Vertebroplasty Studies Skewed, Arizona Pain Specialists Contend
Vertebroplasty Studies Skewed, studies actually show vertebroplasty effective at reducing pain
SCOTTSDALE, AZ) – 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. Both studies actually demonstrate a significant improvement in patients’ pain and ability to function normally.
Tory McJunkin, MD, co-founder of Arizona Pain Specialists, recently performed the procedure on his own grandmother, with a life-changing, pain-relieving outcome. “Clinical data,” Dr. McJunkin explains, “shows 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.”
“The conclusion that vertebroplasty does not help back pain is completely wrong,” states Allen Burton, MD, Professor of Anesthesiology at MD Anderson in Houstona foremost expert on vertebroplasty.”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 vertebroplasties 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.
“Patients who received the vertebroplasty procedure had greater reductions in pain, although this was not a statistically significant difference.”
Dr. McJunkin points out that, “although not a statistically significant difference, patients who received vertebroplasties had greater reductions in pain.”
Demonstrating a statistically significant difference between groups requires a study to have enough patients to consistently detect an actual difference. 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,” notes Dr. Lynch, “the group receiving vertebroplasties would have had significantly better pain reduction than the other treatment groups.”
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 vertebral compression fractures. 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,” he cautions, “for us to conclude that vertebroplasty is ineffective, as some reports have stated.”
Arizona Pain Specialists was co-founded by Dr. Paul Lynch and Dr. Tory McJunkin in Scottsdale, AZ. The clinic utilizes a comprehensive model including cutting-edge interventional pain treatments, chiropractic, biofeedback, relaxation therapy and features on-site physio-rehab, an open MRI, procedure center and research department. The clinic’s website, www.ArizonaPain.com hosts an online textbook resource and receives more than 35,000 views a month.