Abstract
Background
Spinal cord stimulation (SCS) is a technique used worldwide to treat several types of chronic neuropathic pain refractory to any conservative treatment. The aim of this data collection is to enforce evidence of SCS effectiveness on neuropathic chronic pain reported in the literature and to speculate on the usefulness of the trial period in determining the long–term efficacy. Moreover, the very low percentage of undesired side effects and complications reported in our case series suggests that all implants should be performed by similarly well-trained and experienced professionals.
Method
A multicentric data collection on a common database from 11 Italian neurosurgical departments started 3 years ago. Two different types of electrodes (paddle or percutaneous leads) were used. Of 122 patients, 73 % (N = 89) were submitted to a trial period, while the remaining patients underwent the immediate permanent implant (N = 33). Statistical comparisons of continuous variables between groups were performed.
Results
Most of the patients (80 %) had predominant pain to their lower limbs, while only 17 % of patients had prevalent axial pain. Significant reduction in pain, as measured by variation in visual analogue scale (VAS) score, was observed at least 1 year after implantation in 63.8 % of the cases, 59.5 % of patients who underwent a test trial and 71.4 % of patients who underwent permanent implant at once. No statistical differences were found between the lower-limb pain group and the axial pain group.
Conclusions
No relevant differences in long-term outcomes were observed in previously tested patients compared with patients implanted at once. Through this analysis we hope to recruit new centres, to give more scientific value to our results.
Similar content being viewed by others
References
Atkinson L, Sundaraj SR, Brooker C, O’Callaghan J, Teddy P, Salmon J, Semple T, Majedi PM (2011) Recommendations for patient selection in spinal cord stimulation. J Clin Neurosci 18:1295–1302
Bendersky D, Yampolsky C (2013) Is spinal cord stimulation safe? A review of its complications. World Neurosurg 11:S1878-8750(13)00758-4
Burchiel KJ, Anderson VC, Brown FD, Fessier RG, Friedman WA, Pelofsky S, Weiner RL, Oakley J, Shatin D (1996) Prospective multicenter study of spinal cord stimulation for relief of chronic back and extremity pain. Spine 21:2786–2794
Cameron T (2004) Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg 100:254–267
ClinicalTrials.gov (2009) Italian ClinicalService Project. http:/clinicaltrials.gov/ct2/show/NCT01007474. Accessed April 15 2011
Dario A, Fortini G, Bertollo D, Bacuzzi A, Grizzetti C, Cuffari S (2001) Treatment of failed back surgery syndrome. Neuromodulation 4:105–110
de Leon-Casasola OA (2009) Spinal cord and peripheral nerve stimulation techniques for neuropathic pain. J Pain Symptom Manag 38:S28–S38
Dworkin RH, O’Connor AB, Kent J, Mackey SC, Raja SN, Stacey BR, Levy RM, Backonja M, Baron R, Harke H, Loeser JD, Treede RD, Turk DC, Wells CD (2013) Interventional management of neuropathic pain: NeuPSIG recommendations. Pain 154(11):2249–2261
Ferrero P, Grimaldi R, Massa R, Chiribiri A, de Luca A, Castellano M, Cardano P, Trevi GP (2007) Spinal cord stimulation for refractory angina in a patient implanted with a cardioverter defibrillator. Pacing Clin Electrophysiol 30(1):143–146
Frey E, Manchikanti L, Benyamin RM, Schultz DM, Smith KS, Cohen SP (2009) Spinal cord stimulation for patients with failed back surgery syndrome: a systematic review. Pain Physician 12:379–397
Health Quality Ontario (2005) Spinal cord stimulation for neuropathic pain: an evidencebased analysis. Ont Health Technol Assess Ser 5(4):1–78
Kosharskyy B, Rozen D (2006) Feasibility of spinal cord stimulation in a patient with a cardiac pacemaker. Pain Physician 9(3):249–251
Krames ES, Monis S, Poree L, Deer T, Levy R (2011) Using the SAFE principles when evaluating electrical stimulation therapies for the pain of failed back surgery syndrome. Neuromodulation 14(4):299–311
Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O’Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB (2007) Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicenter randomised controlled trial in patients with failed back surgery syndrome. Pain 132(1–2):179–188
Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O’Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB (2008) The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery 63(4):762–770
Kumar K, Toth C, Nath RK, Laing P (1998) Epidural spinal cord stimulation for treatment of chronic pain—some predictors of success. A 15-year experience. Surg Neurol 50:110–121
Kupers RC, van den Oever R, van Houdenhove B, Vanmechelen W, Hepp B, Nuttin B, Gybels JM (1994) Spinal cord stimulation in Belgium: a nation-wide survey on the incidence, indications and therapeutic efficacy by the health insurer. Pain 56(2):211–216
