Neuromodulation : journal of the International Neuromodulation Society
-
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.
-
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.