Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT04824248

Weight Reduction in CLBP

Led by Vrije Universiteit Brussel · Updated on 2025-05-25

84

Participants Needed

2

Research Sites

82 weeks

Total Duration

On this page

Sponsors

V

Vrije Universiteit Brussel

Lead Sponsor

R

Rotterdam University of Applied Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

We will recruit overweight/ obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered in a blended format and will be a combination of online education material and face-to-face sessions with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.

CONDITIONS

Official Title

Weight Reduction in CLBP

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Overweight (BMI �3E�3D 25 kg/m2) or obese (BMI �3E�3D 30 kg/m2) with chronic low back pain
  • Non-specific low back pain for at least 3 months' duration
  • Currently seeking care for low back pain
  • Native Dutch speaker
  • Access to internet and computer/tablet/smartphone
Not Eligible

You will not qualify if you...

  • Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale
  • Evidence of specific spinal pathology such as hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture, or malignancy
  • Evidence of severe underlying comorbidity like diabetes, cardiovascular problems, or metabolic diseases
  • BMI �3E�3D 40 kg/m2
  • Being pregnant or having given birth in the past year
  • Currently receiving dietary or exercise interventions

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Vrije Universiteit Brussel

Brussels, Belgium

Actively Recruiting

2

Rotterdam University of Applied Sciences

Rotterdam, Netherlands

Actively Recruiting

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Research Team

A

Anneleen Malfliet, 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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