Vernon Williams, MD, Director, Center for Sports Neurology and Pain Medicine at Cedars-Sinai Kerlan-Jobe Institute talks about the HF10 stimulator and how it can help chronic pain.
Interview conducted by Ivanhoe Broadcast News in April 2018.
We’re talking about chronic pain and opioids in the news a lot lately, what is different about the HF10 for this treatment?
Dr. Williams: The HF10 falls in the category of what we would call neuromodulation. These are different techniques we have where we can apply different stimuli to parts of the nervous system and you can affect pain that way. Essentially to turn up or turn down certain signals, turn off certain pain signals and get significant improvement in pain without the need for opioids or other pain medications.
Would this be a first line of defense or would patients try the drugs and then switch over to this, how does that work?
Dr. Williams: That’s a good question, normally this is going to be something that’s used in at least moderate to severe pain. And normally this isn’t a first line treatment so often these are individuals who’ve had trials of other things. It may have been medications, it may have been surgery, injections, or it may have been physical therapies. And if they didn’t get significant enough pain relief with those or if they weren’t good candidates for some of those things then this would be an option for them.
And there are other spinal stimulators, how is this one different?
Dr. Williams: This HF10 technology is different in a couple of ways. One is that the frequency of the stimulation is much higher than the frequency of stimulation with some of the older technology. And what that means for the individual is that when they have that stimulator on and it’s covering an area where they have pain they don’t feel paresthesia meaning they don’t feel tingling or buzzing or any kind of uncomfortable sensation. It used to be with the older technologies with those lower frequencies of stimulation individuals would feel stimulation or paresthesia in the area of their pain. That’s kind of how you knew the stimulation was in the right place and what have you. The goal was to try to cover their pain with the paresthesia. This is paresthesia free, HF10 has a higher frequency and the individual patient doesn’t feel any paresthesia, nothing uncomfortable in the area of their pain.
But it is an implanted device?
Dr. Williams: It’s an implanted device.
How does that work?
Dr. Williams: There’s two steps. The first step is an individual has a trial
lead placed and that’s done in a surgery center it’s an outpatient procedure it takes about twenty, twenty five minutes to do. For five to seven days they have a temporary lead placed in the spinal canal and they get to try it and see if it gives them pain relief. If they did get significant pain relief from that trial or temporary lead then they come back for step two. And step two is where the entire system is implanted and it’s all internal. There’s nothing external to the body. The leads are in the spinal canal and then there’s a little lead that connects what’s called an IPG or little generator under the skin normally in the hip or the upper back or the abdomen.
How long does the surgery take?
Dr. Williams: That procedure takes about an hour to an hour and a half. Not long because it’s a brief outpatient procedure; people go home the same day. It’s a very minor surgical procedure.
Does the battery have to be recharged or does it last forever?
Dr. Williams: They have the ability to recharge that battery. There is a charging mechanism that they plug in to a wall and charge and then that can recharge the battery without having to replace that generator.
Theoretically one surgery and that’s it?
Dr. Williams: Correct, correct.
What kind of results have you seen with this?
Dr. Williams: We’ve seen great results. And part of it is because the technology works so well, part of it is because people tend not to have some of the side effects that they would have with the other technology. If you look at the clinical trials and that kind of thing you’ll see that eighty percent or more of individuals who have this kind of technology implanted have significant long term benefit. And that’s a key as well. Sometimes people do well immediately with procedures some of the older technology we would have patients who for the first couple of months said, yeah this is working I’m doing well and four, six months later their pain is back or they’re back on medications or they’re just dissatisfied with those paresthesia’s. This technology works extremely well initially and it seems to have durability. People continue that benefit long term. We’ve been very pleased with the outcomes.
This has only been available in this country for about a year, a year and a half, two years?
Dr. Williams: Yeah this is relatively new technology, it’s been about a couple of years where it’s been widely available. Initially used for people with back pain and lower extremity pain, that can be one leg or both legs. But they’ve also expanded and now we’re seeing individuals implanted with this technology for other indications. Neck and upper extremity pain and there are some trials going on right now which seem to be beneficial in other kinds of pain like diabetic neuropathy and that kind of thing as well.
To get rid of neuropathy?
Dr. Williams: Well to treat the pain associated with neuropathy.
And those are trials that are ongoing right now?
Dr. Williams: Correct.
Who is this procedure specifically for?
Dr. Williams: This is a procedure for individuals who have at least moderate to severe pain and their pain is not acute. In other words it’s been present normally for at least three months or more. And individuals who have tried other interventions without success so normally they’ve had trials of medications or physical therapy or injections and still have significant pain. The other category would be people who may not be good candidates for surgery or for certain kinds of other interventions. Individuals with back pain, back and leg pain or leg pain and as I mentioned other extremity pain as well, what we would describe as neuropathic pain, meaning pain resulting from some injury to a nerve or some dysfunction within the nervous system. That pain tends to be burning or electric or radiating and those would be the kind of candidates that we’d consider this kind of technology for.
Who would not be a candidate?
Dr. Williams: We wouldn’t implant the device in someone who had a trial and didn’t get benefit during the trial. We wouldn’t implant the device in individuals who were poor candidates for surgical intervention or that kind of thing. It’s a minor surgery but it is still a surgical procedure. If individuals are on certain kinds of medications, blood thinner medications they would need to come off of those or they wouldn’t be candidates for this kind of device. Then we’d also warn people about other things. For instance, if they have pacemakers implanted already we wouldn’t want this technology to interfere with their pacemaker. There are some uncommon scenarios where people may not be a good candidate but most of the time people are.
