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Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial
Timothy Deer1, Konstantin V Slavin2, Kasra Amirdelfan3
1The Spine and Nerve Center of the Virginias, Inc., Charleston, WV, USA.
Neuromodulation : Journal of the International Neuromodulation Society
|September 30, 2017
Summary
Burst spinal cord stimulation is safe and effective for chronic pain, outperforming traditional tonic stimulation. Most patients preferred the burst mode, showing sustained preference over one year.
Area of Science:
- Neuromodulation
- Pain Management
- Medical Devices
Background:
- Chronic pain affects millions globally, necessitating advanced treatment options.
- Spinal cord stimulation (SCS) is an established therapy for refractory chronic pain.
- Traditional tonic SCS has limitations, driving research into alternative waveforms.
Purpose of the Study:
- To evaluate the safety and efficacy of a novel SCS device delivering both tonic and burst stimulation.
- To compare burst stimulation against traditional tonic stimulation in patients with chronic trunk/limb pain.
- To assess patient preference between tonic and burst stimulation modes.
Main Methods:
- Multicenter, randomized, unblinded, crossover trial (SUNBURST study) involving 100 subjects.
- Subjects received 12 weeks of tonic stimulation followed by 12 weeks of burst stimulation, or vice versa.
- Primary endpoint: noninferiority of burst vs. tonic stimulation for overall pain reduction (VAS score).
Main Results:
- Burst stimulation was noninferior (p < 0.001) and superior (p < 0.017) to tonic stimulation.
- A significant majority of subjects (70.8%) preferred burst stimulation.
- This preference for burst stimulation was sustained at one year (68.2%).
Conclusions:
- Burst SCS is a safe and effective treatment for chronic pain.
- Burst stimulation offers advantages over traditional tonic stimulation.
- Multimodal SCS devices enhance therapeutic options for pain management.
