High-frequency (10 kHz) Spinal Cord Stimulation for the Treatment of Focal, Chronic Postsurgical Neuropathic Pain: Results from a Prospective Study in Belgium

Abstract

Aim: Chronic postsurgical pain (CPSP) is a common complication of surgery. This study was conducted to evaluate the efficacy and safety of paresthesia-free, 10-kHz spinal cord stimulation (SCS) as a treatment for CPSP. Patients & methods: Subjects in this prospective, single-arm study had an average pain intensity of ≥5 cm on a 10-cm visual analog scale. The subjects who had pain relief of ≥50% (response) with temporary trial stimulation were permanently implanted with 10-kHz SCS and assessed for 1 year. Results: At 12 months, 94% of subjects were responders to 10-kHz SCS, and 88% had pain remission (visual analog scale ≤2.5 cm). Conclusion: The pain relief was durable in CPSP subjects and the safety profile of 10-kHz SCS was as expected.

Clinical Trial registration number: VT005076953 (Privacy Commission of Belgium)

Keywords::

• chronic pain
• neuromodulation
• postsurgical pain
• spinal cord stimulation

Author contributions

B Billet was responsible for conception and design planning, conduct, data analysis and interpretation. K Hanssens and O De Coster were involved in conducting the study, reporting, acquisition of data and interpretation of data. V Minne, A Santos and A Rotte were involved in acquisition of data, interpretation, preparing the draft outline and working with the external medical writer in drafting the manuscript. All authors have reviewed and approved the final manuscript.

Financial & competing interests disclosure

The study was funded by Nevro Corp. B Billet is a consultant for Nevro Corp. V Minne, A Santos and A Rotte are employees of Nevro Corp. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors wish to thank E MacLaren, Galen Medical Writing, LLC for drafting the manuscript and M Bhandaru for assistance in preparation of illustrations. Nevro Corp. provided funding for the writing assistance.

Ethical conduct of research

The study plan, protocols, informed consent forms and all amendments were reviewed and approved by the AZ Delta Ziekenhuis Roeselare-Menen Ethics Committee, and the study was compliant with all relevant recommendations of the 18th World Medical Assembly in Helsinki, Finland, for physicians involved in biomedical research. Participants of the study signed informed consent forms prior to enrollment. Participants of the study signed an informed consent form to publish deidentified data.

Data sharing statement

Clinical trial registration number: VT005076953. All the relevant data is included in the publication. Individual data cannot be shared due to privacy concerns.

Additional information

Funding

The study was funded by Nevro Corp. B Billet is a consultant for Nevro Corp. V Minne, A Santos and A Rotte are employees of Nevro Corp. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. The authors wish to thank E MacLaren, Galen Medical Writing, LLC for drafting the manuscript and M Bhandaru for assistance in preparation of illustrations. Nevro Corp. provided funding for the writing assistance.