High-Dose Spinal Cord Stimulation for Treatment of Chronic Low Back Pain and Leg Pain in Patients With FBSS, 12-Month Results: A Prospective Pilot Study

Objectives To investigate the long-term effect of high-dose spinal cord stimulation (HD-SCS) in patients with chronic refractory low back and leg pain due to failed back surgery syndrome (FBSS). Study Design Prospective case series; pilot study. Materials and Methods Patients with chronic low back and leg pain (CBLP) due to failed back surgery syndrome (FBSS) were screened for SCS according to the Dutch Neuromodulation Society guidelines. Patients with a pain score of >50 (on a visual analogue scale from 0 to 100) for both low back and leg pain, were selected for participation in this study. During intraoperative screening one or two electrodes were implanted to ensure adequate paresthesia coverage of the back and leg pain area. During the 14 days trial period patients received two programs: a conventional or low-dose (LD) program with 30 Hz; 390 mu sec and a high-dose (HD) program with 420 Hz, 400 mu sec. They all started with LD-SCS and changed to HD-SCS after three days. If patients reported more than 50% pain relief with either program a rechargeable neurostimulator was implanted for permanent SCS. The scores for low back pain and leg pain were recorded separately. Other therapy related outcomes that were collected are pain medication use, Quebec back pain disability scale (QBPDS), patient satisfaction, employment status, stimulation settings, and adverse events. We present the 6- and 12-months results. Results are presented as mean +/- SD. Results Thirteen patients, nine females and four males (mean age: 49.7 +/- 8.1 years), were included between July 2015 and March 2016. Eleven patients responded to SCS during the trial period and were implanted with a neurostimulator. Most patients preferred HD-SCS over LD-SCS and the overall use of HD-SCS increased over time. At 6 to 12 months follow-up, two patients discontinued the study. In one patient low back pain returned despite optimal stimulation settings. The second patient was neither satisfied with LD nor HD and had the system explanted. VAS Leg pain at baseline was 71.2 +/- 33.8 and reduced to 25.7 +/- 24.0 at 6 months and 23.4 +/- 32.0 at 12 months. VAS Back pain at baseline was 66.7 +/- 33.2 and reduced to 36.8 +/- 41.6 at 6 months and 26.1 +/- 33.2 at 12 months. Pain medication was significantly reduced and QBPDS improved from 59.2 +/- 12.2 at baseline to 44.1 +/- 13.7 at 12 months. Five patients returned to work and overall patient satisfaction at the end of the study was high. Conclusion This pilot study shows promising results of offering HD-SCS in addition to LD-SCS for treatment of chronic back and leg pain in patients with failed back surgery syndrome.