gms | German Medical Science

68th Annual Meeting of the German Society of Neurosurgery (DGNC)
7th Joint Meeting with the British Neurosurgical Society (SBNS)

German Society of Neurosurgery (DGNC)

14 - 17 May 2017, Magdeburg

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Der therapeutische Effekt des BurstDRTM Microdosing in der Behandlung chronischer Schmerzen

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  • Jan Vesper - Heinrich-Heine-Universität Düsseldorf, Universitätsklinikum Düsseldorf, Funktionelle Neurochirurgie und Stereotaxie, Düsseldorf, Deutschland
  • Philipp Jörg Slotty - Abteilung für Stereotaxie und Funktionelle Neurochirurgie, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Deutschland
  • Katja Pöggel-Krämer - Düsseldorf, Deutschland

Deutsche Gesellschaft für Neurochirurgie. Society of British Neurological Surgeons. 68. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), 7. Joint Meeting mit der Society of British Neurological Surgeons (SBNS). Magdeburg, 14.-17.05.2017. Düsseldorf: German Medical Science GMS Publishing House; 2017. DocP 218

doi: 10.3205/17dgnc781, urn:nbn:de:0183-17dgnc7816

Published: June 9, 2017

© 2017 Vesper et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

Text

Objective: BurstDR™ spinal cord stimulation (SCS) has been shown to be safe and effective in the treatment of chronic refractory pain conditions. In this randomized, double-blinded, crossover study we compared the therapeutic efficacy of standard BurstDR™ stimulation to two energy efficient BurstDR™ Microdosing paradigms.

Methods: Patients with chronic pain due to failed back surgery syndrome or neuropathic pain that were using only BurstDR™ for at least 3 months were enrolled in the study. Subjects evaluated each of the following stimulation paradigms for 2 weeks in a randomized order:

  • Standard BurstDR™ stimulation - 5 pulses per burst, 500Hz intraburst frequency, 40Hz interburst frequency, 1000μs pulse width
  • BurstDR™ Microdosing stimulation paradigm A- BurstDR™ STIM ON for 5s followed by BurstDR™ STIM OFF for 5s
  • BurstDR™ Microdosing stimulation paradigm B - BurstDR™ STIM ON for 5s followed by BurstDR™ STIM OFF for 10s

Subjects completed a one week Visual Analog Scale (VAS) pain diary the last week of evaluation of each stimulation paradigm. VAS, quality of life (EQ-5D) and patient satisfaction questionnaires were completed during each follow up visit. During the final visit, subjects were asked to express their preference between the three stimulation paradigms.

Results: To date 7 subjects have completed the study. Average ± SD VAS scores were 62.1±17.6, 64.7±23.3 and 57.8±19.6 for standard BurstDR™, BurstDR™ Microdosing stimulation paradigms A and B, respectively and not significantly different between each other; equivalent values were obtained from the pain diaries. Average EQ-5D index were 0.51±0.19, 0.46±0.17 and 0.6±0.18 for standard BurstDR™, BurstDR™ Microdosing stimulation paradigms A and B, respectively, and not significantly different between each other. On average subject satisfaction was 3.6±1.3, 2.7±0.75 and 2.14±0.38 (1 = Very satisfied, 5 = Very unsatisfied) for standard BurstDR™, BurstDR™ Microdosing stimulation paradigms A and B, respectively. At the end of the study, three subjects preferred BurstDR™ Microdosing stimulation paradigm B, and 4 did not have a preference between the three stimulation paradigms.

Conclusion: These preliminary results from the study have only limited validity due to the small sample size, but strongly suggest that use of BurstDR™ Microdosing stimulation paradigms (i.e. stimulating with alternating ON and OFF periods) can provide clinically equivalent results to standard BurstDR™ stimulation parameters while substantially reducing battery consumption.