All of the patients in the experiment had compression fractures,
which can happen when osteoporosis makes bones less dense and more
brittle with age. Half of the participants had vertebroplasty, a
procedure that uses injected cement to harden and stabilize bones
and support the spine, and half of them got sham surgeries where
local anesthesia was injected, but no cement.
One year later, patients in both groups felt significantly less
pain, but those who had vertebroplasty didn't experience any more
pain reduction than people who had sham procedures, the study found.
"The majority of fractured spines heal spontaneously in the same way
as other bone fractures do and vertebroplasty doesn't improve this,"
said Dr. Evan Davies, author of an editorial accompanying the study
and a spine surgeon at the University Hospital Southampton in the
UK.
Vertebroplasty has been controversial for years because research to
date has offered a mixed picture of its safety and effectiveness.
Some studies found it improved pain relief, while others didn't, and
it has been linked to rare but serious side effects like paralysis
and potentially fatal blood clots in the lungs.
Compression fractures can be treated with other approaches,
including painkillers, bed rest or a back brace. Untreated, these
fractures can lead over time to deformities in the spine, mobility
restrictions, and diminished height and make it difficult for people
to sit, eat and sleep.
The current study involved 180 patients who were at least 50 years
old and complained of pain related to compression fractures that had
happened within the previous nine weeks.
They were randomly assigned to receive vertebroplasty or sham
procedures, and patients weren't told which group they joined. In
both groups, patients could hear and smell bone cement being mixed
in the operating room and feel needle incisions in their back when
anesthesia was administered.
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While both groups reported a meaningful reduction in pain, the
difference between them was too small to rule out the possibility
that it was due to chance.
With vertebroplasty, however, fewer patients had persistent pain or
secondary fractures during follow-up, said lead study author Dr.
Cristina Firanescu of Elisabeth-Tweesteden Hospital in Tilburg, The
Netherlands.
This suggests there might be a subset of patients who might
potentially benefit from vertebroplasty even if it's not an
effective early treatment for all patients with compression
fractures, Firanescu said by email.
One limitation of the study is that it lacked a control group of
patients who received non-surgical treatments like painkillers, back
braces or bed rest, researchers note in The BMJ.
Another drawback is that all of the patients had recent fractures,
making it unclear if results would be similar for people who had
chronic pain many months after fractures developed. It's also
possible that some patients in the study experienced chronic back
pain unrelated to compression fractures and caused instead by
damaged discs or other issues.
Still, the results suggest that patients should not consider
vertebroplasty for fractures that happened only a month or two ago,
Davies said by email.
"You don't need a vertebroplasty under nine weeks following onset of
pain, because for most people the pain just gets better," Davies
said. "If the pain doesn't improve and imaging suggests the fracture
hasn't healed then it may be appropriate."
SOURCE: https://bit.ly/2IYuYaZ and https://bit.ly/2skZ3aA The BMJ,
online May 9, 2018.
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