Re: OssaTron "double blind"

Posted by ossatron on 1/01/99
Scott, if you are truly interested in understanding the double blind study format, I volunteer my services. A true education would take hours and involve reading hundreds of pages of study protocols. Contact me and I will arrange a meeting. I am often in Birmingham following up on one of our study sites. However, here are some of the hilights of how a study is truly double blinded.

first, there are two different physicians working with the patient. The Dr. who treats the patient and knows if the treatment was a sham or real thing is different from the examining DR. who measures the results. They never discuss the patients with each other. Second, a series of objective pain measurements and subjective evaluations are performed on each patient. Over 100 forms are generated on each patient with followups at 24 hours, 6 weeks, 12 weeks, 6 months and one year. Third, the patient does not see if he has been treated. They are given a series of somewhat painful local anesthetics and a sheet is raised. The equipment is then turned on and the identical treatment protocol folllowed for all patients. The patient does not know the treatment is going to be painful. The patient is forwarned that if the anesthesia takes the treatment is not unccomfortable. Scott, I could go on for hours... but I this format it is probably a waste of time.. I would love to show you the doubleblind protocal and discuss it with you at length. If you have any suggestions on how to improve the double blind format I'm certain that we would implemnt your ideas on future studies..

Obviously you are a skeptic. The FDA is twice as skeptical of all new technology and there studies are designed to weed out inferior technologies. We welcome the challenge. I am confident, having met personally hundreds of people who have benefited, not just heel pain sufferers but nonunion fracture patients whose only other option was amputation. In time you too shall understand our technology. Contact me if you want to invest the time


user-37kbmue.dialup.mindspring.com 18:57:36



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