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Clinical Trials in Belgium / NCT04824248
Recruiting Not applicable

Weight Reduction in CLBP

NCT04824248 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2025-05-01
Last updated
2026-08-20

Condition(s) studied

Chronic Low-back PainOverweight or Obesity

Investigational drug(s) / intervention(s)

Pain Neuroscience EducationCognition-targeted exercise therapyBehavioral weight reduction program

Pain Neuroscience Education: Increase pain coping skills and educating 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.

Cognition-targeted exercise therapy: Daily (physical) activity and exercise therapy. To confront the patient with movements and activities that are feared, avoided and/or painful using a gradual and cognition-targeted approach.

Behavioral weight reduction program: Changes in diet, behavior and a physical exercise to reach weight loss. It will include a lifestyle approach, incorporating behavioral theories and constructs to assist and facilitate healthy energy balance related behavior.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 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 Exclusion Criteria: * Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale * Evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy) * Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases) * BMI ≥ 40 kg/m2 * Being pregnant or given birth in the preceding year * Currently receiving dietary or exercise interventions

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Vrije Universiteit Brussel Brussels Belgium Recruiting
Rotterdam University of Applied Sciences Rotterdam Netherlands Recruiting

More Vrije Universiteit Brussel trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04824248 on ClinicalTrials.gov ↗ ← All trials in Belgium