Actively Recruiting
Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT
Led by Vrije Universiteit Brussel · Updated on 2025-09-22
252
Participants Needed
2
Research Sites
185 weeks
Total Duration
On this page
Sponsors
V
Vrije Universiteit Brussel
Lead Sponsor
B
Bern University of Applied Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) men and women
- Chronic low back pain lasting at least 3 months with current care-seeking and leg pain less than 7 on a 10-point scale
- Continued usual care for at least 6 weeks before and during the study
- Native Dutch speakers in Belgium or native German speakers in Switzerland
You will not qualify if you...
- Body mass index (BMI) of 40 kg/m2 or higher, or healthy fat percentage despite high BMI
- Pregnant, breastfeeding, or gave birth in the previous year
- Receiving or received dietary or exercise treatments within the last 6 weeks
- Evidence of specific spinal problems (e.g., hernia, spinal stenosis, fracture, infection, malignancy) or serious related diseases (e.g., diabetes, cardiovascular, metabolic disorders)
- Other severe diseases under current medical treatment, including diagnosed eating disorders
- Ongoing insurance issues related to back problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Vrije Universiteit Brussel
Brussels, Belgium, 1090
Actively Recruiting
2
Berner Fachhochschule
Bern, Switzerland, 3012
Actively Recruiting
Research Team
A
Anneleen Malfliet, PhD
CONTACT
J
Jo Nijs, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here