Neuromodulation : journal of the International Neuromodulation Society
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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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Randomized Controlled Trial Multicenter Study
Cost-Effectiveness Analysis of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation in the Treatment of Chronic Low Back Pain in Failed Back Surgery Syndrome Patients.
Presently, there is only limited evidence about the cost-effectiveness of peripheral nerve field stimulation (PNFS) and no evidence to date on the cost-effectiveness of PNFS as an add-on therapy to spinal cord stimulation (SCS). In a multicenter randomized controlled trial, PNFS as add-on therapy to SCS demonstrated clinical effectiveness in treating chronic low back pain in failed back surgery syndrome (FBSS) patients. We report here the cost-effectiveness of PNFS as additional therapy. ⋯ From a Dutch national health-care context, when the willingness to pay threshold is up to 60.000 Euros per QALY, PNFS as an add-on therapy to SCS for the treatment of low back pain in FBSS patients has a high probability of being cost-effective.