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Study identifier: NCT05811624 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT

Condition: Overweight or Obesity · Chronic Low-back Pain  ·  Sponsor: Vrije Universiteit Brussel

PhaseNA
Planned participants252
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

Chronic low back pain (CLBP) is the most expensive cause of workrelated disability: it causes the highest number of years lived with disability. The most severe and debilitated CLBP patients often have comorbidities such as overweight and obesity. Despite the growing body of scientific literature pointing towards the close interaction between overweight/obesity and CLBP, few treatment programs for people with CLBP nowadays take overweight into account. Therefore this study will examine the added value of a behavioral weight reduction program (changes in diet, behavior and physical exercise) to current best evidence rehabilitation (pain neuroscience education plus cognition-targeted exercise therapy) for overweight or obese people with CLBP. An international, multicenter randomized controlled trial comparing a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy versus pain neuroscience education and cognition-targeted exercise therapy alone, will be conducted. The primary outcome is pain and the primary endpoint was chosen at 12 months follow-up; secondary outcomes include health care use and daily functioning (see detailed description of outcomes for an overview of all secondary outcomes). If the promising results of the proof of concept study are corroborated, the new intervention will have a high socio-economic impact, including an annual health care cost reduction of €66 million in Switzerland, and €60 milli…

This description comes directly from the study's public registry record.

Talk to the study team

Anneleen Malfliet, PhD  ·  003224774531  ·  anneleen.malfliet@vub.be

Jo Nijs, PhD  ·  jo.nijs@vub.be

Always discuss trial participation with your own doctor first.

Locations (2)

Vrije Universiteit BrusselBrussels, BelgiumRecruiting
Berner FachhochschuleBern, SwitzerlandRecruiting

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Source record: clinicaltrials.gov/study/NCT05811624