Clinical Trial

Weight Reduction in CLBP

Recruiting
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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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-03-26; most recent amendment 2025-05-20.
Status change: Not Yet Recruiting → Recruiting 2021-04-12
Trial Details
NCT Number NCT04824248
Lead Sponsor Vrije Universiteit Brussel
Collaborators: Rotterdam University of Applied Sciences
Conditions Chronic Low-back Pain, Overweight or Obesity
Enrollment 84 participants
Start Date 2025-05-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-25