{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.8","value":"2.5"},{"groupId":"OG001","spread":"2.3","value":".3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"description":"The BPI-QOL questionnaire is designed to show the severity and interference of pain in the lives of patients. This is a 7-item questionnaire that asks respondents the extent to which pain interferes with their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life using a 0-10 numerical rating scale in which 0 represents 'does not interfere' and 10 indicates 'completely interferes'. Responses to the 7 items are averaged to form the pain interference scale score. Lower scores are better, showing less interference in daily activities while higher scores show more interference and hence worse outcomes.","dispersionType":"Standard Deviation","groups":[{"description":"ExAblate 2000: MR guided focused ultrasound","id":"OG000","title":"ExAblate Treatment Arm"},{"description":"ExAblate 2000: MR guided focused ultrasound sham","id":"OG001","title":"ExAblate Sham Control Arm"}],"paramType":"MEAN","populationDescription":"115 subjects were underwent treatment. Of these, 4 subjects terminated treatment prior to full completion. These 4 subjects are excluded from the efficacy analysis. An additional 4 subjects were found to have been enrolled in the study more than once. In a pre-PMA meeting with FDA, it was agreed upon to exclude these 4 subjects from the analysis.","reportingStatus":"POSTED","timeFrame":"3 months post treatment","title":"Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline","type":"SECONDARY","unitOfMeasure":"score on a scale"}