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 overweight 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 pain in individuals with CNLBP and comorbid overweight or obesity.

Design: This is an international multicenter triple-blinded randomized 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 randomly assigned to 1 of 2 treatment arms.

Interventions: The control intervention includes Pain Neuroscience Education and Cognition-Targeted Exercise Therapy. The experimental group receives the same intervention supplemented with a Behavioral Weight 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 quality 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 and 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 therapy guidelines and individualized care for people with CNLBP and comorbid overweight or obesity.