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

Bagg, MK; Lo, S; Cashin, AG; Herbert, R; O’Connell, NE; Lee, H; Hübscher, M; Wand, BM; O’Hagan, E; Rizzo, R; Moseley, GL; Stanton, TR; Maher, GC; Goodall, S; Saing, S; McAuley, JH

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

Bagg, MK Lo, S Cashin, AG Herbert, R O’Connell, NE Lee, H Hübscher, M Wand, BM O’Hagan, E Rizzo, R Moseley, GL Stanton, TR Maher, GC Goodall, S

Saing, S

McAuley, JH

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Publisher:: Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia
Publication Type:: Journal Article
Citation:: Brazilian Journal of Physical Therapy, 2021, 25, (1), pp. 103-111
Issue Date:: 2021-01

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Field	Value	Language
dc.contributor.author	Bagg, MK
dc.contributor.author	Lo, S
dc.contributor.author	Cashin, AG
dc.contributor.author	Herbert, R
dc.contributor.author	O’Connell, NE
dc.contributor.author	Lee, H
dc.contributor.author	Hübscher, M
dc.contributor.author	Wand, BM
dc.contributor.author	O’Hagan, E
dc.contributor.author	Rizzo, R
dc.contributor.author	Moseley, GL
dc.contributor.author	Stanton, TR
dc.contributor.author	Maher, GC
dc.contributor.author	Goodall, S https://orcid.org/0000-0001-6611-6565
dc.contributor.author	Saing, S https://orcid.org/0000-0001-5913-9654
dc.contributor.author	McAuley, JH
dc.date.accessioned	2021-11-18T02:26:57Z
dc.date.available	2020-06-03
dc.date.available	2021-11-18T02:26:57Z
dc.date.issued	2021-01
dc.identifier.citation	Brazilian Journal of Physical Therapy, 2021, 25, (1), pp. 103-111
dc.identifier.issn	1413-3555
dc.identifier.issn	1809-9246
dc.identifier.uri	http://hdl.handle.net/10453/151693
dc.description.abstract	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 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 This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial. Trial registration ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619).
dc.format	Print-Electronic
dc.language	eng
dc.publisher	Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia
dc.relation	http://purl.org/au-research/grants/nhmrc/APP1087045
dc.relation	http://purl.org/au-research/grants/nhmrc/GNT1087045
dc.relation.ispartof	Brazilian Journal of Physical Therapy
dc.relation.isbasedon	10.1016/j.bjpt.2020.06.002
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	1117 Public Health and Health Services
dc.subject.mesh	Humans
dc.subject.mesh	Low Back Pain
dc.subject.mesh	Research Design
dc.subject.mesh	Physical Therapy Modalities
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Chronic Pain
dc.subject.mesh	Chronic Pain
dc.subject.mesh	Humans
dc.subject.mesh	Low Back Pain
dc.subject.mesh	Physical Therapy Modalities
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Research Design
dc.title	The RESOLVE Trial for people with chronic low back pain: statistical analysis plan
dc.type	Journal Article
utslib.citation.volume	25
utslib.location.activity	Brazil
utslib.for	1117 Public Health and Health Services
utslib.for	1117 Public Health and Health Services
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHERE - Centre for Health Economics Research and Evaluation
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health/GSH.Pharmacy
utslib.copyright.status	closed_access	*
pubs.consider-herdc	true
dc.date.updated	2021-11-18T02:26:55Z
pubs.issue	1
pubs.publication-status	Published
pubs.volume	25
utslib.citation.issue	1

Abstract:

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

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http://hdl.handle.net/10453/151693