This episode is sponsored by Medtronic. Painful diabetic peripheral neuropathy (DPN) can significantly impact a person with diabetes and their quality of life. Nalani Hunsaker PA-C, MCMSc, BC-ADM, a paid consultant for Medtronic, joins The Huddle to talk about Medtronic’s spinal cord stimulation therapy option, how the procedure works, and its success in relieving pain from DPN. Please reach out to http://www.medtronic.com/dpnconnect to connect with a Medtronic representative today. If you would like to share more information with your patients check out http://www.medtronic.com/dpnpain. Learn more about DPN and DPN pain here on danatech: Diabetic Peripheral Neuropathy (adces.org)
This episode is sponsored by Medtronic.
Painful diabetic peripheral neuropathy (DPN) can significantly impact a person with diabetes and their quality of life. Nalani Hunsaker PA-C, MCMSc, BC-ADM, a paid consultant for Medtronic, joins The Huddle to talk about Medtronic’s spinal cord stimulation therapy option, how the procedure works, and its success in relieving pain from DPN. Please reach out to http://www.medtronic.com/dpnconnect to connect with a Medtronic representative today. If you would like to share more information with your patients check out http://www.medtronic.com/dpnpain.
Learn more about DPN and DPN pain here on danatech: Diabetic Peripheral Neuropathy (adces.org)
References:
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14. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. March-April 2011;11(2):148-153.
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16. Clifton M, Quirouet A, Pizarro-Berdichevsky J, et al. Infection rate after sacral neuromodulation surgery: a review of 1033 InterStim procedures. J Urol. April 2016;195(4S):851.
17. Bjerknes S, Skogseid IM, Sæhle T, Dietrichs E, Toft M. Surgical site infections after deep brain stimulation surgery: frequency, characteristics and management in a 10-year period. PLoS One. August 14, 2014;9(8):e105288.
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21. Bendel MA, O’Brien T, Hoelzer BC, et al. Spinal Cord Stimulator Related Infections: Findings From a Multicenter Retrospective Analysis of 2737 Implants. Neuromodulation. August 2017;20(6):553-557.
22. Wexner SD, Hull T, Edden Y, et al. Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence. J Gastrointest Surg. July 2010;14(7):1081-1089.15
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27. Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. May 16, 2019;380(20):1895-1905
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29. Petersen EA, Stauss TG, Scowcroft JA, et al. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. April 2021. doi:10.1001/jamaneurol.2021.0538
Spinal Cord Stimulation Brief Summary
INDICATIONS Spinal cord stimulation (SCS) is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. CONTRAINDICATIONS Diathermy - Energy from diathermy can be transferred through the implanted system and cause tissue damage resulting in severe injury or death. WARNINGS Sources of electromagnetic interference (e.g., defibrillation, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact with the system, resulting in unexpected changes in stimulation, serious patient injury or death. An implanted cardiac device (e.g., pacemaker, defibrillator) may damage a neurostimulator, and electrical pulses from the neurostimulator may cause inappropriate response of the cardiac device. Patients with diabetes may have more frequent and severe complications with surgery. A preoperative assessment is advised for some patients with diabetes to confirm they are appropriate candidates for surgery. PRECAUTIONS Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. Avoid activities that put stress on the implanted neurostimulation system components. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site. ADVERSE EVENTS May include: undesirable change in stimulation (uncomfortable, jolting or shocking); hematoma, epidural hemorrhage, paralysis, seroma, infection, erosion, device malfunction or migration, pain at implant site, loss of pain relief, and other surgical risks. Adverse events may result in fluctuations in blood glucose in patients with diabetes. Refer to www. medtronic.com for product manuals for complete indications, contraindications, warnings, precautions and potential adverse events. Rx only. Rev 0422
TYRX™ Neuro Absorbable Antibacterial Envelope Brief Statement
The TYRX™ Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body. The Neuro Antibacterial Envelope contains the antimicrobial agents Minocycline and Rifampin which, have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator. The Neuro Antibacterial Envelope is NOT indicated for use in patients who have an allergy or history of allergies to tetracyclines, Rifampin, or absorbable sutures. The Neuro Antibacterial Envelope is also NOT indicated for use in patients with contaminated or infected wounds, or Systemic Lupus Erythematosus (SLE). This device is intended to be used in conjunction with vagus nerve stimulators or deep brain stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region. The use of this product in patients with compromised hepatic and renal function, or in the presence of hepatotoxic or renal toxic medications, should be considered carefully, because Minocycline and Rifampin can cause additional stress on the hepatic and renal systems. Patients who receive the Neuro Antibacterial Envelope and who are also taking methoxyflurane should be monitored carefully for signs of renal toxicity.
