Painful Peripheral Neuropathies of the Lower Limbs and/or Lower Extremities Treated with Spinal Cord Stimulation: A Systematic Review with Narrative Synthesis

References

• Lehmann HC, Wunderlich G, Fink GR, Sommer C. Diagnosis of peripheral neuropathy. Neurol Res Pract. 2020;2(1):20.
   PubMedGoogle Scholar
• Hanewinckel R, Ikram MA, Van Doorn PA. Peripheral neuropathies. Handb Clin Neurol. 2016;138:263–282.
   PubMedGoogle Scholar
• Jensen TS, Karlsson P, Gylfadottir SS, et al. Painful and non-painful diabetic neuropathy, diagnostic challenges and implications for future management. Brain. 2021;144(6):1632–1645.
   PubMedGoogle Scholar
• Girach A, Julian TH, Varrassi G, Paladini A, Vadalouka A, Zis P. Quality of life in painful peripheral neuropathies: a systematic review. Pain Res Manag. 2019;2019:2091960.
   PubMed Web of Science ®Google Scholar
• Pop-Busui R, Boulton AJ, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136–154.
   PubMed Web of Science ®Google Scholar
• Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162–173.
   PubMed Web of Science ®Google Scholar
• Khdour MR. Treatment of diabetic peripheral neuropathy: a review. J Pharm Pharmacol. 2020;72(7):863–872.
   PubMed Web of Science ®Google Scholar
• Staudt MD, Prabhala T, Sheldon BL, et al. Current strategies for the management of painful diabetic neuropathy. J Diabetes Sci Technol. 2022;16(2):341–352.
   PubMedGoogle Scholar
• Snyder MJ, Gibbs LM, Lindsay TJ. Treating painful diabetic peripheral neuropathy: an update. Am Fam Physician. 2016;94(3):227–234.
   PubMed Web of Science ®Google Scholar
• Arora V, Campbell JN, Chung MK. Fight fire with fire: neurobiology of capsaicin-induced analgesia for chronic pain. Pharmacol Ther. 2021;220:107743.
   PubMed Web of Science ®Google Scholar
• James CF, Tripathi S, Karampatou K, Gladston DV, Pappachan JM. Pharmacotherapy of painful diabetic neuropathy: a clinical update. Sisli Etfal Hastan Tip Bul. 2022;56(1):1–20.
   PubMed Web of Science ®Google Scholar
• North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98–106; discussion 106–107.
   Web of Science ®Google Scholar
• Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1–2):179–188.
   PubMed Web of Science ®Google Scholar
• Kapural L, Yu C, Doust MW, et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: the SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015;123(4):851–860.
   PubMed Web of Science ®Google Scholar
• Kemler MA, De Vet HC, Barendse GA, Van Den Wildenberg FA, Van Kleef M. The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years’ follow-up of the randomized controlled trial. Ann Neurol. 2004;55(1):13–18.
   PubMed Web of Science ®Google Scholar
• Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation. 2015;18(7):603–608; discussion 608–609.
   Web of Science ®Google Scholar
• Sears NC, Machado AG, Nagel SJ, et al. Long-term outcomes of spinal cord stimulation with paddle leads in the treatment of complex regional pain syndrome and failed back surgery syndrome. Neuromodulation. 2011;14(4):312–318; discussion 318.
   PubMed Web of Science ®Google Scholar
• Kemler MA, de Vet HC, Barendse GA, van den Wildenberg FA, van Kleef M. Effect of spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of patients in a randomized controlled trial. J Neurosurg. 2008;108(2):292–298.
   PubMed Web of Science ®Google Scholar
• Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery. 2006;58(3):481–496; discussion 481–496.
   Web of Science ®Google Scholar
• Alo KM, Redko V, Charnov J. Four year follow-up of dual electrode spinal cord stimulation for chronic pain. Neuromodulation. 2002;5(2):79–88.
   PubMed Web of Science ®Google Scholar
• Ohnmeiss DD, Rashbaum RF, Bogdanffy GM. Prospective outcome evaluation of spinal cord stimulation in patients with intractable leg pain. Spine. 1996;21(11):1344–1350; discussion 1351.
