Abstract
Objective
In 2020, Mekhail et al published a formula that predicted the likelihood of a successful
outcome for those who undergo spinal cord stimulation (SCS) for long-term pain management,
based on retrospectively collected clinical and demographic data from one major medical
center. The aim of this study is to validate such a predictive formula, prospectively,
in a cohort of patients from multiple medical practices that are more representative
of real-life clinical practice.
Materials and Methods
For the study, 939 patients who underwent successful SCS or targeted drug delivery
(TDD) trials at multiple independent medical centers in the USA were enrolled into
the Medtronic product surveillance registry data base before they underwent SCS or
TDD device implantation, from 2018 to 2020. The registry data were collected prospectively
but not specifically for this study. The data examined included demographic information,
pain diagnosis, pain scores (visual analog scale [VAS]), Oswestry Disability Index
scores, and quality-of-life scores at baseline and six months after implant. Because
our goal is to validate the previously published predictive formula, in addition to
the outcomes data previously mentioned, we collected the variables necessary for such
a task: sex, age, depression, the presence of neuropathic pain, spine-related pain
diagnosis, and persistent spinal pain syndrome “post laminectomy syndrome.” Spine-related
pain diagnosis included subjects with chronic spine pain who never had back surgery
and whose pain was not radicular nor neuropathic.
Results
Of 619 patients with SCS, 138 (22%) achieved ≥ 50% reductions of the baseline VAS
at six months. The logistic model predicts SCS success with an area under the receiver
operating characteristic curve (AUC) of 80% in the current validation data set. Of
320 patients with TDD, 147 (46%) achieved ≥ 50% reduction of the baseline VAS at six
months. The logistic model predicts TDD success with an AUC of 78% in the current
validation data set.
Conclusion
The study provides real life validation of the previously published predictive formula(4).
Keywords
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Comments
Article info
Publication history
Published online: April 13, 2023
Accepted:
February 24,
2023
Received in revised form:
February 23,
2023
Received:
February 6,
2023
Publication stage
In Press Corrected ProofFootnotes
Source(s) of financial support: The study was internally funded by Evidence-Based Pain Management Research at the Cleveland Clinic, Cleveland, Ohio, USA. Medtronic Neurologic provided access to the registry, and no funds were received.
Conflict of Interest: Nagy Mekhail served as the Medical Monitor for DRG stimulation “Accurate study”; closed-loop SCS “Evoke study”; HF-10 for PDN “Senza-PDN study”; Mild for LSS “Motion study”; ViaDisc-NP Pilot study for Discogenic pain”; and Restore Study for multifidus muscle dysfunction. Nagy Mekhail is also a consultant for Boston Scientific and Relievant Medsystems Inc. He has received research support from Mesoblast, Avanos, and Neuros Medical. The remaining authors reported no conflict of interest.
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© 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.
