The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.
Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study. In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
percutaneous injection of cement into the vertebral body
standard antalgic medical treatment
Hospital Clinic of Barcelona
Barcelona, Catalonia, Spain
Impact into quality of life with the Qualeffo-41 test
Time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year
Analyze pain alleviation with the Analog Visual Scale
Time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year
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