   PubMed Web of Science ®Google Scholar
• Burchiel KJ, Anderson VC, Brown FD, et al. Prospective, multicenter study of spinal cord stimulation for relief of chronic back and extremity pain. Spine. 1996;21(23):2786–2794.
   PubMed Web of Science ®Google Scholar
• Kupers RC, Van den Oever R, Van Houdenhove B, et al. Spinal cord stimulation in Belgium: a nation-wide survey on the incidence, indications and therapeutic efficacy by the health insurer. Pain. 1994;56(2):211–216.
   PubMed Web of Science ®Google Scholar
• North RB, Kidd DH, Zahurak M, James CS, Long DM. Spinal cord stimulation for chronic, intractable pain: experience over two decades. Neurosurgery. 1993;32(3):384–394; discussion 394–385.
   Web of Science ®Google Scholar
• Kapural L, Yu C, Doust MW, et al. Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery. 2016;79(5):667–677.
   PubMed Web of Science ®Google Scholar
• Deer T, Slavin KV, Amirdelfan K, et al. Success using neuromodulation with BURST (SUNBURST) study: results from a prospective, randomized controlled trial using a novel burst waveform. Neuromodulation. 2018;21(1):56–66.
   PubMed Web of Science ®Google Scholar
• Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017;158(4):669–681.
   PubMed Web of Science ®Google Scholar
• Mekhail N, Deer TR, Kramer J, et al. Paresthesia-free dorsal root ganglion stimulation: an accurate study sub-analysis. Neuromodulation. 2020;23(2):185–195.
   PubMed Web of Science ®Google Scholar
• Deer TR, Levy RM, Kramer J, et al. Comparison of paresthesia coverage of patient’s pain: dorsal root ganglion vs. spinal cord stimulation. An Accurate study sub-analysis. Neuromodulation. 2019;22(8):930–936.
   PubMed Web of Science ®Google Scholar
• Strand NH, Burkey AR. Neuromodulation in the treatment of painful diabetic neuropathy: a review of evidence for spinal cord stimulation. J Diabetes Sci Technol. 2022;16(2):332–340.
   PubMedGoogle Scholar
• Raghu ALB, Parker T, Aziz TZ, et al. Invasive electrical neuromodulation for the treatment of painful diabetic neuropathy: systematic review and meta-analysis. Neuromodulation. 2021;24(1):13–21.
   PubMed Web of Science ®Google Scholar
• Henson JV, Varhabhatla NC, Bebic Z, et al. Spinal cord stimulation for painful diabetic peripheral neuropathy: a systematic review. Pain Ther. 2021;10(2):895–908.
   PubMed Web of Science ®Google Scholar
• Liampas A, Rekatsina M, Vadalouca A, Paladini A, Varrassi G, Zis P. Non-pharmacological management of painful peripheral neuropathies: a systematic review. Adv Ther. 2020;37(10):4096–4106.
   PubMed Web of Science ®Google Scholar
• Amato Nesbit S, Sharma R, Waldfogel JM, et al. Non-pharmacologic treatments for symptoms of diabetic peripheral neuropathy: a systematic review. Curr Med Res Opin. 2019;35(1):15–25.
   PubMed Web of Science ®Google Scholar
• Gupta M, Knezevic NN, Abd-Elsayed A, Ray M, Patel K, Chowdhury B. Treatment of painful diabetic neuropathy-A narrative review of pharmacological and interventional approaches. Biomedicines. 2021;9:5.
   Web of Science ®Google Scholar
• D’Souza RS, Langford B, Dombovy-Johnson M, Abd-Elsayed A. Neuromodulation interventions for the treatment of painful diabetic neuropathy: a systematic review. Curr Pain Headache Rep. 2022;26(5):365–377.
   PubMed Web of Science ®Google Scholar
• Pluijms WA, Slangen R, Joosten EA, et al. Electrical spinal cord stimulation in painful diabetic polyneuropathy, a systematic review on treatment efficacy and safety. Eur J Pain. 2011;15(8):783–788.
   PubMed Web of Science ®Google Scholar
• Christelis N, Simpson B, Russo M, et al. Persistent spinal pain syndrome: a proposal for failed back surgery syndrome and ICD-11. Pain Med. 2021;22(4):807–818.
   PubMed Web of Science ®Google Scholar
• Higgins JPT, Thomas J, Chandler J et al. Cochrane handbook for systematic reviews of interventions version 6.3 (updated February 2022). Available from: www.training.cochrane.org/handbook. Accessed May 16, 2023.
