Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform
Objective The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and...
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| Published in | Neuromodulation (Malden, Mass.) Vol. 21; no. 1; pp. 56 - 66 |
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| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Limited
01.01.2018
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1094-7159 1525-1403 1525-1403 |
| DOI | 10.1111/ner.12698 |
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| Summary: | Objective
The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs.
Methods
Following a successful tonic trial, 100 subjects were randomized to receive one stimulation mode for the first 12 weeks, and then the other stimulation mode for the next 12 weeks. The primary endpoint assessed the noninferiority of the within‐subject difference between tonic and burst for the mean daily overall VAS score. An intention‐to‐treat analysis was conducted using data at the 12‐ and 24‐week visits. Subjects then used the stimulation mode of their choice and were followed for one year. Descriptive statistics were used analyze additional endpoints and to characterize the safety profile of the device.
Results
The SUNBURST study demonstrated that burst stimulation is noninferior to tonic stimulation (p < 0.001). Superiority of burst was also achieved (p < 0.017). Significantly more subjects (70.8%) preferred burst stimulation over tonic stimulation (p < 0.001). Preference was sustained through one year: 68.2% of subjects preferred burst stimulation, 23.9% of subjects preferred tonic, and 8.0% of subjects had no preference. No unanticipated adverse events were reported and the safety profile was similar to other spinal cord stimulation studies.
Conclusions
The SUNBURST study demonstrated that burst spinal cord stimulation is safe and effective. Burst stimulation was not only noninferior but also superior to tonic stimulation for the treatment of chronic pain. A multimodal stimulation device has advantages. |
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| Bibliography: | Allen W. Burton, MD is an employee of Abbott (formerly St. Jude Medical). Timothy Deer, MD serves as a paid consultant for Abbott (formerly St. Jude Medical), Axonics, Bioness, Saluda Medical, Spinethera, and Vertos Medical. Alain Y. Fabi, MD serves as a paid consultant for Stryker Corporation. Alain Y. Fabi, MD owns stock in Stryker Corporation, Blaze Biosciences and HistoSonics Inc. He also serves as a paid consultant for Stryker Corporation. Steven Falowski, MD provides research support to Abbott (formerly St. Jude Medical), Medtronic, and Saluda Medical. He also serves as a paid consultant to Abbott (formerly St. Jude Medical), Medtronic, and Nevro. Timothy Houden, MD and Kasra Amirdelfan, MD report no conflicts of interest. Rafael Justiz, MD serves as a paid consultant for Abbott (formerly St Jude Medical), Medtronic Neuromodulation, and Epimed International. Richard B. North, MD serves as an unpaid officer of the nonprofit Neuromodulation Foundation, Inc. He also provides research support to Johns Hopkins University and Sinai Hospital (former employers, 1974‐2013), Abbott (formerly St. Jude Medical, Inc.), Algostim, LLC/Greatbatch, Inc., Boston Scientific Corp., Medtronic, Inc., Nevro Corp. He receives consulting or equity fees from Algostim, LLC and Stimwave, Inc. Richard Paicius, MD is a paid consultant for Abbott (formerly St. Jude Medical), Nevro, and Nuvectra. Jason Pope, MD is a paid consultant for Abbott (formerly St. Jude Medical), Flowonix Medical, Inc., Jazz Pharmaceuticals PLC, Medtronic Inc., and Nevro Corp. He is also a researcher for Abbott (formerly St. Jude Medical), Biotronik, Inc., Flowonix Medical, Inc., Jazz Pharmaceuticals PLC, Nevro Corp., and Saluda Medical Pty. Ltd. Konstantin V. Slavin, MD serves as an advisor/consultant for Abbott (formerly St. Jude Medical), Biotronik, Boston Scientific, Insightec, Medtronic, Neuramodix, Nevro, Nuvectra, and Stimwave. He also serves as a researcher for Abbott (formerly St. Jude Medical), Autonomic Technologies, Boston Scientific, Medtronic, and Neuros. He has also received honoraria or royalty from Karger and Wiley. Peter Staats, MD serves as a paid consultant for Abbott (formerly St. Jude Medical) and researcher for Abbott (formerly St. Jude Medical), Boston Scientific, Medtronic, and Nevro. He also serves on the board of directors for Electrocore Medical. Derron Wilson, MD serves as a paid consultant for Abbott (formerly St. Jude Medical) and research for Abbott (formerly St. Jude Medical). Thomas L. Yearwood, MD, PhD, serves as a paid consultant for Abbott (formerly St. Jude Medical). Source(s) of financial support: Abbott sponsored this study. For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to Conflict of Interest http://www.wiley.com/WileyCDA/Section/id-301854.html ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Feature-3 ObjectType-Evidence Based Healthcare-1 ObjectType-Article-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 |
| ISSN: | 1094-7159 1525-1403 1525-1403 |
| DOI: | 10.1111/ner.12698 |