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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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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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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To investigate the long-term effect of high-dose spinal cord stimulation (HD-SCS) in patients with chronic refractory low back and leg pain due to failed back surgery syndrome (FBSS). ⋯ This pilot study shows promising results of offering HD-SCS in addition to LD-SCS for treatment of chronic back and leg pain in patients with failed back surgery syndrome.
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Observational Study
Predictors of Reduced Opioid Use With Spinal Cord Stimulation in Patients With Chronic Opioid Use.
Spinal cord stimulation (SCS) has gained traction as an alternative to chronic opioid therapy in light of the opioid crisis. Prior reports vary widely in their estimates of its effect on opioid consumption. We therefore aimed to address the following questions: 1) Does chronic opioid use change after SCS? 2) Which patient characteristics predict reduced opioid consumption after SCS? ⋯ With only half of chronic opioid users demonstrating meaningful opioid reduction after SCS implantation, we demonstrate that current SCS technology does not reliably help a larger number of patients reduce opioid usage. Women, older age, and preoperative MED < 65 are predictive of meaningful opioid reduction but only one of these is modifiable. As not all patients saw benefit from their therapies, there is still much room for improvement in the treatment of refractory chronic pain that is associated with failed back surgery syndrome and chronic regional pain syndrome.