and show that this is evidence-based treatment. And evidence-based treatment I think will help. You know, sometimes patients sit on the fence. And they think about the treatment. They think about what they want to do. And I think this study will help patients to decide and help them appreciate even more the benefit chiropractic care has on their chronic low back condition and also if Foot Leveler orthotics are prescribed, what they can expect from the combination of treatments on their chronic low back condition. So I think this will go far in helping formulate treatment plans for chiro practice and helping take care of the chiropractic population. And remember, you know, with chronic low back pain, this is a large part of the group that is prescribed chronic opioid pain medication for chronic low back pain. And it gets out of hand. So we can impact that, those statistics, with conservative care. And this is, I think, an outstanding place for chiropractic care in our country at this time.
Daniel: I agree with you. And that’s also now a major initiative of the Foundation for Chiropractic Progress. Let’s see. We’ve got another question for you. And this is kind of interesting. What was the original purpose of this study? That is, was there an objective that you had in mind that you were looking to accomplish?
Dr. Duarte: Well, you know, the purpose of this randomized controlled trial was really to determine the change in perceived pain levels and the functional health status in patients with chronic low back pain, you know, at the end of six weeks of the shoe orthotic treatment alone or orthotics plus chiropractic treatment. And we’ve called that the plus group. And that was compared, of course, to no treatment at all, which was the wait group. So we hypothesized that the shoe orthotics alone would be significantly better than no treatment for low back pain and disability and that the shoe orthotics plus the chiropractic treatment would be significantly better than the shoe orthotics alone.
Daniel: Got you. And I think we have time to get to one more. I do have to mention, a lot of us here at the office, we do go to trade shows. And we have found that customer orthotics do make a difference if you’re on your feet all day. And we were just talking about that foot pain.
Dr. Duarte: Yeah, absolutely.
Daniel: Let’s see. One more here. A doctor would like to know, did you think of adding… Hold on for a moment. I’ll hold this question up. Did you think of adding a group that was just getting an adjustment alone to show the value of adding orthotics?
Dr. Duarte: You know, actually we did consider that as an option in the design of this study. But we didn’t want to risk getting too spread out with just the chiropractic manipulation alone. So we kept it somewhat based on the pilot study that we did in 2011. And I think just adding the chiropractic treatment and the orthotics was enough of an advance for this study to leave it at that. We didn’t want to spread the results too thin, although I think that’s a great suggestion and something that should be and will be considered for future research.
Daniel: Got you. And we’ve got time for one last question. Did this study have any exclusion criteria?
Dr. Duarte: Yes. Like I said, over 600 people called in. We had promoted this, you know, far and wide through a number of venues. And we did have a fairly strict exclusion criteria. The patient, whoever called in, they couldn’t have one custom-made orthotics for the last six months. They couldn’t be under ongoing active conservative care. So if they were under the treatment of a chiropractor or physical therapist for low back pain or leg pain or foot pain for the last six months, they were excluded. Any patient that was involved in litigation for low back pain was excluded. We excluded people that were not fluent or literate in English because we weren’t able to provide multiple translators in this study. People with brain disorders like dementia and Alzheimer’s, you know, were excluded largely because we had so many questionnaires to be completed. And we felt that we couldn’t get consistent. People with chronic conditions other than low back pain such as multiple sclerosis and fibromyalgia were excluded. And there were a number of others like inflammatory arthritis, other types of spinal pathologies or fractures, patients, people who called in with progressive neurologic defects like spinal cord compression or cauda equina, history of bleeding disorders, any type of aneurysm. So we had quite a list of exclusions. If the patient was pregnant, we had to exclude some patients for that. Low back pain that was not reproducible upon examination, then those patients were excluded. So we had a fairly strict exclusion criteria. And the exams were done by licensed chiropractic physicians with several years of clinical experience. The exams were largely performed by the clinicians at National University in Lombard.
Daniel: Got you. So, obviously, then when you were looking at your various groups, the cohorts that were going to work with, you wanted to make sure to exclude any confounding variables that might have affected your study results.
Dr. Duarte: Correct.
Daniel: Okay. Well, you know, this is really a triumph of evidence-based research, which is something that we hope to see so much more of in chiropractic. And we want to thank you and National University of Health Sciences for showing some leadership here and pointing the way forward. Thank you so much, Dr. Duarte. And at this time, we’d like to thank our sponsor, Foot Levelers, and Dr. Manuel Duarte for today’s webinar. And thank you all for attending. Remember, this webinar, including our speaker’s PowerPoint presentation, has been recorded. If we did not get to your question during the webinar, the questions will be posed to our expert and the answers posted shortly at chiroeco.com/webinar. We’ll alert you when the webinar is available. Thank you, everyone, for attending. And we look forward to seeing you next time. Have a great day.
About the Speaker
Manuel Duarte, DC, MSAc, DABCO, DACBSP has been a full-time faculty member at NUHS for 19 years. His specialty is sports injuries, and he maintains a private practice treating both amateur and professional athletes. In addition to certifications as a chiropractic sports physician and strength training specialist, Duarte has also earned diplomates from the American Board of Chiropractic Orthopedics and the American Chiropractic Board of Sports Physicians.