TUESDAY, Aug. 10 (HealthDay News) -- After studies last year
found that a type of surgery called vertebroplasty was no better
than a sham procedure in treating painful compression fractures, a
new study now suggests the therapy can, in fact, ease some
patients' pain.
In this (typically) outpatient procedure, doctors inject a type
of stabilizing cement into the affected part of the spine.
For some people with weak bones who fracture the small bones in
their spine -- an injury called an acute osteoporotic vertebral
compression fracture -- vertebroplasty can be a safe and effective
treatment, Dutch researchers conclude in the Aug. 10 online edition
of
The Lancet.
The study was funded in part by Cook Medical, which makes
material used in vertebroplasty.
"Pain relief after the procedure is immediate, sustained for one year, and is significantly better than that achieved with conservative treatment and at acceptable costs," wrote a team led by Dr. Caroline Klazen, from St. Elisabeth Ziekenhuis in Tilburg, the Netherlands.
But other experts cast doubt on the findings, noting that for
most of the study participants, pain resolved on its own without
the need for surgery.
The new Dutch study involved 431 patients, aged 50 or older,
with osteoporotic vertebral compression fractures. The patients had
been in pain for six weeks or less. The researchers randomly
assigned them to receive vertebroplasty or conservative
treatment.
Conservative treatment included taking pain relievers, ice and
heat treatments, and later a stretching and back strengthen
program. In addition, a back brace may be called for, experts
say.
However, the researchers noted that more than half (53 percent)
of participants had their pain spontaneously disappear during the
assessment phase of the study.
Among the 202 remaining patients, the 101 treated with
vertebroplasty had greater pain relief after a month and a year,
compared with those who underwent conservative treatment, Klazen's
group found.
But even among those who did not get vertebroplasty, 60 percent
achieved pain relief, leaving only 41 whose pain continued without
therapy.
There were no serious side effects or complications from
vertebroplasty, the researchers stated.
One important drawback to the study was that patients and
doctors knew who received which therapy, Klazen's team noted. That
could have affected patient responses and the radiologists'
assessments, they noted.
Not everyone was convinced by the study findings.
The fact that many people saw their pain clear up on their own,
without the surgical intervention, "confirms that we have been
managing patients appropriately for all these years -- by waiting
six weeks [before treatment]," said Dr. David F. Kallmes a
professor of radiology at the Mayo Clinic. He was not involved in
the study.
Kallmes helped conduct one of the studies published in 2009 in
the
New England Journal of Medicine that found the surgery was no
better than a "sham" procedure in treating compression fracture
pain.
Kallmes noted that of the 431 patients selected for the study,
more than 50 percent improved
without treatment. "And among the 100 who didn't get treated
[with vertebroplasty], 60 percent of those achieved relief at one
month. That means that almost 90 percent of the 330 patients who
didn't receive cement achieved a good outcome without cement," he
said.
If those patients who would not improve without treatment could
be identified, that "would be great," Kallmes said. "But we still
are unable to" spot those patients, he added, so it's difficult to
predict which patients would gain from the surgical technique.
Compared to standard therapy, cost could become a factor, as
well. Although the researchers call vertebroplasty's price tag
"acceptable," total costs can run about $5,000 including the cost
of an MRI scan, Kallmes said.
Another expert, Dr. Eugene J. Carragee, a professor of
orthopedic surgery and chief of the spine surgery center at
Stanford University, is also not a fan of vertebroplasty for most
patients.
"None of the controlled trials, including this one, have even remotely confirmed the 80 to 90 percent rate of complete and immediate pain relief described in original reports of this procedure," he noted.
In fact, about 60 to 70 percent of the effect seen in the
vertebroplasty group was also seen in the control group, Carragee
said. "This strongly suggests that most of the improvement in the
vertebroplasty group was not due to the procedure alone," he
pointed out.
"The vertebroplasty treatment effect probably includes some direct effect and some placebo effect. But it is unlikely that all of the apparent treatment effect is placebo," Carragee added.
More information
For more information on compression fractures of the back, visit
the
U.S. National Library of Medicine.