Abstract
Background: Low back and neck pain are a leading cause of disease burden globally. Opioids are recommended in guidelines for acute low back and neck pain; however, there is a lack of compelling efficacy data to support this. Methods: The OPAL trial is a prospectively registered, triple-blinded, randomised, placebo-controlled trial. Patients with acute (≤12 weeks duration) back and/or neck pain receive guideline care plus either an opioid (oxycodone + naloxone, up to 20 mg per day) or a placebo for up to 6 weeks or earlier, if pain is resolved. The primary outcome is pain measured using the Pain Severity Score of the Brief Pain Inventory with the primary time point being 6 weeks. Secondary outcomes include physical function, time to recovery, quality of life, adverse events and risk of opioid misuse. Outcomes are collected at weeks 2, 4, 6, 12, 26 and 52. Analysis will be done on an intention-to-treat principle. p values of < 0.05 will be considered significant and 95% confidence intervals will be reported. Repeated-measures linear mixed models will be used to assess the effect of the treatment group on the primary outcome and continuous secondary outcomes. Adverse events will be compared between groups using Fisher’s exact test. Cost-effectiveness analyses will be conducted if a treatment effect on pain is seen at week 6. Subgroup analyses will be performed to assess whether pain duration and pain location are treatment effect modifiers. Discussion: The OPAL trial will provide important evidence about whether a short course of opioids is effective in the treatment of acute non-specific low back and/or neck pain. This pre-specified statistical analysis plan details the methodology for the analysis of the OPAL trial results. Trial registration: ACTRN12615000775516. The trial has completed recruitment. Follow-up on the last patient will be completed in March 2022.
| Original language | English |
|---|---|
| Article number | 212 |
| Journal | Trials |
| Volume | 23 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Dec 2022 |
Bibliographical note
Funding Information:Ethics approval has been granted from the Human Research Ethics Committee, The University of Sydney (Project No. 2015-004).
Funding Information:
This work is supported by the National Health and Medical Research Council (NHMRC) of Australia, grant number APP1082480. Supplementary funding was provided by ReturnToWorkSA and the Sydney Medical School Foundation. C-WCL is funded by a Career Development Fellowship and an Emerging Leadership Fellowship from the NHMRC (APP1193939). CGM is funded by a Leadership Fellowship from the NHMRC (APP1194283). The funding source has no role in the trial design and will have no role in the trial conduct, data analysis and interpretation or writing or reporting.
Funding Information:
AJM has received supplementary funding and/or trial medicines from GlaxoSmithKline and Pfizer (Australia) for investigator-initiated NHMRC-funded trials evaluating drug treatment of low back pain. He is also the Program Director of the NHMRC Centre for Research Excellence in Medicines and Ageing. JL has received supplementary funding and/or trial medicines from GlaxoSmithKline and Pfizer (Australia) for investigator-initiated NHMRC-funded trials evaluating drug treatment of back pain. She has received funding from Baxter Biosciences for research evaluating musculoskeletal outcomes in children with haemophilia. ROD has received supplementary funding and/or trial medicines from GlaxoSmithKline and Pfizer (Australia) for investigator-initiated NHMRC-funded trials evaluating drug treatment of back pain. ROD has been a member of an advisory board about paracetamol for GlaxoSmithKline and ibuprofen for Reckitt Benckiser (Australia). Payments went to an audited hospital account for teaching and research purposes. CGM has received supplementary funding and/or trial medicines from GlaxoSmithKline and Pfizer (Australia) for investigator-initiated NHMRC-funded trials evaluating drug treatment of low back pain.
Publisher Copyright:
© 2022, The Author(s).