   Google Scholar
• 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. 2021;78(6):687–698.
   PubMed Web of Science ®Google Scholar
• Petersen EA, Stauss TG, Scowcroft JA, et al. Durability of high-frequency 10-kHz spinal cord stimulation for patients with painful diabetic neuropathy refractory to conventional treatments: 12-month results from a randomized controlled trial. Diabetes Care. 2022;45(1):e3–e6.
   PubMed Web of Science ®Google Scholar
• Galan V, Scowcroft J, Chang P, et al. 10-kHz spinal cord stimulation treatment for painful diabetic neuropathy: results from post-hoc analysis of the SENZA-PPN study. Pain Manag. 2020;10(5):291–300.
   PubMed Web of Science ®Google Scholar
• Chen JL, Hesseltine AW, Nashi SE, et al. A real-world analysis of high-frequency 10 kHz spinal cord stimulation for the treatment of painful diabetic peripheral neuropathy. J Diabetes Sci Technol. 2022;16(2):282–288.
   PubMedGoogle Scholar
• Sills S. Treatment of painful polyneuropathies of diabetic and other origins with 10 kHz SCS: a case series. Postgrad Med. 2020;132(4):352–357.
   PubMed Web of Science ®Google Scholar
• de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial. Pain. 2014;155(11):2426–2431.
   PubMed Web of Science ®Google Scholar
• Slangen R, Schaper NC, Faber CG, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial. Diabetes Care. 2014;37(11):3016–3024.
   PubMed Web of Science ®Google Scholar
• van Beek M, Slangen R, Schaper NC, et al. Sustained treatment effect of spinal cord stimulation in painful diabetic peripheral neuropathy: 24-month follow-up of a prospective two-center randomized controlled trial. Diabetes Care. 2015;38(9):e132–134.
   PubMed Web of Science ®Google Scholar
• van Beek M, Geurts JW, Slangen R, et al. Severity of neuropathy is associated with long-term spinal cord stimulation outcome in painful diabetic peripheral neuropathy: five-year follow-up of a prospective two-center clinical trial. Diabetes Care. 2018;41(1):32–38.
   PubMed Web of Science ®Google Scholar
• Tesfaye S, Watt J, Benbow SJ, Pang KA, Miles J, MacFarlane IA. Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet. 1996;348(9043):1698–1701.
   PubMed Web of Science ®Google Scholar
• Daousi C, Benbow SJ, MacFarlane IA. Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. Diabetic Med. 2005;22(4):393–398.
   PubMed Web of Science ®Google Scholar
• de Vos CC, Rajan V, Steenbergen W, van der Aa HE, Buschman HP. Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. J Diabetes Complications. 2009;23(1):40–45.
   PubMed Web of Science ®Google Scholar
• Pluijms WA, Slangen R, Bakkers M, et al. Pain relief and quality-of-life improvement after spinal cord stimulation in painful diabetic polyneuropathy: a pilot study. Br J Anaesth. 2012;109(4):623–629.
   PubMed Web of Science ®Google Scholar
• Slangen R, Pluijms WA, Faber CG, Dirksen CD, Kessels AG, van Kleef M. Sustained effect of spinal cord stimulation on pain and quality of life in painful diabetic peripheral neuropathy. Br J Anaesth. 2013;111(6):1030–1031.
   PubMed Web of Science ®Google Scholar
• Pluijms WA, Slangen R, van Kleef M, Joosten EA, Reulen JP. Increased contact heat evoked potential stimulation latencies in responders to spinal cord stimulation for painful diabetic polyneuropathy. Neuromodulation. 2015;18(2):126–132; discussion 132.
   PubMed Web of Science ®Google Scholar
• Denisova NP, Rogov DY, Rzaev DA, Khabarova EA, Dmitriev AB. Spinal cord stimulation in the treatment of chronic pain syndromes. Zh Vopr Neirokhir Im N N Burdenko. 2016;80(2):47–52.
   PubMedGoogle Scholar
• Zhou PB, Bao M. Clinical effect analysis of spinal cord electrical stimulator implantation for diabetic foot. Neuromodulation. 2021;2021:5.
