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"Current evidence does not support the use of spinal augmentation to relieve pain after vertebral fracture," concludes a new report commissioned by the American Society for Research on Bone and Minerals (ASBMR) ).
The report, with lead author Peter R. Ebeling, MBBS, Monash University, Clayton, Australia, was published online Jan. 24 Journal of Bone and Mineral Research.
The most common vertebral augmentation procedures are percutaneous vertebroplasty (where medical grade cement is injected to melt bone) and balloon kyphoplasty (where a balloon is used to lift the compressed area of the spine prior to insertion of cement).
Although spinal augmentation procedures are part of the standard care of patients with painful spinal fractures caused by osteoporosis, these procedures were introduced into practice before high-quality evidence allowing for Establish their effectiveness and their security are not available, write the authors.
The review showed that vertebroplasty did not allow pain control significantly better than placebo in five randomized placebo-controlled trials.
During this time, there was little evidence of benefit from kyphoplasty in a clinical trial of this procedure compared to nonsurgical management, which did not involve a placebo group.
In an editorial, ASBMR President Bart L. Clarke and Dr. Sundeep Khosla, both of the Mayo Clinic College of Medicine in Rochester, Minnesota, write "for unfortunate patients who have suffered a fracture Vertebral, the workgroup's message is clear: Vertebroplasty does not relieve fracture-related pain and kyphoplasty should generally be performed only in the context of a placebo-controlled clinical trial. "
"When [vertebral augmentation] is proposed, patients must be fully informed of the evidence, "stress Ebeling and his colleagues.
In the meantime, they stress that it is imperative that anti-osteoporotic drugs be started, continued or modified (in case of treatment failure) in patients with recent vertebral fracture.
Painful fractures improve over time, procedures without a quick fix
Every year in the United States, there are about 750,000 new vertebral compression fractures in patients with osteoporosis, and about one third of patients experience acute and chronic back pain, write Ebeling and colleagues.
The pain usually decreases with time but can last for months, note Clarke and Khosla.
"About 81,690 patients underwent vertebroplasty and 169,413 patients underwent kyphoplasty in the United States between 2006 and 2014", despite the lack of clear evidence of their efficacy and potential safety concerns .
Thus, the ASBMR was instructed with the working group to investigate this issue. The new report builds on a related report on kyphoplasty released in 2017.
"The message to doctors and their patients with painful vertebral fractures is that procedures to stabilize vertebral fractures should not be a first choice of treatment," Ebeling said in an ASBMR statement.
"Although patients who underwent these surgeries may have had a short-term pain reduction, we found that there was no significant long-term benefit in improving pain," he says. disability related to back and quality of life compared to those not procedures. "
"It's a painful disease," he added, "which, for most people, improves spontaneously over time and can be treated with short-term pain medication."
Similarly, Clarke stated that they usually did not perform spinal augmentation until 4-6 weeks in his center because "we found that with painkillers and d? other painkillers, our patients often recovered in less than 6 weeks. "
"This report makes it clear that these procedures are not a quick fix," he added, and provides recommendations to guide doctors.
The authors report that potential damage from vertebroplasty and balloon kyphoplasty include cement leaks, adjacent fractures, and more serious adverse events.
There is also no evidence that these procedures increase the risk of vertebral fractures or badociated serious adverse events.
Ensure that patients receive medications for osteoporosis
The authors were commissioned only to study the "efficacy and safety of vertebral augmentation and other non-pharmacological approaches to treat pain after vertebral fracture," but they also briefly mentioned the importance of the products. Pharmaceuticals for Osteoporosis for Secondary Prevention of Fractures
"It is essential that anti-osteoporotic drugs are started, continued or modified (if treatment fails) in patients with a recent vertebral fracture," they write, "because data from several randomized controlled trials indicate that anti-osteoporosis medications reduce the risk of subsequent vertebral fractures by 40% to 70% ".
"Even reaching this minimal goal at a time when many (or most) patients who clearly deserve pharmacological treatment would not receive it would be a major victory for public health," editorialists added.
The review also revealed that there is no evidence that the spinal splint reduces pain immediately following a vertebral fracture, although poor quality data suggest that wearing a corset for 2 hours day for 6 months could be helpful.
And it was proven that exercise could improve mobility and reduce pain and fear of falling.
"Preparations and exercises, which are relatively safe and inexpensive, can provide limited benefit," the editorialists write.
Clarke has served on a scientific advisory board and has received research grants from Shire as well as data oversight committees for Amgen and Bristol-Myers Squibb. Khosla currently sits on scientific advisory committees for Bone Therapeutics, Active Life Scientific and Surrozen.
J Bone Miner Res. Posted online 24 January 2019. Full text, Editorial
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