Treating Chronic, Intractable Pain with a Miniaturized Spinal Cord Stimulation System: 1-Year Outcomes from the AUS-nPower Study During the COVID-19 Pandemic

References

• Taylor RS. Spinal cord stimulation in complex regional pain syndrome and refractory neuropathic back and leg pain/failed back surgery syndrome: results of a systematic review and meta-analysis. J Pain Symptom Manage. 2006;31(4 Supplement):S13–S19. doi:10.1016/j.jpainsymman.2005.12.010
   PubMedGoogle Scholar
• Labaran L, Jain N, Puvanesarajah V, Jain A, Buchholz AL, Hassanzadeh H. A retrospective database review of the indications, complications, and incidence of subsequent spine surgery in 12,297 spinal cord stimulator patients. Neuromodulation. 2020;23(5):634–638. doi:10.1111/ner.12952
   PubMed Web of Science ®Google Scholar
• Orhurhu V, Gao C, Agudile E, et al. Socioeconomic disparities in the utilization of spinal cord stimulation therapy in patients with chronic pain. Pain Pract. 2021;21(1):75–82. doi:10.1111/papr.12936
   PubMed Web of Science ®Google Scholar
• Harmsen IE, Hasanova D, Elias GJB, et al. Trends in clinical trials for spinal cord stimulation. Stereotact Funct Neurosurg. 2020;27:1–12.
   Google Scholar
• Karri J, Joshi M, Polson G, et al. Spinal cord stimulation for chronic pain syndromes: a review of considerations in practice management. Pain Physician. 2020;23(6):599–616.
   PubMed Web of Science ®Google Scholar
• Thomson S, Huygen F, Prangnell S, et al. Appropriate referral and selection of patients with chronic pain for spinal cord stimulation: European consensus recommendations and e-health tool. Eur J Pain. 2020;24(6):1169–1181. doi:10.1002/ejp.1562
   PubMed Web of Science ®Google Scholar
• Manchikanti L, Pampati V, Vangala BP, et al. Spinal Cord Stimulation Trends of Utilization and Expenditures in Fee-For-Service (FFS) Medicare Population from 2009 to 2018. Pain Physician. 2021;24(5):293–308. doi:10.36076/ppj.2021.24.401
   PubMed Web of Science ®Google Scholar
• Verrills P, Sinclair C, Barnard A. A review of spinal cord stimulation systems for chronic pain. J Pain Res. 2016;9:481–492. doi:10.2147/JPR.S108884
   PubMed Web of Science ®Google Scholar
• London D, Mogilner A. Spinal cord stimulation: new waveforms and technology. Neurosurg Clin N Am. 2022;33(3):287–295. doi:10.1016/j.nec.2022.02.006
   PubMed Web of Science ®Google Scholar
• Pope JE, Falowski S, Deer TR. Advanced waveforms and frequency with spinal cord stimulation: burst and high-frequency energy delivery. Expert Rev Med Devices. 2015;12(4):431–437. doi:10.1586/17434440.2015.1026805
   PubMed Web of Science ®Google Scholar
• Ghosh PE, Gill JS, Simopoulos T. The evolving role of high-frequency spinal cord stimulation as salvage therapy in neurostimulation. Pain Pract off J World Inst Pain. 2020;20(7):706–713. doi:10.1111/papr.12898
   PubMed Web of Science ®Google Scholar
• Mekhail N, Levy RM, Deer TR, et al. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020;19(2):123–134. doi:10.1016/S1474-4422(19)30414-4
   PubMed Web of Science ®Google Scholar
• Al-Kaisy A, Royds J, Al-Kaisy O, et al. Explant rates of electrical neuromodulation devices in 1177 patients in a single center over an 11-year period. Reg Anesth Pain Med. 2020;45(11):883–890. doi:10.1136/rapm-2020-101681
   PubMed Web of Science ®Google Scholar
• Pope JE, Deer TR, Falowski S, et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation. 2017;20(6):543–552. PMID: 28714533. doi:10.1111/ner.12634
   PubMed Web of Science ®Google Scholar
• Van Buyten JP, Wille F, Smet I, et al. Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study. Neuromodulation. 2017;20(7):642–649. PMID: 28834092; PMCID: PMC5656934. doi:10.1111/ner.12642
   PubMed Web of Science ®Google Scholar
