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• W19372661 abstract "Each subject signed an Informed Consent (IC) for treatment, stipulating that her data may be gathered and published. The IC defined risks and side effects of therapy and required each patient to be cleared for therapy by her physician before attending therapy. Patients were invited but not required to participate.Unlike medical research, collecting and reporting data on “physical therapy massage” does not require the approval of specific regulatory boards. Manual physical therapy is practiced daily in thousands of physical therapy clinics around the world and has been for decades. The Women's Health Section of the American Physical Therapy Association endorses (and now teaches) manual work at the structures of the female urogenital tract and has for 30 years.Notwithstanding the above, we consulted 2 highly respected research physicians before starting our investigations. One is a gynecologist researcher and former chief of staff of a major US hospital. The other was clinical research director for a large (public) provider of in vitro fertilization (IVF). A lifelong researcher, he was also Vice President of Research and Development Worldwide for a large (public) pharmaceutical company. Both concurred that an IC was sufficient to gather and compile data for our study.We also consulted a medical attorney before we started. He confirmed the above and drafted an opinion that no specific Internal Review Board (IRB) approval was required for reporting results of this noninvasive work.In this case, I cite the following 3 specific reasons: The American Physical Therapy Association requires that research in physical therapy “abide by ethical standards” without mention of the Helsinki Agreement or any other regulating body.The treatment rendered (physical therapy massage) is commonly accepted, recognized by the American Medical Association as Current Procedural Techniques, and has been for decades. It is taught in virtually every physical therapy school in the world, has been practiced in the United States for more than 50 years, and is well recognized to have little risk or side effects. As it uses no drugs, surgery, physical agents, devices, or modalities (just our hands), “physical therapy massage” is considered safe, with very low risk.The unique aspect of our work is its (patent-protected) protocol, its use in women with infertility and sexual dysfunction, and it use as an adjunct to IVF.The US Department of Health & Human Services limits the IRB requirement in the United States to entities that are regulated by the federal government. Unlike universities, hospitals, and pharmaceutical companies, private physical therapy and massage clinics do not fall under that jurisdiction.With regard to payment, there is no requirement to provide free treatment for patients who receive physical therapy and also permit their data to be gathered for clinical research. Patients were charged as regular paying patients, in accordance with standard industry practices. All subjects were “patients presenting with infertility or abdominopelvic pain-related problems and also indicating sexual pain or dysfunction,” as stated in the study.We did not consider the possibility of “spontaneous improvement,” as the conditions (and improvements) under investigation were not the primary focus of therapy. We plan to do so in future investigations. In this initial report, each patient acted as her own control.The improved sexual function and decreased dyspareunia noted in this study stemmed from “side effects” to our therapy for adhesions and pelvic pain. We do not view increased sexual function as a significant marker but rather as an interesting positive side effect of the therapy." @default.
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• W19372661 date "2005-01-01" @default.
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• W19372661 title "Author's Reply to Reader's Response to “Increasing Orgasm and Decreasing Dyspareunia by a Manual Physical Therapy Technique”" @default.
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