Neuromodulation : journal of the International Neuromodulation Society
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Multicenter Study Observational Study
Peripheral nerve field stimulation (PNFS) in chronic low back pain: a prospective multicenter study.
The goal of this study was to evaluate the long-term efficacy and safety of peripheral nerve field stimulation (PNFS) for chronic low back pain (cLBP). ⋯ This prospective, multicenter study confirms that PNFS is an effective therapy for the management of cLBP. Significant improvements in many aspects of the pain condition were measured, and complications were minimal.
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Review Multicenter Study
A case series review of spinal cord stimulation migration rates with a novel fixation device.
A retrospective review of a consecutive case series of 66 permanent spinal cord stimulation implants utilizing a novel tissue fixation device was performed. The purpose of this case series review is to examine the impact of a novel lead anchor to tissue fixation system and determine if it is a viable alternative to standard tissue fixation methods. ⋯ These data suggest this novel method of tissue fixation may be a viable alternative for fixation of spinal cord stimulator leads to soft tissue. In this case series there were no reported incidents of migration or complications related to the novel device.
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Randomized Controlled Trial Multicenter Study
Peripheral nerve field stimulation for the management of localized chronic intractable back pain: results from a randomized controlled study.
Improved device technology has caused a renewed interest in peripheral nerve field stimulation (PNfS). This study sought to obtain preliminary estimates of the safety and efficacy of PNfS in patients with localized chronic intractable pain of the back. ⋯ A total of 44 patients were enrolled at five sites. Of these patients, 32 were implanted with a trial system and 30 completed phase I. During phase I, there were significant differences in mean VAS scores between minimal stimulation and subthreshold stimulation (p = 0.003), low frequency stimulation (p < 0.001), and standard stimulation (p < 0.001). Twenty-four patients were classified as responders to the therapy, and 23 patients received permanent system placement. Significant differences in VAS scores were observed between baseline and all follow-up visits during phase II (p < 0.001) CONCLUSIONS: The results provide evidence to support safety and effectiveness of PNfS as an aid in the management of chronic, localized back pain.
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Multicenter Study Clinical Trial
Bolus intrathecal injection of ziconotide (Prialt®) to evaluate the option of continuous administration via an implanted intrathecal drug delivery (ITDD) system: a pilot study.
This study evaluated efficacy and safety of bolus doses of ziconotide (Prialt®, Eisai Limited, Hertfordshire, UK) to assess the option of continuous administration of this drug via an implanted intrathecal drug delivery system. ⋯ Our data demonstrated that mean VAS was reduced by approximately 25% at the group level after IT ziconotide bolus. Treatment efficacy did not vary with sex, center, age, or pain etiology. Ziconotide bolus was generally well tolerated. Larger studies are needed to determine if bolus dosing with ziconotide is a good predictor of response to continuous IT ziconotide via an intrathecal drug delivery system.
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Multicenter Study Clinical Trial
A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain.
This multicenter prospective trial was conducted to evaluate the clinical performance of a new neurostimulation system designed to treat chronic pain through the electrical neuromodulation of the dorsal root ganglia (DRG) neurophysiologically associated with painful regions of the limbs and/or trunk. ⋯ Results of this clinical trial demonstrate that neurostimulation of the DRG is a viable neuromodulatory technique for the treatment of chronic pain. Additionally, the capture of discrete painful areas such as the feet combined with stable paresthesia intensities across body positions suggest that this stimulation modality may allow more selective targeting of painful areas and reduce unwanted side-effects observed in traditional spinal cord stimulation (SCS).