Carpal Tunnel Syndrome and Static Magnetic Field Therapy

这项可行性研究，通过有限的假设检验，将为评估静磁场(SMF)治疗腕管综合征(CTS)疗效的R01收集初步数据。治疗磁铁是一种自助方式，1999年在美国的销售额估计为3.5亿美元。这项建议的目标是与NCCAM 2005-2009年战略计划保持一致，鼓励进行研究，为消费者提供作出医疗保健决策所需的信息。目前英文文献中关于SMF疗法的科学文献不足以教育消费者。这些随机对照试验(RCT)的特点是磁设备、给药方案、治疗持续时间和频率、假对照和结果的异质性。选择CTS进行研究是因为它是一种常见的疾病(患病率为0.1-3%)，在医疗保健和工作损失天数方面成本高昂。CTS非常适合于对SMF治疗等新的干预措施的严格评估，因为诊断可以在临床和电生理上得到证实，靶组织很容易获得可量化的SMF，并且CTS的主观和客观结果指标已经存在。有轻度到中度CTS的60名参与者将被招募，并被随机分配到三种不同磁场剂量中的一种。在六周的睡眠时间里，参与者将佩戴三块磁铁中的一块，贴在腕管的位置上。参与者将在治疗后接受为期12周的跟踪。波士顿腕管问卷(BCTQ)是我们的主要结果衡量标准。二次探讨正中神经传导研究(NCS)的五个参数，以寻找正中神经电生理改变的证据。具体目标1将评估应计、留存率和遵从率以及盲目议定书的充分性。具体目标2将获得关于三种不同剂量SMFS的安全性和有效性的初步数据。疗效将通过BCTQ评分的单方差分析来确定，比较所有组在基线、治疗6周和12周时的得分。具体目标3将通过比较基线、6周和12周后的NCS来探讨正中神经传导的电生理变化。这项研究将提供进行更大规模的SMF治疗CTS的随机对照试验所需的数据和方法。

This feasibility study, with limited hypothesis testing, will collect preliminary data for a R01 that will evaluate the efficacy of static magnetic field (SMF) therapy for carpal tunnel syndrome (CTS). Therapeutic magnets are a self-help modality with estimated sales of $350 million in the US in 1999. The objective of this proposal is in alignment with the NCCAM Strategic Plan 2005-2009 encouraging research that will provide consumers with information needed to make decisions about their health care. The scientific literature currently available on SMF therapy in the English language literature is an insufficient base with which to educate consumers. These randomized controlled trials (RCT) reported are marked by heterogeneity of magnetic devices, dosing regimens, duration and frequency of treatments, sham controls and outcomes. CTS is chosen for study because it is a common (prevalence 0.1-3%) and costly condition in terms of medical care and lost days of work. CTS is ideally suited for the rigorous assessment of a novel intervention such as SMF therapy because the diagnosis can be clinically and electrophysiologically confirmed, the target tissues are easily accessible to a quantifiable SMF and validated subjective and objective outcome measures for CTS already exist. Sixty participants with mild to moderate CTS will be recruited and randomized to one of three different magnetic field dosages. For six weeks, during the hours of sleep, participants will wear one of the three magnets taped over the site of the carpal tunnel. Participants will be followed for a post-treatment period of 12 weeks. The Boston Carpal Tunnel Questionnaire (BCTQ) is our primary outcome measure. Five parameters of median nerve conduction studies (NCS) will secondarily be explored for evidence of electrophysiological change in the median nerve. Specific Aim 1 will assess accrual, retention and compliance rates and adequacy of a blinding protocol. Specific aim 2 will obtain preliminary data on the safety and effectiveness of three different dosages of SMFs. Effectiveness will be determined using a one-way ANOVA of BCTQ scores comparing all groups at baseline, after a 6-week treatment and at 12 weeks. Specific Aim 3 will explore electrophysiological changes in median nerve conduction, by comparing NCS at baseline, 6 weeks and after 12 weeks follow-up. This study will provide the data and methodologies needed for conducting a larger RCT of SMF therapy for the treatment of CTS.