Coping with persistent pain, effectiveness research into self-management (COPERS): statistical analysis plan for a randomised controlled trial

Trials. 2014 Feb 15:15:59. doi: 10.1186/1745-6215-15-59.

Abstract

Background: The Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS) trial assessed whether a group-based self-management course is effective in reducing pain-related disability in participants with chronic musculoskeletal pain. This article describes the statistical analysis plan for the COPERS trial.

Methods and design: COPERS was a pragmatic, multicentre, unmasked, parallel group, randomised controlled trial. This article describes (a) the overall analysis principles (including which participants will be included in each analysis, how results will be presented, which covariates will be adjusted for, and how we will account for clustering in the intervention group); (b) the primary and secondary outcomes, and how each outcome will be analysed; (c) sensitivity analyses; (d) subgroup analyses; and (e) adherence-adjusted analyses.

Trial registration: ISRCTN24426731.

Publication types

  • Multicenter Study
  • Pragmatic Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adaptation, Psychological
  • Chronic Pain / diagnosis
  • Chronic Pain / psychology
  • Chronic Pain / therapy*
  • Cluster Analysis
  • Data Interpretation, Statistical
  • Disability Evaluation
  • Group Processes*
  • Humans
  • Models, Statistical
  • Musculoskeletal Pain / diagnosis
  • Musculoskeletal Pain / psychology
  • Musculoskeletal Pain / therapy*
  • Pain Management / methods*
  • Pain Measurement
  • Research Design
  • Self Care / methods*
  • Time Factors
  • Treatment Outcome

Associated data

  • ISRCTN/ISRCTN24426731