This cluster trial will compare two ways of prescribing analgesia, including opioids, for patients with low back pain. The first offers patients pain relief options such as heat wrap in addition to opioids, and the second is usual care.
Patients with low back pain will be eligible when the study GP considers it appropriate to prescribe an opioid medicine for back pain at the study visit.
Our team hope to recruit 410 patient-participants (205 per arm) from at least 40 participating general practices in urban, and regional/remote/very remote locations across NSW.
The study team will be in regular contact with study GPs throughout the trial to provide support, discuss trial progress, conduct refresher training and any follow-up questionnaires.
Geographic location the project wishes to recruit from:
New South Wales. Noting if targets are not met within NSW, recruitment may be extended nationally.
Principal investigator:
Dr Christina Abdel Shaheed
Co- investigators:
Professor Chris Maher
A/Professor Rowena Ivers (GP)
Professor Andrew McLachlan
Professor Fiona Blyth
Professor Louisa Degenhardt
Dr Thomas Lung
Associate Professor Patrick Kelly
A/Professor Fiona Stanaway
Dr Rachel Thompson
Associate Investigators:
Dr Sharon Reid (GP)
Dr Michael Wright (GP)
Professor Bradley Martin
Rawa Osman
Carol Bennett
Jarrod McMaugh
Gabrielle Campbell
Professor Kirsten McCaffery
Dr Hazel Jenkins
Professor Simon French
Dr Stephanie Mathieson
Compensation offered:
- $100 per patient enrolled
- $30 for patient screening
- $100 for training visit
- $100 for interview (if assigned to intervention)
GP inclusion criteria:
- Consult with patients who have LBP.
- Has no prescribing restrictions, that is, eligible to prescribe an opioid analgesic (including schedule 8 opioid analgesics).
- Consent to researchers gaining access to their prescribing data.
GP exclusion criteria:
- Participating GPs at that practice has received an education visit by any organisation on judicious opioid prescribing in the previous 12 months.
*GP Clinics must have one practising GP registered with APHRA.
Patient inclusion criteria:
- Adults (≥18 years)
- Low back pain of any duration at the time of presentation
- Has been prescribed an opioid analgesic for LBP by the participating GP.
- Sufficient understanding of English to complete questionnaires, or translation available.
- Holds an Australian Medicare card number (for data linkage purposes).
- Willingness to give written informed consent to participate in the trial and grant researchers access to their Medicare/Pharmaceutical Benefits Scheme and other trial-related data.
Patient exclusion criteria:
- Children (<18 years)
- Engaged in an opioid tapering regimen at the time of enrolment into the study i.e., have already begun to reduce their opioid medicine within the past month
- Be actively treated for cancer or receiving palliative treatment.
Commencement date of the project:
April 2022
Closing date for recruitment:
March 2026
Time involvement:
GPs: Till recruitment target is met (12-15 patient-participants). If participating in an interview GPs will be followed up for up to 16 weeks after target is met.
Patient Participant: One year period.
Availability of CPD points:
Yet to be determined.
Contact details:
If you are interested in participating, please email the Project manager or Clinical Trials Assistant.
Lisa Vizza | Project Manager |
lisa.vizza@sydney.edu.au
Sarah Diprose | Clinical Trials Assistant |
sarah.diprose@sydney.edu.au
Rowena Ivers| Co-Investigator and General Practictioner|
rivers@uow.edu.au