Background Non-specific chronic low back pain (NSCLBP) is a major public health and global socioeconomic burden associated with a complex interplay of biopsychosocial factors. Despite scientific signs of progress, treatment of NSCLBP often tends to stick to a biomechanical model, without targeting psychological and social factors. To enhance the clinical efficacy of usual physiotherapy for NSCLBP, the development of clinical strategies is to be pursued. This study aims to assess the effectiveness of multidimensional physiotherapy based on a biopsychosocial approach compared to usual care physiotherapy, on clinical findings and electroencephalography spectrum in non-specific chronic low back pain. Methods This study is a triple-blind, two-arm (1:1) randomized controlled trial with a 4 months follow-up. Seventy NSCLBP patients will be randomly allocated to either the experimental (multidimensional physiotherapy) or the active control group (usual physiotherapy); each group will receive 6 weeks of physiotherapy. The main outcome is pain and secondary outcomes are brain function, quality of life, disability, lumbar flexion range of motion, and psychosocial correlates. Assessment will be performed at baseline, post-treatment, and at 1 and 4 months follow-up. Discussion Findings may provide evidence on the effectiveness of multidimensional physiotherapy on clinical findings and brain characteristics and might provide evidence towards showing the role of brain and biopsychosocial factors on chronic pain. Trial registration ClinicalTrials.gov NCT04270422, Registered on 17 February 2020, IRCT Identifier: IRCT20140810018754N11
Background: Many people with non-specific chronic low back pain (NSCLBP) do not recover with current conventional management. Systematic reviews show multidimensional treatment improves pain better than usual active interventions. It is unclear whether multidimensional physiotherapy improves pain better than usual physiotherapy. This study determines the effectiveness of this treatment to reduce pain and disability and improve quality of life, pain cognitions, and brain function in individuals with NSCLBP. Methods: 70 eligible participants aged 18 to 50 years with NSCLBP were randomized into either the experimental group (multidimensional physiotherapy) or the active control group (usual physiotherapy). Pain intensity was measured as the primary outcome. Disability, quality of life, pain Catastrophizing, kinesiophobia, fear Avoidance Beliefs, active lumbar range of motion, and brain function were measured as secondary outcomes. The outcomes were measured at pre-treatment, post-treatment, 10, and 22 weeks. Data were analyzed using intention-to-treat approaches. Results: There were 17 men and 18 women in the experimental group (mean [SD] age, 34.57 [6.98] years) and 18 men and 17 women in the active control group (mean [SD] age, 35.94 [7.51] years). Multidimensional physiotherapy was not more effective than usual physiotherapy at reducing pain intensity at the end of treatment. At the 10 weeks and 22 weeks follow-up, there were statistically significant differences between multidimensional physiotherapy and usual physiotherapy (mean difference at 10 weeks, -1.54; 95% CI, -2.59 to -0.49 and mean difference at 22 weeks, -2.20; 95% CI, –3.25 to –1.15). The standardized mean difference and their 95% confidence intervals (Cohen's d) revealed a large effect of pain at 22 weeks: (Cohen’s d, -0.89; 95% CI (-1.38 to-0.39)). There were no statistically significant differences in secondary outcomes. Conclusions: In this randomized controlled trial, multidimensional physiotherapy resulted in statistically and clinically significant improvements in pain compared to usual physiotherapy in individuals with NSCLBP at 10 and 22 weeks. Trial Registration: ClinicalTrials.gov NCT04270422; IRCT IRCT20140810018754N11.
Background: Non-specific chronic low back pain (NSCLBP) is a major public health and global socioeconomic burden associated with a complex interplay of biopsychosocial factors. Despite scientific signs of progress, treatment of NSCLBP often tends to stick to a biomechanical model, without targeting psychological and social factors. To enhance clinical efficacy of usual physiotherapy for NSCLBP, the development of clinical strategies is to be pursued. This study aims to assess the effectiveness of multidimensional physiotherapy based on biopsychosocial approach compared to usual care physiotherapy, on clinical findings and Electroencephalography spectrum in non-specific chronic low back pain.Methods: This study is a triple-blind, two-arm (1:1) randomized controlled trial with a 4-months follow-up. 70 NSCLBP patients will be randomly allocated to either the experimental (multidimensional physiotherapy) or the active control group (usual physiotherapy), each group will receive 6-weeks of physiotherapy. The main outcome is pain and secondary outcomes are brain function, quality of life, disability, lumbar flexion range of motion and psychosocial correlates. Assessment will be performed at baseline, post-treatment and at 1- and 4-months follow-up.Discussion: Findings may provide evidence on the effectiveness of multidimensional physiotherapy on clinical findings and brain characteristics and might provide evidence towards showing the role of brain and biopsychosocial factors on chronic pain.Trial registration: ClinicalTrials.gov Identifier: NCT04270422, Registered 17 February 2020, https://clinicaltrials.gov/ct2/show/NCT04270422?term=NCT04270422&draw=2&rank=1IRCT Identifier: IRCT20140810018754N11
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