And age wouldn’t be a restriction either?
Dr. Williams: No, no.
What else about the HF10 I haven’t asked you that you wanted to include? You know who the patient is we’re going to talk to but how did this help her and how did that come about?
Dr. Williams: Alisha is an individual who we had treated for a while for upper extremity pain. Severe what we call neuropathic upper extremity pain. She had been through trials of physical therapy, she had been through trials of medications, she had been through trials of injections and she would make marginal progress. But her pain was still significantly affecting her function, her quality of life, even her ability to work and complete activities of daily living, that kind of thing. She was frustrated with her pain, we talked to her about this as an option and she hesitantly agreed to the trial. But at the time of the trial she recognized that she was having significant improvement in her pain from the technology. And so she went ahead and we pursued the implantation and she has done wonderfully well since she’s had the implant done. She’s been able to dramatically reduce many medications, completely eliminate other medications. But more than that her quality of life has improved dramatically. I walk in the room and see her she’s like a different person as compared to the way she was before. Her entire body language, her overall disposition is much better now and so she is looking forward again to a healthy, happy life and living happily ever after with the technology. That certainly wasn’t the case beforehand. Her life was really dominated by pain.
What haven’t I asked you about HF10 that you think we should include in the story?
Dr. Williams: Well we talked about the fact that HF10 is a form of neuromodulation. There are other forms but this is a really effective form of neuromodulation where these stimuli have an effect on the spinal cord and the nerves ability to send these pain signals. One of the things that we really like about this technology is that we can dramatically reduce the need or eliminate the need for medications. You know there’s lots and lots of problems with opioid epidemic side effects and complication to not just opioids but anti-inflammatory medications, muscle relaxer medications. We know that people have significantly difficulty sleeping because of pain so then they’re on medications for sleep. One of the things that I’m most excited about is that this technology can dramatically reduce and eliminate all of these medications and these toxicities that often come along with medications in individuals. I think that’s a huge part of their benefit and advantage.
So moving on, tell me a little bit about the CTE study.
Dr. Williams: This study was interesting and we’re seeing a collection of this information, this evolution and addition of information related to this issue of CTE and other chronic neurologic impairment that may be related to either concussion or sub-concussive injuries. This is a huge issue because there’s so many people who are affected right now with chronic neurologic impairment related to combat sports or collusion sports or what have you. And then there’s this wave of individuals who play certain sports and there’s a concern about whether or not they are at risk for CTE and what needs to be done about it. This particular study identified the concept that in individuals who started playing tackle football before age twelve as compared to individuals who started playing tackle football after age twelve, those ones who started beforehand were more likely to develop long term neurologic complications. Some of the symptoms associated with CTE and some of the findings seen at pathology are related to CTE. So that’s the concern. My feeling is that I think it’s an important piece of information but I think we need to take it in context. And what I mean by that is I think there are pieces of information that certainly make us concerned about the potential risk for participation in collision sports and contact sports. But we also need to balance that with some of the benefits that are associated with playing contact sports and collision sports and we need to you know avoid the possibility of kind of throwing the baby out with the bath water. We do know that now as compared to ten years ago or certainly twenty or thirty years ago, we do know that now there are lots and lots of measures that have been put in place to help protect the brain. So many of the things that we’re seeing in individuals who played a long time ago may be less of an issue now because we’ve instituted all of these concepts, all of these different measures to help protect the brain. We need to keep that in context and keep that in mind as well.
But when a mom hears this and little Johnny is ten years old and playing tackle football her automatic knee jerk reaction is going to be to pull him out.
Dr. Williams: Well it might be, I hope not, this is my personal opinion, I hope not but that might be their automatic opinion or knee jerk reaction. But there’s a lot we don’t know. So what we don’t know is how important is it that the individual participated in a sport or had exposure to some of these contact injuries at a certain age. Is it more important the duration of time that they were exposed, does it matter what level they were exposed at. In other words if you played before or after twelve but never played in college or never played as a pro what effect does that have. What are the individual genetic risks that one person may have and another person doesn’t have. And then there may be scenarios where people have structural changes in the brain but that didn’t have any significant effect on their function during life or what have you. We know if we look at other areas of the body we can do for instance MRI’s of the spine and see significant structural abnormalities even if in an individual whose performance and function is completely normal. So there’s still a lot to learn and I think that it’s important to do this kind of work and to study these kinds of things and collect the information but we don’t want to draw conclusions prematurely. That’s the caution that I would have.
After just one study, it sounds like a whole field that needs to be studied more deeply.
Dr. Williams: Absolutely, and that’s being done. Again I don’t ignore this information but I think it’s only a piece of information and it needs to be considered in the context of the bigger picture and in the context of what we don’t yet know. My personal opinion is that that’s an important piece of information, it has not resulted in me feeling that individuals should not play tackle football before age twelve. I think that again that’s one piece of information, there are other pieces of information that need to be considered. And there are quite frankly going to be some differences in the calculus from one individual in a family to another as to what risk is most important to them.
Great.
END OF INTERVIEW
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Cheryl Aasa, Dr. William’s Office Assistant
310-665-7286
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