Is Vertebroplasty a Sham Procedure? Our Experts Weigh In
For this story, I am going to give you the punch line right up front — you can’t believe everything you hear, even when it’s reported in the most reputable of medical journals! A treatment called vertebroplasty can be a godsend for people with severe pain from a spinal compression fracture… despite reports in The New England Journal of Medicine saying that it is no more effective than a sham treatment. With medical research, details matter — in this case, they made all the difference. At least that’s what I — and a few highly respected physicians I spoke with — thought. I’ll share the story and let you decide for yourself.
The NEJM reports caught my eye because I’ve personally heard from several patients (back in my previous job as a medical reporter) that vertebroplasty really works — it can deliver fast, effective and lasting relief from the agonizing pain of spinal compression fracture. When I saw this new research disputing the validity of a treatment that both patients and doctors say makes a dramatic difference, I decided to investigate.
Cement in the Spine
Vertebroplasty is quite straightforward. It’s an outpatient procedure, performed under local anesthesia with optional sedation. Using imaging guidance, a radiologist places a needle into the spinal fracture, injecting bone cement that quickly hardens and stabilizes the fracture. Wade Wong, DO, a neuroradiologist with the department of radiology at the University of California, San Diego, School of Medicine, told me that “it’s like a permanent cast — but it’s on the inside of the body instead of the outside,” and described its potential for pain relief as “pretty dramatic.”
Developed in the early 1990s, vertebroplasty is growing more popular over time, not less. A wide body of research demonstrates success rates in the 90% to 95% range, and for a host of reasons it’s better than the other treatment alternatives, which include bracing (which restricts movement)… narcotics (which just mask the pain)… and bed rest (which results in even more bone loss in patients already suffering from brittle bones).
About That Research…
Critics have claimed that the research supporting the efficacy of vertebroplasty didn’t meet the scientific gold standard — randomized, blind studies where patients wouldn’t know if they received the real treatment or not. So that’s what this new set of studies set out to do — they were randomized and double-blind, comparing vertebroplasty with sham treatment. The surprising — and controversial — results, published in NEJM last year, said that the two were equally effective.
Study details:The studies were set up so that all patients went through the same pre-op preparation. Those receiving the sham treatment even had needles inserted near their spines, though they didn’t actually puncture the bone surface. After one week, as well as one, three and six months later, pain relief was about the same for both patient groups — the ones who got the real vertebroplasty and those who received the fake treatment.
Study Was Poorly Designed
But it’s the opinion of Dr. Wong, as well as our own medical experts — consulting editors Andrew L. Rubman, ND, and Richard O’Brien, MD — that this widely reported research had serious flaws.
The most egregious of these is that researchers recruited for the study patients whose fractures were likely already healed. Fractures up to 12 months old were accepted in the study, noted Dr. O’Brien, calling this the study’s “fatal flaw.” “Whatever healing your bone will do has already taken place within about three months,” he explained, adding that “treating such fractures with vertebroplasty at 12 months is the precise equivalent of splinting your finger a year after you broke it — it’s nonsense.”
The research had other deficiencies as well, the doctors said, including the following —
- Possible selection bias. One-third of the recruited patients declined to participate, so it seems likely that those who did choose to enroll would heal even without treatment. Why? Because if you are in terrible pain, you’re unlikely to be interested in being in a study where your likelihood of getting the “real” treatment is just 50%.
- Everyone got pain relief. Everyone in the study was given a strong local anesthetic that itself offered significant pain relief. This sets up a situation where people feel better quickly, creating a bias toward a positive experience on the part of the patients in the study.
- Mail-in results. Follow-up to the study wasn’t done in person but via mailed questionnaire, which Dr. Wong feels is not as accurate as in-person diagnoses.
What it All Means
It’s also worth noting that a key concern guiding this research was whether Medicare and insurers should pay for vertebroplasty, which costs about $3,000. This is a legitimate question, of course, but in the opinions of these doctors, these studies didn’t answer it persuasively.
Far more convincing is the real-life experience of doctors and patients who’ve had vertebroplasty and say that it works. Dr. Wong told me that his patients and their families are convinced that vertebroplasty delivers positive results and would want a repeat procedure if another vertebral compression fracture were to occur. Not only that, he said, they’ve told him that they would readily recommend the procedure to a friend in similar circumstances. In his view — and that of many other doctors — those are the most significant results. Don’t rule out vertebroplasty on the basis of this flawed research — it may or may not be the right procedure for you, but if your doctor suggests it, it’s worth considering.