COMFORT:
Clinical Observation Management and Function of Low Back Pain Relief Therapies
The COMFORT trial, also known as the Clinical Observation, Management, and Function Of low back pain Relief Therapies trial, is a significant initiative aimed at supporting general practitioners (GPs) in providing opioid stewardship for patients with low back pain. Low back pain affects 1 in 4 Australians and is a leading cause for opioid analgesic prescriptions globally. Despite evidence that opioids provide minimal or no benefit for low back pain and have an established profile of harms, they are still commonly prescribed.
​
The COMFORT trial will compare two ways of prescribing an opioid analgesic:
-
The traditional way, where GPs carefully prescribe the medicine as part of usual care.
-
An alternative approach, where patients are offered other pain relief options in addition to the opioid analgesic.
​
The trial aims to determine which method works best in managing low back pain while minimizing the risks associated with opioid use. The trial will evaluate a multifaceted intervention to support GPs and their patients in implementing the recommendations in the latest opioid prescribing guidelines. This includes educational outreach visits to GPs promoting opioid stewardship and non-pharmacological interventions such as heat wraps and patient education about the possible harms and benefits of opioids.
​
The trial will involve at least 40 general practices, with a total of 410 patient-participants who have been prescribed an opioid for low back pain. The primary outcome will be the cumulative dose of opioid dispensed over one year from the enrolment visit. Secondary outcomes include the prescription of other medications, health services utilization, and patient-reported outcomes such as pain, quality of life, and adverse events.
If successful, the COMFORT trial has the potential to transform care for people with low back pain globally by providing evidence-based strategies for opioid stewardship and improving patient outcomes.
Funding: National Health and Medical Research Council APP2000989 (2022-2026)
​
Lead Investigator: Dr Christina Abdel Shaheed
​
Chief Investigators: Prof Chris Maher, Prof Andrew McLachlan, A/Prof Rowena Ivers, Prof Louisa Degenhardt, A/Prof Patrick Kelly, A/Prof Fiona Blyth, Dr Thomas Lung, A/Prof Fiona Stanaway, A/Prof Rachel Thompson. Professional Staff: Lisa Vizza (Project Manager), Chantay Lenord (Clinical Trial Assistant), Sarah Diprose (Clinical Trial Assistant).
​
Further information:
