• What is chronic pain?
• Overview of your treatment options
• How does spinal cord stimulation work?
• Who is a good candidate for spinal cord stimulation?
• Clinical evidence & patient testimonials
• What to expect with spinal cord stimulation
• Insurance coverage
i’m an interventional pain physician in northern california our practice is
called IPM medical group and i’ve been in practice here at PM for about 23
years I’m an interventional pain physician and I’ve engaged in a lot of
different interventions in order to help my patients control their chronic pain
I’ve also been doing research for the last 15 years and I’ve been honored to
be involved in some of the most cutting-edge research and bringing new
technologies to be able to treat my patients better for their chronic pain I
have over 70 publications and I’ve written a lot of book chapters on
interventional pain management and in particular spinal cord stimulation and
it’s my pleasure to speak to all of you tonight about a breakthrough treatment
in chronic pain and we’re going to get into a lot more detail about this right now
tonight we’re going to talk about chronic pain and all the treatment
options that may be available out there for it then we’re going to talk about
the unique benefits of HFX and how HFX can potentially
provide you with long-term pain relief and if you’re wondering what HFX is stay
tuned in the next few slides we’re going to talk about it in a lot more detail
studies showing long-term pain relief was incredibly important not only for
the clinicians and the scientists but it should also be important to the patients
as well so we’ll look at the studies that have shown how HFX can provide the
patients with far better chronic low back and leg pain relief
we’re also going to talk about what you expect from HFX and how to
have a conversation with your own physician about HFX and
whether it’s the right type of treatment for you insurance coverage is incredibly
important we’ll touch on that tonight and we’ll hear some stories from people
who have regained their independence using HFX and I think a patient-centric
presentation like this one should actually start with the patient’s story
so we’ll start with Geri who’s actually one of my own patients that’s her on the
beach on the right side she had really bad scoliosis in her spine with a lot of
this degeneration and pinched nerves and for those of you who don’t know what
scoliosis is it’s basically a torturous spine a spine that has a lot of twists
and turns in it and unfortunately she was born with that but it was pretty
much debilitating her she was housebound and she couldn’t do anything without
pain she was looking for pain relief and more importantly she wanted to be able
to get out of the house and stop all her medications we tried her with HFX
she loved it we ended up implanting her HFX and she was able to get
incredible pain relief she actually told us she happened she was 98% pain-free
and was traveling all over the place without any problems in fact the picture
that you see on the right side is her attending her granddaughter’s wedding in
on the beach in jamaica these are the kind of super success stories that
excite me as a physician and obviously excite the patients as well not everybody can get 98% pain relief but
we all agree that anything that can potentially improve the patient’s pain on a long-term basis is a huge step in
the right direction so treating chronic pain can be very challenging it can last for several
months to several years despite appropriate treatments and natural coping efforts
pain can be very different among individuals two different people can have
the same type of illness or the same type of injury or surgery but their pain
presentation and the amount of pain they suffer from may differ from each other
from night to day there are all kinds of different types
of pain out there the two main ones are nociceptive and neuropathic pain that’s
dr jargon for mechanical pain or nerve pain mechanical pain is no susceptible pain
it’s the pain that patients feel with arthritis in their knees and hips
neuropathic pain is nerve pain and nerve pain is what we try to treat with HFX
to the best of our ability a lot of patients have a mixed
nociceptive neuropathic pain and they may be suffering from both
mechanical and nerve pain so what is nerve pain well it’s actually it
results from a damaged nerve and nerve fibers that are sending the wrong signal to the brain
an injury may have been present at some point the injury may have been long gone
but the the wiring sends the wrong signal to the brain damaged nerves can
overproduce the pain signals and the stronger the pain signal the stronger
the pain with nerve pain it’s really generally harder to identify the source
in fact one of the most common questions for my new patients when they come to see me is
where is this pain coming from can we just go to the source and fix that
problem and frankly my answer more often than not is I don’t
know I really don’t know the problem may have been fixed a long time ago but the
nerves continue to send the wrong pain signal to the brain it may come from illness injury or no
identifiable source at all but make no mistake about it pain doesn’t matter whether it’s
mechanical or nerve pain is very complex it has the physical component which we
all know about but there’s mental and emotional components to it as well
the more pain you have the more depressed and anxious you may become the
more depressed and anxious you are the more pain you’re going to suffer from
as a physician, I have all kinds of different tools in my toolbox to try to
treat the patients and they have different tiers for it for example the
first year can be things like physical therapy and exercise which is by far one of the most
important things we can do for our patients we want our patients to increase their function
while they’re reducing their pain that’s why we engage in physical therapy and exercise
lifestyle changes can make a big difference if somebody’s obese and
they’re having back and knee pain maybe some weight loss is
indicated before we start any medicines or do any type of interventional therapies
