Neuromodulation : journal of the International Neuromodulation Society
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Neuromodulation
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Randomized Controlled Trial Multicenter Study
Spinal cord stimulation versus re-operation in patients with failed back surgery syndrome: an international multicenter randomized controlled trial (EVIDENCE study).
This paper presents the protocol of the EVIDENCE study, a multicenter multinational randomized controlled trial to assess the effectiveness and cost-effectiveness of spinal cord stimulation (SCS) with rechargeable pulse generator versus re-operation through 36-month follow-up in patients with failed back surgery syndrome. ⋯ As the first multicenter randomized controlled trial of SCS versus re-operation and the first to use only rechargeable SCS pulse generators, the EVIDENCE study will provide up-to-date evidence on the treatment of failed back surgery syndrome.