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Spinal cord stimulation in patients with critical limb ischemia: A preliminary evaluation of a multicentre trial

Rückenmarkstimulation in der Behandlung bei Patienten mit kritischer Beinischämie: Vorläufige Evaluierung einer Multizenterstudie

  • Main Topics: Spinal Cord Stimulation In The Treatment Of Chronic Critical Limb Ischemia And Angina Pectoris
  • Published:
Acta Chirurgica Austriaca Aims and scope Submit manuscript

Summary

Background: Spinal cord stimulation (SCS) is known to reduce chronic pain. The technique was offered to patients with critical limb ischemia due to atherosclerosis, in which vascular reconstruction was not possible.

Methods: 37 patients were randomized for standard treatment with analgesics and vasoactive drugs (n=18) or electrical stimulation of the spinal cord in addition to the standard treatment (n=19). The primary outcome measures were pain relief and limb salvage. Follow-up covered a period of 4 years.

Results: Amputation-free survival at 2 years was 39 % for standard treatment and 61 % for the stimulation plus standard treatment (p=0.08, NS). Most amputations occurred within the first year after randomization. Pain relief was statistically significant in favor of the stimulation treatment (p<0.001). None of the patients with good pain relief in the SCS-group was amputated. Limb salvage of this subgroup in the standard treatment was 75 % at one year.

Conclusions: A larger multicenter randomized trial comparing SCS and conservative treatment is required to further establish the value of SCS in the treatment of critical limb ischemia. Follow-up of 2 years seems adequate to evaluate the effects of SCS.

Zusammenfassung

Grundlagen: Der schmerzlindernde Effekt der epiduralen Rückenmarkstimulation (RMS) ist bei Patienten mit chronischen Schmerzen wiederholt nachgewiesen worden. Wir berichten über unsere Erfahrung mit der RMS bei Patienten mit austherapierter kritischer Extremitätenischämie.

Methodik: In einer prospektiven Studie wurden 37 Patienten in 2 Gruppen randomisiert, in eine Gruppe (n=18), die mit einer „Standardbehandlung“ (Analgetika und vasoaktive Medikation) behandelt wurden, und in eine Gruppe (n=19), die zusätzlich stimuliert worden ist. Alle Patienten wurden in ein standardisiertes Nachsorgeprogramm aufgenommen, das die schmerzhemmenden Effekte sowie Amputationsrate dokumentiert. Der Follow-up betrug durchschnittlich 4 Jahre.

Ergebnisse: Die Extremitätenerhaltung betrug nach 2 Jahren 39 % für die Gruppe mit „Standardtherapie“ und 61 % für die Gruppe, welche zusätzlich stimuliert wurde. Dieses Ergebnis war jedoch statistisch nicht signifikant (p=0,08). Die meisten Amputationen traten innerhalb des 1. Jahres nach Randomisierung auf. Der schmerzhemmende Effekt war signifikant besser in der Patientengruppe, die stimuliert worden ist (p<0,001). Keiner der Patienten mit signifikanter Schmerzlinderung wurde amputiert. Die Extremitätenerhaltung für diese Untergruppe mit „Standardtherapie“ betrug nach einem Jahr 75 %.

Schlußfolgerungen: Eine umfangreichere randomisierte Multizenterstudie, welche eine konservative Therapie mit der Stimulation vergleicht, ist notwendig. Ein Follow-up von 2 Jahren scheint ausreichend zu sein, um die Effekte der Stimulation zu evaluieren.

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References

  1. Augustinsson LE, Holm J, Carlsson CA, et al: Epidural electrical stimulation of severe limb ischemia. Evidences of pain relief, increased blood flow and a possible limb-saving effect. Ann Surg 1985; 202: 104–111.

    Article  PubMed  CAS  Google Scholar 

  2. Broseta J, Barbera J, de Vera JA, et al: Spinal cord stimulation in peripheral arterial disease. A cooperative study. J Neurosurg 1986; 64: 71–80.

    PubMed  CAS  Google Scholar 

  3. Bunt TJ, Holloway GA, Lawrence P, et al: Experience with epidural spinal stimulation in the treatment of end-stage peripheral vascular disease. Sem Vasc Surg 1991; 4:216–220.

    Google Scholar 

  4. Carlsson AM: Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue score. Pain 1983; 16: 87–101.

    Article  PubMed  CAS  Google Scholar 

  5. Cook AW, Oygar A, Baggenstos P, et al: Vascular Disease of extremities: Electrical stimulation of spinal cord and posterior roots. N Y State J Med 1976; 76: 365–368.

    Google Scholar 

  6. European working group on critical leg ischemia: Second European consensus document on chronic critical leg ischemia. Eur J Vase Surg 1992; 5 (suppl A): 1–32.

    Google Scholar 

  7. Galley D, Rettori R, Boccalon H, et al: La stimulation électrique médullaire dans les artériopathies des membres inférieurs: une étude multicentrique chez 244 patients. J Mal Vase 1992; 17: 208–213.

    CAS  Google Scholar 

  8. Graber JN, Lifson A: The use of spinal cord stimulation for severe limb threatening ischemia: a preliminary report. Ann Vase Surg 1987; 1: 578–581.

    Article  CAS  Google Scholar 

  9. Groth KE: Spinal cord stimulation for the treatment of peripheral vascular disease — European Multi-center Study. In Fields (ed): Advances in Pain Research and Therapy. New York, Raven Press. 1985, pp 861–870.

