NCT05811624 Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT
| NCT ID | NCT05811624 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vrije Universiteit Brussel |
| Condition | Overweight or Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 252 participants in total. It began in 2023-04-13 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Patients with BMI ≥ 40 kg/m² will be excluded as people being morbid obese are eligible to undergo abdominal surgery. Because BMI may not always correspond to the same body fat percentage in different individuals (e.g., athletic types with higher muscle mass may also have BMIs ≥ 25 km/kg²), each participant's body fat percentage will be measured using the TANITA and compared to the body fat percentage reference values. Participants with exceeding BMI but falling into the healthy fat percentage range (which is sex-, age- and ethnicity dependent will be excluded. * Pregnant, currently breastfeeding or given birth in preceding year. * Currently receiving dietary or exercise interventions or received in the past 6 weeks. * Show evidence of specific spinal pathology based on self-report (e.g., hernia, spi-nal stenosis, spondylolisthesis, infection, spinal fracture or malignancy), or a se-vere underlying comorbidity specific diagnoses that interfere with treatment (e.g., diagnosed diabetes, cardiovascular problems, metabolic diseases) * Other severe diseases based on current medication intake or being currently treated by a medical doctor for a specific diagnosis, (e.g. diagnosed eating disorders). * Ongoing problems or cases with insurance companies regarding their back.
Contact & Investigator
Jo Nijs, PhD
PRINCIPAL INVESTIGATOR
Vrije Universiteit Brussel
Frequently Asked Questions
Who can join the NCT05811624 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Overweight or Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05811624 currently recruiting?
Yes, NCT05811624 is actively recruiting participants. Contact the research team at anneleen.malfliet@vub.be for enrollment information.
Where is the NCT05811624 trial being conducted?
This trial is being conducted at Brussels, Belgium, Bern, Switzerland.
Who is sponsoring the NCT05811624 clinical trial?
NCT05811624 is sponsored by Vrije Universiteit Brussel. The principal investigator is Jo Nijs, PhD at Vrije Universiteit Brussel. The trial plans to enroll 252 participants.
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