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Statistical Analysis Plan The aim of this study is to determine if the treatment effect of the Resonator™ device for the active treatment groups is greater than that for the placebo group. The study will be considered a success if, using the Intent-To-Treat (ITT) Last Observation Carried Forward (LOCF) analysis, the primary endpoint is statistically significant at the 0.05 level. PRIMARY EFFICACY OUTCOME MEASURE: The primary efficacy outcome measure in this pilot study is the mean change from baseline to study endpoint in the 3-recording average of the subject‟s Daily Pain Rating on the 0-100 Numeric Pain Intensity Scale recorded each morning in the Subject Daily Diary. The Baseline Pain Rating will be calculated as the average of the 3 pain ratings recorded by the subject in his or her Subject Daily Diary during the 3-day Baseline Standardization Phase. The study Endpoint Pain Rating will be calculated as the average of the 3 pain ratings recorded by the subject in his or her Subject Daily Diary on Days 15, 16 and 17 of the post-procedure phase. The mean change will be calculated as the difference in mean group score from baseline to study endpoint. As this is an observational pilot study, there are no pre-established individual subject or study success criteria; rather, it is a goal of this study that the results be used to assist in developing individual subject and study success criteria for a potential subsequent full-scale clinical study. Evaluation Time Point |
4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722 |