• Patel SK, Gozal YM, Saleh MS, Gibson JL, Karsy M, Mandybur GT. Spinal cord stimulation failure: evaluation of factors underlying hardware explantation. J Neurosurg Spine. 2019;32(1):133–138. doi:10.3171/2019.6.SPINE181099
   Web of Science ®Google Scholar
• Reddy RD, Moheimani R, Yu GG, Chakravarthy KV. A review of clinical data on salvage therapy in spinal cord stimulation. Neuromodulation. 2020;23(5):562–571. doi:10.1111/ner.13067
   PubMed Web of Science ®Google Scholar
• Dougherty MC, Woodroffe RW, Wilson S, Gillies GT, Howard MA, Carnahan RM. Risk factors and survival analysis of spinal cord stimulator explantation. Neuromodulation. 2021;24(1):61–67. doi:10.1111/ner.13173
   PubMed Web of Science ®Google Scholar
• Simopoulos T, Aner M, Sharma S, Ghosh P, Gill JS. Explantation of Percutaneous spinal cord stimulator devices: a retrospective descriptive analysis of a single-center 15-year experience. Pain Med Malden Mass. 2019;20(7):1355–1361.
   PubMed Web of Science ®Google Scholar
• Gill JS, Kohan LR, Hasoon J, et al. A survey on the choice of spinal cord stimulation parameters and implantable pulse generators and on reasons for explantation. Orthop Rev. 2022;14(4):39648. doi:10.52965/001c.39648
   Web of Science ®Google Scholar
• Desai MJ, Salmon J, Verrills P, et al. A novel pulsed stimulation pattern in spinal cord stimulation: clinical results and postulated mechanisms of action in the treatment of chronic low back and leg pain. Neuromodulation. 2023;26(1):182–191. doi:10.1016/j.neurom.2022.10.053
   PubMed Web of Science ®Google Scholar
• Salmon J, Bates D, Du Toit N, et al. Early experience with a novel micro Spinal Cord Stimulation (SCS) system for the management of chronic intractable pain of the back and legs. Neuromodulation. 2023;26(1):172–181. doi:10.1016/j.neurom.2022.11.002
   PubMed Web of Science ®Google Scholar
• Malinowski MN, Heit G, Poree LR, et al. Novel spinal cord stimulation system with a battery-free micro-implantable pulse generator. Pain Pract. 2022;22(6):592–599. PMID: 35509116. doi:10.1111/papr.13124
   PubMed Web of Science ®Google Scholar
• Deer TR, Sayed D, Pope JE, et al. Emergence from the COVID-19 pandemic and the care of chronic pain: guidance for the interventionalist. Anesth Analg. 2020;131(2):387–394. doi:10.1213/ANE.0000000000005000
   PubMed Web of Science ®Google Scholar
• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011;152(10):2399–2404. doi:10.1016/j.pain.2011.07.005
   PubMed Web of Science ®Google Scholar
• Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the brief pain inventory for chronic nonmalignant pain. J Pain off J Am Pain Soc. 2004;5(2):133–137. doi:10.1016/j.jpain.2003.12.005
   PubMed Web of Science ®Google Scholar
• Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine. 2000;25(22):2940–52; discussion 2952. doi:10.1097/00007632-200011150-00017
   Web of Science ®Google Scholar
• EuroQol Group. EuroQol--A new facility for the measurement of health-related quality of life. Health Policy Amst Neth. 1990;16(3):199–208. doi:10.1016/0168-8510(90)90421-9
   PubMed Web of Science ®Google Scholar
• Beck AT, Steer RA, Carbin MG. Psychometric properties of the beck depression inventory: twenty-five years of evaluation. Clin Psychol Rev. 1988;8(1):77–100. doi:10.1016/0272-7358(88)90050-5
   Web of Science ®Google Scholar
• Guy W; National Institute of Mental Health (U.S.). Psychopharmacology Research Branch. Division of Extramural Research Programs. ECDEU assessment manual for psychopharmacology [Internet]. Rockville, Md: U.S. Dept. of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976 [ cited May 25, 2021]: 616. Available from: http://archive.org/details/ecdeuassessmentm1933guyw. Accessed January 10, 2024.
