SHAM DEVICE, PILL PLACEBO OR TREATMENT FOR ARM PAIN

描述(改编自调查人员摘要)：此应用程序基于 根据观察，一种设备产生的安慰剂效应的幅度 比一片药片产生的能量更大。如果这是大体上正确的，那么有 对医学临床试验设计的重要意义 设备和我们对安慰剂效应作用的理解 随机对照试验(RCT)。这是一个分两个阶段的研究。在第一个 在此阶段，研究人员将估计安慰剂的相对剂量 假针灸程序与不活跃的口腔治疗相关的效果 继发性上肢持续性疼痛的治疗 重复性劳损(RSI)最显著的是腕管综合征(CTS)。在……里面 第二阶段，中国传统针灸的平行RCT和 小剂量阿米替林(AMI)与各自的安慰剂治疗相比 指挥。在第一阶段，240名RSI患者将被随机分配到 接受安慰剂设备(最近验证的假针灸设备)或 安慰剂(假急性心肌梗死)。第一阶段的主要假设是患者 对假设备的反应会比安慰剂更好。第二阶段将看到 I期患者随机分为活动组和非活动组 治疗。来自第一阶段假针灸手臂的患者将接受 要么是TCA，要么继续收到虚假版本。服用安慰剂的患者 第一阶段的避孕药将接受急性心肌梗死或继续接受安慰剂治疗 避孕药。这些研究的结果将包括对性质和 上肢疼痛的严重程度、功能、握力和握力以及情绪。

DESCRIPTION (adapted from investigator's abstract): This application is based on observations that the magnitude of the placebo effect produced by a device is greater than that produced by a pill. If this is generally true, there are significant implications for the design of clinical trials involving medical devices and for our understanding of the role of the placebo effect in randomized controlled trials (RCT). This is a two phase study. In the first phase, the investigators will estimate the relative magnitudes of placebo effects associated with a sham acupuncture procedure versus an inactive oral treatment in patients with persistent upper extremity pain secondary to repetitive strain injury (RSI) most notably, carpal tunnel syndrome (CTS). In the second phase, parallel RCTs of traditional Chinese acupuncture (TCA) and low-dose amitriptyline (AMI) versus their respective placebo treatments will be conducted. In Phase I, 240 patients with RSI will be randomly assigned to receive a placebo device (a recently validated sham acupuncture device) or a placebo pill (dummy AMI). The primary hypothesis in Phase I is that patients will respond better to the sham device than the placebo pill. Phase II will see patients in each arm of Phase I randomly assigned to active or inactive treatment. Patients from the sham acupuncture arm of Phase I will receive either TCA or continue to receive the sham version. Patients in the placebo pill arm of Phase I will receive either AMI or continue receiving the placebo pill. Outcomes in these studies will include assessments of the nature and severity of upper extremity pain, function, grip and pinch strength, and mood.