Power and Sample Size Calculations for Clinical Trials of Myofascial Pain of Jaw Muscles

Abstract

When a clinical trial is planned, the approximate number of subjects needed for significant differences between/among groups to be detected must be estimated. Sample-size calculations provide the investigator with this information. This paper discusses the choice of outcome measures and describes the steps used to estimate the numbers of subjects necessary for a study that compares treatments for patients with chronic myofascial pain of jaw muscles. Within- and between-subject variances were estimated for the chosen variables, the subjects' pain ratings on visual analogue scales. Sample sizes were then calculated for theoretical differences between groups by pre-treatment means and overall standard deviations (Cohen, 1977). The results of this analysis can be used by other researchers when planning studies involving these types of patients.