Weight Reduction in CLBP
Recruiting · NCT04824248 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
2 locations listed.
- Vrije Universiteit Brussel - Brussels, Belgium
- Rotterdam University of Applied Sciences - Rotterdam, Netherlands