Contemporary nonmalignant pain treatment algorithms commence with conservative non-invasive strategies, later progressing from minimally invasive interventions to invasive techniques or implantable devices. The most commonly used implantable devices are spinal cord stimulation (SCS) systems or targeted drug delivery (TDD) devices. Historically, SCS had been considered in advance of TDD, positioning TDD behind SCS failures. Following Institutional Review Board approval, data were extracted from electronic medical records of patients who underwent SCS trial in the Department of Pain Management at Cleveland Clinic from 1994 to 2013. The sample size was analyzed in two cohorts: those who succeeded with SCS and those who failed SCS and consequently proceeded to TDD. Univariate and multivariate analyses were performed and a predictive formula for successful outcomes was created. 945 patients were included in the cohort of which 119 (12.6%) subjects achieved adequate pain relief with TDD after failure of SCS. Gender, age, depression and primary pain diagnosis were significantly different in this subgroup. Males were 52% less likely to experience pain relief with SCS. The odds of SCS success decreased as age increased by 6% per year. Patients with comorbid depression, interestingly, were 63% more likely to succeed with SCS. A logistic model was created to predict SCS success which was used to create a predictive formula. Older male patients diagnosed with spine-related pain were more likely to benefit from TDD than SCS. This observation potentially identifies a subgroup in whom consideration for TDD in advance of SCS failure could prove more efficient and cost effective. These retrospective findings warrant prospective comparative studies to validate this derived predictive formula.
- interventional pain management
- neuromodulation: intrathecal therapy
- neuromodulation: spinal cord stimulation
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Contributors NM conceived of the study. NM initiated the study design and all authors helped with implementation. SA provided statistical expertise in study design and conducted the statistical analyses. GA helped with the data collection. NM and DSM wrote the manuscript. SC, YS and RB provided viable input, article review, and edits. All authors contributed to the approval of the final manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests NM: Medical Monitor for: DRG stimulation “Accurate study”; Closed-loop SCS “Evoke study”; HF-10 for PDN “Senza-PDN study”; Mild for LSS “Motion study”; Ultra High Pulse width SCS “Hi-Fi study”. Consultant: Boston Scientific, Sollis Therapeutics and Relievant Medsystems Inc. Research Support: Mallinckrodt, Mesoblast, Avanos, and Neuros Medical. RB: Consulting: Jazz, Medtronic, Nuvectra, Premier, Pfizer, Salix, Stimwave, TerCera. Scientific research support paid to my institution: Abbott, Boston Scientific, Neurana, Nuvectra, Pfizer, Stimwave.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.