Department of Anesthesia and Pain Management, AZ Nikolaas, St Niklaas, Belgium; and
Editor’s Choice: Prospective Nonrandomized Trial
High-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back Pain Patients: Results of a Prospective Multicenter European Clinical Study
Article first published online: 30 NOV 2012
© 2012 International Neuromodulation Society
Neuromodulation: Technology at the Neural Interface
Volume 16, Issue 1, pages 59–66, January/February 2013
How to Cite
2012. High-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back Pain Patients: Results of a Prospective Multicenter European Clinical Study. Neuromodulation 2012; e-pub ahead of print. DOI: 10.1111/ner.12006, , , ,
Conflict of Interest: Drs. Van Buyten, Al-Kaisy, and Smet received fees related to the presentation of study results at scientific congresses from Nevro Corp. The other authors reported no conflicts of interest.
For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http://www.wiley.com/bw/submit.asp?ref=1094-7159&site=1
Source(s) of financial support: This study was sponsored by Nevro Corp.
- Issue published online: 1 FEB 2013
- Article first published online: 30 NOV 2012
- Manuscript Accepted: 8 OCT 2012
- Manuscript Revised: 30 JUL 2012
- Manuscript Received: 16 MAY 2012
- Nevro Corp
- axial back pain;
- failed back surgery syndrome;
- high-frequency stimulation;
- low back pain;
- spinal cord stimulation
The objective of this prospective, open-label, multicenter European clinical trial was to quantify the efficacy and safety of a spinal cord stimulation (SCS) system that utilizes high-frequency (up to 10 kHz) waveforms, which do not produce paresthesia, for the treatment of chronic, intractable pain of the back and/or limbs.
Material and Methods
Eighty-three patients, with significant back pain, were recruited for a trial of high-frequency stimulation through two percutaneous eight-contact epidural leads. Patients' pain ratings, disability, sleep disturbances, and satisfaction, as well as complication rates, were assessed for up to six months.
After a trial period, 88% (72 out of 82) of patients reported a significant improvement in visual analog scale (VAS) scores and underwent permanent implantation of the high-frequency SCS system. Mean back pain VAS of 8.4 was reduced to 2.7 at six months (p< 0.001). Mean leg pain VAS of 5.4 was reduced to 1.4 at six months (p< 0.001). Seventy-four percent of patients had greater than 50% back pain relief at six months. There were significant improvements in Oswestry disability score and sleep, and reductions in pain medication use. Adverse events observed were those seen with conventional SCS therapy—lead migration, wound infection, and pain around implant site.
In a cohort of patients with difficult-to-treat chronic back pain, high-frequency SCS provided significant and sustained low back pain and leg pain relief to more than 70% of treated subjects. Notably, this was achieved without paresthesia. Patients also experienced significant improvement in disability and sleep. Overall, the results confirm a favorable safety and efficacy profile of the high-frequency SCS system.