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

Fiona Blyth; Louisa Degenhardt; Christopher Maher; Kirsten McCaffery; Patrick J Kelly; Thomas Lung; Simon French; Sharon Reid; Hazel Jenkins; Christina Abdel Shaheed; Rachel Thompson; Stephanie Mathieson; Gabrielle Campbell; Andrew McLachlan; Rowena Ivers; Fiona Stanaway; Michael Wright; Carol Bennett; Lisa Vizza; Philip James Clare; Bradley Martin; Rawa Osman; Monika Boogs; Jarrod McMaugh

doi:10.1136/bmjopen-2023-075286

BMJ Open (Nov 2023)

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

Fiona Blyth,
Louisa Degenhardt,
Christopher Maher,
Kirsten McCaffery,
Patrick J Kelly,
Thomas Lung,
Simon French,
Sharon Reid,
Hazel Jenkins,
Christina Abdel Shaheed,
Rachel Thompson,
Stephanie Mathieson,
Gabrielle Campbell,
Andrew McLachlan,
Rowena Ivers,
Fiona Stanaway,
Michael Wright,
Carol Bennett,
Lisa Vizza,
Philip James Clare,
Bradley Martin,
Rawa Osman,
Monika Boogs,
Jarrod McMaugh

Affiliations

Fiona Blyth: 1 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Louisa Degenhardt: 6 National Drug and Alcohol Research Centre (NDARC), Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
Christopher Maher: 2 Sydney Musculoskeletal Health, University of Sydney, Sydney, New South Wales, Australia
Kirsten McCaffery: 1 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Patrick J Kelly: 1 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Thomas Lung: 1 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Simon French: 14 Department of Chiropractic, Macquarie University, Sydney, New South Wales, Australia
Sharon Reid: 9 Specialty of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Hazel Jenkins: 14 Department of Chiropractic, Macquarie University, Sydney, New South Wales, Australia
Christina Abdel Shaheed: 1 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Rachel Thompson: 7 Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Stephanie Mathieson: 2 Sydney Musculoskeletal Health, University of Sydney, Sydney, New South Wales, Australia
Gabrielle Campbell: 16 School of Psychology, University of Queensland, Queensland, Queensland, Australia
Andrew McLachlan: 4 Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Rowena Ivers: 3 Graduate School of Medicine, University of Wollongong, Sydney, New South Wales, Australia
Fiona Stanaway: 1 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Michael Wright: 11 Centre for Health Economics Research Evaluation, University of Technology Sydney, Sydney, New South Wales, Australia
Carol Bennett: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Lisa Vizza: 1 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Philip James Clare: 1 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Bradley Martin: 10 Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Arkansas, Arkansas, USA
Rawa Osman: 13 Quality Use of Medicines (QUM) Connect, Sydney, New South Wales, Australia
Monika Boogs: 18 Painaustralia Consumer Advisory Group, Canberra, ACT, Australia
Jarrod McMaugh: 19 Pharmaceutical Society of Australia, Canberra, ACT, Australia

DOI: https://doi.org/10.1136/bmjopen-2023-075286
Journal volume & issue: Vol. 13, no. 11

Abstract

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Introduction 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 This is a cluster randomised controlled trial 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.Ethics and dissemination The trial received ethics approval from The University of Sydney Human Research Ethics Committee (2022/511). The results will be disseminated via publications in journals, media and conference presentations.Trial registration number ACTRN12622001505796.

Published in BMJ Open

ISSN: 2044-6055 (Online)
Publisher: BMJ Publishing Group
Country of publisher: United Kingdom
LCC subjects: Medicine
Website: https://bmjopen.bmj.com

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