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; G Lorimer Moseley; Tasha R Stanton; Christopher G Maher; Stephen Goodall; Sopany Saing; James H McAuley

doi:10.1016/j.bjpt.2020.06.002

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

Braz J Phys Ther. 2021 Jan-Feb;25(1):103-111. doi: 10.1016/j.bjpt.2020.06.002. Epub 2020 Jun 18.

Authors

Matthew K Bagg¹, Serigne Lo², Aidan G Cashin³, Rob D Herbert⁴, Neil E O'Connell⁵, Hopin Lee⁶, Markus Hübscher⁴, Benedict M Wand⁷, Edel O'Hagan³, Rodrigo R N Rizzo⁸, G Lorimer Moseley⁹, Tasha R Stanton⁹, Christopher G Maher¹⁰, Stephen Goodall¹¹, Sopany Saing¹¹, James H McAuley⁸

Affiliations

¹ 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.
² Melanoma Institute Australia, University of Sydney, Sydney, Australia.
³ 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.
⁴ Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.
⁵ Department of Clinical Sciences, College of Health and Life Sciences, Brunel University London, Kingston Lane, Uxbridge, United Kingdom.
⁶ 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.
⁷ School of Physiotherapy, The University of Notre Dame Australia Fremantle, Perth, Australia.
⁸ Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; School of Medical Sciences, University of New South Wales, Sydney, Australia.
⁹ Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; IIMPACT in Health, University of South Australia, City East Campus, Australia.
¹⁰ Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
¹¹ Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia.

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).

Keywords: Back pain; Chronic pain; Clinical trial; Statistical data analysis.

MeSH terms

Chronic Pain / therapy*
Humans
Low Back Pain / physiopathology
Low Back Pain / therapy*
Physical Therapy Modalities / standards
Randomized Controlled Trials as Topic
Research Design