Abstract
Introduction
Persistent spinal pain syndrome (PSPS) or failed back surgery syndrome (FBSS) refers
to new or persistent pain following spinal surgery for back or leg pain in a subset
of patients. Spinal cord stimulation (SCS) is a neuromodulation technique that can
be considered in patients with predominant leg pain refractory to conservative treatment.
Patients with predominant low back pain benefit less from SCS. Another neuromodulation
technique for treatment of chronic low back pain is subcutaneous stimulation or peripheral
nerve field stimulation (PNFS). We investigated the effect of SCS with additional
PNFS on pain and quality of life of patients with PSPS compared with that of SCS alone
after 12 months.
Materials and Methods
This is a comparative study of patients with PSPS who responded to treatment with
either SCS + PNFS or SCS only following a multicenter randomized clinical trial protocol.
In total, 75 patients completed the 12-month follow-up: 21 in the SCS-only group and
54 in the SCS + PNFS group. Outcome measures were pain (visual analog scale), quality
of life (36-Item Short Form Survey [SF-36]), anxiety and depression (Hospital Anxiety
and Depression Scale [HADS]), overall health (EuroQol Five-Dimension [EQ-5D]), disability
(Oswestry Disability Index [ODI]), and pain assessed by the McGill questionnaire.
Results
There were no significant differences in baseline characteristics between the two
groups. Both groups showed a significant reduction in back and leg pain at 12 months
compared with baseline measurements. No significant differences were found between
the groups in effect on both primary (pain) and secondary parameters (SF-36, HADS,
EQ-5D, ODI, and McGill pain).
Conclusion
In a subgroup of patients with chronic back and leg pain, SCS alone provided similar
long-term pain relief and quality-of-life improvement as PNFS in addition to SCS.
In patients with refractory low back pain not responding to SCS alone, adding PNFS
should be recommended.
Clinical Trial Registration
The Clinicaltrials.gov registration number for the study is NCT01776749.
Keywords
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Comments
Article info
Publication history
Published online: January 26, 2022
Accepted:
October 31,
2021
Received in revised form:
October 4,
2021
Received:
June 29,
2021
Footnotes
Source(s) of financial support: The authors reported no funding sources. Medtronic provided an unrestricted grant for the original randomized clinical trial (RCT). However, the data presented in the this article were not part of the original RCT.
Conflict of Interest: Hendrik P.J. Buschman is a Medtronic employee and holds Medtronic stock options. The remaining authors reported no conflict of interest.
Identification
Copyright
© 2021 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.
