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Proceedings Paper

Managing tissue heating in laser therapy to enable double-blind clinical study
Author(s): Brian Catanzaro; Luis de Taboada; Jackson Streeter
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Paper Abstract

Laser devices in clinical applications must eventually be tested via clinical trials. An essential component in clinical trials is the double-blind study whereby the patient and the treating physician have no knowledge as to whether a given treatment is active or placebo. In pharmaceuticals, the problem is easily addressed. With laser therapy this can be very challenging. For some optical therapies, laser heating of tissue, by even as little as a few degrees can indicate to the patient and/or the physician that the device is active, un-blinding the study. This problem has been analyzed for a specific laser therapy using a combination of clinical data, analytical methods, finite element modeling, and laboratory testing. The methods used arrived at a solution, but not necessarily one that could have been predicted easily. This paper will present a model of tissue heating and the methods used to mask the effects from the laser in an effort to make active treatment and placebo indistinguishable.

Paper Details

Date Published: 28 February 2006
PDF: 10 pages
Proc. SPIE 6140, Mechanisms for Low-Light Therapy, 61400U (28 February 2006); doi: 10.1117/12.674400
Show Author Affiliations
Brian Catanzaro, CFE Services (United States)
Luis de Taboada, PhotoThera (United States)
Jackson Streeter, PhotoThera (United States)

Published in SPIE Proceedings Vol. 6140:
Mechanisms for Low-Light Therapy
Michael R. Hamblin; Ronald W. Waynant; Juanita Anders, Editor(s)

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