Spinal Fusions Ineffective for Fracture Pain, Says ASBMR

Marlene Busko

January 25, 2019

"Routine use of vertebral augmentation for pain relief after vertebral fracture is not supported by current data," a new report commissioned by the American Society for Bone and Mineral Research (ASBMR) concludes.

The report, with lead author Peter R. Ebeling, MBBS, Monash University, Clayton, Australia, was published online January 24 in the Journal of Bone and Mineral Research.

The most common vertebral augmentation procedures are percutaneous vertebroplasty (where a medical-grade cement is injected to fuse the bone) and balloon kyphoplasty (where a balloon is used to lift the compressed area of the spine before cement is inserted). 

Although vertebral augmentation procedures are part of standard care for patients with painful spine fractures caused by osteoporosis, these procedures were introduced into practice before there was any high-quality evidence to establish their efficacy and safety, the authors write.

The review found that vertebroplasty did not provide significantly better pain control than placebo in five randomized placebo-controlled trials. 

Meanwhile, there was weak evidence of benefit of kyphoplasty in one clinical trial of this procedure versus nonsurgical management, which had no placebo arm.

In an accompanying editorial, ASBMR President Bart L. Clarke, MD, and Sundeep Khosla, MD, both from the Mayo Clinic College of Medicine, Rochester, Minnesota, write, "for those unfortunate patients who have suffered a vertebral fracture, the message of the Task Force is clear: vertebroplasty does not work to relieve pain from the fracture, and kyphoplasty should generally only be done in the context of a placebo-controlled clinical trial."

"When [vertebral augmentation] is offered, patients should be fully informed about the evidence," Ebeling and colleagues stress.

Meanwhile, they stress it is imperative in patients with recent vertebral fracture that anti-osteoporotic medications are started, continued, or changed (in the case of treatment failure).

Painful Fractures Improve With Time, Procedures No Magic Bullet

There are approximately 750,000 new vertebral compression fractures in patients with osteoporosis each year in the United States, and about a third of the patients have acute and chronic back pain, Ebeling and colleagues write.

The pain generally diminishes over time but can last months, Clarke and Khosla note.

"An estimated 81,690 patients underwent vertebroplasty and 169,413 patients underwent kyphoplasty in the United States between 2006 and 2014," despite an absence of any clear evidence for efficacy and potential safety concerns.

Thus, the ASBMR was charged with the task force to investigate this. The new report builds on a related report about kyphoplasty published in 2017.

"The message for doctors and their patients suffering from painful spinal fractures is that procedures to stabilize spinal fractures should not be a first choice for treatment," Ebeling said in a statement by the ASBMR.

"While patients who had these surgeries may have had a short-term reduction in pain, we found that there was no significant benefit over the long-term in improving pain, back-related disability, and quality of life when compared with those who did not have the procedures."

"This is a painful condition," he added, "that for most people spontaneously gets better with time and can be managed with analgesic medications over the short-term."

Similarly, Clarke said that they do not usually perform vertebral augmentation before 4 to 6 weeks at his center because "we've seen that with analgesics and other pain relief, our patients often get better within about 6 weeks."

"This report makes it clear that these procedures are not a magic bullet," he added, and it provides recommendations to guide physicians.

Potential harms from vertebroplasty and balloon kyphoplasty, the authors report, include cement leakage, adjacent fractures, and more serious adverse events.

It's also not clear from the evidence whether these procedures increase the risk of vertebral fractures or related serious adverse events.

Ensure Patients Are Receiving Osteoporosis Medication

Although the authors were only mandated to investigate "the efficacy and safety of vertebral augmentation and other nonpharmacological approaches to treat pain after vertebral fractures," in the review, they also briefly mention the importance of pharmaceuticals for osteoporosis for secondary prevention of fractures.

"It is critical that anti-osteoporotic medications are started, continued, or changed (in the case of treatment failure) in patients with recent vertebral fracture," they write, "since data from several randomized controlled trials indicate anti-osteoporosis medications reduce the risk of subsequent vertebral fractures by 40% to 70%."

"Even accomplishing this minimal goal at a time when many (or most) patients who clearly warrant pharmacological therapy are not receiving it would be a significant public health victory," the editorialists add.

The review also found there was no evidence that spinal bracing reduced pain immediately after vertebral fracture, although low-quality evidence suggested that wearing a brace for 2 hours a day over 6 months might help.

And there was evidence that exercise may improve mobility and reduce pain and fear of falling.

"Bracing and exercise, which are relatively safe and inexpensive, may provide some limited benefit," the editorialists write.

Clarke has served on a scientific advisory board and received research grants from Shire and has served on data monitoring committees for Amgen and Bristol-Myers Squibb. Khosla currently serves on scientific advisory boards for Bone Therapeutics, Active Life Scientific, and Surrozen.

J Bone Miner Res. Published online January 24, 2019. Full text, Editorial

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