Weight reduction program for chronic low-back pain
The Added Value of a Behavioral Weight Reduction Program to Blended Rehabilitation in Patients With Chronic Low Back Pain: A Randomized Clinical Trial
NA · Vrije Universiteit Brussel · NCT04824248
This study is testing if a weight loss program combined with pain education and exercise can help overweight people with chronic low back pain feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vrije Universiteit Brussel (other) |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT04824248 on ClinicalTrials.gov |
What this trial studies
This study recruits overweight or obese individuals aged 18 to 65 who suffer from chronic nonspecific low back pain. Participants will be randomly assigned to one of two groups for a 10-week intervention, combining online education and face-to-face sessions with a physical therapist. The experimental group will receive a behavioral weight reduction program alongside pain neuroscience education and cognition-targeted exercise therapy, while the control group will only receive pain education and exercise therapy. The primary outcome measured will be pain intensity, with secondary outcomes including body composition and physical activity levels.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese individuals with chronic low back pain who are seeking care and can participate in a blended intervention format.
Not a fit: Patients with severe leg pain, specific spinal pathologies, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce pain and improve quality of life for patients with chronic low back pain who are overweight or obese.
How similar studies have performed: Other studies have shown promising results with similar approaches combining weight management and pain education, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels and 1 other locations
- Vrije Universiteit Brussel — Brussels, Belgium (RECRUITING)
- Rotterdam University of Applied Sciences — Rotterdam, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Anneleen Malfliet, PhD
- Email: anneleen.malfliet@vub.be
- Phone: 003224774503
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.
Conditions: Chronic Low-back Pain, Overweight or Obesity, chronic low back pain, chronic pain, physiotherapy, physical therapy, weight reduction, pain management