Those in the placebo arm went through the motions of surgery, including being brought into the procedure room and being sedated before surgeons put novocaine in the skin and over the bone, said study author Dr. David F. Kallmes, a professor of radiology at the Mayo Clinic in Rochester, Minn.
After one month, both groups had experienced a similar, and significant, reduction in pain.
"Like every other trial, patients with vertebroplasty gained substantial benefit. Pain was cut almost in half," Kallmes said. "To our shock and amazement, however, there was no difference in pain relief, function or quality of life between the groups."
The second study, done in Australia, used essentially the same methodology with 78 participants.
Again, there were significant and similar declines in pain and other measurements in both groups six months after surgery.
"We conclude that the procedure seems to work but not apparently because of the cement," Kallmes said.
It could be the placebo effect or something as simple as the effect of the novocaine on the bone, breaking the cycle of pain, he added. Kallmes is currently enrolling patients in a trial to see if novocaine on the bone gives the same benefit as vertebroplasty.
But even now, many physicians do not favor vertebroplasty as the first-line treatment.
"I think we should take the middle road," Kallmes said. "We should discuss with the patient in a completely informed manner what the options are, and I think we have options. I still counsel patients that they should try ongoing medical therapy but I don't think it's unethical to do the procedure at this point. I think it's suboptimal."
"I always try bracing and analgesics and physical therapy to try to get the patients to feel better without any intervention at all," Toussaint added. "But if those measures don't work, I still think it is an option."
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