Jodi Lavin-Tompkins
Hello and welcome to ADCES's podcast, The Huddle: Conversations with the diabetes care team. In each episode, we speak with guests from across the diabetes care space to bring you perspectives, issues, and updates that elevate your role, inform your practice, and ignite your passion. This episode is sponsored by Medtronic.
I'm Jodi Lavin-Tompkins, Director of Accreditation and Content Development at the Association of Diabetes Care and Education Specialists. My guest today is Nalani Hunsaker, an advanced diabetes management expert currently practicing in both California and Hawaii. Nalani, welcome to the program and please introduce yourself.
Nalani Hunsaker
Hi Jodi, thank you so much for having me. It's really a privilege to be speaking with you in this amazing community about painful diabetic peripheral neuropathy of the lower extremities which is such a critical topic and potentially devastating complication of diabetes. Before we dive deeper into DPN though, I'd like to share with you Jodi a bit about my background and why I'm so passionate about diabetes management and person-centered care.
I was diagnosed with type 1 diabetes when I was just eight years old and unfortunately I didn't have many resources available to me in my early years. My family and I struggled to gain knowledge about my diabetes and what my future would be like. So after many years, my mom and I decided to go to a conference where we learned about insulin pump therapy from a P.A. and fellow type 1. And my mom, she sort of did the mom thing after the talk and she ran up to him and introduced us. And he was just, he was so kind and he and his wife both actually really changed our lives. They volunteered to have dinner with my family and I, and they just shared their knowledge with us. And he was the first person with diabetes I'd ever seen who actually used their diabetes as a strength to help others. And I decided that that was my calling as well. I always joke that I went from wanting to be a tightrope walker in the circus to wanting to be a PA. And it just never changed.
[Jodi chuckles]
Nalani
And… I know. And this personal experience with diabetes has made me want to help others. So I went to P.A. school, trained in San Diego with actually the same P.A. and then opened a practice with an endocrinologist in an underserved area of California where I functioned as the associate director of the diabetes program, helped build out a residency and fellowship program and served as a faculty. And then about a year ago, I moved back to the island of Kauai where I grew up and it's a privilege to now serve this community as well. And my primary focus when managing diabetes is really on quality of life. And I see the significant impact that painful diabetic peripheral neuropathy of the lower extremities has on people's quality of life because it often goes untreated or undertreated. And I found that pain management is just crucial. And we have a duty as diabetes specialists to listen to our patients and ensure that their DPN pain is addressed because ultimately the reduction in pain can change their lives and facilitate their ability to better take care of their diabetes and themselves as a whole.
Jodi
Well, thank you so much for sharing that inspiring personal story, Nalani. I'm also wondering if you could just share with us more about the people who actually get painful DPN and what is the typical profile that you see?
Nalani
Absolutely. So the typical painful DPN profile is someone who is usually between 45 and 75 years old and they often have type 2 diabetes so they can have any type. And this person has bilateral pain in their feet and lower legs that initially will feel like a stabbing or burning pain, but then will progress to numbness. And the pain often gets worse when individuals are trying to sleep or rest. And that's when I normally see that patients report it. And what's especially dangerous about painful DPN is that a person may not notice that they have slow healing sores due to the numbness, which could progress to infection ultimately.
Jodi
Right. And that is something we obviously want to avoid and we don't want to happen.
Nalani
Absolutely.
Jodi
So, could you let us know about the treatment options for this condition?
Nalani
Of course. Individuals who often struggle, they often struggle with finding DPN pain relief, utilizing first line treatments, because in my experience, they just aren't very good. You know, there's anti-convulsants, anti-depressants. But even if individuals do find relief, the side effects of these medications often cause fatigue, weight gain, and can really impact quality of life as well. In my professional experience, if a person can't be active or play with their kids because of their DPN, and then they still can't do that because of fatigue caused by their treatment, then quality of life isn't improved and it's still not acceptable. So there's a non-opioid, non-drug therapy now called spinal cord stimulation, or SCS, that has been commercially available for over 50 years for patients with chronic intractable pain. But Medtronic's SCS therapy for deep hand pain of the lower extremities was FDA approved in January of 2022.
