Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial
Potential Therapeutic Effect of Low Amplitude Burst Spinal Cord Stimulation on Pain.
The SUNBURST Study, a USA-based controlled cross-over trial demonstrated that burst spinal cord stimulation was superior compared to tonic stimulation in suppressing chronic intractable pain. However, when on burst stimulation, participants preferred lower to higher amplitudes. This led to the hypothesis that lower burst amplitudes will correlate with lower pain scores while higher amplitudes will be associated with higher pain scores. ⋯ In burst spinal cord stimulation, in contrast to tonic stimulation, lower amplitudes are more effective in suppressing pain than high amplitudes.
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Randomized Controlled Trial
Explantation Rates of High Frequency Spinal Cord Stimulation in Two Outpatient Clinics.
To report the explantation rates of high frequency 10 kHz spinal cord stimulation (SCS) in a real-world setting. ⋯ Recently, high frequency SCS technology has been demonstrated as more effective in treatment of lower- and leg-pain, compared to conventional low frequency SCS, in a 12-month randomized controlled trial (SENZA-RCT). Longer term results have yet to be published. In this study, we found that the explantation rate was much higher than expected, based on the prior studies demonstrating its efficacy. As the use of neuromodulation continues to grow, longitudinal data will be critical in understanding its long-term effects on treated patients.
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Randomized Controlled Trial Multicenter Study
Analgesic Efficacy of "Burst" and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study.
The aim of this study was to compare the efficacy in reducing pain intensity in adult subjects suffering from chronic back and leg pain of burst (BST) and tonic sub-threshold stimulation at 500 Hz (T500) vs. sham stimulation delivered by a spinal cord stimulation (SCS) device capable of automated postural adjustment of current intensity. ⋯ The findings suggest a superior outcome versus sham from T500 stimulation over BST stimulation and a practical equivalence between BST and sham in a group of subjects with leg and back pain habituated to tonic SCS and having achieved a stable status with stimulation.
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Randomized Controlled Trial
Randomized Prospective Study in Patients With Complex Regional Pain Syndrome of the Upper Limb With High-Frequency Spinal Cord Stimulation (10-kHz) and Low-Frequency Spinal Cord Stimulation.
The objective of this prospective randomized study of cases and controls was to evaluate the efficacy of treatment with low-frequency spinal cord stimulation (LF-SCS) and 10 kHz spinal cord stimulation (10-kHz SCS) in patients diagnosed with complex regional pain syndrome type I (CRPS) with upper limb involvement. ⋯ Patients experienced considerable improvement after SCS. The results show that LF-SCS has very good results when compared with conventional treatment. The results obtained with 10-kHz SCS are encouraging, with the advantages of the absence of paresthesia making it an alternative in the treatment of CRPS.
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Randomized Controlled Trial
To Trial or Not to Trial Before Spinal Cord Stimulation for Chronic Neuropathic Pain: The Patients' View From the TRIAL-STIM Randomized Controlled Trial.
Objectives Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL-STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence that an SCS screening trial strategy provides superior patient outcomes as compared with a no trial approach. ⋯ Participants' rated preferences show similar support for a one-stage procedure without a screening trial. Conclusions Our findings indicate an overwhelming preference among participants for a one-stage SCS procedure both before and after the implant, regardless of which procedure they had undergone. The qualitative study findings further support the TRIAL-STIM RCT results.