Actively Recruiting
Combined Lifestyle Intervention Delivered by Physio/Exercise Therapists for Persistent Low Back Pain in Overweight or Obese Patients A Randomized Trial with Economic Evaluation
Led by Willeke Boonstra · Updated on 2025-01-24
318
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Low back pain (LBP) is a major cause of disability worldwide and is associated with high healthcare costs. Lifestyle factors such as lack of physical activity, stress, poor sleep, excess weight, and unhealthy diet contribute to LBP and increased care needs. Many LBP patients visiting hospitals are overweight, forming a complex group often referred back to primary care because specialists cannot provide high-value care. This study evaluates whether integrating a combined lifestyle intervention into standard care can improve management and reduce costs for overweight or obese patients with persistent LBP referred from hospitals to primary care over 36 months. The trial studies a combined lifestyle intervention delivered by physiotherapy and exercise therapists, which integrates one of five recognized lifestyle programs (BeweegKuur, CooL, SSIB, SLIMMER, X-Fittt) with low back pain care. This intervention targets lifestyle factors like physical activity, sleep, and stress, alongside clinical factors related to LBP such as muscle strength, endurance, and mobility. The study compares this intervention to usual care over a period of 36 months. Participants will be assessed at baseline and multiple time points up to 36 months. Physical activity will be measured by the average daily steps using the activPAL device, and physical functioning will be assessed with the Roland Morris Disability Questionnaire. These outcomes are tracked at baseline, 6, 12, 24, and 36 months, with the primary focus on results at 36 months. The study also monitors the effectiveness and cost-effectiveness of the combined lifestyle intervention in improving physical function and activity in this patient group.
CONDITIONS
Official Title
A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with persistent (3 months or more) non-specific low back pain who are referred back from the hospital to primary care
- Body mass index (BMI) of 30 or higher OR BMI of 25 or higher with at least one comorbidity (osteoarthritis, sleep apnea, cardiovascular disease risk factors, or type 2 diabetes)
- Decreased physical functioning, with a Roland Morris Disability Questionnaire score of 4 or more out of 24
- Average low back pain intensity of 3 or higher out of 10 over the past week
- Age 18 years or older
You will not qualify if you...
- Specific low back pain causes such as tumor or fracture
- Back surgery in the past six months
- Psychiatric diseases that could hinder participation
- Pregnancy or less than 9 months postpartum
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vrije Universiteit Amsterdam
Amsterdam, Netherlands
Actively Recruiting
Research Team
G
Gwendolyne Scholten-Peeters, PhD, PT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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