Jodi
OK, so how does this spinal cord stimulation or SCS as you refer to it work?
Nalani
SCS uses a neurostimulator. It's actually really cool, Jodi. And similar to a pacemaker and about the size of a matchbox, and it's surgically implanted under the skin above a person's buttocks or in their upper lower back area. An SCS delivers mild electrical impulses to an area near the person's spine through beads that are placed in the epidural space. And the electrical impulses interrupt pain signals from reaching the person's brain.
Jodi
Wow, very interesting. I'm wondering if SCS has any impact on a person's overall diabetes management?
Nalani
Definitely. Treating a person's DPN pain with SCS has been shown to improve quality of life and reduce the number or amount of medications they're on. And I've seen many people become more active, which obviously has a huge impact on their diabetes management. While SCS therapy doesn't treat the underlying cause of diabetes or DPN pain, it reduces the amount of pain that the person experiences. And that's critical to improving their quality of life.
Jodi
Yes, reduction in pain is very critical, very important. So I'm wondering if you have a specific patient that you saw in mind that you could give as an example for the audience. Because I think that sort of brings the treatment to life for the audience.
Nalani
Yeah, and I think one of my best examples is one of my first patients that I had at my old practice in California. I was fortunate enough to share offices with a very talented neurosurgeon, and he actually referred me a young woman in her 20s with type 1 diabetes and very severe DPN. And as I mentioned earlier, the clinic I helped open in California was in a location with no prior diabetes care access. And so unfortunately, she had developed many diabetes complications. Her DPN was one of the most debilitating for her. She and I worked together to manage her diabetes and get her in a safe glucose range to do the trial and implant, and we actually started her on an insulin pump and we did a lot of education with her and she ended up doing really well. And once her A1C was at an appropriate level, the neurosurgeon did the trial with her, which resulted in significant DPN pain improvement, and she followed through with the implant shortly after. It was amazing. Her demeanor completely changed after that. She became more active. She got stronger. She was just generally so much happier when I would see her. And she even started to consider family planning. And it was just really wonderful and inspiring to see. And I think that patient really sold me on the effects of spinal cord stimulation and how it can improve deep pain.
Jodi
Well, that's so great that it worked for her. I wonder, how can a person know whether this SCS will help them with their painful DPN?
Nalani
That's a really great question and one of the questions that I had in the beginning as well. And I think what's really great about this therapy is that individuals can actually try it out for up to 10 days under the guidance of a trained physician who's often a pain specialist before committing to the implant. And the trial shows the person and the pain specialists if it works and if their pain relief is effective and if SCS is the right therapy for them.
Jodi
That's so great that there is a trial run so people know if it can be the right therapy for them. And I'm sure our audience is interested in understanding about the procedure itself. So can you tell us how invasive is the SCS procedure? What is the recovery time? And is there any infection risk?
Nalani
Those are all questions that I had as well initially. So I think you're right in asking these questions and it's important to know these things before going in. So both the trial and the implant procedures are minimally invasive and outpatient. And the trial procedure requires only light sedation and only takes about 25 minutes to insert temporary trial leads into the epidural space that are then connected to a temporary external neurostimulator. Individuals are able to turn on the stimulator within that same day to see if the therapy works for them. And then a Medtronic representative will follow up with the person each day of their trial to check in and to optimize their stimulation programming settings under the direction of the pain physician.
So following a successful trial, the leads are then removed and the implant procedure is scheduled. The implant procedure takes about 45 minutes to insert leads and connect them to the neurostimulator that is then implanted under the skin to the individual's body. The person will return to the pain physician for follow-up and there they will work with the physician and the Medtronic representative to set up the therapy and provide programming options on the person's own therapy remote. As with all surgical procedures, of course infection is possible, but the risk is low for SCS implant procedures and Medtronic knows that extra consideration is needed, particularly for people with diabetes.
And Medtronic is the only company that offers an antibiotic eluting envelope that surrounds the SCS implant when it's placed in the surgical pocket in the person's body. And this envelope is fully absorbable by the body and elutes antibiotics over a seven day period to protect the surgical pocket from infection immediately following the implant procedure.
Jodi
Well, that's interesting. So you mentioned that Medtronic has one unique thing about their implant with the antibiotic eluting envelope. But I'm wondering, how does Medtronic differentiate its neurostimulators from other manufacturers in other ways?
