Spinal Cord Stimulation (SCS) is a proven treatment for chronic pain, but there is still a need for additional high-quality prospective clinical study data. The final results of a prospective multi-centered study of the Genesis IPG (ANS; Plano, TX) are presented.

Materials and Methods

This study was designed as a prospective, multi-centered, 3 month post-implantation study. After informed consent was obtained, patients were screened according to the inclusion/exclusion criteria. The primary endpoint was to observe if there is pain reduction as demonstrated by the Visual Analog Scale (VAS) at the 3 month visit. Data were also collected on overall pain relief, verbal percentage of pain relief, satisfaction, quality of life, change in medication usage and adverse events.

Results

The mean reduction of VAS from baseline to 3 months was 58.6%. The mean percentage of patient reported pain relief as “Excellent” or “Good” was 67.3% and 77.3% respectively. The majority of patients (81.8%) reported decreased medication use since implant. Also, 90.9% of patients reported being “Very Satisfied” or “Satisfied” with SCS therapy and 84.1% of patients reported quality of life as “Greatly Improved” or “Improved” since implant. Out of 51 patients implanted, there were 4 serious Adverse Events, 2 of which were not related to therapy, one patient reported a serious infection and one patient reported serious pain and/or redness at the implant site.

Conclusions

The Genesis® IPG in combination with the percutaneous leads offers a safe and effective treatment option in the management of chronic intractable pain.