   Google Scholar
• Ostelo RW, de Vet HC. Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol. 2005;19(4):593–607. PMID: 15949778. doi:10.1016/j.berh.2005.03.003
   PubMed Web of Science ®Google Scholar
• Button KS, Kounali D, Thomas L, et al. Minimal clinically important difference on the beck depression inventory--II according to the patient’s perspective. Psychol Med. 2015;45(15):3269–3279. PMID: 26165748; PMCID: PMC4611356. doi:10.1017/S0033291715001270
   PubMed Web of Science ®Google Scholar
• Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–121. PMID: 18055266. doi:10.1016/j.jpain.2007.09.005
   PubMed Web of Science ®Google Scholar
• Deer T, Skaribas I, McJunkin T, et al. Results from the partnership for advancement in neuromodulation registry: a 24-month follow-up. Neuromodulation. 2016;19(2):179–187. PMID: 26890015. doi:10.1111/ner.12378
   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. PMID: 26218762. doi:10.1097/ALN.0000000000000774
   PubMed Web of Science ®Google Scholar
• Fishman M, Cordner H, Justiz R, et al. Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Pain Pract. 2021;21(8):912–923. PMID: 34363307; PMCID: PMC9290817. doi:10.1111/papr.13066
   PubMed Web of Science ®Google Scholar
• Medtronic, Inc. Implant manual for IntellisTM with AdaptiveStimTM technology (97715) and IntellisTM (97716) rechargeable neurostimulators. Available from: https://www.manualslib.com/manual/1760170/Medtronic-Intellis.html. Accessed May 10, 2021.
   Google Scholar
• Summary of Safety and Effectiveness Data (SSED). Nevro. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130022B.pdf. Accessed May 10, 2021.
   Google Scholar
• Baranidharan G, Bretherton B, Richert G, et al. Pocket pain, does location matter: a single-centre retrospective study of patients implanted with a spinal cord stimulator. Reg Anesth Pain Med. 2020;45(11):891–897. doi:10.1136/rapm-2020-101752
   PubMed Web of Science ®Google Scholar
• Dietvorst S, Decramer T, Lemmens R, et al. Pocket pain and neuromodulation: negligible or neglected? Neuromodulation. 2017;20(6):600–605. PMID: 28699685. doi:10.1111/ner.12637
   PubMed Web of Science ®Google Scholar
• Hasoon J, Urits I, Mahmood S, Kaye AD. Restoring successful spinal cord stimulation therapy for a patient with severe pocket pain utilizing nalu micro-implantable pulse generator. Orthop Rev. 2022;14(3):35326.
   Web of Science ®Google Scholar
• MAUDE - Manufacturer and User Facility Device Experience. Available from: https://www.fda.gov/medical-devices/letters-health-care-providers/conduct-trial-stimulation-period-implanting-spinal-cord-stimulator-scs-letter-health-care-providers. Accessed January 10, 2024.
   Google Scholar
• Costandi S, Mekhail N, Azer G, et al. Longevity and utilization cost of rechargeable and non-rechargeable spinal cord stimulation implants: a comparative study. Pain Pract. 2020;20(8):937–945. PMID: 32543118. doi:10.1111/papr.12926
   PubMed Web of Science ®Google Scholar
• Nalu medical implant manual for the nalu neurostimulation system. Available from: https://nalumed.com/wp-content/uploads/2021/12/MA-000007-Rev-J.pdf. Accessed July 7, 2023.
   Google Scholar