Nalani
There's actually a lot of reasons why I choose Medtronic for my patients. And one of the biggest ones is that pain is personal, and Medtronic provides the most options to align with people's lifestyles. They have rechargeable and recharge-free devices. They have different electrical stimulation programs.And each person can adjust their stimulation during their trial and after implant to customize their pain relief. So each person will get their own therapy remote for immediate programming changes and adjustments as needed. And we know in the diabetes technology space that it's not one size fits all and that people have individual needs and Medtronic really accommodates that. And as you all know, having MRI access is especially important for our patients who have comorbidities. I particularly think of breast cancer because in the endocrinology space, a very large portion of our patients are women who have annual breast exams. And if your patient has an abnormal breast ultrasound, you would never want their cancer treatment or diagnosis to be delayed because of their SCS device limiting MRI compatibility. And only Medtronic's SCS device will ensure that the patient has the MRI and diagnostic access that they deserve because the materials used in their SCS devices safely dissipate radio frequency energy during the MRI scan.
Jodi
OK, well, a common question that comes up with any procedure is the coverage. So is SCS covered by insurance?
Nalani
Yes, it's so exciting.
There is universal Medicare coverage for all SCS procedures for DPN pain. And there's broad coverage for individuals with private insurance coverage or commercial payers. As of April 2024, 72% of patients with health insurance are covered for SCS therapy for DPN pain. And if your patient's health plan doesn't cover SCS therapy for DPN pain, Medtronic has a lot of resources to help them advocate.
Jodi
If our listeners run across a patient who is suffering from painful DPN of the lower extremities, what should they do next?
Nalani
I know that SDS can be a scary concept, but this is where we as diabetes specialists come in. You know, most people in pain are ready to do something about it. They just need information. You know, they need information, guidance, and most importantly, support in deciding what to do. So initially I approach these people with DPN by teaching them about SCS therapy. And I usually start early and then I provide them with brochures that they can take home to discuss with their family. And then eventually I'll refer them to a trusted care management clinician. And then the representatives at Medtronic are also great resources because they can help educate you and provide you with appropriate materials to have these conversations with patients at your clinic. And I think a lot of people might be surprised to learn that, you know, especially as diabetes specialists, that Medtronic really is our holistic partner for diabetes management. So to be connected with a Medtronic representative, you can head to medtronic.com/dpnconnect, and the Medtronic rep will help by providing information to your patients as well as help you identify local pain management offices in your area that will work with you to see if your patient's painful DPN can be treated with spinal cord stimulation. Medtronic also offers TAP programs or therapy awareness patient programs, which are led by pain management, but for an endocrinology patient base. And it's crucial that we as diabetes specialists work with pain management offices to support individuals with painful DPN. Medtronic does a really great job with building relationships and facilitating multidisciplinary connections while keeping patient outcomes and pain relief at the forefront.
Nalani
Well, Nalani you've given us a great overview and lots of detailed information about Medtronic's SCS therapy for DPN pain of the lower extremities. And I'm just wondering if you have any final thoughts you'd like to share with our audience?
Nalani
Yes, I think that ultimately when we are seeing patients with diabetes, we want to do what's best for them. And we need to listen to them when they talk about their pain. It's a huge life limiting aspect to their lives. And it's often not addressed because many of us assume that it's getting taken care of somewhere else in the care continuum. And we're treating the whole person with diabetes, as you know, Jodi, and diabetes care and education specialists can really make a difference in helping to reduce a person's pain and improve their quality of life with SCS therapy.
Jodi
Well, Nalani, I want to thank you for taking the time to join us for this episode of The Huddle and for sharing your knowledge and experience with our audience. As a diabetes care and education specialist, I know how useful this information is for practice. So I'm sure our listeners really appreciate hearing your firsthand experience.
Nalani
Thank you so much for having me, Jodi. It's really a privilege to be here.
Jodi
And thank you, everyone, for listening to this week's episode of The Huddle. Make sure to download the resources discussed in today's episode, and you can find them linked in the show notes. And remember, ADCES membership gets you free access to resources, education, and networking to improve your practice and optimize outcomes for your clients. Learn more about what ADCES can do for you at adces.org/join. The information in this podcast is for informational purposes only and may not be appropriate or applicable to your individual circumstances. This podcast does not provide medical or professional advice and is not a substitute for consultation with a health care professional. Please consult your health care professional for any medical questions.