Effects of a multidimensional approach based on exercise and mindfulness on pain, disability, quality of life, mental health, and gait parameters in patients with non-specific chronic low back pain: the BACKFIT randomized controlled trial.

Abstract

Abstract Background. Low back pain (LBP) is among the most common types of chronic pain and the leading cause of disability worldwide. The BACKFIT randomized controlled trial is a multidimensional intervention that aims to determine the effectiveness of a multidimensional program, based on supervised exercise and mindfulness, compared to a control group on pain and disability, quality of life, mental health, and gait parameters in patients with non-specific chronic low back pain (NSCLBP). Methods. 105 individuals. Inclusion criteria: Previously diagnosed with NSCLBP, be ≥ 18 and ≤ 65 years old, able to read and understand the informed consent, able to walk, move and communicate without external help. Exclusion criteria: serious lumbar structural disorders, acute or terminal illness, physical injury, mental illness, and medical prescriptions that prevented participating in the study. Individuals who will meet inclusion criteria will be randomly assigned to a supervised resistance exercise intervention group (2 days per week, 45 minutes per session), a multidimensional intervention group (same as supervised resistance exercise intervention group, and mindfulness 1 day per week, 2.5 hours per session) or a control group (usual care, 2 days per week, 45 minutes per session). The intervention will last 8 weeks. Primary outcome will be pain threshold, perceived acute pain, and disability due to pain. Secondary measures will be body composition, muscular fitness, gait parameters, device-measured physical activity and sedentary behaviour, self-reported sedentary behaviour, quality of life, pain catastrophizing, mental health, sleep duration and quality, and central sensitization. Discussion. This paper describes the protocol performed by a multidisciplinary team of experts in Physical Therapy and Sports Sciences. Combining physical (exercise) and psychological (mindfulness) therapy, might determine greater benefits in pain, disability, quality of life, mental health, and gait parameters in individuals with NSCLBP. This multidimensional approach might be effective for short- and intermediate-term improvement on pain and functioning in patients with chronic musculoskeletal pain. Moreover, if the multidimensional program is effective, will diminish future costs of clinical treatment and low-cost alternatives for health professionals will be available. Trial registration: NCT05443880.