BACKGROUND: For patients with critical limb ischaemia, spinal-cord stimulation has been advocated for the treatment of ischaemic pain and the prevention of amputation. We compared the efficacy of the addition of spinal-cord stimulation to best medical treatment in a randomised controlled trial. METHODS:120 patients with critical limb ischaemia not suitable for vascular reconstruction were randomly assigned either spinal-cord stimulation in addition to best medical treatment or best medical treatment alone. Primary outcomes were mortality and amputation. The primary endpoint was limb survival at 2 years. FINDINGS: The mean (SD) age of the patients was 72.6 years (10.3). Median (IQR) follow-up was 605 days (244-1171). 40 (67%) of 60 patients in the spinal-cord-stimulator group and 41 (68%) of 60 patients in the standard group were alive at the end of the study, (p=0.96). There were 25 major amputations in the spinal-cord-stimulator group and 29 in the standard group, (p=0.47). The hazard ratio for survival at 2 years without major amputation in the spinal-cord stimulation group compared with the standard group was 0.96 (95% CI 0.61-1.51). INTERPRETATION: Spinal-cord-stimulation in addition to best medical care does not prevent amputation in patients with critical limb ischaemia.
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BACKGROUND: For patients with critical limb ischaemia, spinal-cord stimulation has been advocated for the treatment of ischaemic pain and the prevention of amputation. We compared the efficacy of the addition of spinal-cord stimulation to best medical treatment in a randomised controlled trial. METHODS: 120 patients with critical limb ischaemia not suitable for vascular reconstruction were randomly assigned either spinal-cord stimulation in addition to best medical treatment or best medical treatment alone. Primary outcomes were mortality and amputation. The primary endpoint was limb survival at 2 years. FINDINGS: The mean (SD) age of the patients was 72.6 years (10.3). Median (IQR) follow-up was 605 days (244-1171). 40 (67%) of 60 patients in the spinal-cord-stimulator group and 41 (68%) of 60 patients in the standard group were alive at the end of the study, (p=0.96). There were 25 major amputations in the spinal-cord-stimulator group and 29 in the standard group, (p=0.47). The hazard ratio for survival at 2 years without major amputation in the spinal-cord stimulation group compared with the standard group was 0.96 (95% CI 0.61-1.51). INTERPRETATION: Spinal-cord-stimulation in addition to best medical care does not prevent amputation in patients with critical limb ischaemia.
Authors: V Tronnier; R Baron; F Birklein; S Eckert; H Harke; D Horstkotte; P Hügler; M Hüppe; B Kniesel; C Maier; G Schütze; R Thoma; R D Treede; V Vadokas Journal: Schmerz Date: 2011-09 Impact factor: 1.107
Authors: Yuanjia Zhu; Jinsuh Jung; Shreya Anilkumar; Sidarth Ethiraj; Sarah Madira; Nicholas A Tran; Danielle M Mullis; Kerriann M Casey; Sabrina K Walsh; Charles J Stark; Akshay Venkatesh; Alexander Boakye; Hanjay Wang; Y Joseph Woo Journal: Sci Rep Date: 2022-06-15 Impact factor: 4.996
Authors: Eric Benoit; Thomas F O'Donnell; Mark D Iafrati; Enrico Asher; Dennis F Bandyk; John W Hallett; Alan B Lumsden; Gregory J Pearl; Sean P Roddy; Krishnaswami Vijayaraghavan; Amit N Patel Journal: J Transl Med Date: 2011-09-27 Impact factor: 5.531