Landau B, Levy RM (1993) Neuromodulation techniques for medically refractory chronic pain. Annu Rev Med 44:279–287
Magimbi AS, de Leon-Casasola OA (2000) Spinal cord stimulation. Tech Reg Anesth Pain Manag 4:132–136
Manca A, Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O’Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, Taylor RJ, Goeree R, Sculpher MJ (2008) Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial). Eur J Pain 12:1047–1058
Meglio M, Cioni B, Rossi GF (1989) Spinal cord stimulation in management of chronic pain. J Neurosurg 70:519–524
Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J (2011) Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract 11(2):148–153
Melzack R, Wall P (1965) Pain mechanism: a new theory. Science 150(3699):971–979
Monahan K, Casavant D, Rasmussen C, Hallet N (1998) Combined use of a true-bipolar sensing implantable cardioverter defibrillator in a patient having a prior implantable spinal cord stimulator for intractable pain. Pacing Clin Electrophysiol 21(12):2669–2672
North RB, Kidd DH, Farrokhi F, Piantadosi SA (2005) Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery 56(1):98–106, discussion 106–7
North RB, Kumar K, Wallace MS, Henderson JM, Shipley J, Hernandez J, Mekel-Bobrov N, Jaax KN (2011) Spinal cord stimulation versus re-operation in patients with failed back surgery syndrome: an international multicenter randomized controlled trial (EVIDENCE Study). Neuromodulation 14:330–336
North RB, Wetzel FT (2002) Spinal cord stimulation for chronic pain of spinal origin: a valuable long-term solution. Spine 27(22):2584–2592
Ohnmeiss DD, Rashbaum RF (2001) Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J 1(5):358–363
Pereira M, Lunet N, Azevedo A, Barros H (2009) Differences in prevalence, awareness, treatment and control of hypertension between developing and developed countries. J Hypertens 27(5):963–975
Poree L, Krames E, Pope J, Deer TR, Levy R, Schultz L (2013) Spinal cord stimulation as treatment for complex regional pain syndrome should be considered earlier than last resort therapy. Neuromodulation 16(2):125–141
Quigley DG, Arnold J, Eldridge PR, Cameron H, McIvor K, Miles JB, Varma TR (2003) Long-term outcome of spinal cord stimulation and hardware complications. Stereotact Funct Neurosurg 81(1–4):50–56
Reverberi C, Dario A, Barolat G (2013) Spinal cord stimulation (SCS) in conjunction with peripheral nerve field stimulation (PNfS) for the treatment of complex pain in failed back surgery syndrome (FBSS). Neuromodulation 16(1):78–82
Schimpf R, Wolpert C, Herwig S, Schneider C, Esmailzadeh B, Lüderitz B (2003) Potential device interaction of a dual chamber implantable cardioverter defibrillator in a patient with continuous spinal cord stimulation. Europace 5(4):397–402
Sears NC, Machado AG, Nagel SJ, Deogaonkar M, Stanton-Hicks M, Rezai AR, Henderson JM (2011) Long-term outcomes of spinal cord stimulation with paddle leads in the treatment of complex regional pain syndrome and failed back surgery syndrome. Neuromodulation 14(4):312–318
Slavin KV, Vaisman J, Pollack KL, Simopoulos TT, Kowlowitz E, Weinand ME, Norregaard TV (2013) Treatment of chronic, intractable pain with a conventional implantable pulse generator: a meta-analysis of 4 clinical studies. Clin J Pain 29:78–85
Sparkes E, Raphael JH, Duarte RV, le Marchand K, Jackson C, Ashford RL (2010) A systematic literature review of psychological characteristics as determinants of outcome for spinal cord stimulation therapy. Pain 150:284–289
Taylor RS (2006) 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 Manag 31(4 Suppl):S13–S19
Taylor RS, Buyten JP, Buchser E (2013) Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: a systematic review and analysis of prognostic factors. Spine 30:152–160
Turner J, Hollingworth W, Comstock B, Deyo R (2010) Spinal cord stimulation for failed back surgery syndrome: outcomes in a workers’ compensation setting. Pain 148:14–25
van Buyten JP, van Zundert J, Vueghs P, Vanduffel L (2001) Efficacy of spinal cord stimulation: 10 years of experience in a pain centre in Belgium. Eur J Pain 5(3):299–307
van de Kelft E, de la Porte C (1994) Long-term pain relief during spinal cord stimulation. The effect of patient selection. Qual Life Res 3(1):21–27
[No authors listed] (2013) The global dominance of diabetes. Lancet 382(9906):1680
Acknowledgments
Medtronic Italia provided technical support in terms of national data repository for data collection, and statistical analysis. No financial support was given to any author.
Conflicts of interest
None.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Colombo, E.V., Mandelli, C., Mortini, P. et al. Epidural spinal cord stimulation for neuropathic pain: a neurosurgical multicentric Italian data collection and analysis. Acta Neurochir 157, 711–720 (2015). https://doi.org/10.1007/s00701-015-2352-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00701-015-2352-5