Evidence map›Paper›PMID 35287698›Full record

Trial reportTrials2022

OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain-a statistical analysis plan.

Caitlin Mp Jones, Chung-Wei Christine Lin, Richard O Day, Bart W Koes, Jane Latimer, Chris G Maher, Andrew McLachlan, Laurent Billot

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Caitlin Mp JonesInstitute for Musculoskeletal Health, Sydney Local Health District and The University of Sydney, Level 10N, KGV Building, Missenden Road, Camperdown, Sydney, New South Wales, Australia. caitlin.jones@sydney.edu.au.ORCID http://orcid.org/0000-0002-9887-2493
Chung-Wei Christine LinInstitute for Musculoskeletal Health, Sydney Local Health District and The University of Sydney, Level 10N, KGV Building, Missenden Road, Camperdown, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0001-6192-7238
Richard O DayDepartment of Clinical Pharmacology & Toxicology, St Vincent's Hospital Sydney and St Vincent's Clinical School, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0002-6045-6937
Bart W KoesDepartment of General Practice, Erasmus MC, Rotterdam, The Netherlands.ORCID https://orcid.org/0000-0002-0450-9969
Jane LatimerInstitute for Musculoskeletal Health, Sydney Local Health District and The University of Sydney, Level 10N, KGV Building, Missenden Road, Camperdown, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0002-4809-5753
Chris G MaherInstitute for Musculoskeletal Health, Sydney Local Health District and The University of Sydney, Level 10N, KGV Building, Missenden Road, Camperdown, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0002-1628-7857
Andrew McLachlanFaculty of Pharmacy and The Centre for Education and Research on Ageing (CERA), The University of Sydney and Concord Hospital, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0003-4674-0242
Laurent BillotThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.ORCID https://orcid.org/0000-0002-4975-9793
The University of Sydney · AUUNSW Sydney · AUErasmus MC · NL

Funding

National Health and Medical Research Council APP1082480
6 · The paper itself

Abstract

backgroundLow 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.

methodsThe 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 registrationACTRN12615000775516 . The trial has completed recruitment. Follow-up on the last patient will be completed in March 2022.

Indexed as

Acute PainAnalgesiaAnalgesics, OpioidHumansPain MeasurementQuality of LifeAnalgesics, OpioidLow back painNeck painOpioidsPlacebo-controlled trialStatistical analysis plan

Identifiers

PMID35287698
PMCPMC8919636
OpenAlexW4220733588

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.