TriangleNCT00656305 · OUTCOME
Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- 3 months post treatment
What was measured
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.
Analysis population: 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.
Groups in this outcome
ExAblate Treatment Arm
ExAblate 2000: MR guided focused ultrasound
ExAblate Sham Control Arm
ExAblate 2000: MR guided focused ultrasound sham
| Group | Source count |
|---|---|
| ExAblate Treatment Arm | 81 |
| ExAblate Sham Control Arm | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ExAblate Treatment Arm | 2.5 | 2.8 | Not reported | Not reported | Not reported |
| ExAblate Sham Control Arm | .3 | 2.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.8
- value
- 2.5
- group Id
- OG001
- spread
- 2.3
- value
- .3
- denoms
- counts
- group Id
- OG000
- value
- 81
- group Id
- 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.
- dispersion Type
- 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
- param Type
- MEAN
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- 3 months post treatment
- title
- Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice