Neuromodulation : journal of the International Neuromodulation Society
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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.
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The recent availability of paraesthesia/sensation free spinal cord stimulation (SCS) modalities allow the design of clinical trials of SCS using placebo/sham controls and blinding of patients, clinicians, and researchers. The aims of this study were to: 1) systematically review the current evidence base of randomized controlled trials (RCTs) of SCS placebo/sham trials and 2) to undertake a methodological critique of their methods. Based on this critique, we developed a checklist for the design and reporting of future RCTs of SCS. ⋯ To date the methods of placebo/sham control and blinding in RCTs have been poorly reported, leading to concerns about the validity and replicability of the findings. Important aspects that need to be clearly reported in the design of placebo-/sham-controlled RCTs of SCS include the transparent reporting of stimulation programming parameters, patient position during perception threshold measurement, management of the patient handheld programmer, frequency of recharging, and assessment of the fidelity of blinding.
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Spinal cord stimulation (SCS) is considered an effective pain-relieving treatment for patients with Failed Back Surgery Syndrome (FBSS). Despite the clinical effectiveness, it is unknown whether the altered functional connectivity in such patients, as compared to healthy persons, can be influenced by SCS. Therefore, the goal of this study is to evaluate whether brain connectivity assessed by EEG differs between baseline and SCS in patients with FBSS. ⋯ The differences in power spectrum and connectivity between the three conditions lead to the hypothesis that HD SCS differs from CON SCS on average power spectrum, suggesting that HD SCS may have a higher contribution on the excitatory bottom-up pathway.