Abstract
Objective
In our previous multicenter randomized controlled trial, we demonstrated the clinical
effectiveness of peripheral nerve field stimulation (PNFS) as add-on therapy to spinal
cord stimulation (SCS) for the treatment of chronic back pain in patients with persistent
spinal pain syndrome (PSPS) or failed back surgery syndrome (FBSS). To our knowledge,
no previous study has investigated the effect of PNFS as an add-on to SCS on the energy
consumption of the implanted neurostimulators. Therefore, in this study, we compared
the specific stimulation parameters and energy requirements of a previously unreported
group of patients with only SCS with those of a group of patients with SCS and add-on
PNFS. We also investigated differences that might explain the need for PNFS in the
treatment of chronic low back pain.
Materials and Methods
We analyzed 75 patients with complete sets of stimulation parameters, with 21 patients
in the SCS-only group and 54 patients in the SCS + PNFS group. Outcome measures were
average visual analog scale score, SCS parameters (voltage, frequency, and pulse width),
SCS charge per second, and total charge per second. We analyzed baseline characteristics
and differences between and within groups over time.
Results
Both groups had comparable patient characteristics at baseline and showed a significant
decrease in back and leg pain. SCS charge per second did not significantly differ
between the groups at baseline or at 12 months. The total charge per second was significantly
higher in the active SCS + PNFS group than in the SCS-only group at baseline; in the
SCS + PNFS group, this persisted for up to 12 months, and the SCS charge per second
and total charge per second increased significantly over time.
Conclusions
Our results show that add-on PNFS increases the total charge per second compared with
SCS alone, as expected. However, further research is needed because our results do
not directly explain why some patients require add-on PNFS to treat low back pain.
Keywords
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Article info
Publication history
Published online: March 10, 2022
Accepted:
November 29,
2021
Received in revised form:
November 14,
2021
Received:
August 26,
2021
Footnotes
Source(s) of financial support: This data base analysis received no financial support.
Conflict of Interest: Hendrik P.J. Buschman is a Medtronic employee. The remaining authors reported no conflict of interest.
Identification
Copyright
© 2021 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.