Thomas M Kinfe1,2, Bogdan Pintea1, Carolina Link3, Sandra Roeske4,5, Erdem Güresir1, Ági Güresir1, Hartmut Vatter1. 1. Department of Neurosurgery, Rheinische Friedrich Wilhelms University Hospital, Bonn, Germany. 2. Department of Neurosurgery, Division of Functional Neurosurgery and Neuromodulation, Rheinische Friedrich Wilhelms University Hospital, Bonn, Germany. 3. Department of Anesthesiology, Rheinische Friedrich Wilhelms University Hospital, Bonn, Germany. 4. DZNE, German Center for Neurodegenerative Diseases, Bonn, Germany. 5. Rheinische Friedrich Wilhelms University Hospital, Bonn, Germany.
Abstract
BACKGROUND: Conventional spinal cord stimulation (SCS) exhibits pain relief and improved quality of life in refractory failed back surgery syndrome. However, patients suffering from predominant back pain failed to achieve a favorable neuromodulation outcome. Currently, two new stimulation concepts, the burst and the HF10 stimulation paradigms successfully suppress intractable back pain levels in this difficult-to-treat subgroup. To date, literature data comparing both stimulation patterns is lacking. METHODS: A prospective, observational study was conducted including 16 refractory Failed-back surgery syndrome (FBSS) patients with previous spine surgery and predominant back pain (70% of overall pain) with or without leg pain eligible for burst or high-frequency SCS. At baseline and at a three-month follow-up the pain intensity (back pain (VASB )/leg pain (VASL ), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), changes in severity of depressive symptoms (Beck Depression Inventory [BDI]) and any adverse event related to the implantation and the stimulation were recorded. RESULTS: Overall baseline VASB was significantly suppressed in 14 FBSS patients (eight burst/six patients with 10 HF10) from baseline 7.9 ± 0.7 to 2.3 ± 1 (p < 0.001), while the overall VASL declined significantly from 3.1 ± 1.5 to 1.9 ± 0.83 (p < 0.01). The burst patients experienced significant VASL reduction (burst 1.8 ± 0.7 (p < 0.009) compared to HF10 patients 2.2 ± 1). Two patients failed 10 HF10-trial. The BDI [23.3 ± 2.1 to 13.5 ± 4.5 (p < 0.001)] and the PSQI [7.6 ± 3.7 to 4.2 ± 1.4 (p < 0.003)] dropped down significantly for both modalities. No implantation/stimulation-related complications were observed. CONCLUSIONS: Burst and HF10 SCS performed efficiently and safely in intractable FBSS patients with predominant back pain and deserve more refined, specific investigations to determine their efficacy.
BACKGROUND: Conventional spinal cord stimulation (SCS) exhibits pain relief and improved quality of life in refractory failed back surgery syndrome. However, patients suffering from predominant back pain failed to achieve a favorable neuromodulation outcome. Currently, two new stimulation concepts, the burst and the HF10 stimulation paradigms successfully suppress intractable back pain levels in this difficult-to-treat subgroup. To date, literature data comparing both stimulation patterns is lacking. METHODS: A prospective, observational study was conducted including 16 refractory Failed-back surgery syndrome (FBSS) patients with previous spine surgery and predominant back pain (70% of overall pain) with or without leg pain eligible for burst or high-frequency SCS. At baseline and at a three-month follow-up the pain intensity (back pain (VASB )/leg pain (VASL ), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), changes in severity of depressive symptoms (Beck Depression Inventory [BDI]) and any adverse event related to the implantation and the stimulation were recorded. RESULTS: Overall baseline VASB was significantly suppressed in 14 FBSS patients (eight burst/six patients with 10 HF10) from baseline 7.9 ± 0.7 to 2.3 ± 1 (p < 0.001), while the overall VASL declined significantly from 3.1 ± 1.5 to 1.9 ± 0.83 (p < 0.01). The burst patients experienced significant VASL reduction (burst 1.8 ± 0.7 (p < 0.009) compared to HF10 patients 2.2 ± 1). Two patients failed 10 HF10-trial. The BDI [23.3 ± 2.1 to 13.5 ± 4.5 (p < 0.001)] and the PSQI [7.6 ± 3.7 to 4.2 ± 1.4 (p < 0.003)] dropped down significantly for both modalities. No implantation/stimulation-related complications were observed. CONCLUSIONS: Burst and HF10 SCS performed efficiently and safely in intractable FBSS patients with predominant back pain and deserve more refined, specific investigations to determine their efficacy.