DESCRIPTION
Implantable Peripheral nerve stimulation (PNS) is a type of neuromodulation therapy in which electrodes are surgically placed next to a selected peripheral nerve considered to be the source of chronic pain. The peripheral nervous system refers to parts of the nervous system outside the brain and spinal cord. Treatment of this type of pain is challenging and currently available treatments are often not sufficient, prompting a renewed interest in the use of neuromodulation techniques, PNS is being proposed to treat acute and chronic pain in individuals who have failed to get relief from pain medication, physical therapy and are not candidates for spine surgery. PNS differs from other electrical stimulation therapies as the source is delivered directly to the peripheral nerve versus the surrounding tissues or spine.
PNS involves surgery that places a small electrical device (wire like electrode) next to one of the peripheral nerves that is located beyond the brain or spinal cord. The electrode delivers rapid electrical pulses that feel like mild tingles. During the testing period, the electrode is connected to an external device. If the trial is successful, a generator is then placed in the individual’s body. The individual is then able to control stimulation by turning the device on and off and adjusting stimulation parameters as needed.
Examples of FDA approved PNS devices include: Reactiv8® Implantable Restorative Neurostimulation, Sprint® Peripheral Nerve Stimulation System, StimRouter® PNS System and the StimQ PNS System and Nalu Neurostimulation Systems. The examples listed are only types of FDA approved peripheral nerve stimulation devices. Please note that each one may have different indications for use to treat different areas of pain or dysfunction (e.g., Reactiv8® Implantable Restorative Neurostimulation’s function is to aid in the management of chronic pain by restoring function back to the multifidus muscle).
POLICY
Implantable peripheral nerve stimulation devices for the treatment of acute and chronic pain are considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g., statement.
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ADDITIONAL INFORMATION
Overall, the current level of evidence associated with implantable PNS devices is insufficient to support long-term safety, efficacy, and effects of the technology on health outcomes. Additional high quality level published evidence without bias and significant study limitations are needed.
SOURCES
American Society of Anesthesiologists. (2010, April). Practice guidelines for chronic pain management. An updated report by the american society of anesthesiologists task force on chronic pain management and the american society of regional anesthesia and pain medicine. Retrieved April 27, 2023 from https://pubs.asahq.org/anesthesiology/article/112/4/810/10691/Practice-Guidelines-for-Chronic-Pain-ManagementAn.
Ardeshiri, A., Shaffrey, C., Stein, K-P., & Sandalcioglu, I E. (2022). Real-world evidence for restorative neurostimulation in chronic low back pain—a consecutive cohort study. World Neurosurgery, https://doi.org/10.1016/j.wneu.2022.09.104. (Level 4 evidence)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for Electrical nerve stimulators (160.7). Retrieved February 22, 2023, from http://www.cms.gov.
Char, S., Jin, M.Y., Francio, V.T., Hussain, N., Wang, E.J., Morsi, Mahmoud., et al. (2022). Implantable peripheral nerve stimulation for peripheral neuropathic pain: A systematic review of perspective studies. Biomedicines, 10 (10), 2606. (Level 2 evidence)
Deer, T., Pope, J., Benyamin, R., Vallejo, R., Friedman, A., Caraway, D., et al. (2016). Prospective, multicenter, randomized, double-blinded, partial crossover study to assess the safety and efficacy of the novel neuromodulation system in the treatment of patients with chronic pain of peripheral nerve origin. Journal of the International Neuromodulation Society, 19 (1), 91-100. Abstract retrieved April 27, 2023, from PubMed database.
Deer, T.R., Esposito, M.F., McRoberts, W.P., Grider, J.S., Sayed, D., Verrills, P., et al. (2020). A systematic literature review of peripheral nerve stimulation therapies for the treatment of pain. Pain Medicine, 21 (8), 1590-1603. (Level 2 evidence)
Deer, T.R., Gilmore, A.C., Desal, M.j., Li, S., DePalma, M.J., Hopkins, T.J., et al. (2021). Percutaneous peripheral nerve stimulation of the medial branch nerves for the treatment of chronic axial back pain in patients after radiofrequency ablation. Pain Medicine, 22 (3), 548-560. (Level 4 evidence)
Gilligan, C., Volschenk, W., Russo, M., Green, M., Gilmore, C., Mehta, V., et al. (2021). An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial. Pain, 162 (10), 2486 – 2498. (Level 2 evidence)
Gilligan, C., Volschenk, W., Russo, M., Green, M., Gilmore, C., Mehta, V., et al. (2023). Long-term outcomes of restorative neurostimulation in patients with refractory chronic low back pain secondary to multifidus dysfunction: two-year results of the reActiv8-B pivotal. trial. Journal of the International Neuromodulation Society, 26 (1), 87-97. (Level 3 evidence)
