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.
