By Bianca Nogrady
A sham-controlled, double-blind study of vertebroplasty for acute osteoporotic vertebral compression fractures has found the procedure did not achieve significantly greater pain relief than the sham procedure.
The study, published in the BMJ, enrolled 180 patients with up to three painful vertebral compression fractures, a Visual Analogue Scale (VAS) pain score of five or above for up to nine weeks, and reduced bone density. They were randomised either to vertebroplasty or a sham procedure involving an injection of local anaesthetic and two incisions on either side of the vertebral body followed by verbal and physical cues of surgery.
Pain scores over the following 12 months decreased significantly in both groups, with a mean reduction in VAS score of five in the vertebroplasty group and 4.75 in the sham group.
However, there were no significant differences in pain scores between the two groups at any measurement point. The same was seen for secondary endpoints of quality of life and physical functioning scores, new fracture rate or analgesic use, although there was a significantly greater reduction in strong opioid use in the vertebroplasty group.
About 80% of patients in both groups believed they had undergone vertebroplasty.
Associate Professor Paul Bird at UNSW Sydney and rheumatologist told Pain Management Today that there was a window of opportunity to provide benefit with vertebroplasty, and that window was less than six weeks.
‘It’s a good study but the mean duration is 43 days to treatment, so unfortunately they’re hitting right at the time where vertebroplasty is probably not going to work much better than placebo,’ he said.
Associate Professor Bird noted that the 2016 Vertebroplasty for Acute Painful Osteoporotic fractures (VAPOUR) trial, which he was involved with, found people with two weeks of symptoms had the greatest response to vertebroplasty.
BMJ 2018; 361: k1551.