• Leonardo Kapural, Cong Yu, Matthew W Doust, Bradford E Gliner, Ricardo Vallejo, B Todd Sitzman, Kasra Amirdelfan, Donna M Morgan, Lora L Brown, Thomas L Yearwood, Richard Bundschu, Allen Burton, Thomas Yang, Ramsin Benyamin, and Abram H Burgher.
• Neurosurgery. 2015 Aug 1;62 Suppl 1:228-9.

IntroductionA randomized controlled trial with appropriate statistical power and long-term outcomes is the hallmark of level 1 clinical evidence. The SENZA-RCT multicenter pivotal study was powered to directly compare highfrequency spinal cord stimulation (SCS) at 10 kHz (HF10 therapy) and traditional lowfrequency (∼50 Hz) SCS. The comparative efficacy of these modalities for the treatment of chronic back and leg pain for 18 months is presented.MethodsBaseline assessments were performed before the randomization of 198 patients. One hundred seventy-one patients responded during a trial phase of the assigned SCS system and were implanted. Eighteen month results were available for 165 of these patients. Responders were defined as having at least 50% pain reduction, while pain remitters were defined as having a VAS pain score of 2.5 or less out of 10.ResultsAt 18 months, back pain decreased to a greater degree for patients receiving HF10 therapy (64.9% ± 30.8%) than with traditional SCS (42.5% ± 35.9%), P < .001. Similarly, leg pain decreased to a greater degree for HF10 therapy patients (65.4% ± 35.2%) than with traditional SCS (45.0% ± 40.3%), P < .001. More patients were pain responders to HF10 therapy than traditional SCS (back pain: 75.9% for HF10 therapy, 47.7% for traditional SCS, P < .001; leg pain: 77.0% for HF10 therapy, 53.8% for traditional SCS, P < .001). More patients were also pain remitters with HF10 therapy than traditional SCS (back pain: 62.1% for HF10 therapy, 30.8% for traditional SCS, P < .001; leg pain: 64.4% for HF10 therapy, 38.5% for traditional SCS, P < .001). Patients classified as remitters in both groups combined had a back pain score of 1.2 ± 0.8 and a leg pain score of 1.0 ± 0.8. Safety profiles were similar.ConclusionThe SENZA-RCT study provides strong level 1 evidence in support of long-term use HF10 therapy compared with traditional low-frequency SCS for the treatment of chronic back and leg pain.

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