Introduction: A randomized controlled trial with appropriate statistical power and long term outcomes is the hallmark of Level 1 clinical evidence. The SENZA-RCT multi-center pivotal study was powered to directly compare high frequency spinal cord stimulation (SCS) at 10 kHz (HF10™ therapy) and traditional low frequency (~50 Hz) SCS. The comparative efficacy of these modalities for the treatment of chronic back and leg pain for 18 months is presented.
Methods: Baseline assessments were performed prior to randomization of 198 patients. 171 patients responded during a trial phase of the assigned SCS system and were implanted. 18 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.
Results: At 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<0.001. 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<0.001. More patients were pain responders to HF10 therapy than traditional SCS (Back pain: 75.9% for HF10 therapy, 47.7% for traditional SCS, p<0.001; Leg pain: 77.0% for HF10 therapy, 53.8% for traditional SCS, p<0.001). 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<0.001; Leg pain: 64.4% for HF10 therapy, 38.5% for traditional SCS, p<0.001). 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.
Conclusions: The SENZA-RCT study provides strong Level 1 evidence in support of long-term use HF10 therapy as compared with traditional low-frequency SCS for the treatment of chronic back and leg pain.
Patient Care: Provide physicians with long-term Level 1 evidence supporting the safety and efficacy of spinal cord stimulation for the treatment of chronic back and leg pain.
Learning Objectives: 1. Understand the differences between 10 kHz high frequency and traditional low frequency (~50 Hz) spinal cord stimulation
2. Understand the comparative safety and efficacy these to SCS modalities in treating chronic back and leg pain over an 18 month period.