The ESCAPE trial for older people with chronic low back pain: Protocol of a randomized controlled trial

BACKGROUND: Low-back pain is one of the most common health conditions worldwide. It is defined as pain below the costal margin and above the inferior gluteal folds. Current guidelines recommend management of chronic health (e.g., low back pain) conditions in older people at primary health care settings using active strategies (e.g., exercise). In non-specific low back pain, high quality evidence supports active strategies for general population. However, the management of non-specific low back pain in the older people has been overlooked and evidence is limited to a small number of low powered randomized controlled trials with high risk of bias. METHODS: This is a prospectively registered, open, two-arm randomised controlled trial comparing the group-based exercise and waiting list in pain intensity (11-item Pain Numerical Rating Scale) and disability (Roland Morris questionnaire) of older people (i.e., 60 years old or over) with chronic non-specific low back pain. One hundred and twenty patients will be recruited from Diamantina, Brazil. Follow-ups will be conducted in post-treatment (8 week) and 6- and 12-months post-randomisation. DISCUSSION: Our hypothesis is that group-based exercise will be better than waiting list in reducing pain intensity and disability in older people with chronic non-specific low back pain. IMPACT: The practice of individualized exercise has been studied for the management of chronic non-specific low back pain in older people. However, the group exercise, even showing high quality evidence for the improvement of several important outcomes in this population, has been ignored until now. Thus, the results of this study have the potential to indicate a viable and accessible strategy for managing chronic non-specific low back pain in the older people. TRIAL REGISTRATION: The study was prospectively registered at www.ensaiosclinicos.gov.br (RBR-9j5pqs). Date-11/18/2020.