The research project aims at a two-stage development and efficacy testing of a proprietary (U.S. Patent pending) acupressure garment (the Relief Brief) in decreasing pain and symptom distress associated with primary dysmenorrhea. Stage 1 consists of the development of the final manufactured form of the Relief Brief requiring approximately six months; Stage II involves a six-month clinical trial administered to a treatment group (Relief Brief) and a control group (ibuprofen only) to test the safety and effectiveness of the Relief Brief. The specific aims of this clinical trial, with women (N=70) who experience dysmenorrhea are: 1) To determine the effectiveness of the Relief Brief aimed at reducing symptom severity and pain intensity measures, and 2) to determine the ease of use and any adverse effects associated with using the Relief Brief. Data will be analyzed using parametric statistics to answer the study aims. The goal of the proposed research is to present further evidence for the submission of a 510k application to enable the product to be market ready for women's use.
Thesaurus Terms: acupressure /acupuncture, analgesia, consumer product, human therapy evaluation, menstrual cycle disorder, technology /technique development clinical trial, pain alternative medicine, clinical research, female, human subject
