A new study published in The BMJ compared vertebroplasty to a sham procedure for treating acute osteoporotic compression fractures.
The researchers from the Netherlands and Boston-based Massachusetts General Hospital studied 91 patients receiving vertebroplasty and 89 receiving a sham procedure in four community hospitals in the Netherlands. All patients received local subcutaneous lidocaine and bupivacaine at each pedicle, with the vertebroplasty patients also receiving cementation.
Follow-up analysis occurred at one day, one week, one month, three months, six months and 12 months. Researchers defined significant pain relief as a 1.5 point decrease in visual analogue scale scores from baseline.
Here are seven study insights.
1. Researchers found the mean reduction in the VAS score to be statistically significant in both groups at all follow-ups compared to the baseline.
2. The following reflects the mean difference in VAS scores between the two groups:
- At baseline: 0.20
- At one day: −0.43
- At one week: −0.11
- At one month: 0.41
- At three months: 0.21
- At six months: 0.39
- At 12 months: 0.45
3. Researchers emphasized changes in VAS scores during the 12-month follow-up didn't differ significantly between the two groups.
4. Further, secondary outcomes didn't prove statistically significant between the two groups.
5. Both groups experienced similar statistically significant reductions in analgesic use.
6. The study reported two adverse events (respiratory insufficiency and vasovagal reaction) in the vertebroplasty cohort.
7. Researchers concluded the vertebroplasty patients didn't experience statistically significant greater pain relief than the sham procedure patients.