Lifestyle Intervention in People With Overweight and Obesity and Chronic Low Back Pain: Study Protocol for an International Multicenter Randomized Controlled Trial

Importance: Chronic low back pain (CLBP) is a global health problem with significant clinical, social, and economic challenges. Over 80% of CLBP cases are non-specific (CNLBP), causing the highest number of years lived with disability. People with CNLBP often have comorbidities such as o verweight or obesity, which negatively impact symptoms and treatment outcomes. Objective: The objective is to evaluate whether a lifestyle intervention combining diet, physical activity, and evidence-based physical therapy can reduce p ain in individuals with CNLBP and comorbid over weight or obesity. Design: This is an international multicenter triple-blinded randomiz ed controlled trial (RCT). Setting: The trial will be conducted in Belgium and Switzerland, with interventions delivered in hospitals (ambulatory care) and outpatient private practices. Participants: In total, 252 adults will be included and r andomly assigned to 1 o f 2 treatment arms. Interventions: The control intervention includes Pain Neuroscience Education and Cognition-Targeted Exercise Therapy. The experimental group receives the same i ntervention supplemented with a Behavioral We ight Reduction Program. Main Outcomes and Measures: The primary outcome is pain intensity (assessed using the Brief Pain Inventory). Secondary outcomes include other pain-related outcomes, body composition measures, energy balance related behavior, medical consumption, indirect health-related costs, and qualit y of life. Assessments will occur at baseline, post-intervention, and at 3-, 6-, 9-, and 12-months follow-up. Conclusion: This study is the first international multicenter RCT integrating a lifestyle approach into evidence-based physical therapy for people with CNLBP and comorbid overweight or obesity. It will assess whether addressing comorbid overweight or obesity enhances pain reduction a nd other health outcomes in this population. Relevance: The results will push the field forward, leading to new knowledge about the (cost-)effectiveness of this approach, which will provide key insights for different stakeholders, help optimizing t herapy guidelines and individualized care for people with CNLBP and comorbid overweight or obesity.