Text Message intervention to improve function in people with low back pain TEXT4myBACK

The TEXT4myBACK trial aims to examine the effect of lifestyle-focused program delivered by text message on function in people with non-persistent low back pain. The lifestyle-focused intervention is delivered as a mobile phone text message over a period of 12 weeks. The statistical analysis plan pre-specifies the method of analysis for every outcome and key variables collected in the trial. The primary outcome is a composite endpoint incorporating measures of pain, functional status, patient reported impression of change, generic quality of life, levels of activity, hospital as well as medication use at 3-months follow-up that will be categorised into a hierarchy with number one ranked as most important according to clinical importance. The primary composite endpoint will be analysed using a hierarchical win ratio approach. Win-ratio approach maintains sequential assessment of outcomes while simultaneously assessing the effect of intervention for multiple outcomes as a single measure. Secondary, exploratory and subgroup group analysis have been pre-specified as well.