Actively Recruiting
A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity: a Randomized Controlled Trial with Parallel Economic Evaluation
Led by Willeke Boonstra · Updated on 2025-01-24
318
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined lifestyle intervention integrated into standard care for patients with persistent low back pain (LBP) who are overweight or obese and referred back to primary care from the hospital. The study aims to improve physical functioning and physical activity over 36 months, while also reducing healthcare and societal costs. Lifestyle factors like physical inactivity, stress, sleep quality, excess weight, and diet are addressed because they contribute to LBP and related health risks such as diabetes and cardiovascular disease. The intervention is delivered by certified physio/exercise therapists following Dutch clinical guidelines. It includes a two-year program where the first six months focus on behavioral change, and the next 18 months focus on maintaining new healthy habits. The program uses group and individual sessions with techniques such as motivational interviewing and self-monitoring. Patients set their own goals and treatment is tailored to their lifestyle risks and LBP clinical factors. The comparison group receives usual care as prescribed by medical specialists, which may include education, exercise therapy, pain medication, or referral back to primary care. Participants will attend scheduled assessments at baseline and multiple follow-up points over 36 months. Researchers will measure physical activity using a device that tracks daily steps and assess physical functioning with a disability questionnaire. Additional evaluations include pain intensity, weight, sleep quality, diet, inflammation markers, quality of life, healthcare costs, and overall perceived effect. These measurements will help determine the effectiveness and cost-effectiveness of the combined lifestyle intervention compared to usual care in this patient group.
CONDITIONS
Brief 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 related condition such as osteoarthritis, sleep apnea, cardiovascular risk factors, or type 2 diabetes
- Decreased physical functioning with a Roland Morris Disability Questionnaire score of 4 or higher out of 24
- Average low back pain intensity of 3 or higher out of 10 over the past week
- 18 years old 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 interfere with participation
- Pregnancy or less than 9 months postpartum
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 years
Participants receive a combined lifestyle intervention integrated with low back pain care, focusing on behavioral change and maintenance over two years.
Group and individual sessions throughout the first 6 months for behavioral change, followed by ongoing support for 18 months
Duration - Up to 36 months from baseline
Participants are assessed for physical activity, pain, weight, sleep quality, food intake, inflammation, quality of life, and costs up to 36 months from baseline.
Assessments at baseline, 3, 6, 9, 12, 18, 24, 30, and 36 months
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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