The RESOLVE Swiss trial for people with chronic non-specific low back pain: statistical analysis plan for a cluster randomised controlled trial

Statistical analysis plan for the RESOLVE Swiss cluster randomised controlled trial, together with the R code that reproduces every sample size, design effect and power figure reported in it. RESOLVE Swiss is a two-arm parallel-group cluster randomised trial in Swiss physiotherapy practices, comparing graded sensorimotor retraining combined with pain science education against usual physiotherapy. The practice is the unit of randomisation and the participant is the unit of analysis. The primary outcome is back-specific disability, measured with the Roland-Morris Disability Questionnaire at 18 weeks. The repository holds the manuscript source, the sample size and power scripts, and a verification suite that reproduces each published number twice, once from the closed-form expressions of Teerenstra et al. (2012) and once from an independent simulation of the underlying data generating process. Trial registration: German Clinical Trials Register DRKS00039237, registered 4 February 2026. Swiss BASEC number 2025-00784.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2026-09-08
DOI
https://doi.org/10.5281/zenodo.22655090
Primary Topic
Musculoskeletal pain and rehabilitation
Type
preprint
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preprint

The RESOLVE Swiss trial for people with chronic non-specific low back pain: statistical analysis plan for a cluster randomised controlled trial

Andrea Stehrenberger, Jürgen Degenfellner, Silvia Careddu, Fabian Pfeiffer et al.
Zenodo (CERN European Organization for Nuclear Research)
Musculoskeletal pain and rehabilitation
preprint

The RESOLVE Swiss trial for people with chronic non-specific low back pain: statistical analysis plan for a cluster randomised controlled trial

Andrea Stehrenberger, Jürgen Degenfellner, Silvia Careddu, Fabian Pfeiffer, Thomas Benz, Bettina Sommer
preprint en

Abstract

Statistical analysis plan for the RESOLVE Swiss cluster randomised controlled trial, together with the R code that reproduces every sample size, design effect and power figure reported in it. RESOLVE Swiss is a two-arm parallel-group cluster randomised trial in Swiss physiotherapy practices, comparing graded sensorimotor retraining combined with pain science education against usual physiotherapy. The practice is the unit of randomisation and the participant is the unit of analysis. The primary outcome is back-specific disability, measured with the Roland-Morris Disability Questionnaire at 18 weeks. The repository holds the manuscript source, the sample size and power scripts, and a verification suite that reproduces each published number twice, once from the closed-form expressions of Teerenstra et al. (2012) and once from an independent simulation of the underlying data generating process. Trial registration: German Clinical Trials Register DRKS00039237, registered 4 February 2026. Swiss BASEC number 2025-00784.

Zenodo (CERN European Organization for Nuclear Research)
ZHAW Zurich University of Applied Sciences (CH)
Quality Education
Musculoskeletal pain and rehabilitation
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