More than 80% of the population are plagued by back pain and according to the 2018 Lancet series, the majority of patients are receiving the wrong care – particularly the inappropriate over-prescription of opioids.
While we have good evidence on harms with opioid analgesics such as addiction, overdose, and death; we have no evidence on whether opioids are effective for a new episode of spinal pain
“The OPAL trial is a direct response to one of the main findings from The Lancet series: while we have good evidence on harms with opioid analgesics such as addiction, overdose, and death; we have no evidence on whether opioids are effective for a new episode of spinal pain.
"Given this background, OPAL is one of the most important trials in this field and the results are eagerly awaited by the back pain community,” says Professor Chris Maher, co-author of The Lancet series on back pain and OPAL trial Chief Investigator.
The OPAL trial looks to address this by providing practioners with evidence on the benefits and harms of opioids in patients with acute spinal pain. It differs from studies that “compare opioids against other pain medicines, which can tell you which medicine is superior but does not tell you whether the medicine should be used at all in the first place if there is no placebo-controlled evidence to support that,” according to Associate Professor Christine Lin, Lead Investigator of OPAL.
The trial, currently in participant recruitment phase, is a collaboration between the University of Sydney, UNSW and Erasmus University Medical Center (Netherlands).
The double-blind study is conducted by randomly allocating opioid medicine or placebo to participants for up to 6 weeks. Their pain level and other clinical outcomes will be assessed at regular intervals. Side effects and long term effects will also be assessed.
Interestingly, the OPAL trial made a recent discovery - although opioids are being heavily prescribed, some general practitioners (GPs) avoid prescribing opioids as a blanket rule. “This is not an ideal situation because there may be people for whom pain relief from opioids is justified and their right to pain relief is being denied,” Associate Professor Lin explains.
We will provide a definitive answer and rigorous evidence to inform patients whether opioids are beneficial.
“What the OPAL study will do is provide quality evidence to help doctors decide whether opioids should be used in acute spinal pain. We will provide a definitive answer and rigorous evidence to inform patients whether opioids are beneficial if they experience a new episode of spinal pain.”