NCT06594796 A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity
| NCT ID | NCT06594796 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Willeke Boonstra |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 318 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 318 participants in total. It began in 2025-01-20 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients with persistent (≥3 months) non-specific LBP who are referred back from the hospital to primary care * Either BMI≥30 OR BMI≥25 with at least one comorbidity (osteoarthritis, sleep apnea, risk factors for cardiovascular diseases or type 2 diabetes) * Decreased physical functioning (RMDQ ≥4 out of 24) * Average LBP intensity of ≥3 out of 10 over the past week (NPRS) * ≥18 years old Exclusion Criteria: * Specific LBP (e.g., tumor or fracture) * Back surgery in the past six months * Psychiatric diseases that could hinder participation * Pregnancy or ≤9 months postpartum
Contact & Investigator
Gwendolyne Scholten-Peeters, PhD, PT
PRINCIPAL INVESTIGATOR
VU University of Amsterdam
Frequently Asked Questions
Who can join the NCT06594796 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06594796 currently recruiting?
Yes, NCT06594796 is actively recruiting participants. Contact the research team at g.g.m.scholten-peeters@vu.nl for enrollment information.
Where is the NCT06594796 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06594796 clinical trial?
NCT06594796 is sponsored by Willeke Boonstra. The principal investigator is Gwendolyne Scholten-Peeters, PhD, PT at VU University of Amsterdam. The trial plans to enroll 318 participants.