Program with exercise, pain education and mindfulness for adults with chronic low back pain

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2026
INTERVENTION: This is a two‐arm parallel randomized controlled clinical trial with blinded assessor and 1:1 allocation, composed of 60 adult participants with chronic low back pain, randomly allocated through a sequence generated by RANDOM.ORG using block randomization of 6 participants and allocation concealment by opaque, sealed and sequentially numbered envelopes. Intervention Group (IG): Participants allocated to the Intervention Group will receive an integrated biopsychosocial protocol for chronic low back pain including pain neuroscience education, mindfulness practices and progressive therapeutic exercises. Eight face‐to‐face group sessions will be conducted twice a week, lasting approximately 70 minutes each, structured sequentially with gradual progression of exercise complexity and load according to principles of graded exposure to movement and clinical safety. Control Group (CG): Participants allocated to the Control Group will receive a minimal educational intervention consisting of four weekly face‐to‐face sessions lasting approximately 45 to 60 minutes each, conducted by a health professional, including general information about low back pain, postural guidance, ergonomics, physical activity and self‐care, without prescription or supervision of specific therapeutic exercises. Assessments will be performed by previously trained assessors blinded to participant allocation at baseline, post‐intervention, 3‐month follow‐up and 6‐month follow‐up. CONDITION: C23.888.592.612.274 Pain Management ; Chronic Pain PRIMARY OUTCOME: A reduction in chronic low back pain intensity is expected in participants undergoing the integrated biopsychosocial protocol, verified using the Numeric Rating Scale (NRS, 0–10), based on the observation of a minimum reduction of 2 points between baseline, post‐intervention, 3‐month follow‐up and 6‐month follow‐up assessments; SECONDARY OUTCOME: A reduction in fear of movement is expected, verified using the Tampa Scale for Kinesiophobia (TSK), based on the observation of reduced scores between assessment periods ; A reduction in functional disability is expected, verified using the Roland‐Morris Disability Questionnaire (RMDQ), based on the observation of reduced total scores between assessment periods ; ; A reduction in pain catastrophizing is expected, verified using the Pain Catastrophizing Scale (PCS), based on the observation of decreased total scores after the intervention ; A reduction in symptoms of anxiety and depression is expected, verified using the Hospital Anxiety and Depression Scale (HADS), based on the observation of reduced anxiety and depression subscale scores ; An improvement in functional movement patterns is expected, verified using the Functional Movement Screen (FMS), based on the observation of increased total scores in post‐intervention and follow‐up assessments ; An improvement in health‐related quality of life is expected, verified using the EuroQol EQ‐5D‐3L, based on the observation of improved quality of life indices and visual analog scale scores ; An improvement in lumbar muscular endurance is expected, verified using the Biering‐Sørensen Test, based on the observation of increased isometric holding time ; An increase in mindfulness levels is expected, verified using the Five Facet Mindfulness Questionnaire (FFMQ), based on the observation of increased total scores after the intervention ; An increase in pain self‐efficacy is expected, verified using the Pain Self‐Efficacy Questionnaire (PSEQ), based on the observation of increased total scores after the intervention ; INCLUSION CRITERIA: Age = 18 years; Both sexes; Diagnosis of non‐specific chronic low back pain lasting 3 months or longer; Pain intensity = 4 points on the Numeric Pain Rating Scale (0–10); Ability to understand and follow the protocol instructions; Availability to participate in the study sessions and assessments; Agreement to participate by signing the Informed Consent Form
Epistemonikos ID: 1348f2134edb1068bf73ee9086ef54ce81b65511
First added on: Jul 25, 2026