Lifestyle Intervention in Overweight/Obese People Suffering From Chronic Low Back Pain: an International Multi-center Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Adults (18 - 65 years)

• Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) women and men.

• CLBP (n=252), which is defined as nonspecific low back pain for at least 3 months duration, currently seeking care for low back pain and leg pain not ≥ 7 (on a maximum of 10) on a numeric rating scale.

• Continue usual care 6 weeks prior to (to obtain a steady stat) and during study participation.

• Depending on the country of inclusion: Native Dutch speaker (for Belgium) or Native German speaker (for Switzerland).

Locations
Other Locations
Belgium
Vrije Universiteit Brussel
RECRUITING
Brussels
Switzerland
Berner Fachhochschule
RECRUITING
Bern
Contact Information
Primary
Anneleen Malfliet, PhD
anneleen.malfliet@vub.be
003224774531
Backup
Jo Nijs, PhD
jo.nijs@vub.be
Time Frame
Start Date: 2023-04-13
Estimated Completion Date: 2026-11
Participants
Target number of participants: 252
Treatments
Experimental: Experimental Intervention
Physiotherapy intervention, including behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy.
Active_comparator: Control Intervention
Physiotherapy intervention, including pain neuroscience education and cognition-targeted exercise therapy alone.
Related Therapeutic Areas
Sponsors
Leads: Vrije Universiteit Brussel
Collaborators: Bern University of Applied Sciences, University of Applied Sciences and Arts of Southern Switzerland

This content was sourced from clinicaltrials.gov