Carpal Tunnel Syndrome and Static Magnetic Field Therapy

本可行性研究采用有限假设检验，将收集R 01的初步数据，以评价静磁场（SMF）治疗腕管综合征（CTS）的疗效。治疗磁铁是一种自助模式，1999年在美国的销售额估计为3.5亿美元。该提案的目标是与NCCAM 2005-2009年战略计划保持一致，鼓励开展研究，为消费者提供有关其保健的决策所需的信息。目前在英语文献中可获得的关于SMF治疗的科学文献不足以教育消费者。这些随机对照试验（RCT）报告的特点是异质性的磁性设备，给药方案，治疗的持续时间和频率，假对照和结果。选择CTS进行研究是因为它是一种常见的（患病率为0.1-3%），并且在医疗保健和损失的工作天数方面成本高昂。CTS非常适合于对新型干预（如SMF治疗）进行严格评估，因为诊断可以在临床和电生理学上得到证实，靶组织很容易获得可量化的SMF，并且已经存在经验证的CTS主观和客观结局指标。 将招募60名患有轻度至中度CTS的参与者，并随机分配至三种不同磁场剂量之一。 在六周的睡眠时间里，参与者将佩戴三个磁铁中的一个，贴在腕管部位。将对参与者进行为期12周的治疗后随访。波士顿腕管问卷（BCTQ）是我们的主要结局指标。正中神经传导研究（NCS）的五个参数将作为正中神经电生理变化的证据进行二次探索。具体目标1将评估累积率、保留率和依从率以及设盲方案的充分性。具体目标2将获得三种不同剂量SMF的安全性和有效性的初步数据。将使用基线、6周治疗后和12周时比较所有组的BCTQ评分的单因素ANOVA确定有效性。具体目标3将通过比较基线、6周和12周随访后的NCS来探索正中神经传导的电生理变化。本研究将提供进行SMF治疗CTS的更大规模RCT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.