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Overweight Or Obesity / Physiotherapy intervention, including pain neuroscience education and cognition- / Chronic Low Back Pain · Interventional Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned international multicenter RCT comparing a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy to pain neuroscience education and cognition-targeted exercise therapy alone in overweight or obese patients with chronic low back pain. The study is currently recruiting and has not yet reported results; primary outcomes measured by Brief Pain Inventory average pain intensity at 12 months post-intervention are not yet available.
Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Overweight or Obesity, Chronic Low-back Pain; age from 18 Years; to 65 Years. Intervention: Experimental Intervention. Compared with: Control Intervention — Active Comparator. n = 252. 2 sites: Belgium, Switzerland.
This is a planned international multicenter RCT comparing a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy to pain neuroscience education and cognition-targeted exercise therapy alone in overweight or obese patients with chronic low back pain. The study is currently recruiting and has not yet reported results; primary outcomes measured by Brief Pain Inventory average pain intensity at 12 months post-intervention are not yet available.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a clinical trial registry record describing a planned study with no results posted; enrollment is ongoing and primary outcomes at 12 months have not yet been reported.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05811624). This is a study registration, not published results. Lead sponsor: Vrije Universiteit Brussel. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 252 participants (ESTIMATED). Conditions: Overweight or Obesity, Chronic Low-back Pain. Interventions: BEHAVIORAL: Physiotherapy intervention, including behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy.; BEHAVIORAL: Physiotherapy intervention, including pain neuroscience education and cognition-targeted exercise therapy alone.. Primary outcome measures: Brief Pain Inventory - Average pain Intensity , Change from baseline to 12 months post-intervention. Brief 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.
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