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Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT
Sponsor: Vrije Universiteit Brussel
Summary
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 million in Flanders, and is expected to increase life expectancy in the long term.
Official title: Lifestyle Intervention in Overweight/Obese People Suffering From Chronic Low Back Pain: an International Multi-center Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
252
Start Date
2023-04-13
Completion Date
2026-11
Last Updated
2025-09-22
Healthy Volunteers
No
Interventions
Physiotherapy intervention, including behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy.
14 weeks, 18 treatment sessions This includes: * 3 sessions of Pain Neuroscience Education during the first two weeks (of which the second one will be held online). The aim is to to reconceptualize pain, to increase pain coping skills and to convince the patients that pain is in the brain, and that hypersensitivity of the central nervous system rather than local tissue damage contributes to their symptoms. * 15 sessions which will focus simultaneously on cognition-targeted exercise therapy and behavioral weight reduction. The aim of the exercise program is to confront the patient with movements and activities that are feared, avoided and/or painful. The behavioral weight reduction program includes a lifestyle approach, with changes in diet, behavior, and a physical exercise weight loss program, all aiming for a caloric deficit of 500 to 700 kcal/day.
Physiotherapy intervention, including pain neuroscience education and cognition-targeted exercise therapy alone.
14 weeks, 18 treatment sessions This includes: * 3 sessions of Pain Neuroscience Education during the first two weeks (of which the second one will be held online). The aim is to to reconceptualize pain, to increase pain coping skills and to convince the patients that pain is in the brain, and that hypersensitivity of the central nervous system rather than local tissue damage contributes to their symptoms. * 15 sessions which will only focus on cognition-targeted exercise therapy. The aim of the exercise program is to confront the patient with movements and activities that are feared, avoided and/or painful.
Locations (2)
Vrije Universiteit Brussel
Brussels, Belgium
Berner Fachhochschule
Bern, Switzerland