Artikel
Burst or tonic stimulation? First results of a placebo controlled, doubled blinded, randomized study for the treatment of FBSS patients
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Veröffentlicht: | 13. Mai 2014 |
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Objective: Spinal cord stimulation is an established method for treatment of chronic pain in FBSS patients. In the last decades only tonic stimulation patterns were used to modulate the pain. There were several reports that indicate that burst stimulation offers other opportunities and advantages. The goal of this study was to evaluate the pain level during placebo stimulation, burst stimulation, 500 Hz tonic stimulation with tonic 40-50 Hz stimulation as a baseline.
Method: The study was designed as a double blind, randomized, prospective, cross over study. 20 patients were enrolled and completed the study at the investigational site. The patients were randomized to one of six treatment sequences.
Results: The data shows that the NRS scores were significantly lower during burst stimulation compared to either 500Hz stimulation or placebo stimulation, indicating that burst stimulation results in greater pain relief. Significantly more patients preferred burst stimulation over all other stimulation modes. There were no adverse events during the study.
Conclusions: The results of this study indicates that burst stimulation reduces pain intensity and pain quality significantly as compared to tonic 500Hz, tonic 40-50Hz and Placebo stimulation.