Surgery to repair spinal fractures is no more effective for pain relief than a sham procedure in older patients with osteoporosis, according to researchers in the Netherlands and the US.
They said their results “do not support vertebroplasty as standard pain treatment in patients with osteoporotic vertebral fractures”.
“Percutaneous vertebroplasty did not result in statistically significant more pain relief than a sham”
Vertebroplasty involves injecting a cement into the fractured bone to stabilise it and to relieve pain. However, the researchers noted that previous studies had reported conflicting results and there was ongoing debate about its benefits, risks, and cost-effectiveness.
As a result, they compared pain relief in patients undergoing vertebroplasty or a sham procedure, where patients were given local anaesthetic injections, but no bone cement.
The trial involved 180 adults aged older than 50 years, with one to three painful vertebral compression fractures of up to nine weeks old. Participants were randomly assigned to either vertebroplasty or the sham procedure.
Researchers then measured mean reductions in pain scores at one day, one week, and one, three, six, and 12 months after the procedure. They also looked at differences in quality of life and disability over 12 months.
Pain was measured using a visual analogue scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Clinically significant pain relief was defined as a decrease of 1.5 points in VAS score from the start of the study.
The mean reduction in VAS pain score was statistically significant in both groups at all follow-up points after the procedure, compared with baseline, the researchers found.
However, they said the changes in VAS scores did not differ significantly between the groups over the 12- month follow-up period. In addition, vertebroplasty had no effect on quality of life or on disability, they said in the British Medical Journal.
They stated: “Percutaneous vertebroplasty to treat patients with acute osteoporotic vertebral compression fractures did not result in statistically significant more pain relief than a sham procedure during 12 months’ follow-up.”
“This trial suggests that vertebroplasty should not be offered to patients with fractures of less than six to nine weeks’ duration”
They noted there was a place for vertebroplasty “when efficacy outweighs the risks”. But, they said their results “do not support using percutaneous vertebroplasty as standard pain treatment in patients with acute osteoporotic vertebral compression fractures”.
Evan Davies, consultant spinal surgeon at Southampton General Hospital, said the trial suggested vertebroplasty “should not be offered to patients with three or fewer painful osteoporotic vertebral fractures of less than six to nine weeks’ duration”.
However, questions remained on its place in the management of chronic painful fractures, and, more specifically, whether cement augmentation had any role in the prevention of long term morbidity and mortality, he said in a linked editorial in the BMJ.
“This trial suggests that vertebroplasty should not be offered to patients with three or fewer painful osteoporotic vertebral fractures of less than six to nine weeks’ duration,” he added.