Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty (RFA)
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|ClinicalTrials.gov Identifier: NCT02082314|
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : October 14, 2016
Bone metastases are a cause of significant morbidity in cancer patients. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death (1). These metastases frequently give rise to complications that reduce patients' quality of life. These include: pain, fractures, and decreased mobility, ultimately reducing performance status.
Radiofrequency ablation therapy with cementoplasty/vertebroplasty for painful bone metastases has been shown to be feasible, efficacious, and safe. However, patient reported outcomes have yet to be determined.
|Condition or disease||Intervention/treatment|
|Neoplasms Cementoplasty Quality of Life||Procedure: RFA Vertebroplasty|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||April 2016|
- Pain response [ Time Frame: Baseline to 6 weeks post treatment ]To determine the complete and partial pain response rates in patients who undergo radiofrequency ablation (RFA) and/or cementoplasty/vertebroplasty for spinal/pelvic metastases.
- Functional Interference [ Time Frame: Baseline - 6 weeks post treatment ]To investigate how functional interference of pain changes
- Quality of Life [ Time Frame: Baseline - 6 weeks post treatment ]To investigate quality of life changes
- Side-effects [ Time Frame: Baseline-6 weeks post treatment ]To investigate acute side effects of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082314
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Elizabeth David, MD||Sunnybrook Health Sciences Centre|