gms | German Medical Science

Introduction: Despite significant progress in medical and neuromodulative therapy of chronic pain syndromes dominant back pain remains still a challenge. While contemporary paddle leads seem to be the good therapeutic solution for this group of patients, the lead placement requires invasive surgical procedures. Novel 16 contact lead coupled with Precision Spectra™ SCS System is designed as a minimal-invasive approach to improve pain relief in dominant back pain patients.The goal of this study was to demonstrate the safety and efficacy of a percutaneous implanted 32 contact lead system for SCS in patients suffering from dominant back pain treated in our center.

Material and methods: Data was collected prospectively from December 2013 till June 2014. The patients were implanted with double 16 contact leads using a percutaneous approach. All implantations have been done under local anesthesia. Prior to the final implantation of the IPG (Precision Spectra™ SCS System, USA), all patients underwent seven days of trial stimulation. Both the paresthesia coverage as well as pain reduction were primary endpoints of the study.

Results: 15 patient suffering from dominant back pain have been implanted with the investigated SCS system from December 2013 till June 2014. The leads were placed mostly between Th4 and Th12, depending on the results of the intraoperative testing. A complete paresthesia coverage and over 50% pain reduction (median VAS decrease from 7 to 3) using the Illumina 3D™ programming algorithm incorporating lead placement, lead spacing, lead and contact offset, and dCSF could be achieved. There were no major complications.

Conclusion: The percutaneous approach using 2x16 contact leads proves to be effective and safe in one year follow up. Placement is done under local anesthesia, which allows for an intraoperative testing of the paraesthesia coverage enabling an optimal clinical outcome. The approach is less invasive than implanting a standard paddle lead. With an advantage of Illumina 3D™ Programming Algorithm software, taking into account a complex 3-dimensional environment of the lead it is possible to achieve very precise paresthesia coverage without unwanted side effects and therefore significant pain reduction in patients with dominant back pain.