Actively Recruiting
A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity
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 the leading cause of disability worldwide and is costly. Lifestyle factors, such as physical inactivity, stress, sleep, excess weight, and an unhealthy diet contribute to the burden of LBP and the associated increasing demand for care. Moreover, approximately 65% of LBP patients who visit the hospital are overweight. This group is considered a complex patient group. Of the LBP patients who visit the hospital, 74% are referred back to primary care as medical specialists cannot offer them high value care. Targeting both lifestyle factors (e.g., physical activity, sleep and stress) and clinical factors related to low back pain (e.g., muscle strength, endurance, mobility) is important in the management of this group of LBP patients to improve important outcomes (e.g., functioning, physical activity) and reduce costs. Addressing lifestyle factors may also offer additional health benefits like decreased risks of diabetes and cardiovascular diseases. The primary objective of this project is to improve the management of this complex group of LBP patients, that is, patients who are overweight or obese and who are referred back to primary care from the hospital because medical specialists cannot offer them high value care, and to reduce healthcare and societal costs. The primary research question is: 'Is a combined lifestyle intervention, integrated into standard care for LBP, delivered by physio/exercise therapists effective and cost-effective in improving physical functioning and/or physical activity over a 36-month period compared to usual care in overweight or obese LBP patients who are referred back from the hospital to primary care?' It is hypothesized that the combined lifestyle intervention, integrated into standard care for LBP, is both effective and cost-effective in managing LBP in patients who are overweight or obese over a 36-month period.
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
AI-Powered 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
CONTACT
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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