Gilligan, C., Volschenk, W., Russo, M., Green, M., Gilmore, C., Mehta, V., et al. (2023). Three-year durability of restorative neurostimulation effectiveness in patients with chronic low back pain and multifidus muscle dysfunction. Journal of the International Neuromodulation Society, 26 (1), 98-108. (Level 3 evidence)
Gilligan, C., Volschenk, W., Russo, M., Green, M., Gilmore, C., Mehta, V., et al. (2024). Five-year longitudinal follow-up of restorative neurostimulation shows durability of effectiveness in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. Neuromodulation, published online March 12. (Level 3 evidence)
Gilmore, C.A., Deer, T.R., Desai, M.J., Hopkins, T.J., Li, S., DePalma, M.J., et al. (2023). Durable patient-reported outcomes following 60-day percutaneous peripheral nerve stimulation (PNS) of the medial branch nerves. Interventional Pain Medicine,2 (2023), 100243. (Level 3 evidence)
Gilmore, C.A., Desai, M.J., Hopkins, T.J., Li, S., DePalma, M.J., Deer, T.R., et al. (2021). Treatment of chronic axial back pain with 60-day percutaneous medial branch PNS: Primary end point results from a prospective, multicenter study. Pain Practice: The Official Journal of World Institute of Pain, 21 (8), 877-889. (Level 3 evidence)
Gilmore, C.A., Patel, J., Esebua, L-G., & Burchell, M. (2020), A review of peripheral nerve stimulation techniques targeting the medial branches of the lumbar dorsal rami in the treatment of chronic low back pain. Pain Medicine, 21 (Suppl 1), S41-S46. (Level 4 evidence)
Helm, S., Shirsat, N., Calodney, A., Abd-Elsayed, A., Kloth, D., Soin, A., et al. (2021). Peripheral nerve stimulation for chronic pain: A systematic review of effectiveness and safety. Pain Therapy, 10, 985-1002. (Level 2 evidence)
Kaye, A D., Ridgell, S., Alpaugh, E.S., Mouhaffel, A., Kaye, A.J., Cornett, E.M., et al. (2021). Peripheral nerve stimulation: a review of techniques and clinical efficacy. Pain and Therapy, 10, 961-972. (Level 3 evidence)
Llfeld, B.M., Plunkett, A., Vijjeswarapu, A.M., Hackworth, R., Dhanjal, S., Turan, A., et al. (2021). Percutaneous peripheral nerve stimulation (neuromodulation) for postoperative pain: a randomized, sham controlled pilot study. Anesthesiology, 135, 85-110. (Level 3 evidence)
Naidu, Ramana., Li, S., Desai, M.J., Sheth, S., Crosby, N.D., & Boggs, J.W. (2022). 60-day pns treatment may improve identification of delayed responders and delayed non-responders to neurostimulation for pain relief. Journal of Pain Research, 15, 733-743. (Level 5 evidence)
North American Spine Society. (2020). Evidence-based clinical guidelines for multidisciplinary spine care: diagnosis and treatment of low back pain. Retrieved February 23, 2023 from https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCare/Guidelines/LowBackPain.pdf.
Oswald, J., Shahi, V., & Chakravarthy, K.V. (2019). Prospective case series on the use of peripheral nerve stimulation for focal mononeuropathy treatment. Pain Management, 9 (6), 551-558. Abstract retrieved April 27, 2023, from PubMed database.
Reverberi, C., Dario, A., Barolat, G., & Zuccon, G. (2014). Using peripheral nerve stimulation (PNS) to treat neuropathic pain: a clinical series. Journal of the International Neuromodulation Society, 17 (8), 777-783. Abstract retrieved April 27, 2023, from PubMed database.
U.S. Food and Drug Administration. (2016, March). Center for Devices and Radiological Health. 510 (k) Premarket Notification Database. K152178. Retrieved February 24, 2023, from https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152178.pdf.
U.S. Food and Drug Administration. (2018, July). Center for Devices and Radiological Health. 510 (k) Premarket Notification Database. K181422. Retrieved February 24, 2023, from https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181422.pdf.
U.S. Food and Drug Administration. (2019, October). Center for Devices and Radiological Health. 510 (k) Premarket Notification Database. K190047. Retrieved February 24, 2023, from https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190047.pdf.
U.S. Food and Drug Administration. (2020, June). Center for Devices and Radiological Health. Premarket approval Notification Database. P190021. Retrieved February 24, 2023, from https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190021A.pdf.
U.S. Food and Drug Administration. (2021, March). Center for Devices and Radiological Health. 510 (k) Premarket Notification Database. K203547. Retrieved February 24, 2023, from https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203547.pdf.
Wilson, R.D., Gunzler, D.D., Bennett M.E., & Chae, J. (2014). Peripheral nerve stimulation compared to usual care for pain relief of hemiplegic shoulder pain: A randomized controlled trial. American Journal of Physical Medicine & Rehabilitation, 93 (1), 17-28. (Level 2 evidence)
Winifred S. Hayes, Inc. Medical Technology Assessment. (2022, May; last update search May 2023). Percutaneous peripheral nerve stimulation for treatment of chronic pain. Retrieved June 16, 2023 from www.Hayesinc.com/subscribers. ( 45 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 9/30/2023
MOST RECENT REVIEW DATE: 9/30/2023
ID_BT
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