Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05811624

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 2 locations

1

Vrije Universiteit Brussel

Brussels, Belgium, 1090

Actively Recruiting

2

Berner Fachhochschule

Bern, Switzerland, 3012

Actively Recruiting

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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

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