The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.
Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and "No Previous RT"
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Targeted-radiofrequency ablation (t-RFA)
Radiofrequency-targeted vertebral augmentation (RF-TVA)
USC
Los Angeles, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks
The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.
Time frame: Mean change from baseline to 6 weeks
Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks
Measured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.
Time frame: Mean Change from Baseline prior to 6 weeks
Brief Pain Inventory Q3 Worst Pain Score by Visit
The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.
Time frame: Week 1, Week 2, Week 6
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