Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Lifestyle intervention for patients with persistent low back pain and obesity

Official title: 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

Run by VU University of Amsterdam · NCT06594796 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment318 (estimated)
SponsorVU University of Amsterdam
Academic / other
Locations1 site (Amsterdam)
StatusRecruiting
StartedJanuary 20, 2025
Main results expectedFebruary 2029
Study endsFebruary 2029
Registry record updatedJanuary 24, 2025
Trial IDNCT06594796 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promising results with lifestyle interventions for similar patient populations, indicating potential for success in this approach.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.