Vertebral fractures are breaks in one or more spinal bones. Often caused by osteoporosis, they are most prevalent in elderly people and can create a lot of back pain. There are two types of surgeries that can be given to address spinal fractures: Vertebroplasty and kyphoplasty. The surgeries are related in that cement is injected to stabilize the bone and reduce pain. Also, both are minimally invasive procedures.
Two new studies found that vertebroplasty is not really effective for relieving back pain due to osteoporotic spinal fractures. The studies, similar to one another and published in the August 6, 2009 issue of the New England Journal of Medicine are the first randomized controlled trials to be done on the effectiveness of vertebroplasty.
One study looked at 71 people and the other, 131 people. Half the participants were given a vertebroplasty (an injection of bone cement into the fractured area), and the other half were given a shot of a temporary pain reliever, a fake vertebroplasty, if you will. Participants then filled out questionnaires designed to assess their level of pain, as well as their ability to carry on with their usual activities. In both studies, the pain relief obtained was about the same for all patients. In other words, it didn't seem to matter whether the patient had the real vertebroplasty or the harmless injection - the outcome was about the same.
With the health care debate raging, this discovery provides an excellent example of how money can be wasted with needless medical procedures. This is, of course, provided that the study findings are valid. Although the studies were well designed (both were randomized, blinded trials), they were small. It's possible the results may not truly represent how well vertebroplasty reduces back pain in the entire population of people with painful osteoporotic spinal fractures. In an editorial in the current issue of The New England Journal of Medicine, Dr. James N. Weinstein estimates there are approximately 1.4 million persons worldwide who suffer from spinal fractures, with about 750,000 in the US. He also says that approximately 1/3 receive vertebroplasty. So 200 study participants seem like a drop in the bucket when compared to the number of vertebroplasties that are given. Just the same, I agree with President Obama - why spend money on medical procedures that are not doing the job of, in this case, relieving back pain?
Like many types of back surgeries, the use of vertebroplasties are on the rise. Weinstein says the number of procedures given have doubled in the last 6 years. He also estimates that in 2002, the cost of treating osteoporotic spinal fractures was, collectively, between 12 and 18 billion dollars. The two studies published this week in the New England Journal of Medicine are comparative effectivness studies, the type now called for by the President. Comparative effectiveness studies are those that evaluate the outcome of the various treatment options for a given condition.
Relief for back pain is elusive at best. For the most part, there is little correlation between the diagnostic and treatment options given by doctors and substantial pain relief for patients. Only recently has the medical profession chosen to address the hodgepodge of possibilities for relieving back pain by organizing research backed guidelines doctors can follow. Keep in mind, though, that not all back pain treatments have been fully studied at this time.
James N. Weinstein, D.O., M.S. Balancing Science and Informed Choice in Decisions about Vertebroplasty. New England Journal of Medicine. August 6, 2009.
Rachelle Buchbinder, Ph.D., et al. A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures. < i>New England Journal of Medicine. August 6, 2009.
David F. Kallmes, M.D., et al. A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. < i>New England Journal of Medicine. August 6, 2009.