Introduction: Treatment of low-back pain using Spinal Cord Stimulation (SCS) has been historically challenging. Advances in surgical leads and programming capabilities have been thought to potentially enable improved low-back pain relief using SCS. A recently introduced 32-contact surgical lead, which couples multiple independent current control (MICC) and anatomically-based neural targeting stimulation algorithms, allows for patient-specific programming optimization. We present here a real world, observational study of this 32-contact surgical lead.
Methods: A multi-center, consecutive, observational study of a new 32-contact surgical lead was carried out using the Precision Spectra SCS System (Boston Scientific) in 100 subjects out to 12 months post-implant. We examine medical history, procedural information, programming parameters, and clinical outcomes including pain reduction (NRS), activities of daily living, and change in pain medications.
Results: Surgical lead placement distribution was between T7 and L2, with most at T9 (26%). A mean reduction of 5.1 points (SD 2.15, p<0.001) from 7.8 (baseline) to 2.6 in overall pain was observed. A subset of subjects reporting low-back pain only exhibited a mean decrease of 6.0 points (SD 2.12, p<0.001) from 8.3 (baseline) to 2.2. Of these, 83.1% percent of subjects showed =50% back pain reduction. Increases in activities of daily living and reduction in pain medication usage were also observed in a majority of subjects.
Conclusions: Subjects implanted with a 32-contact surgical lead using a neural targeting algorithm demonstrated significant low-back pain reduction. These results support the postulate that advanced surgical leads and programming capabilities can foster improved low-back pain relief in subjects treated using SCS.
Patient Care: By enabling more options and capabilities for patients, this can help facilitate more personalized SCS therapy that can be customized to the individual patient.
Learning Objectives: To collect real world evidence of low back pain relief outcomes using a new 32-contact surgical lead and a system that uses unique programming algorithms that can achieve highly customized, patient-specific stimulation settings capable of robust and specific neural targeting.