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EVALUATE Trial (Saluda Evoke)

Level 1 evidence comparing open-loop vs closed-loop SCS.

Study Overview

The EVALUATE study was a double-blind, randomized controlled trial (N=134) that established the superiority of ECAP-controlled closed-loop spinal cord stimulation for chronic back and leg pain.

Outcomes at 24 Months

MetricClosed-LoopOpen-Loop
Responders (≥50% pain relief)83%61%
Time in Therapeutic Window95.2%47.9%