    Google Scholar 

  10. Horsch S, Claeys L: Epidural spinal cord stimulation in the treatment of severe peripheral arterial occlusive disease. Ann Vasc Surg 1994; 8: 468–474.

    Article  PubMed  CAS  Google Scholar 

  11. Jacobs MJ, Jörning PJ, Joshi SR, et al: Epidural spinal cord electrical stimulation improves microvascular blood flow in severe limb ischemia. Ann Surg 1988; 207: 129–133.

    Article  Google Scholar 

  12. Jivegard LEH, Augustinsson LE, Holm J, Risberg B, Ortenwall P: Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb Ischaemia: a prospective randomized controlled study. Eur J Vasc Endovasc Surg 1995; 9: 421–425.

    Article  PubMed  CAS  Google Scholar 

  13. Kaada B: Promoted healing of chronic ulceration by transcutaneous nerve stimulation. VASA 1983; 12: 262–269.

    PubMed  CAS  Google Scholar 

  14. Klomp HM, Spincemaille GH, Steyerberg EW, Berger MY, Habbema JD, van Urk H: Design issues of a randomised controlled clinical trial on spinal cord stimulation in critical limb ischaemia. eses study group. Eur J Vase Endovasc Surg 1995; 10: 478.

    Article  CAS  Google Scholar 

  15. Kraineck J, Thoden U, Reichert T: Pain reduction in amputees by long term spinal cord stimulation: Long term follow up study over 5 years. J Neurosurg 1980; 52: 346–360.

    Google Scholar 

  16. LaPorte C, Siegfried J: Lumbosacral spinal fibrosis (spinal arachnoiditis): Its diagnosis and treatment by spinal cord stimulation. Spine 1983; 8: 593–603.

    Article  Google Scholar 

  17. Linderoth B, Fedorcsak I, Meyerson BA: Peripheral vasodilatation after spinal cord stimulation: Animal studies of putative effector mechanisms. Neurosurg 1991; 28: 187–195.

    Article  CAS  Google Scholar 

  18. Long DM: Patient selection and the result of spinal cord stimulation for chronic pain. In Hosobuchi H, Corbin T (ed): Indications for spinal cord stimulation. Proceedings of a Symposium, Amsterdam: Excerpta Medica 1981, pp 76–80.

    Google Scholar 

  19. Mackel R: Properties of cutaneous afferents in diabetic neuropathy. Brain 1989; 112: 1359–1376.

    Article  PubMed  Google Scholar 

  20. Malone JM: Therapeutic and economic impact of a modern amputation program. Ann Surg 1979; 189: 798–802.

    Article  PubMed  CAS  Google Scholar 

  21. Meglio M, Cioni B, Lago AD, et al: Pain control and improvement of peripheral blood flow following epidural spinal cord stimulation. Case report. J Neurosurg 1981; 54: 821–823.

    Article  PubMed  CAS  Google Scholar 

  22. Meglio M, Cioni B: Personal experience with spinal cord stimulation in chronic pain management. Appl Neurophysiol 1982; 45: 195–200.

    Article  PubMed  CAS  Google Scholar 

  23. Ray CD, Burton CV, Fifson A: Neurostimulation as used in a large clinical practice. Appl Neurophysiol 1982; 45: 160–166.

    Article  PubMed  CAS  Google Scholar 

  24. Richardson RR, Siqueira EB, Cerullo LJ: Spinal epidural neurostimulation for the treatment of acute and chronic intractable pain: initial and long term results. Neurosurg 1979; 5: 344–348.

    Article  CAS  Google Scholar 

  25. Rivers SP: Successful conservative therapy of severe limb-threatening ischemia: The value of nonsympathectomy. Surgery 1986; 99: 759–762.

    PubMed  CAS  Google Scholar 

  26. Shatin D, Mullett K, Hults G: Totally implantable spinal cord stimulation for chronic pain. Design and efficacy. Pace 1986; 9: 577–583.

    CAS  Google Scholar 

  27. Siegfried J, Lazorthes Y: Long term follow up of dorsal cord stimulation for chronic pain syndromes after multiple lumbar operations. Appl Neurophysiol 1982; 45: 201–204.

    Article  PubMed  CAS  Google Scholar 

  28. Tallis RC, Illis LS, Sedgwick EM, et al: Spinal cord stimulation in peripheral vascular disease. J Neurol Neurosurg Psych 1983; 46: 478–484.

    Article  CAS  Google Scholar 

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Authors and Affiliations

  1. Department of Vascular Surgery, University Hospital Dijzigt, Rotterdam, The Netherlands

    H. M. Klomp

  2. Department of Public Health, Erasmus University, Rotterdam, The Netherlands

    E. W. Steyerberg & J. D. F. Habbema

  3. Department of Neurosurgery, University Hospital Maastricht, P. Debyelaan 25, NL-6202, AZ-Maastricht, The Netherlands

    G. H. Spincemaille, H. M. Klomp, E. W. Steyerberg & J. D. F. Habbema

Authors
  1. G. H. Spincemaille
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  2. H. M. Klomp
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  3. E. W. Steyerberg
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  4. J. D. F. Habbema
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the ESES study group

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Correspondence to G. H. Spincemaille.

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Spincemaille, G.H., Klomp, H.M., Steyerberg, E.W. et al. Spinal cord stimulation in patients with critical limb ischemia: A preliminary evaluation of a multicentre trial. Acta Chir. Austriaca 32, 49–51 (2000). https://doi.org/10.1007/BF02949228

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  • DOI: https://doi.org/10.1007/BF02949228

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