Spinal Cord Stimulation in Patients with Critical Limb Ischernia: A Preliminary Evaluation of a Multicentre Trial

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 ischernia. Follow-up of 2 years seems adequate to evaluate the effects of SCS.