This training program will support the Pi's transition to a full time career as an independent investigator of CAM manual therapies for chronic low back pain (cLBP). It combines a program of formal coursework, mentorship by experts in relevant research methods, and the supervised conduct of a pilot clinical trial of Structural Integration (SI) (a CAM manual therapy) plus usual care versus usual care alone, for cLBP. The clinical trial will also include an embedded mechanistic pilot trial. This program will provide training in the design and ethical conduct of CAM clinical trials of therapeutic effectiveness and hypothesized mechanistic factors, training in relevant methods of statistical and mathematical analysis, knowledge of the human musculoskeletal, endocrine and immune systems, and training in methods of research in human biomechanics and psychophysiological reactivity to stress. The Pi's development as an independent investigator will advance current NCCAM priorities on the methodologically rigorous investigation of the effectiveness and therapeutic mechanisms of CAM manual therapies, and also a long-standing priority on the investigation of CAM therapies for chronic low back pain. In addition to its value as a training experience, the research conducted under this award will collect preliminary data on the therapeutic effectiveness, if any, of SI compared to usual care for cLBP. It will also collect data on the demographics, recruitment, retention, and treatment compliance of patients enrolled in these trials, and on the degree to which SI can be delivered in a standardized and safe manner to this clinical population. These types of data will be necessary to plan a larger, more adequately powered clinical trial. In addition, the embedded mechanistic study will collect preliminary data on pre- versus post-treatment changes in factors which are hypothesized to contribute to a significant therapeutic effect of SI on cLBP, including postural sway, coordination of gait, and reactivity of the low back muscles and cardiovascular system to an affective stress task. These data may contribute to better understandings of SI and cLBP specifically, and may also benefit our understanding of CAM manual therapies and chronic musculoskeletal pain in general.
This program will support the Pi's transition to a career as an independent investigator of CAM manual therapies for chronic low back pain. It will also provide preliminary data on the effectiveness of Structural Integration, a CAM manual therapy, as a treatment for chronic low back pain, and on pre- versus posttreatment changes in factors which may contribute to that therapeutic effect: balance, coordination in walking, and contractions of the low back muscles in response to experiences of emotional stress.
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