Unpublished MSc thesis, Wiener Schule für Osteopathie, 2007/03, 104, type of study: ,rct,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,

Free full text   (https://www.osteopathicresearch.com/s/orw/item/2998)

Keywords:

biliary [7]
cystic fibrosis [13]
gallbladder diseases [2]
liver [53]
WSO [508]

Abstract:

This master these is an example of the submission an osteopathic clinical study to an ethics commission. It shows the planning procedure backgrounds and results of the controlled, randomized pilot study on osteopathic treatment of the liver and biliary tracts in cystic fibroses (CF). The study will be conducted in total compliance with the Helsinki declaration. Careful and professional planning is obligatory for a good clinical study. This has to consider both scientific and formal-administrative aspects. To be able to fulfill these criteria, it is absolutely necessary to cooperate with clinically experienced scientists (physicians, biometricians). This paper includes the planning phase, the protocol, the case report form, the application form and the informed consent form of the pilot study on osteopathic treatment of the hepatobiliary system in CF. The drafting of the study protocol is like going through a checklist for avoidance of sources of error, to assess in advance security of the patients, statistical evaluation possibilities and organizational and legal aspects. This paper could be a model for osteopaths and osteopathic students who are interested in the management and planning procedure of osteopathic clinical studies.