Neuromodulation : journal of the International Neuromodulation Society
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Review Case Reports
Spinal Cord Stimulation for Management of Pain in Chronic Pancreatitis: A Systematic Review of Efficacy and Complications.
Spinal cord stimulation (SCS) has been used to manage pain in patients with chronic pancreatitis (CP). The aim of this systematic review was to summarize the effectiveness and complications of SCS in the management of pain associated with CP. ⋯ This systematic review suggests that SCS has a potentially efficacious role in reducing pain and opioid use in patients with CP.
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Review Case Reports
Spinal Cord Stimulation for Management of Pain in Chronic Pancreatitis: A Systematic Review of Efficacy and Complications.
Spinal cord stimulation (SCS) has been used to manage pain in patients with chronic pancreatitis (CP). The aim of this systematic review was to summarize the effectiveness and complications of SCS in the management of pain associated with CP. ⋯ This systematic review suggests that SCS has a potentially efficacious role in reducing pain and opioid use in patients with CP.
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The United States Food and Drug Administration (FDA) ensures that patients in the United States have access to safe and effective medical devices. The division of neurological and physical medicine devices reviews medical technologies that interface with the nervous system, including many neuromodulation devices. This article focuses on neuromodulation devices and addresses how to navigate the FDA's regulatory landscape to successfully bring devices to patients.
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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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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.