Artikel
Burst or tonic stimulation? Results from a prospective placebo controlled, double blinded, study – 2y follow up
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Autoren
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Jan Vesper
- Heinrich-Heine-Universität Düsseldorf, Universitätsklinikum Düsseldorf, Funktionelle Neurochirurgie und Stereotaxie, Düsseldorf, Deutschland
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Philipp Jörg Slotty
- Abteilung für Stereotaxie und Funktionelle Neurochirurgie, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Deutschland
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Jaroslaw Maciaczyk
- Abt. Funktionelle Neurochirurgie und Stereotaxie, Neurochirurgische Universitätsklinik, Universitätsklinikum Düsseldorf, Düsseldorf, Deutschland
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Stefan Schu
- Dusiburg, Deutschland
| Veröffentlicht: | 9. Juni 2017 |
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Gliederung
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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 and to show long-term outcome among this population.
Methods: 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. Twenty patients with FBSS and a pre-existing SCS system each received 3 treatment allocations in random order for a period of 1 week: Tonic 500 Hz Stimulation, Burst Stimulation, and Placebo Stimulation.
Results: The primary outcome measure was overall pain intensity measured on a numerical rating scale (NRS), 6.9 (baseline) vs. 4.2 (tonic) (p<0.001), tonic vs. 2.08 (burst) (p<0.001). Secondary outcome measures were pain quality measured using the Short Form McGill Pain Questionnaire (SFMPQ). Additional data were collected relating to pain related disability measured using the Oswestry Disability Index (ODI). Mean overall NRS and SFMPQ scores were not significantly different between Tonic 500 Hz Stimulation and Placebo Stimulation. Although the lowest mean ODI score was observed under Burst Stimulation, no significant differences were found between the ODI categories. No adverse events occurred, and Burst Stimulation was significantly preferred by 17 patients (80%). Positive results sustained during the long-term follow up. After two years mean VAS score under burst stimulation was three (range 0-6) (p<0.001), one pat. died, one was lost for FU, one suffered from stroke and was switched off.
Conclusion: The lowest mean NRS and SFMPQ scores were observed under Burst Stimulation. For the Burst Stimulation treatment group, mean NRS and SFMPQ scores were significantly decreased compared with the other treatment groups. Overall, Burst Stimulation resulted in significantly better constant pain relief and improved pain quality during the 2y follow-up.
