Pain Management Chronic Pain
Conditions
Interventions
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 seq
Sponsors
Universidade Estadual Paulista - UNESP
Universidade Estadual Paulista - UNESP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: History of lumbar spine surgery within the last 6 months; Presence of severe neurological disorders; Active inflammatory rheumatic diseases; Vertebral fracture, tumor, or spinal infection; Cognitive impairment preventing adequate understanding of instructions; Pregnancy; Any clinical condition contraindicating participation in therapeutic exercise; Concurrent participation in another structured program for low back pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 fear of movement is expected, verified using the Tampa Scale for Kinesiophobia (TSK), based on the observation of reduced scores between assessment periods ;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 ;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 ;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 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 improvement in lumbar muscular endurance is expected, verified using the Biering-Sørensen Test, based on the observation of increased isometric holding time ;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 | — |
Countries
BR
Contacts
Public ContactLeonardo Segateli
Faculdade de Medicina de Marília (FAMEMA)
Outcome results
None listed