Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

Musculoskeletal pain in children and adolescents

ABSTRACT Introduction Musculoskeletal (MSK) pain in children and adolescents is responsible for substantial personal impacts and societal costs, but it has not been intensively or systematically researched. This means our understanding of these conditions is limited, and healthcare professionals have little empirical evidence to underpin their clinical practice. In this article we summarise the state of the evidence concerning MSK pain in children and adolescents, and offer suggestions for future research. Results Rates of self-reported MSK pain in adolescents are similar to those in adult populations and they are typically higher in teenage girls than boys. Epidemiological research has identified conditions such as back and neck pain as major causes of disability in adolescents, and in up to a quarter of cases there are impacts on school or physical activities. A range of physical, psychological and social factors have been shown to be associated with MSK pain report, but the strength and direction of these relationships are unclear. There are few validated instruments available to quantify the nature and severity of MSK pain in children, but some show promise. Several national surveys have shown that adolescents with MSK pain commonly seek care and use medications for their condition. Some studies have revealed a link between MSK pain in adolescents and chronic pain in adults. Conclusion Musculoskeletal pain conditions are often recurrent in nature, occurring throughout the life-course. Attempts to understand these conditions at a time close to their initial onset may offer a better chance of developing effective prevention and treatment strategies.