Poster Presentation Sydney Spinal Symposium 2026

SAGE (safer analgesia): a protocol for a pragmatic cluster randomised controlled trial to reduce the use of high-risk medicines in people with chronic back and/or neck pain (#109)

Christina Abdel Shaheed 1 2 , Andrew J McLachlan 3 , Stephanie Mathieson 1 3 , Rowena Ivers 4 , Philip Clare 5 6 , Fiona Blyth 1 , Fiona Stanaway 1 , Louisa Degenhardt 6 , Danijela Gnjidic 3 , Simon French 7 , Rachel Thompson 8 , Sarah Hilmer 9 , Marina Pinheiro 1 2 , Gustavo Machado 1 2 , Timothy Austin 10 , Tania Gardner 8 , Sweekriti Sharma 1 2 , Alexandra Bennett 11 , Monika Boogs 12 , Jarrod McMaugh 13 , Lisa Vizza 1 2 , Aron Downie 7 , Marguerite Tracy 14 15 , Ria Hopkins 6 , Rawa Osman 16 , Richard I Lindley 17 , Chris Hayes 18 , Kirsten McCaffery 1 15 , Christopher Maher 1 2
  1. Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
  2. Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, New South Wales, Australia
  3. Sydney School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia
  4. Graduate School of Medicine, University of Wollongong, Wollongong, New South Wales, Australia
  5. Prevention Research Collaboration, The University of Sydney, Sydney, New South Wales, Australia
  6. National Drug & Alcohol Research Centre (NDARC), Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia
  7. Department of Chiropractic, Macquarie University,, Sydney, New South Wales, Australia
  8. Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
  9. Kolling Institute, Northern Sydney Local Health District and The University of Sydney, St. Leonards, New South Wales, Australia
  10. Pain Management Research Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
  11. New South Wales Therapeutic Advisory Group, Sydney, New South Wales, Australia
  12. Painaustralia Consumer Advisory Group, Canberra, Australian Capital Territory, Australia
  13. Pharmaceutical Society of Australia, Canberra, Australian Capital Territory, Australia
  14. General Practice Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
  15. Sydney Health Literacy Lab, School of Public Health, University of Sydney, Sydney, New South Wales, Australia
  16. QUM Connect, Sydney, New South Wales, Australia
  17. Westmead Applied Research Centre, The University of Sydney, Sydney, New South Wales, Australia
  18. College of Health, Medicine, and Wellbeing, University of Newcastle, , Newcastle, NSW, Australia

Introduction Chronic back and neck pain are often treated with opioid medicines, gabapentinoids and benzodiazepines, despite their high-risk profile and potential limited efficacy. Deprescribing interventions tailored to individuals with complex, chronic back and/or neck pain are needed. This trial will evaluate the effect of the safer analgesia (SAGE) intervention (training of general practitioners (GPs) in deprescribing and support to deprescribe) on cessation and/or reduction of the target high-risk medicine (a benzodiazepine, gabapentinoid or opioid) for people with chronic back and/or neck pain.

Methods SAGE (ACTRN12625000953437) is a pragmatic cluster randomised trial that will be conducted with ≥ 30 general practices in Australia randomly assigned in a 1:1 ratio to the SAGE intervention or no intervention (usual care control group). The SAGE care-model is a GP-facing intervention comprising (i) training for GPs in deprescribing and access to deprescribing resources and (ii) deprescribing support—to assist the deprescribing process for their patients, GPs can conduct a long GP consultation (20–40-min duration), refer to trained physiotherapists for the provision of psychologically informed physiotherapy sessions and provide alternate pain management options including heat wrap and diclofenac gel. A total of 320 adult patient-participants experiencing chronic back and/or neck pain (≥ 3 months duration) prescribed a target high-risk medicine (benzodiazepine, gabapentinoid or opioid) persistently for this pain will be recruited via participating general practices. The primary outcome is cessation of dispensation of the patient-participant’s high-risk medicine (a benzodiazepine, gabapentinoid or opioid) prescribed by their trial GP at 1 year with an observation window of the preceding 4 weeks. Secondary outcomes include self-reported outcomes such as pain, quality of life and adverse events. Analyses will follow an intention-to-treat approach with a nested economic evaluation and per-protocol analysis planned separately.

Conclusion If successful, SAGE has the potential to transform the management of chronic back and neck pain.