Percutaneous vertebroplasty for acute osteoporotic vertebral compression fractures may not provide analgesic benefits superior to a sham procedure, according to a report published in The British Medical Journal.
For this multicenter double-blind study (Clinicaltrials.gov identifier: NCT01200277), patients ≥50 years of age with 1 to 3 fractures and focal back pain rated ≥5 on a 0 to 10 visual analog scale (VAS) were randomly assigned to receive vertebroplasty (n=90; mean age, 74.7 years; 74% women) or a simulated sham operation (n=86; mean age, 76.9 years; 77% women). Mean reduction in pain intensity at time points ranging from 1 day to 12 months after intervention was the study’s primary outcome (with a ≥1.5 reduction on the VAS considered clinically significant). Changes in quality of life and disability (assessed with the Rolland-Morris questionnaire) were secondary outcomes. Both procedures involved intrapedicle injections of lidocaine and bupivacaine. Patients receiving vertebroplasty were also injected with polymethylmethacrylate.
Patients in both groups experienced significant improvements in pain levels at all time points compared with baseline, but no intergroup differences were reported at any time point of the 12-month study. Between-group mean VAS differences ranged from -0.43 (at the 1-day follow-up) to 0.45 (12 months), with a mean VAS difference of 0.13 (95% CI, -0.41 to 0.66; P =.48) between baseline and 1 year.
Secondary outcomes (quality of life and disability) were also comparable in patients receiving vertebroplasty or a sham procedure, even after adjusting for opioid intake.
Analgesic use was reduced in both groups at all assessment points, with no difference between the vertebroplasty and sham groups at any time point. Two adverse events (respiratory insufficiency and a vasovagal response) were reported by patients who received vertebroplasty.
Study limitations included lack of a conservative management control group, not accounting for patients’ other medical treatments, and possible selection bias.
“These results suggest that factors aside from instillation of polymethylmethacrylate might have accounted for the observed clinical improvement after vertebroplasty; for example, the effect of local anaesthesia, expectations of pain relief (placebo effect), natural healing of the fracture, and regression to the mean,” concluded the study authors.
Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018;361:k1551.