Neuromodulation : journal of the International Neuromodulation Society
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Spinal cord stimulation (SCS) is a well-established procedure for chronic neuropathic pain. Research has established patients with personal psychiatric history do not fare as well as their correspondents following SCS surgery. We explored whether a documented psychiatric family history (PFH) correlated with worse outcomes following SCS surgery. ⋯ Subjects with PFH may experience less improvement in disability following SCS as compared to subjects without PFH. They may take longer to achieve the same outcomes, including pain relief and decrease in pain rumination. Our findings show that improvements in the PFH cohort are equivalent to that of the no PFH cohort on all measures except ODI at 12-month follow-up. Thus obtaining a detailed PFH prior to performing SCS is important in order to implement pre-operative coping training for PFH patients, rather than exclusion from SCS.
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Randomized Controlled Trial Multicenter Study
Comparison of Paresthesia Mapping to Anatomical Placement in Burst Spinal Cord Stimulation: Initial Trial Results of the Prospective, Multicenter, Randomized, Double-Blinded, Crossover, CRISP Study.
In this prospective, multicenter, double-blinded, randomized, crossover study, we compared the therapeutic efficacy of burst SCS delivered using a lead implanted with the paresthesia mapping approach to a lead implanted with an anatomic placement approach. ⋯ The trial results of this study suggest that similar clinical outcomes can be achieved in burst SCS when performing lead placement either using paresthesia mapping or anatomical placement with imaging references.
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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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Since its introduction in 1967, neuromodulation through spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRGs) has advanced significantly in both the technology and indications for use. There are now over 14,000 SCS implants performed worldwide every year. This review focuses on mechanisms behind the loss of efficacy in neuromodulation and current data on salvage therapy, defined as the conversion of a neuromodulation device to an alternative SCS or DRG stimulation, in the event of loss of efficacy or failure of a trial. ⋯ There is limited evidence for the appropriate treatment alternatives, but from data currently available the conversion from conventional tonic stimulation to burst, high frequency (10 kHz), multiple wave forms, and/or DRGs may be appropriate in select patients and will require further research to determine the most appropriate first line salvage in the context of the underlying pain pathology.
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Spinal cord stimulation (SCS) is a known therapy for a variety of chronic pain conditions, but over time a number of patients proceed to explants. ⋯ Our data correlates explants with less pain relief and more depression. Women are more likely to have explants than men. The role of physiologic and psychosocial variables leading to this difference has yet to be elucidated.