medicines can be indicated although we don’t use medicines the way we used to
pain medications specifically opioids have a lot of side effects there’s
physical dependence and there’s a rate of addiction this is the reason why we try to stay
away from medications as much as we can and engage in more conservative measures
to try to treat the pain patients pain before we get to medications
but the next year if those things fail is things like nerve blocks epidural
steroid injections and nerve ablation I do thousands of nerve blocks on
epidural injections in my practice per year and I know that they help the patients
but they never help on a long-term basis if we’re lucky we get about four to six
weeks worth of pain relief from each injection nerve ablation on the other hand
is a very good therapy for the right patient and it can provide the patients
with about six months worth of pain relief but that indication is very limited to
certain patients with certain types of conditions and it’s mostly for mechanical pain
there’s also pain pumps as the last tier pain pumps are medications infused at a
much lower constant concentration and right next to the
spinal cord they’ve fallen out of favor in the recent past mainly because of the
fact that there’s still medications and the patients can suffer from the same
type of side effects that they would from oral medications as well
surgery can be indicated but then again the results of surgery can be very
limited and the patients may continue to suffer from their chronic pain
last but not least is spinal cord stimulation which is near and dear to my
heart this is the reason why I’m sitting in front of you today and presenting on
HFX which is the next frontier in spinal cord stimulation and
by far one of the best therapies out there but before we talk about HFX let me tell
you what spinal cord stimulation is spinal cord stimulation has been around
for 55 years it’s nothing new it’s a way for us to send very minute
electrical impulses to the spinal cord which will in turn mask the pain signal
from going to the brain the way I explain this to my patients is
that hey when you hit your funny bone what do you do you take your hand and
you rub that area with your other hand and the reason you do that is because
the tactile sensation the touch sensation distracts the pain signal from
going to the brain now imagine a very sophisticated system doing the exact
same thing right over the spinal cord for chronic debilitating pain
despite the fact that spinal cord stimulation has been around for over 55 years
the long term data for it especially for low back pain and leg pain was quite limited
this is when HFX came into the picture after about 12 years of development and
research the FDA approved HFX as the new frontier in spinal cord stimulation in 2015
and this was indeed a comprehensive solution to treat complex dynamic and
the unique nature of chronic pain for the patients the FDA looked at a lot of data
including a very important scientific research study that I had the honor to
be of being involved in before they approved this device to be
used here in the united states and also around the world
it’s one of the most advanced spinal cord stimulated devices available on the
market and it eliminates a lot of the limitations that the traditional spinal
cord simulators have had over the years in fact this chart can show you exactly what’s
happening between the differences between HFX and traditional spinal cord stimulation
look at the top line the most robust body of clinical evidence in spinal cord stimulation and that’s no joke
HFX has been studied time and time again with some of the best scientific
evidence in history of spinal cord stimulation and traditional spinal cord stimulation despite
the fact that it’s been around for a very long time continues to have
good but very limited scientific evidence for it there’s significant relief for both back
and leg pain with HFX that’s not to say that traditional spinal cord stimulation
doesn’t work for low back and leg pain it actually does but the long-term data can be anemic and
HFX simply works far better for the treatment of chronic low back and leg
pain based on the scientific evidence available to us it offers programs that can be used
while sleeping and driving this is unique to HFX because it uses a
frequency that doesn’t cause tingling for the patients so the patients can use
the device 24 hours a day seven days a week and they can get better sleep and
function better during the day and they can also drive based on the FDA labeling
labeling for HFX device it offers programs without a tingling sensation that reduces the amount of
jolting so as the patients move back and forth you don’t have any unpleasant
jolting by the way the tingling may be very pleasant with traditional spinal cord stimulation at
the beginning but it can become cumbersome and very annoying for the
patients in the long run HFX offers high frequency spinal cord
stimulation at 10,000 hertz this is unique to HFX no other company can offer
that to anyone but aside from that it can also offer any other frequency that
has ever been studied in the human body in the same device
so this is by far the most comprehensive solution in terms of spinal cord
stimulation for my patient population and potentially your case as well
it the battery is designed for a 10 plus battery life the device is a
rechargeable device it needs to be charged once a day for about 30 minutes
or so and guess what I was involved in the randomized control trial that was performed
before the FDA approval back in 2012 and I still have patients continue to enjoy
excellent pain relief using their original battery from 2012. we’re getting into 2022 fairly soon I
bet you anything that some of these patients will trickle back in in order
for them to be able to get their battery changed at that time as I said I had the honor of being
involved in one of the largest studies ever done in spinal cord stimulation for
the study of low back and leg pain this was a randomized controlled trial
that we scientists and physicians consider the gold standard
