Behavioral weight reduction program for overweight or obese patients with chronic low back pain

Is this trial a fit for you?

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

What this trial studies

This clinical trial investigates the effectiveness of a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy for overweight or obese individuals suffering from chronic low back pain (CLBP). The study aims to compare this combined approach against standard pain neuroscience education and cognition-targeted exercise therapy alone. By focusing on lifestyle changes such as diet and physical activity, the trial seeks to address the complex health needs of patients with CLBP and comorbid obesity. Participants will be recruited from multiple international centers, ensuring a diverse patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults (18 - 65 years)
* Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) women and men.
* CLBP (n=252), which is defined as nonspecific low back pain for at least 3 months duration, currently seeking care for low back pain and leg pain not ≥ 7 (on a maximum of 10) on a numeric rating scale.
* Continue usual care 6 weeks prior to (to obtain a steady stat) and during study participation.
* Depending on the country of inclusion: Native Dutch speaker (for Belgium) or Native German speaker (for Switzerland).

Exclusion Criteria:

* Patients with BMI ≥ 40 kg/m² will be excluded as people being morbid obese are eligible to undergo abdominal surgery. Because BMI may not always correspond to the same body fat percentage in different individuals (e.g., athletic types with higher muscle mass may also have BMIs ≥ 25 km/kg²), each participant's body fat percentage will be measured using the TANITA and compared to the body fat percentage reference values. Participants with exceeding BMI but falling into the healthy fat percentage range (which is sex-, age- and ethnicity dependent will be excluded.
* Pregnant, currently breastfeeding or given birth in preceding year.
* Currently receiving dietary or exercise interventions or received in the past 6 weeks.
* