gms | German Medical Science

Introduction: SCS is an established method for treatment of chronic pain in patients with a failed back surgery syndrome. The treatment of patients with a dominant back pain remains crucial. Modern stimulation pattern, like 10 000 Hz stimulation offer a new technical solution for this group of patients. But beside the elegant effects of lacking overstimulation and no unwanted paraesthesia beside the in the area of pain, has this stimulation as well its pitfalls.

Material and methods: The goal of this analysis, which partly was detected retrospective and partly prospective in a multicenterstudy, was to demonstrate experiences and to evaluate care giver requirements in patients with 10 000Hz stimulation.

A total of 70 patients with FBSS and predominant back pain were included. Out of the total 45 data sets were collected retrospectively (a majority all-in-one surgery), 25 prospectively controlled (undergoing 4 days trial period prior to generator implantation). All patients were implanted with double 8 contact leads using a percutaneous approach. All patients have been implanted with an IPG (Senza System™, Nevro Corp. USA).

Results: 45 patients have been implanted from 2011-2013. Out of those 44 patients underwent a SCS trial period of one week, 21 have been implanted all in one. There were no major complications. The 1 and 2 year data showed different results. Whereas 23 systems have been explanted in other centers for loss loss of pain relief, 14 had a positive long-term outcome, 10 had loss of pain relief after a few month. However all patients with so called failure were lost for follow-up. Since 2014 we changed the recruitment and follow up policy. 25 patients were evelauted in a prospective trial. We did not observed any drop outs so far.

Conclusion: The retrospective datashow this percutaneous approach to be effective and safe in a follow-up series for four years. However, in all explanted patients the IPG was unexpected turned off, or was not reprogrammed as required due to lack of follow up. Especially elderly patients have problems with the daily charching and turned the IPG occasionally off. Even two younger patients turn the IPG unwanted with a magnetic field off. In all prospectively detected patients we observed good stable clinical outcomes. Paraesthesia free SCS systems need as well as tonic low frequency SCS Systems a close follow up in the long term in order to generate stable long term results.