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Introduction Insomnia is prevalent among patients visiting physiotherapists due to musculoskeletal complaints and associated with poorer pain prognosis. Cognitive-Behavioural Therapy for Insomnia (CBT-I) may be effective for improving sleep quality and pain-related outcomes in these patients, but its availability and utility are limited in daily physiotherapy practice. The aim of this randomised controlled trial (RCT) is to evaluate the effectiveness of digital CBT-I in addition to usual treatment in patients with chronic musculoskeletal complaints and insomnia, compared with usual treatment only.Methods and analysis In this RCT, eligible and consenting participants will be randomised (1:1 ratio) to one of two interventions: (1) digital CBT-I adjunct to physiotherapy treatment or (2) usual physiotherapy treatment. Patients with musculoskeletal complaints and insomnia visiting a physiotherapist in Norway will be invited to participate in the study. We aim to include 188 participants to detect a difference in the primary outcome. Outcome variables will be assessed at baseline (prior to randomisation) and at 6-week, 3-month, 6-month and 12-month follow-up. The primary outcome is between-group difference in insomnia severity, assessed with the Insomnia Severity Index (0–28 points) at 3 months. Secondary outcomes include between-group differences in pain intensity, physical function, work ability, health-related quality of life, mental distress, and self-reported use of sleep and pain medication. Exploratory analyses will identify patient characteristics influencing the effect of the digital intervention.Ethics and dissemination This trial is approved by the Regional Committee for Medical and Health Research Ethics in Central Norway (Ref. 2023/533381). The results of the trial will be published in peer-review journals and disseminated at national and international conferences.Trial registration number ISRCTN91221906.

BACKGROUND: Population-based studies have reported conflicting findings on the relationship between physical activity and pain, and most studies reporting a relationship are cross sectional. Temporal relationships are therefore difficult to infer and associations may be subject to confounding from a variety of other factors. The aim of the current study was to investigate the association between exercise and pain longitudinally and to use within subjects analyses to remove between subjects confounding. METHODS: In the population-based HUNT 3 study, participants reported both pain and level of exercise. A random sub-sample of 6419 participants was in addition invited to report their last week pain and exercise every three months over a 12 month period (five measurements in total). We used multilevel mixed effects linear regression analyses to prospectively estimate the association between regular levels of exercise (measured in HUNT 3) and subsequent longitudinal reporting of pain. We also estimated within-subjects associations (i.e. the variation in pain as a function of variation in exercise, over time, within individuals) to avoid confounding from between subject factors. RESULTS: Among those invited to participate (N = 6419), 4219 subjects returned at least two questionnaires. Compared with subjects who reported no or light exercise, those who reported moderate levels of exercise or more at baseline, reported less pain in repeated measures over a 12 month period in analyses adjusted for age, sex,education and smoking. Adjusting for baseline level of pain distinctly attenuated the findings. Within subjects, an increase in exercise was accompanied by a concurrent reduction in intensity of pain. However, we found no indication that exercise level at one occasion was related to pain reporting three months later. CONCLUSION: This longitudinal population-based study indicates that exercise is associated with lower level of pain and that this association is close in time.