Study Questions Popular Spinal Fracture Treatment

Recently, while casually listening to National Public Radio, I heard a familiar name: Dr. James Weinstein.

“Hey, that’s  Shelsey’s dad,” I thought. A former neighbor of ours, his daughter and my son caught the same elementary school bus, and I knew Jim casually – as a “back doctor.”

As it turns out, Dr. Weinstein is director of the Dartmouth Institute for Health Policy and Clinical Practice. And he was commenting on NPR about vertebroplasty, an increasingly popular treatment for the debilitating, painful spinal fractures experienced by a number of osteoporosis sufferers.

A relatively new procedure, vertebroplasty injects acrylic cement into spinal bones, filling in cracks that develop as a result of osteoporosis. The injection has given relief to hundreds of thousands of osteoporosis patients, many of whom report their pain easing immediately after the injection.

One problem: Recently released studies, detailed in the August issue of the New England Journal of Medicine, report that patients who think they’re receiving vertebroplasty, but receive a placebo instead, show just as much improvement as patients who receive the actual treatment.

In other words, vertebroplasty works because the patient is convinced it will – not because it actually cures anything.

How did this kind of serious treatment make its way through the necessary clinical trials without being able to prove benefit compared to a placebo?

Turns out it didn’t. Vertebroplasty became available to osteoporosis patients in the 1990s, and results were so immediately positive that randomized clinical trials – where one group of patients receives the actual treatment, and a second a “sham treatment,” or placebo – were never conducted.

Until last year. Dr. David F Kallmes, a radiologist at the Mayo Clinic, helped develop vertebroplasty, and has been performing the procedure for 15 years. He’s also lead author of one of the new studies. Dr. Kallmes, in a recent New York Times interview, said he’s “shocked at the results” of the trial he led.

“I’m going to be the most reviled radiologist on the planet,” he noted, referring to the possibility that once vertebroplasty’s efficacy is called into question, insurance companies and Medicare may decide to drop coverage.

A relatively pricey treatment, vertebroplasty can cost upwards of $3,000, not including the approximately $1,000-$2000 for preliminary diagnostic work. About 73,000 Americans received the treatment last year, representing over $300 million health-care dollars.

Spent on what appears to be a sham.

But is scientific evidence going to discourage pain sufferers from seeking what seems to be a very effective treatment? Not likely. Especially if insurance still covers it.

Dr. Kallmes is presently conducting a follow-up study to determine if the local anesthetic given to patients receiving vertebroplasty provides some relief in and of itself. He says it’s also a possibility that with time, patients will heal naturally and feel relief, regardless of whether they receive treatment. In the meantime, he says he’s not ready to give up on the treatment.