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Use of beat-to-beat cardiovascular variability data to determine the validity of sham therapy as the placebo control in osteopathic manipulative medicine research

Journal: The Journal of the American Osteopathic Association Date: 2014/11, 114(11):Pages: 860-6. doi: Subito , type of study: article

Free full text   (https://www.degruyter.com/document/doi/10.7556/jaoa.2014.172/html)

Keywords:

biomedical research [44]
heart rate [97]
osteopathic manipulative treatment [3800]
OMT [3780]
placebos [5]
research design [12]
article [2563]

Abstract:

Osteopathic manipulative medicine researchers often use sham therapy as the placebo control during clinical trials. Optimally, the sham therapy should be a hands-on procedure that is perceptually indistinguishable from osteopathic manipulative treatment, does not create an effect on its own, and is not a treatment intervention. However, the sham therapy itself may often influence the outcome. The use of cardiovascular variability (eg, beat-to-beat heart rate variability) as a surrogate for the autonomic nervous system is one objective method by which to identify such an effect. By monitoring cardiovascular variability, investigators can assess autonomic nervous system activity as a response to the sham therapy and quickly determine whether or not the selected sham therapy is a true placebo control. The authors provide evidence for assessment of beat-to-beat heart rate variability as one method for assuring objectivity of sham therapy as a placebo control in osteopathic manipulative medicine research.


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