Many of the hundreds of patients I see in my New York practice come in with similar expectations that treating back pain is straightforward and simple, especially when we know the cause is something like a vertebral compression fracture (VCF). Vertebral compression deformities and fractures can be caused by osteoporosis or by cancer, and affect an estimated 750,000 Americans each year.
The reality is that successfully treating even the most common kinds of back pain requires patients who are informed about treatment options and their efficacy, and that doctors exercise good judgment in working with patients to determine the best course of action from among dozens of options.
The need for transparency and collaboration between doctors and their patients was made clear at a recent conference of the American Society of Spine Radiology, where researchers presented two separate studies on vertebral augmentation, a minimally invasive procedure for treating VCFs in which a doctor injects medical cement into a fractured vertebra.
I was the first to perform vertebral augmentation in New York, and have performed thousands of them over the past 20 years. Of the hundreds of different procedures I perform on a routine basis, it’s the closest thing to a perfect procedure there is. The 20- to 30-minute process presents minimal risk, and provides virtually instant relief for patients experiencing extreme, debilitating pain.
While every doctor who performs the procedure swears by it, researchers continue to investigate is credibility. At the ASSR conference, lead researchers on teams from Australia and the Netherlands presented the latest research on vertebroplasty for the first time on U.S. soil.
The VAPOUR trial in Australia proved that vertebroplasty is effective in patients with severe pain and fractures of less than six weeks in duration. Subgroup analysis suggests that benefits are highest in the weight-bearing middle and lower segments of the spinal column .
This trial also showed a large benefit for admitted patients who are the most disabled and are the most at risk for complications from lying in bed. By treating this group of patients, they have a better chance of avoiding pulmonary embolism, DVT, and more bone loss.
The VERTOS IV trial in the Netherlands demonstrated augmentation preserves against additional fractures and more height being lost.
Neither of these studies is perfect. For starters, they compare a procedure doctors do perform — vertebral augmentation — with one no doctor performs in the real world. In the “sham” procedure used as a control, doctors inject a pain reliever called lidocaine into the painful area of the spine, but do nothing to stabilize the fracture. That’s like treating a broken arm with an injection of pain killers but without resetting the bone or putting a cast around it. That is not functional improvement!
But that doesn’t mean there aren’t lessons for doctors and patients to learn from this research. The biggest takeaway from these and other studies is that data like that found in VAPOUR and VERTOS IV should be used for proper informed consent for patients so they can understand the potential risks and benefits of their treatment options.
No single procedure is right for every patient, and doctors have a responsibility to choose the right procedure for each unique patient. Back pain is a complex beast, with many possible contributing factors. For patients with severe pain tied directly to a fracture, vertebral augmentation may be the best option. Not everyone gets better, but the research shows vertebral augmentation provides both short-term relief and long-term stability. For others with more contributing factors, the options become more complex.
Patients, too, have a responsibility to choose a doctor with experience and ask questions. What are the risks of the treatment plan you’re recommending? What are the benefits? Do patients with my symptoms have a good chance of getting better? If surgery is the best option, what kind of nutrition and rehab plan will help the healing process go faster?
What we should certainly not take away from the latest research is that vertebral augmentation is a bad option for everyone. Medical study in general is hardly ever about determining whether a procedure (or a drug) is good or bad. If a new treatment rises to the level of scientific investigation, it’s usually regarded as having some benefit. These investigations, then, are about helping doctors determine what kind of patients experience the most benefits, and which should be pursuing other options.
Too often, broad decisions are based on studies that were never intended to address every possible use case. In Australia, for example, vertebral augmentation is no longer covered by the government-run insurance system because of sloppy studies of small subsets of patients.
Studies that should have been used to determine which patients will be helped by vertebral augmentation have resulted in limiting access for all patients — even those for whom the procedure could bring life-changing healing.
The latest research isn’t the final word on vertebral augmentation, nor is it intended to be. But it does provide more data points for doctors and patients to consider in their quest for a return to full health, and points to the importance of transparency and collaboration in the doctor-patient relationship. Clearly stabilizing a painful fracture makes sense. Doing safely and in the proper conditions is what makes for the best outcomes.
Dr. Allan Brook is a neuroradiologist practicing in the Bronx, New York.
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