in the type of scientific evidence available to us in this study a whole
bunch of patients with chronic low back and leg pain were randomized to HFX
or traditional spinal cord stimulation and we followed these patients for a full 24 months long-term
two years of follow-up in these patients and what we were able to show
was that with HFX the patients were able to get about 77%
pain relief in their lower back and 73% pain relief in their leg pain
with HFX versus about 50 with the traditional spinal cord stimulator
so the results were good in both arms of the study but HFX clearly did far better
for the patient population and this is the reason why it’s my choice for my patients
so people also achieve long-term relief from HFX in the real
world because the scientific studies are all good and dandy that’s wonderful that
we could get that kind of data that’s the foundation but what happens in real
life well there was a study with real life patients just like you in the real world
enjoying HFX for their chronic trunk and limb the study was conducted on 1600 patients
worldwide and these patients were able to show how 74% of them were able to get
50% or more pain relief in their low back and leg pain at
the two-year mark aside from that there was a 72% improvement in their function
as 68% improvement in their sleep which doesn’t sound like much but to me that’s
amazing if I can help my patients sleep better then they’re going to function
better during the day and they’re going to be better people for themselves and
for their family members and the quality of life improved by
about 90% in these patients as well you may be asking okay well that’s great
that’s yet another study how are your patients doing in your practice and this
is a snapshot of my own patients that in my clinic here in northern California
there was a 72% reduction in the medications used for the patients
and that’s huge to me if the patients are taking less medicines that means
they have less side effects if they have less side effects that
means that they can function better there’s less trips to the pharmacy and
less copay stay all of that is music to my ears
85 % of them were able to achieve long-term pain relief and with long-term
I mean years I’m not talking about months or weeks 84% of them have
improvement in their function and 89% reported an
improvement in their sleep once again huge success all the way around for my successful HFX patients
so who’s the best candidate for HFX well people who have debilitating pain after
trying surgeries physical therapy and medications could potentially be good candidates for this
but patients themselves can’t determine whether they’re good candidates for
HFX this is the reason why they need to be able to see a doctor like me
in order for the two of them physician and the patient determine if the patient is actually a
good candidate for HFX some patients may not be good candidates for surgery and they continue to suffer
from low back and leg pain some of those patients may be excellent candidates for HFX
people who want to decrease their medications or avoid pain medications
altogether may be excellent candidate or this type of therapy
potential candidates are people with spine pain, arm pain, leg pain, foot pain,
hip and knee pain and also groin pain can be excellent candidates for HFX
so what’s the process well first and foremost you go on see your physician a
physician like me who offers HFX and if your physician doesn’t
do that we have a way for you to get referred to the right physician who can
actually, at least speak to you about what HFX is and whether
it’s the right therapy for you at your consultation your provider will
evaluate your condition and decide whether if you’re a good candidate or
not and answer all your questions about HFX
if you’re a good candidate then you go through a temporary trial
the patients get to test drive this system before they get the implant
and in my opinion, that’s by far one of the best benefits about it
the trial is incredibly simple it takes about 15 minutes to do in an outpatient setting
the wires are placed through needles right next to the spinal cord the wires
will be coming out of the skin and they get connected to an outside device and
the patients use that for about a week the patient himself or herself will
decide if this is the right therapy for them they will consult with their
physician at the end of the trial and the physician will pull the leads out in
the office within three to five seconds it’s a very simple process and if
they’re a good candidate then they move forward to a permanent implant
the permanent implant is also an outpatient procedure it takes a
little while longer it takes about 45 minutes to an hour to complete and a
small device is implanted under the skin and the wires are run through needles
again right next to the spinal cord and the patients are sent home the same day
there may be a little bit of pocket pain and incisional pain from the
surgery for just a few days but within four to six weeks the patients don’t
really feel the device anymore and it just helps them with their pain overall
using HFX patients can start to have pain relief right away I usually
tell my patients that it may take 24 to 48 hours before they start to see some relief
but as long as they’re patient and the setting can be adjusted by the
representative from the company we could potentially get that very quickly
these are all the different components in HFX that’s the trial battery on the top left
the leads are placed what the leads look like the wires on the right side as you can see
and then as they’re coming out of the skin they get connected to us out to
that outside device which is actually smaller than my cell phone here
and that that goes into a pocket right at the waist of the patient the
patient uses it for about six to seven days and they come in and they say dr
Amirdelfan I love it it helped my pain I walked more I stood more I was I
was a better person for my family I absolutely want it but they say you know
what it didn’t help me and I don’t want it and by the way nine out of ten
patients in my practice move forward to a permanent implant
