What Is the Best Way to Manage Vertebral Fracture Pain?
Kallmes DF, Comstock BA, Heagerty PJ, et al
N Engl J Med. 2009;361:569-579
Osteoporotic vertebral fractures are a significant cause of increased morbidity (and perhaps mortality) worldwide. Certainly, prevention is the preferred approach, but once fracture occurs, noninvasive therapy may have limited benefit in controlling pain. As such, the hope was that vertebroplasty -- instillation of medical cement into the collapsed vertebra to re-expand and/or stabilize the fracture -- would prove to be a good option for such patients.
In the current study by Kallmes and colleagues, 131 patients with 1-3 painful osteoporotic vertebral fractures were randomized to receive either vertebroplasty (using polymethylmethacrylate) or sham procedure (local anesthesia but no cement). Additional inclusion criteria were: fracture location from T4 to L5, inadequate pain relief, and duration less than 1 year from onset of pain. Outcomes included patient-reported measures of pain and disability. Subjects were allowed to cross over to the other study arm after 1 month.
At 1 month, reported pain and disability were not statistically different between the 2 groups, although the vertebroplasty-treated patients did have a higher rate of improvement in reported pain. By the third month more patients in the sham arm had crossed over to the treatment arm (43% vs 12%; P < .001), although their reported measures of pain and disability were not different.
The study authors concluded that pain and pain-related disability were similar between those treated with vertebroplasty and sham procedure.
This study did not demonstrate superiority of vertebroplasty in terms of patient-reported pain or disability, although the trend for greater improvement in pain at 1 month in the vertebroplasty group and the greater number of crossovers from the sham group suggest that there may be some benefit from vertebroplasty that was not detected due to power issues or inadequate assessment of improvement by the patient-reported outcomes.
There are several limitations of this study: (1) The authors report the use of opiates in each group, but other pain medications were not recorded; is it possible that the use of other medications made a difference in outcomes? Or did the procedure result in decreased use of other medications? (2) Details of the type and extent of fractures were not reported; is there a particular type of compression fracture that is most responsive to intervention? (3) The study outcome measures (pain and pain-related disability) were limited; are there other measures that are improved with vertebroplasty, such as reduction in future fractures due to improved mechanics, or reduction in use of potentially toxic pain medications (such as NSAIDs)? (4) The duration of follow-up was short; what might the results have been at longer follow-up?
These issues notwithstanding, the results of this study may influence the rapidity with which healthcare providers refer patients for vertebroplasty. We should not forget that fracture prevention should be the main goal.
Abstract
A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures
Kallmes DF, Comstock BA, Heagerty PJ, et al
N Engl J Med. 2009;361:569-579
Study Summary
Osteoporotic vertebral fractures are a significant cause of increased morbidity (and perhaps mortality) worldwide. Certainly, prevention is the preferred approach, but once fracture occurs, noninvasive therapy may have limited benefit in controlling pain. As such, the hope was that vertebroplasty -- instillation of medical cement into the collapsed vertebra to re-expand and/or stabilize the fracture -- would prove to be a good option for such patients.
In the current study by Kallmes and colleagues, 131 patients with 1-3 painful osteoporotic vertebral fractures were randomized to receive either vertebroplasty (using polymethylmethacrylate) or sham procedure (local anesthesia but no cement). Additional inclusion criteria were: fracture location from T4 to L5, inadequate pain relief, and duration less than 1 year from onset of pain. Outcomes included patient-reported measures of pain and disability. Subjects were allowed to cross over to the other study arm after 1 month.
At 1 month, reported pain and disability were not statistically different between the 2 groups, although the vertebroplasty-treated patients did have a higher rate of improvement in reported pain. By the third month more patients in the sham arm had crossed over to the treatment arm (43% vs 12%; P < .001), although their reported measures of pain and disability were not different.
The study authors concluded that pain and pain-related disability were similar between those treated with vertebroplasty and sham procedure.
Viewpoint
This study did not demonstrate superiority of vertebroplasty in terms of patient-reported pain or disability, although the trend for greater improvement in pain at 1 month in the vertebroplasty group and the greater number of crossovers from the sham group suggest that there may be some benefit from vertebroplasty that was not detected due to power issues or inadequate assessment of improvement by the patient-reported outcomes.
There are several limitations of this study: (1) The authors report the use of opiates in each group, but other pain medications were not recorded; is it possible that the use of other medications made a difference in outcomes? Or did the procedure result in decreased use of other medications? (2) Details of the type and extent of fractures were not reported; is there a particular type of compression fracture that is most responsive to intervention? (3) The study outcome measures (pain and pain-related disability) were limited; are there other measures that are improved with vertebroplasty, such as reduction in future fractures due to improved mechanics, or reduction in use of potentially toxic pain medications (such as NSAIDs)? (4) The duration of follow-up was short; what might the results have been at longer follow-up?
These issues notwithstanding, the results of this study may influence the rapidity with which healthcare providers refer patients for vertebroplasty. We should not forget that fracture prevention should be the main goal.
Abstract
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