   Google Scholar
• Kumar K, Toth C, Nath RK. Spinal cord stimulation for chronic pain in peripheral neuropathy. Surg Neurol. 1996;46(4):363–369.
   PubMedGoogle Scholar
• Eldabe S, Espinet A, Wahlstedt A, et al. Retrospective case series on the treatment of painful diabetic peripheral neuropathy with dorsal root ganglion stimulation. Neuromodulation. 2018;21(8):787–792.
   PubMed Web of Science ®Google Scholar
• de Vos CC, Bom MJ, Vanneste S, Lenders MW, de Ridder D. Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. Neuromodulation. 2014;17(2):152–159.
   PubMed Web of Science ®Google Scholar
• Galan V, Scowcroft J, Chang P, et al. Ten kHz spinal cord stimulation for the treatment of chronic peripheral polyneuropathy: 12-month results from prospective open-label pilot study. Pain Pract. 2021;21(8):898–906.
   PubMed Web of Science ®Google Scholar
• Abd-Elsayed A, Schiavoni N, Sachdeva H. Efficacy of spinal cord stimulators in treating peripheral neuropathy: a case series. J Clin Anesth. 2016;28:74–77.
   PubMed Web of Science ®Google Scholar
• Devulder J, De Colvenaer L, Rolly G, Caemaert J, Calliauw L, Martens F. Spinal cord stimulation in chronic pain therapy. Clin J Pain. 1990;6(1):51–56.
   PubMed Web of Science ®Google Scholar
• Koetsier E, van Kuijk SMJ, Melli G, et al. Dorsal root ganglion stimulation for the management of intractable painful polyneuropathy: a prospective pilot study. Neuromodulation. 2021;24(4):685–694.
   PubMed Web of Science ®Google Scholar
• Ho KWD, Rempe T, Jerath N, Antony A. Dorsal root ganglion stimulation as a potentially effective treatment for painful hereditary and idiopathic axonal polyneuropathy: a retrospective case series. Neuromodulation. 2020;23(2):234–238.
   PubMed Web of Science ®Google Scholar
• Falowski S, Pope JE, Early RA. US experience with stimulation of the dorsal root ganglia for the treatment of peripheral neuropathy in the lower extremities: a multicenter retrospective case series. Neuromodulation. 2019;22(1):96–100.
   PubMed Web of Science ®Google Scholar
• Mekhail NA, Argoff CE, Taylor RS, et al. High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN). Trials. 2020;21(1):87.
   PubMed Web of Science ®Google Scholar
• Nevro Corp. CA2016-5 US SENZA-PDN-1 statistical analysis plan, version 3.0; 2019. Available from: https://clinicaltrials.gov/ProvidedDocs/20/NCT03228420/SAP_001.pdf. Accessed June 10, 2022.
   Google Scholar
• Farrar JT, Young JP Jr., LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158.
   PubMed Web of Science ®Google Scholar
• Al-Kaisy A, Palmisani S, Smith TE, et al. Long-term improvements in chronic axial low back pain patients without previous spinal surgery: a cohort analysis of 10-kHz high-frequency spinal cord stimulation over 36 months. Pain Med. 2018;19(6):1219–1226.
   PubMed Web of Science ®Google Scholar
• Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study. Pain Med. 2014;15(3):347–354.
   PubMed Web of Science ®Google Scholar
• Liem L, Russo M, Huygen FJ, et al. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Neuromodulation. 2013;16(5):471–482; discussion 482.
   PubMed Web of Science ®Google Scholar
• Duarte RV, Nevitt S, Maden M, et al. Spinal cord stimulation for the management of painful diabetic neuropathy: a systematic review and meta-analysis of individual patient and aggregate data. Pain. 2021;162(11):2635–2643.
   PubMed Web of Science ®Google Scholar
• Eldabe S, Buchser E, Duarte RV. Complications of spinal cord stimulation and peripheral nerve stimulation techniques: a review of the literature. Pain Med. 2016;17(2):325–336.
   PubMed Web of Science ®Google Scholar
• Baron R, Maier C, Attal N, et al. Peripheral neuropathic pain: a mechanism-related organizing principle based on sensory profiles. Pain. 2017;158(2):261–272.
   PubMed Web of Science ®Google Scholar
• Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
   PubMed Web of Science ®Google Scholar