Researchers at St Elisabeth Ziekenhuis (Tilburg, The Netherlands) and University Medical Center Utrecht (The Netherlands) conducted a randomized trial that recruited 431 patients from the radiology departments of six hospitals in the Netherlands and Belgium, between Oct 1, 2005, and June 30, 2008. The patients were aged 50 years or older, had vertebral compression fractures evident on spine radiographs, and had experienced back pain for six weeks or less with a visual analogue scale (VAS) score of five or more. The primary outcome was pain relief at one month and one year, as measured by VAS score. Clinically significant pain relief was defined as a decrease in VAS score from baseline of three points or more; pain-free days were defined as days with a VAS score of three or lower.

The results showed that 229 (53%) of the patients had spontaneous pain relief during assessment; the other 202 patients with persistent pain were randomly and equally allocated to treatment (101 to vertebroplasty and 101 to conservative treatment). The researchers found that vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and one month was -5.2 after vertebroplasty and -2.7 after conservative treatment, and between baseline and one year was -5.7 after vertebroplasty and -3.7 after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2.6 at one month and 2.0 at one year. No serious complications or adverse events were reported. The study was published ahead of print on August 9, 2010, in the Lancet.

"In a selected subgroup of patients with acute osteoporotic vertebral fractures and persistent pain, vertebroplasty is effective and safe,” concluded lead author Caroline Klazen M.D., and colleagues. "Pain relief after the procedure is immediate, sustained for one year, and is significantly better than that achieved with conservative treatment and at acceptable costs.”

The "vertebroplasty controversy” erupted after two studies that tested vertebroplasty against a placebo were published in the New England Journal of Medicine (NEJM) in August 2009. Many experts were stunned by the results that suggested that patients got the same modest pain relief whether they received vertebroplasty or a dummy injection.

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St Elisabeth Ziekenhuis
University Medical Center Utrecht