Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial
Redefining Spinal Cord Stimulation "Trials": A Randomized Controlled Trial Using Single-Stage Wireless Permanent Implantable Devices.
"Traditional" spinal cord stimulation (SCS) trials with percutaneous electrodes externalized to a pulse generator (PG) are typically limited in duration due to risk of infection. Newer miniaturized wireless SCS technology eliminates the percutaneous extension (as well as PGs implanted for chronic use), thus facilitating a single-stage implantation after which the device can remain indefinitely. ⋯ Using wireless SCS devices that allow for an extended trial period and evaluation of various waveforms, we observed a high rate trial success rate with both HFS and LFS waveforms, with minimal incidence of infection. Long-term follow-up will address the cost-effectiveness and morbidity associated with this technology, which facilitates single-stage treatment.
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Randomized Controlled Trial Multicenter Study
Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects.
The WHISPER randomized controlled trial (RCT) evaluates safety and clinical effectiveness of subperception spinal cord stimulation (SCS) at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain. ⋯ Subperception SCS at ≤1.2 kHz is safe and effective in subjects with extreme physical disability and previously implanted for chronic pain. Further, by providing study participants with different waveform options, increased pain relief was achieved.
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Randomized Controlled Trial Multicenter Study
Anatomic Lead Placement Without Paresthesia Mapping Provides Effective and Predictable Therapy During the Trial Evaluation Period: Results From the Prospective, Multicenter, Randomized, DELIVERY Study.
The purpose of this study was to compare the trial success rate between anatomic lead placement (AP) and paresthesia-mapped (PM) lead placement techniques for spinal cord stimulation (SCS) using a nonlinear burst stimulation pattern. ⋯ When using a nonlinear burst stimulation pattern, anatomic or PM lead placement technique may be used. Nonresponders to subthreshold stimulation had a higher conversion rate when a PM technique was used. AP resulted in shorter procedure times with a similar safety profile and was strongly preferred by trialing physicians.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of Neural Activity in Chronic Pain Patients During Tonic and Burst Spinal Cord Stimulation Using Fluorodeoxyglucose Positron Emission Tomography.
Burst spinal cord stimulation (SCS) is a novel stimulation paradigm that seems to provide better pain relief compared to the classic tonic SCS with minimal paresthesia sensation. Based on source localized electroencephalography and clinical data, it has been proposed that burst stimulation as defined by Dirk De Ridder exerts this greater effect by not only modulating the lateral and the descending pain-inhibitory pathways (similar to tonic SCS) but also modulating the medial pain pathway, which encodes the affective, motivational aspects of pain. ⋯ Dr. Yearwood, Dr. De Ridder, Dr. Falowski, and Dr. Vanneste are the consultants of Abbott. Dr. Venkatesan is an employee of Abbott. Hye Bin Yoo and Dr. Wing Ting To have no conflicts of interest to report.