Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial Multicenter Study
Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study.
Spinal cord stimulation is a recognized treatment of chronic neuropathic and vascular pain. Recent data suggest that the use of very high-frequency (HF) stimulation modes does produce analgesia without paresthesia. ⋯ This is the first randomized double-blind study on SCS. HFSCS was equivalent to sham for the primary outcome (improvement of PGIC) as well as for both the secondary outcomes (VAS and EQ-5D index). There was a highly statistically significant "period effect" (p = 0.006) with improved PGIC scores in the first study period regardless of the treatment. The same trend was seen for VAS and EQ-5D. It appears that the effect of HFSCS and sham is equal and only the order in the sequence, not the nature of the treatment, seems to dictate the effect.
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Multicenter Study Clinical Trial
Novel spinal cord stimulation parameters in patients with predominant back pain.
To examine the feasibility of novel high-frequency spinal cord stimulation therapy in a cohort of patients with chronic predominant back pain during a four day, percutaneous trial. ⋯ Patients with predominant back pain reported a substantial reduction in overall pain and back pain when trialed with high-frequency spinal cord stimulation therapy.
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Multicenter Study
Rate of complications among the recipients of intrathecal baclofen pump in Japan: a multicenter study.
To evaluate the incidence of complications of intrathecal baclofen (ITB) therapy for spasticity in Japan, where a unique training course and nationwide registration are required. ⋯ The requirement of taking of a training course before starting ITB seemed to reduce complications. Although there were surgery-related complications, the rate of complications in Japan appeared to be lower than those reported in larger series of ITB. However, whether the reported rates can be primarily ascribed to a mandatory training course requires further investigations.
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Multicenter Study Clinical Trial
Subthalamic deep brain stimulation with a new device in Parkinson's disease: an open-label trial.
We aimed to evaluate the safety and efficacy of subthalamic nucleus deep brain stimulation (STN-DBS) with a new stimulator (Beijing PINS Medical Co., Ltd, PNS 1101) in Parkinson's disease (PD). ⋯ STN-DBS with the PINS device significantly improved the symptoms of PD when compared with baseline in this trial. This new device may be recommended for the treatment of patients with advanced PD; however, a randomized, double-blinding trial will be required.
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Multicenter Study
Rechargeable vs. nonrechargeable internal pulse generators in the management of dystonia.
To test if deep brain stimulation (DBS) treatment of dystonia was similar in patients before and after implantation of rechargeable internal pulse generators (IPGs). ⋯ Rechargeable IPGs should be the IPGs of choice for dystonic patients receiving DBS as IPGs offer similar treatment efficacy to nonrechargeable IPGs with advantages in terms of costs and reductions in reimplantation frequency.