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Full-Text Articles in Medicine and Health Sciences
The Resolve Trial For People With Chronic Low Back Pain: Statistical Analysis Plan, Matthew K. Bagg, Serigne Lo, Aidan G. Cashin, Robert D. Herbert, Neil E. O'Connell, Hopin Lee, Markus Hubscher, Benedict M. Wand, Edel O'Hagan, Rodrigo R.N Rizzoli, G Lorimer Moseley, Tasha R. Stanton, Christopher G. Maher, Stephen Goodall, Sopany Saing, James H. Mcauley
The Resolve Trial For People With Chronic Low Back Pain: Statistical Analysis Plan, Matthew K. Bagg, Serigne Lo, Aidan G. Cashin, Robert D. Herbert, Neil E. O'Connell, Hopin Lee, Markus Hubscher, Benedict M. Wand, Edel O'Hagan, Rodrigo R.N Rizzoli, G Lorimer Moseley, Tasha R. Stanton, Christopher G. Maher, Stephen Goodall, Sopany Saing, James H. Mcauley
Physiotherapy Papers and Journal Articles
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 …