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

Chronic Pain / therapy Humans Low Back Pain / physiopathology Physical Therapy Modalities / standards Randomized Controlled Trials as Topic Research Design
Back pain Chronic pain Clinical trial Statistical data analysis

Journal

Brazilian journal of physical therapy
ISSN: 1809-9246
Titre abrégé: Braz J Phys Ther
Pays: Brazil
ID NLM: 101615124

Informations de publication

Date de publication:
Historique:
received: 02 03 2020
revised: 12 05 2020
accepted: 03 06 2020
pubmed: 20 8 2020
medline: 27 4 2021
entrez: 20 8 2020
Statut: ppublish

Résumé

Statistical 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. We 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. This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial. ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619).

Sections du résumé

BACKGROUND BACKGROUND
Statistical 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.
RESULTS RESULTS
We 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.
CONCLUSION CONCLUSIONS
This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial.
TRIAL REGISTRATION BACKGROUND
ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619).

Identifiants

DOI: 10.1016/j.bjpt.2020.06.002 PMID: 32811786 PMC: PMC7817870
pubmed: 32811786
pii: S1413-3555(20)30188-X
doi: 10.1016/j.bjpt.2020.06.002
pmc: PMC7817870
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

103-111

Informations de copyright

Copyright © 2020 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier España, S.L.U. All rights reserved.

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Auteurs

Matthew K Bagg (MK)

Centre 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 Lo (S)

Melanoma Institute Australia, University of Sydney, Sydney, Australia.

Aidan G Cashin (AG)

Centre 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 Herbert (RD)

Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.

Neil E O'Connell (NE)

Department of Clinical Sciences, College of Health and Life Sciences, Brunel University London, Kingston Lane, Uxbridge, United Kingdom.

Hopin Lee (H)

Centre 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 Hübscher (M)

Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.

Benedict M Wand (BM)

School of Physiotherapy, The University of Notre Dame Australia Fremantle, Perth, Australia.

Edel O'Hagan (E)

Centre 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 Rizzo (RRN)

Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; School of Medical Sciences, University of New South Wales, Sydney, Australia.

G Lorimer Moseley (GL)

Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; IIMPACT in Health, University of South Australia, City East Campus, Australia.

Tasha R Stanton (TR)

Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; IIMPACT in Health, University of South Australia, City East Campus, Australia.

Christopher G Maher (CG)

Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.

Stephen Goodall (S)

Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia.

Sopany Saing (S)

Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia.

James H McAuley (JH)

Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; School of Medical Sciences, University of New South Wales, Sydney, Australia.

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Classifications MeSH

questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Manifestations neurologiques › Douleur chronique › The RESOLVE Trial for people with chronic low...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › The RESOLVE Trial for people with chronic low...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Manifestations neurologiques › Dorsalgie › Lombalgie › The RESOLVE Trial for people with chronic low...
questionsmedicales.fr › Thérapeutique › Techniques de physiothérapie › The RESOLVE Trial for people with chronic low...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › The RESOLVE Trial for people with chronic low...
questionsmedicales.fr › Disciplines des sciences naturelles › Science › Recherche › Plan de recherche › The RESOLVE Trial for people with chronic low...