Carpal Tunnel Syndrome and Static Magnetic Field Therapy

本可行性研究将通过有限的假设检验收集R01的初步数据，以评估静磁场（SMF）治疗腕管综合征（CTS）的疗效。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。该提案的目标与国家医疗保健协会2005-2009年战略计划相一致，鼓励开展研究，为消费者提供有关其医疗保健决策所需的信息。目前在英语文献中关于SMF治疗的科学文献是一个不足以教育消费者的基础。这些报告的随机对照试验（RCT）的特点是磁性装置、给药方案、治疗持续时间和频率、假对照和结果的异质性。之所以选择CTS作为研究对象，是因为它是一种常见的疾病（患病率为0.1-3%），而且在医疗保健和工作损失方面费用高昂。CTS非常适合对一种新的干预措施（如SMF治疗）进行严格的评估，因为诊断可以在临床和电生理学上得到证实，目标组织可以很容易地获得可量化的SMF，并且CTS的主观和客观结果测量已经存在。将招募60名患有轻度至中度CTS的参与者，并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，参与者将佩戴贴在腕管部位的三个磁铁中的一个。参与者将接受为期12周的治疗后随访。波士顿腕管调查问卷（BCTQ）是我们的主要结果测量。本文将进一步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变化的证据。具体目标1将评估盲法方案的应计率、保留率和合规率以及充分性。具体目标2将获得关于三种不同剂量的smf的安全性和有效性的初步数据。将使用BCTQ评分的单因素方差分析来确定有效性，比较所有组在基线、治疗6周后和12周时的BCTQ评分。特异性目的3将通过比较基线、6周和12周随访后的NCS，探讨正中神经传导的电生理变化。本研究将为开展更大规模的SMF治疗CTS的随机对照试验提供所需的数据和方法。

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.