Multimodal Intervention Based on Physical Exercise, Mindfulness, Behaviour Change and Education to Improve Pain and Health in Patients with Chronic Primary Low Back Pain: a Study Protocol of the HEALTHYBACK Randomised Controlled Trial

The HEALTHYBACK trial is based on a multimodal intervention to determine the effectiveness of a supervised physical exercise, mindfulness, behaviour change and pain neuroscience education programme on several health variables in individuals with chronic primary low back pain (CPLBP). The study will be a randomised controlled trial among 70 individuals diagnosed with CPLBP (aged 18-65 years). The intervention will be conducted in person within a hospital setting for 16 weeks and comprises a first phase (16 sessions supervised physical exercise (2 days/week, 45 min/session), mindfulness (1 day/week, 2.5 hours/session), behaviour change (daily/24 hours via a wrist-worn activity prompting device) and pain neuroscience education (1 day/biweekly, 2 hours/session)) and a second phase (16 sessions functional full-body muscle strengthening exercise, 3 days/week, 50 min/session). The primary outcomes will include perceived acute pain, pain pressure threshold, conditioned pain modulation, temporal summation of pain and disability due to pain. Secondary measures will include physical fitness, body composition, gait parameters, device-measured physical activity and sedentary behaviour, haematological profile, self-reported sedentary behaviour, quality of life, pain catastrophising, mental health, sleep duration and quality, and symptoms related to central sensitisation. The groups will undergo pretest (before the intervention), post-test (after each phase of the intervention) and retest (at a 6-week detraining period after the intervention) measurements. The results will determine the effectiveness of multidimensional interventions on several health parameters in individuals with CPLBP. They will provide knowledge for pain management and functioning in affected individuals, which might diminish the need for primary healthcare services. Trial registration number: NCT06114264.