Behavioral weight reduction program for overweight or obese patients with chronic low back pain
Lifestyle Intervention in Overweight/Obese People Suffering From Chronic Low Back Pain: an International Multi-center Randomized Controlled Trial
This study tests if a weight loss program that includes education about pain and special exercises can help overweight or obese people with chronic low back pain feel better compared to just the education and exercises alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vrije Universiteit Brussel Academic / other |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT05811624 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy for overweight or obese individuals suffering from chronic low back pain (CLBP). The study aims to compare this combined approach against standard pain neuroscience education and cognition-targeted exercise therapy alone. By focusing on lifestyle changes such as diet and physical activity, the trial seeks to address the complex health needs of patients with CLBP and comorbid obesity. Participants will be recruited from multiple international centers, ensuring a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 who are overweight or obese and have been experiencing chronic low back pain for at least three months.
Not a fit: Patients with a BMI of 40 kg/m² or higher, as well as those with specific health conditions that may require surgical intervention, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce pain and disability in overweight or obese patients with chronic low back pain.
How similar studies have performed: Previous studies have indicated a positive correlation between weight management and improvements in chronic pain conditions, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brussels and 1 other locations
- Vrije Universiteit Brussel — Brussels, Belgium (Recruiting)
- Berner Fachhochschule — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jo Nijs, PhD — Vrije Universiteit Brussel
- Study coordinator: Anneleen Malfliet, PhD
- Email: anneleen.malfliet@vub.be
- Phone: 003224774531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.