Objectives
Methods of energy delivery for traditional spinal cord stimulation (SCS) systems consist
of adjusting programming parameters to affect the total charge delivered per unit
time. One high electrical charge delivery method being considered is subthreshold
high density (HD) programming. To date, there is limited clinical evidence for the
efficacy and safety of paresthesia-free HD programming. The aim of this study was
to examine the efficacy and safety of HD programming.
Materials and Methods
A retrospective review was performed on HD-programmed SCS patients with a minimum
of one year follow-up. Three HD categories were examined: trial, implant, and conversion
(i.e., patients with conventional SCS who were converted to HD settings). High density
amplitude settings were below paresthesia threshold. Patients were classified as responders
to HD if they preferred the paresthesia-free HD setting to the conventional setting
and demonstrated ≥50% pain reduction compared to baseline pain score on delivery and
no-stimulation related neurological deficit. Adverse effects were documented.
Results
Seventeen patients were identified, including 11 conversion patients and six patients
who had positive response to HD programming during the trial and then were implanted.
For trial/implant and conversion patients, both HD and conventional programming significantly
reduced the numerical pain rating scale (NRPS) compared to baseline (p ≤ 0.026). Pain scores were not significantly different between the HD and traditional
programs for the trial (p = 0.060), implant (p = 0.632), and conversion categories (p = 0.658). Through at least 12 months of follow-up, eight (47%) patients continued
to be HD responders.
Conclusions
In subpopulations, HD programming may be a viable option to deliver subthreshold pain
reduction. Randomized, controlled trials with extended follow-up are needed to further
evaluate HD programming.
Keywords:
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COMMENTS
Article info
Publication history
Accepted:
March 30,
2017
Received in revised form:
March 7,
2017
Received:
January 23,
2017
Footnotes
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/WileyCDA/Section/id-301854.html
Source(s) of financial support: This study was not supported by any grants or by any manufacturer or third-party research funding. No manufacturer involvement occurred with this manuscript.
Work for this project was completed at Pain Diagnostics and Interventional Care, Sewickley, PA, USA.
Identification
Copyright
© 2017 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.
