METHODS: Eligible patients with a beneficial effect from their SCS treatment were instructed to deactivate their SCS device in a home setting and to reactivate it when their pain returned. The primary outcome was duration of carryover time defined as the time interval from deactivation to reactivation. Central clinical parameters (age, sex, indication for SCS, SCS treatment details, pain score) were registered and correlated with carryover time using nonparametric tests (Mann-Whitney/Kruskal-Wallis) for categorical data and linear regression for continuous data.
RESULTS: In total, 158 patients were included in the analyses. A median carryover time of five hours was found (interquartile range 2.5;21 hours). Back pain as primary indication for SCS, high-frequency stimulation, and higher pain score at the time of deactivation were correlated with longer carryover time.
CONCLUSIONS: This study confirms the existence of the carryover effect and indicates a remarkably high degree of interindividual variation. The results suggest that the magnitude of carryover may be correlated to the nature of the pain condition and possibly stimulation paradigms.
BACKGROUND: The Clinicaltrials.gov registration number for the study is NCT03386058.
方法:符合SCS治疗效果的患者被指导在家中停用SCS装置,并在疼痛恢复时重新激活。主要结果是保留时间的持续时间,定义为从去激活到再激活的时间间隔。中心临床参数(年龄,性别,SCS指示,SCS治疗详情,对疼痛评分)进行登记,并使用非参数检验(Mann-Whitney/Kruskal-Wallis)对分类数据进行关联,对连续数据进行线性回归.
结果:总计,158名患者被纳入分析。发现中位结转时间为5小时(四分位数间距2.5;21小时)。背痛是SCS的主要指征,高频刺激,停用时较高的疼痛评分与较长的遗留时间相关。
结论:这项研究证实了结转效应的存在,并表明个体间的变异程度非常高。结果表明,残留的程度可能与疼痛状况的性质以及可能的刺激范例有关。
背景:本研究的Clinicaltrials.gov注册号为NCT03386058。