Lifestyle intervention for patients with persistent low back pain and obesity
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
This study is testing a new lifestyle program for people with ongoing low back pain who are overweight to see if it can help them feel better and improve their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VU University of Amsterdam Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06594796 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients suffering from persistent low back pain (LBP) who are also overweight or obese. It aims to implement a combined lifestyle intervention delivered by physiotherapists and exercise therapists, targeting both lifestyle factors and clinical aspects of LBP. The intervention includes strategies to improve physical activity, sleep, and stress management, alongside physiotherapy and exercise therapy. By addressing these factors, the study seeks to enhance patient functioning and reduce healthcare costs associated with LBP.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with persistent non-specific low back pain and a BMI of 25 or higher, particularly those with additional health comorbidities.
Not a fit: Patients with specific causes of low back pain, recent back surgery, or psychiatric conditions that may hinder participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients with persistent low back pain and obesity.
How similar studies have performed: Other studies have shown promising results with lifestyle interventions for similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam
- Vrije Universiteit Amsterdam — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Gwendolyne Scholten-Peeters, PhD, PT — VU University of Amsterdam
- Study coordinator: Gwendolyne Scholten-Peeters, PhD, PT
- Email: g.g.m.scholten-peeters@vu.nl
- Phone: 31 205988557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.