SHAM DEVICE, PILL PLACEBO OR TREATMENT FOR ARM PAIN

描述（改编自研究者摘要）：本申请基于 根据观察结果，器械产生的安慰剂效应的大小 比一颗药丸产生的能量更大如果这通常是正确的， 临床试验设计的重大影响，涉及医疗 以及我们对安慰剂效应在 随机对照试验（RCT）。这是一项两阶段研究。上 在第一阶段，研究人员将估计安慰剂的相对幅度， 与假针灸程序相比， 治疗继发于持续性上肢疼痛的患者 重复性劳损（RSI），最明显的是腕管综合征（CTS）。在 第二阶段，中国传统针灸（TCA）的平行RCT， 低剂量阿米替林（AMI）与其各自的安慰剂治疗， 进行。在I期，240例RSI患者将被随机分配至 接受安慰剂设备（最近验证的假针灸设备）或 安慰剂药丸（模拟AMI）。第一阶段的主要假设是， 对假器械的反应比安慰剂更好第二阶段将看到 I期每组中随机分配至活性或非活性组的患者 治疗来自I期假针灸组的患者将接受 要么TCA，要么继续接受假版本。安慰剂 I期的药丸组将接受AMI或继续接受安慰剂 丹这些研究的结果将包括评估这些疾病的性质， 上肢疼痛的严重程度、功能、握力和捏力以及情绪。

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.