Regional anesthesia and pain medicine
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Reg Anesth Pain Med · May 2024
Observational StudyRadiographic lead migration in percutaneous spinal cord stimulator trials.
Lead migration during spinal cord stimulator (SCS) trials is relatively neglected in the literature and presents a different set of challenges compared with fully implanted leads. There is no consensus on what constitutes a clinically significant amount of radiographic lead migration during SCS trials. We wished to evaluate the incidence and extent of radiographic lead migration during percutaneous SCS trials, to investigate the risk factors for lead migration and whether this has impacted on trial success. ⋯ Radiographic lead migration of approximately half of a vertebral level in a caudal direction can be expected during percutaneous SCS trials and this can be anticipated by siting leads half of a vertebral level higher to accommodate for this. Additional factors should be considered in the setting of radiographic lead migration to determine whether this can be considered clinically significant.
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Reg Anesth Pain Med · May 2024
Randomized Controlled Trial Multicenter Study Comparative StudyECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial.
The evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in RCTs. The aim of this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop SCS (CL-SCS) is associated with better outcomes when compared with fixed-output, open-loop SCS (OL-SCS) 36 months following implant. ⋯ This long-term evaluation with objective measurement of SCS therapy demonstrated that ECAP-controlled CL-SCS resulted in sustained, durable pain relief and superior holistic treatment response through 36 months. Greater neural activation and increased accuracy of therapy delivery were observed with ECAP-controlled CL-SCS than OL-SCS.
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Reg Anesth Pain Med · May 2024
ReviewEvaluating the balance of benefits and harms in chronic pain clinical trials: prioritizing individual participants over individual outcomes.
Randomized clinical trials (RCTs) generally assess efficacy and safety separately, with the conclusion of whether a treatment is beneficial based solely on the efficacy endpoint. However, assessing and combining efficacy and safety domains, using a single composite outcome measure, can provide a more comprehensive assessment of the overall effect of a treatment. Furthermore, composite outcomes can incorporate information regarding the relationship between the individual outcomes. In fact, such outcomes have been suggested in the clinical trials literature for at least 15 years. ⋯ Composite outcomes of benefits and harms are underutilized in chronic pain RCTs. The advantages and challenges of using such outcomes are discussed.