A Cochrane review [Abstract] 1 included 6 studies with a total of nearly 450 patients. In all studies, patients received control treatment with or without spinal cord stimulation (SCS). Control treatment consisted of optimum conservative treatment (local wound care, analgesics, anticoagulants, and antibiotics, if deemed necessary), and in one study additional prostaglandin therapy was given to both groups.
Limb salvage after 12 months was significantly higher in the SCS group (RR 0.71, 95% CI 0.56 to 0.90; RD -0.11, 95% CI -0.20 to -0.02). Nine patients need to be treated to prevent one more major amputation (NNT 9, 95% CI 5 to 50). Significant pain relief occurred in both treatment groups, but was more prominent in the SCS group, in which the patients required significantly less analgesics. In the SCS group, significantly more patients reached Fontaine stage II than in the conservative group (RR 4.9, 95% CI 2.0 to 11.9; RD 0.33, 95% CI 0.19 to 0.47). Overall, no significantly different effect on ulcer healing was observed with the two treatments.
Overall risk of complications of additional SCS treatment was 17%, 95% CI 12 to 22%, indicating a number needed to harm of 6 (95% CI 5 to 8). Complications of SCS treatment consisted of implantation problems (9%, 95% CI 4 to 15%) and changes in stimulation requiring re-intervention (15%, 95% CI 10 to 20%). Infections of the lead or pulse generator pocket occurred less frequently (3%, 95% CI 0 to 6%).
A cost comparison was made in only one study. The average overall costs at two years were 36,500 euros, in the SCS group and 28,600 euros, in the conservative group. The difference (EUR 7900) was significant (P < 0.009).
Comment: The quality of evidence is downgraded by imprecise results (few patients and wide confidence intervals).
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