Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial Multicenter Study
Postoperative Infections Associated With Prolonged Spinal Cord Stimulation Trial Duration (PROMISE RCT).
In the PROMISE study, a multinational randomized controlled trial (RCT) of the effectiveness of spinal cord stimulation (SCS) with multicolumn surgical leads as a treatment of low back pain, clinicians followed their usual practice. An early, unplanned safety analysis revealed that the infection rate in Belgium (5/23), where trial duration was a median 21.5 days, was significantly higher than the 1/64 rate observed in the other study countries (median 5.8 days, p < 0.01). This report reviews infections observed in the PROMISE study after study completion. ⋯ Although not part of the preplanned analysis, our observation supports the hypothesis of a cause-effect relationship between trial duration and the risk of infection and the conclusion that prolonged SCS trials should be avoided.
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Burst and high-frequency spinal cord stimulation (SCS), in contrast to low-frequency stimulation (LFS, < 200 Hz), reduce neuropathic pain without the side effect of paresthesia, yet it is unknown whether these methods' mechanisms of action (MoA) overlap. We used empirically based computational models of fiber threshold accommodation to examine the three MoA. ⋯ The model, based on empirical data, predicts that, at clinical amplitudes, burst and high-frequency SCS do not activate large-diameter fibers that produce paresthesia while driving medium-diameter fibers, likely different from LFS, which produce analgesia via different populations of dorsal horn neural circuits.
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Review Case Reports
Spinal Cord Stimulation for Neuropathic Pain Treatment in Brachial Plexus Avulsions: A Literature Review and Report of Two Cases.
At least 50% of individuals who suffer a brachial plexus avulsion (BPA) will develop chronic pain, frequently more debilitating than their functional limitations. Similar to other neuropathic pain states, BPA pain is often refractory to pharmacological agents. Despite spinal cord stimulation (SCS) first being used for BPA in 1974, there have been no published literature reviews examining the current evidence of SCS for the treatment of neuropathic pain following BPA. In addition to a clinical review of the literature for this indication, we also share our experience with high-frequency SCS (HF-SCS) for BPA-related pain. ⋯ Despite published reports showing benefit for pain control in patients with BPA, the overall low quality, retrospective evidence included in this review highlights the need for a rigorous prospective study to further address this indication.
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The aim of the study is to investigate whether benzodiazepine use differs between patients with favorable and unfavorable spinal cord stimulation (SCS) treatment outcome. We hypothesize that the patients with unfavorable SCS outcome would exhibit a higher level of benzodiazepine use. ⋯ The benzodiazepine use in patients with poor SCS outcome illustrates the role of anxiety in SCS outcomes and the need for multidisciplinary treatment of pain.
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Spinal cord stimulation (SCS) is a recommended treatment method for patients afflicted by failed back surgery syndrome (FBSS). Although SCS is shown to be clinically effective, not many patients return to work (RTW). The aim of this study is to assess the RTW rate of these patients. ⋯ Unlike the well-analyzed effectiveness of SCS, RTW remains an underutilized outcome measure. The RTW rate in our series was the second lowest in the reviewed literature. We demonstrated that half of the patients with an implanted SCS either did not resume their work or left their job.