Evidence map›Paper›PMID 32811786›Full record

ArticleBrazilian journal of physical therapy

The RESOLVE Trial for people with chronic low back pain: statistical analysis plan.

Matthew K Bagg, Serigne Lo, Aidan G Cashin, Rob D Herbert, Neil E O'Connell, Hopin Lee, Markus Hübscher, Benedict M Wand, Edel O'Hagan, Rodrigo R N Rizzo and 6 more

Abstract read
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In one paragraph

Article in Brazilian journal of physical therapy. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Trial
  2. Trial
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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

16 authors.

Matthew K BaggCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; Prince of Wales Clinical School, University of New South Wales, Prince of Wales Hospital Campus, Sydney, Australia; New College Village, University of New South Wales, Sydney, Australia. Electronic address: m.bagg@neura.edu.au.
Serigne LoMelanoma Institute Australia, University of Sydney, Sydney, Australia.
Aidan G CashinCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; Prince of Wales Clinical School, University of New South Wales, Prince of Wales Hospital Campus, Sydney, Australia.
Rob D HerbertCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.
Neil E O'ConnellDepartment of Clinical Sciences, College of Health and Life Sciences, Brunel University London, Kingston Lane, Uxbridge, United Kingdom.
Hopin LeeCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Windmill Road, Headington, United Kingdom; School of Medicine and Public Health, University of Newcastle, University Drive, Newcastle, Australia.
Markus HübscherCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.
Benedict M WandSchool of Physiotherapy, The University of Notre Dame Australia Fremantle, Perth, Australia.
Edel O'HaganCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; Prince of Wales Clinical School, University of New South Wales, Prince of Wales Hospital Campus, Sydney, Australia.
Rodrigo R N RizzoCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; School of Medical Sciences, University of New South Wales, Sydney, Australia.
G Lorimer MoseleyCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; IIMPACT in Health, University of South Australia, City East Campus, Australia.
Tasha R StantonCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; IIMPACT in Health, University of South Australia, City East Campus, Australia.
Christopher G MaherInstitute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
Stephen GoodallCentre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia.
Sopany SaingCentre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia.
James H McAuleyCentre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; School of Medical Sciences, University of New South Wales, Sydney, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStatistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control.

resultsWe report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results.

conclusionThis statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial.

trial registrationACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619).

Indexed as

Chronic PainHumansLow Back PainPhysical Therapy ModalitiesRandomized Controlled Trials as TopicResearch DesignBack painChronic painClinical trialStatistical data analysis

Identifiers

PMID32811786
PMCPMC7817870

What OpenQuestion holds

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Registered trials

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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.