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An invasive and potentially risky procedure used to stabilise the spinal cord after a vertebral fracture is ineffective in reducing back pain, a new Australian study has found.
Results were published in the New England Journal of Medicine yesterday.
Co-investigator on the study, Professor Peter Ebeling, Chair, University of Melbourne Department of Medicine, Western Hospital, says “the study reveals this widely used procedure to reduce back pain provides no relief at all.”
“In light of the new evidence, the use of this procedure needs to be reviewed,” he says.
Professor Ebeling, an expert on osteoporosis, initiated the collaboration with Professor Rachelle Buchbinder a back pain expert and epidemiologist from Monash University and Cabrini Hospital. University of Melbourne researchers Professor John Wark and Dr Peter Mitchell also contributed to the study.
In Australia the procedure is widely used and is currently reimbursed through Medicare.
“Until now however, there has been no blinded or placebo-controlled trial to test the procedure’s effectiveness, “says Professor Ebeling.
More than 70 participants took part in the randomized controlled trial. Half the participants received an injection of bone cement into the vertebra and half receiving an injection of anaesthetic to the same area.
Both groups were assessed for pain and quality of life at one week, and one, three and six months following the procedure. Using a questionnaire they were asked to rate the level of pain they experienced. Although both groups experienced a reduction in pain, there was no difference in the level of pain reduction between the two groups.
“Both groups of participants did experience a reduction in pain, which may be due to a strong placebo effect, the effect of the local anesthetic around the bone, or simply the fact that pain improves over time. However, the results of the study lead us to conclude that the invasive procedure is not effective,” says Professor Ebeling.
Patients will be followed up to monitor the long-term effects of the procedure and for any additional fractures.
The study has been supported by the Arthritis Foundation of Australia and The National Health and Medical Research Council.