Poster Presentation Sydney Spinal Symposium 2025

Clinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised controlled trial protocol (#3)

Christina Abdel Shaheed 1 2 , Rowena Ivers 3 , Lisa Vizza 1 2 , Andrew McLachlan 4 , Fiona Blyth 1 , Fiona Stanaway 1 , Philip Clare 5 6 , Rachel Thompson 7 , Louisa Degenhardt 6 , Sharon Reid 8 , Bradley Martin 9 , Michael Wright 9 10 , Rawa Osman 11 , Simon French 12 , Kirsten McCaffery 1 13 , Gabrielle Campbell 14 , Hazel Jenkins 12 , Stephanie Mathieson 1 2 , Monika Boogs 15 , Jarrod McMaugh 16 , Carol Bennett 17 , Christopher Maher 1 2
  1. Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia
  2. Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, NSW, Australia
  3. Graduate School of Medicine, University of Wollongong, Sydney, New South Wales, Australia
  4. Faculty of Medicine and Health, Sydney Pharmacy School, University of Sydney, Sydney, NSW, Australia
  5. Prevention Research Collaboration, Sydney, New South Wales, Australia
  6. National Drug and Alcohol Research Centre (NDARC), Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
  7. Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
  8. Specialty of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
  9. Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Arkansas, United States of America
  10. Sydney Medical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
  11. Quality Use of Medicines (QUM) Connect, Sydney, New South Wales, Australia
  12. Department of Chiropractic, Macquarie University,, Sydney, New South Wales, Australia
  13. Sydney Health Literacy Lab, School of Public Health, University of Sydney, Sydney, New South Wales, Australia
  14. School of Psychology, University of Queensland, Brisbane, Queensland, Australia
  15. Painaustralia Consumer Advisory Group, Canberra, Australian Capital Territory, Australia
  16. Pharmaceutical Society of Australia, Canberra, Australian Capital Territory, Australia
  17. Australian Communications Consumer Action Network, Sydney, New South Wales, Australia

Aims: Low back pain (LBP) is commonly treated with opioid analgesics despite evidence that these medicines provide minimal or no benefit for LBP and have an established profile of harms. International guidelines discourage or urge caution with the use of opioids for back pain; however, doctors and patients lack practical strategies to help them implement the guidelines. This trial will evaluate a multifaceted intervention to support general practitioners (GPs) and their patients with LBP implement the recommendations in the latest opioid prescribing guidelines.

Methods and Analysis plan:  COMFORT [1] is a cluster randomised controlled trial (ACTRN12622001505796) that will evaluate the effect of educational outreach visits to GPs promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids, on GP prescribing of opioids medicines dispensed. At least 40 general practices will be randomised in a 1:1 ratio to either the intervention or control (no outreach visits; GP provides usual care). A total of 410 patient–participants (205 in each arm) who have been prescribed an opioid for LBP will be enrolled via participating general practices. Follow-up of patient–participants will occur over a 1-year period. The primary outcome will be the cumulative dose of opioid dispensed that was prescribed by study GPs over 1 year from the enrolment visit (in morphine milligram equivalent dose). Secondary outcomes include prescription of opioid medicines, benzodiazepines, gabapentinoids, non-steroidal anti-inflammatory drugs by study GPs or any GP, health services utilisation and patient-reported outcomes such as pain, quality of life and adverse events. Analysis will be by intention to treat, with a health economics analysis also planned.

Conclusions: If effective, the COMFORT intervention has the potential to safely reduce opioid use for back pain and transform back pain management in Australia and globally.

  1. Abdel Shaheed C, Ivers R, Vizza L, et alClinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised controlled trial protocolBMJ Open 2023;13:e075286. doi: 10.1136/bmjopen-2023-075286