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The pain relief mechanism of SCS using conventional tonic stimulation is based on the gate control theory. It is essential for the amelioration of pain that the elicited paresthesia overlaps the painful area.
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The conventional SCS consists of the application of tonic stimulation that induces a sense of paresthesia. Spinal cord stimulation (SCS) is one of the neuromodulation therapies that has been used for decades to treat chronic neuropathic pain. For this reason, non-pharmacological approaches such as neuromodulation therapies have been developed. However, many patients do not respond to pharmacological treatment. Pharmacological treatment of neuropathic pain consists mainly of the use of pregabalin, antidepressants, and opioids. The estimated prevalence of neuropathic pain ranges from 1 to 7%. Neuropathic pain is caused by lesions in somatosensory pathways of the peripheral or central nervous system. The secondary outcomes will be evaluated as follows: (1) the relationships between causative disease and improvement rate by each stimulation pattern (2) comparison of pain improvement between the DTM and FAST stimulation patterns in all cases and by causative disease (3) changes in assessment items preoperatively to 24 months after the implantation (4) preoperative factors associated with long-term effects defined as continuing for more than 12 months and (5) adverse events related to this study 3 months after the implantation. The primary analysis will compare pain improvement between the new stimulation patterns and the conventional tonic stimulation pattern in the SCS trial. Pain improvement is defined as more than 33% reduction in the pain VAS. A stimulation-off period for 1 day is set between each stimulation pattern to wash out the residual previous stimulation effects. Each stimulation will then be performed for 2 days, and a visual analog scale (VAS) for pain will be evaluated before and after each stimulation pattern. In the SCS trial, participants will be randomly assigned to 4 groups receiving stimulation, including tonic, DTM, and FAST.
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This study consists of two steps: SCS trial (first step) and SCS system implantation (second step). The Creative Commons Public Domain Dedication waiver ( ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.Ī single-center, open-label, crossover, randomized clinical trial to investigate the superiority of SCS using the latest new stimulation patterns over conventional tonic stimulation for neuropathic pain is planned. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.