Vertebroplasty was no better than sham procedures in a randomized trial. In previous trials, vertebroplasty for pain relief has not outperformed sham procedures in patients with acute osteoporotic compression fractures (e.g., NEJM JW Gen Med Sep 1 2009 and N Engl J Med2009; 361:569 and 557). To address some methodological limitations in these trials, investigators conducted a randomized, double-blind, sham-controlled trial using stricter inclusion and exclusion criteria, longer follow-up, and no crossovers. The study cohort involved 180 participants (age, ≥50) with one to three acute vertebral compression fractures, T5–L5 focal back pain at the level of fracture for as long as 6 weeks, pain scores of ≥5 (on a 10-point scale), and osteoporosis. Both vertebroplasty and sham groups received local anesthetic infiltration at each pedicle. Cement injections were given to the vertebroplasty group and were simulated in the sham group. In both groups, mean reductions in pain scores were clinically significant (i.e., mean decrease of ≥1.5 points) at all follow-up times, ranging from 1 day to 1 year. However, no statistically significant differences in pain scores were found between the vertebroplasty and sham groups at any follow-up time. Likewise, investigators found no differences between groups for quality-of-life and disability outcomes. |
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These negative results are unsurprising, as pain often subsides naturally within a few weeks, and placebo effects of invasive procedures can be substantial. However, an editorialist notes that we still don’t know whether improving or preventing progression of kyphosis with vertebroplasty is associated with improved quality of life and disability. Finally, these results do not apply to patients with multiple myeloma or vertebral metastases.