Core C The Clinical Core (CC) of the CERC, under the joint direction of Drs. Ajay Wasan and Ted Kaptchuk, will facilitate all clinical activities of the three proposed Projects, providing supervisory support and critical expertise to unify all clinical aspects of our human subjects experimental designs. The success of the entire CERC endeavor depends to a great degree on the recruitment, characterization, and retention of patients. The investigators have extensive, published experience recruiting patients for large acupuncture trials, and we anticipate that these methods will yield the target enrollment. Dr. Wasan, pain specialist, psychiatrist and clinical researcher who is expert in the area of low back pain, will leading the screening and characterization of all patients recruited for all CERC projects. Important to the overall CERC research design, treatment context is unique in each Project: equipoise in Project 1, "augmented" vs. "limited" in Project 2, and fidelity to treatment protocols in Project 3;adherence to the characteristics of each context is critical. The CC has unique experience establishing replicable treatment contexts in acupuncture trials, and will ensure compliance to context in all Projects. Quantitative sensory testing (QST) will be used in Projects 1 and 2 to assess potential abnormalities of mechanisms underpinning pain perception, interpersonal differences in pain responses, and intrapersonal changes in pain processing as a function of treatment or intervention. Because potential emergencies and medical and psychiatric complications may occur in all of the CERC projects, it is important that these studies be conducted with the highest degree of patient safety;Dr. Wasan will provide critical expertise in and oversee these procedures. In brief, to ensure the successful completion of the Projects the CC will: 1) recruit, characterize, randomize, and support retention of subjects;2) ensure fidelity to acupuncture protocols and context procedures for all Projects;3) implement the no-treatment waitlist control for Projects 1 and 2;4) supervise, perform, and analyze quantitative sensory testing for Projects 1 and 2;5) provide back-up medical care for emergencies, medical or psychiatric complications related to acupuncture treatment for all Projects;and 6) organize and interact with Data Safety Monitoring Board for all Projects.

Public Health Relevance

The Clinical Core will bring to the CERC critical expertise to support the clinical activities of all three Projects. The Core will oversee subject recruitment, ensure compliance to all clinical protocols, perform quantitative sensory test and provide backup medical care in the case of study-related complications and emergencies.

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