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

Chung-Wei Christine Lin, Andrew J McLachlan, Jane Latimer, Ric O Day, Laurent Billot, Bart W Koes, Chris G Maher

Open access · goldAbstract readRandomized Controlled Trial

In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 21% 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, 12 citations in OpenAlex.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Chung-Wei Christine LinThe George Institute for Global Health and Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.

Andrew J 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.

Jane LatimerThe George Institute for Global Health and Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.

Ric O DayDepartment of Clinical Pharmacology & Toxicology, St Vincent's Hospital Sydney and Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.

Laurent BillotThe George Institute for Global Health and Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.

Bart W KoesDepartment of General Practice, Erasmus MC, Rotterdam, The Netherlands.

Chris G MaherThe George Institute for Global Health and Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.

University of Sydney · AUConcord Repatriation General Hospital · AUErasmus University Rotterdam · NLSt Vincent's Hospital Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLow back pain and neck pain are extremely prevalent and are responsible for an enormous burden of disease globally. Strong analgesics, such as opioid analgesics, are recommended by clinical guidelines for people with acute low back pain or neck pain who are slow to recover and require more pain relief. Opioid analgesics are widely and increasingly used, but there are no strong efficacy data supporting the use of opioid analgesics for acute low back pain or neck pain. Concerns regarding opioid use are further heightened by the risks of adverse events, some of which can be serious (eg, dependency, misuse and overdose). METHODS AND ANALYSIS: OPAL is a randomised, placebo-controlled, triple-blinded trial that will investigate the judicious use of an opioid analgesic in 346 participants with acute low back pain and/or neck pain who are slow to recover. Participants will be recruited from general practice and randomised to receive the opioid analgesic (controlled release oxycodone plus naloxone up to 20 mg per day) or placebo in addition to guideline-based care (eg, reassurance and advice of staying active) for up to 6 weeks. Participants will be followed-up for 3 months for effectiveness outcomes. The primary outcome will be pain severity. Secondary outcomes will include physical functioning and time to recovery. Medication-related adverse events will be assessed and a cost-effectiveness analysis will be conducted. We will additionally assess long-term use and risk of misuse of opioid analgesics for up to 12 months. ETHICS AND DISSEMINATION: Ethical approval has been obtained. Trial results will be disseminated by publications and conference presentations, and via the media. TRIAL REGISTRATION NUMBER: ACTRN12615000775516: Pre-results.

Indexed as

Acute PainAdolescentAdultAgedAnalgesics, OpioidAustraliaCost-Benefit AnalysisFemaleHumansLow Back PainMaleMiddle AgedNaloxoneNeck PainOxycodonePain MeasurementAnalgesics, OpioidNaloxoneOxycodonelow back painneck painOpioid analgesics

Identifiers

PMID27558901

DOI10.1136/bmjopen-2016-011278

PMCPMC5013345

OpenAlexW2514964383

What OpenQuestion holds

Textmetadata

LicenceCC BY-NC

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.