the permanent implant looks just like what you see on the right side it’s a
small device it looks like a pacemaker and the leads are implanted and that
particular device is implanted within the subcutaneous path
usually right above the belt line in the patient’s lower back
the bottom right is the remote control the remote control will help you turn
the system on or off increase or decrease the amplitude or
choose from different programs very much like a tv remote control
you the patient is in full control of the remote and you can control the system
but don’t think that after the implant you’re going to be alone with this
particular system there’s an entire team ready to help you outside of the company
representative to be able to optimize your solution for you to get the best
therapy possible out of your HFX spinal cord stimulator
the bottom left shows the charger that’s the charger for the IPG or the what we
call the battery and the charger is used every day it’s a wireless charger so
you’re not exactly plugged into the wall or anything like that just goes in your
pocket that little blue paddle sits on top of the battery to charge it
for about 30 to 45 minutes every day that has never been an issue for any of
my patients because most almost all patients get such good
pain relief that they’re happy to charge the device just like they charge their
cell phones or their ipads every day insurance coverage I know every single
one of you is thinking is my insurance gonna cover this and the
answer is absolutely these devices have been around for a very very long time
and insurance covers all of them especially HFX because it
has far better evidence than even traditional spinal cord stimulator out
there Aetna Humana united healthcare blue cross and blue shield and especially medicare cover
HFX for patients with chronic painin the trunk and limb and most recently
HFX was also approved by the FDA for painful diabetic neuropathy
and we’re delighted to hear that because that’s a very challenging problem to treat
and HFX has been proven to be very helpful for that patient population as well
most states Medicaid policies also cover HFX workers comp in all states covers it
except for Washington state there’s some difficulty here in California
with HFX and also spinal cord stimulators all together but we’re
hoping to be able to resolve those issues in the near future
some VA’s are also offering HFX and within their interventional pain clinics
and any specific plan questions including out-of-pocket costs can be
answered by doctors like myself or your insurer there’s a lot of common questions that
come about HFX- is it safe in one short answer yes
it safely stimulates the spinal cord to interfere with the normal sensory
perception it doesn’t interact with anything else it doesn’t numb you up
if you step on a nail you’re still gonna feel that nail if someone comes and
pinches your back or your leg you’re still gonna feel it in the same
intensity that you did before HFX treats the chronic pain it doesn’t mask the acute pain which
could potentially protect you from hazards out there in the environment
I’ve tried everything else why should I try this well first of all if everything
else has failed then this may be one of the best solutions for you out there
even if you’ve tried traditional spinal cord stimulation in the past and it’s
been a failure this may still be an excellent solution for you and you
should absolutely at least talk to your physician to see if you’re a good candidate for it
will I feel anything? well with this system no you don’t
unlike the traditional spinal cord stimulators and any other thing out there
there is no tingling associated with it this device works in the background in
order to provide the patients with some of the best pain relief possible
without interfering with daily lives with their daily lives but if a patient by any chance wants the
tingling from time to time because it
feels good to them this particular device can also do that for the patients as well
by the way HFX is the only device on the market that has been labeled as
paresthesia-free or tingling-free by the FDA is the trial procedure reversible?
absolutely the leads are put in within 15 minutes and they’re removed within
three seconds in fact for that matter even the permanent implant is reversible if by
chance your pain goes away after a few years and you don’t want the device
anymore the device can be very easily implant explanted in an outpatient
procedure of about 20 to 30 minutes can I turn my device off if I need to?
yeah absolutely you have a remote control to be able to not only turn off
your device but choose the different programs or increase or decrease your amplitude
can I have an MRI scan with HFX? the answer is yes
HFX has been FDA approved for full-body MRI and under certain conditions and the
conditions is basically some minor adjustments that need to be made on the
MRI system for the patients to be able to undergo an MRI scan but the short answer is yes
absolutely you can have an MRI with HFX we started with one of my patients we’re
going to end up with another one in this presentation with one of the other ones
this is Chris he’s an absolutely pleasant guy and I’m
so delighted to have him in my practice as you can see and his wife are very
much into sailing and they live here in the bay area and they spend a lot of
time on their sailboats and what he told us was that at age 71
I can get back to enjoying my life thanks to HFX for providing me
with 80% pain relief consistently these are the kind of patients that make
me happy and give me the sense of accomplishment
that I have from providing them with this type of therapy
so what’s the first step there’s actually a website at
www.NevroHFX.com where you can go and actually read up on HFX to see if it’s
the right solution for you or not my presentation today should just be the
preamble for you to become curious about this go to NevroHFX.com
read up on it write down your questions and maybe find a physician in your area
that actually offers you this kind of a solution for you to be able to go out
and have an educated discussion about if this is the right treatment for you or not
