Two studies released today in the New England Journal of Medicine claim to demonstrate that vertebroplasty, a procedure to treat some painful spine fractures, is not effective. This is incorrect, as both studies actually demonstrate a significant improvement in patients' pain and ability to function normally.
Tory McJunkin, MD, co-founder of Arizona Pain Specialists, has a personal connection because his grandmother recently had the procedure performed with a life-changing, pain-relieving outcome. Dr. McJunkin explains that “Clinical data show that this procedure relieves pain and improves patients' quality of life. I have seen amazing results from vertebroplasty in my practice and for my grandmother.”
Allen Burton, MD, Professor of Anesthesiology at MD Anderson in Houston, one of the foremost experts on vertebroplasty, stated, “The conclusion that vertebroplasty does not help back pain is completely wrong. If you look closely at the study design, what they are calling a placebo is actually a facet injection.”
“These studies actually show that both treatments are effective,” said Paul Lynch, MD, co-founder of Arizona Pain Specialists. “The studies did not use a true control group condition, where patients would receive no treatment. The 'control' patients actually received a different effective treatment and both groups demonstrated highly clinically significant reductions in pain. This demonstrates that vertebroplasty is an effective procedure, although facet injections are also effective.”
Pain is often measured on a 0 to 10 scale, with higher numbers indicating greater pain. The studies demonstrate that patients who received the vertebroplasty procedure had reductions in pain of 2.3 and 3.0 points in the two studies, compared to reductions of 1.7 and 2.6 for the facet injection procedure.
Dr. McJunkin said, “Note that patients who received the vertebroplasty procedure had greater reductions in pain, although this was not a statistically significant difference.”
To demonstrate statistical differences between groups requires that the study have enough patients for the statistics to have sufficient power to detect the differences. Both studies reported that they were unable to enroll enough patients to have reasonable statistical power. One study noted that they needed 250 patients but only enrolled 131. “The trends in the data demonstrate that if the studies had enough patients, the group receiving vertebroplasty would have had significantly better pain reduction than the other treatment groups,” noted Dr. Lynch.
Several large studies have examined and concluded the clinical benefit and efficacy of vertebroplasty for painful vertebral compression fractures. In 2006, Spine Journal released a systematic review of all available data showing 87% relief of pain with vertebroplasty. A 2007 study in the American Journal of Neuroradiology concluded that “Percutaneous Vertebroplasty is a safe & effective method to treat VCF. An immediate improvement in pain is expected for most patients, and disability, mobility, and pain medication use are improved during the short- and long-term periods.”
Dr. Lynch agrees with this overall assessment. “Vertebroplasty is only one of several effective treatments, but for some patients it is the best option. These studies, like most studies, have several problems. It would be inappropriate for us to conclude that vertebroplasty is ineffective, as some reports have stated,” he concludes.
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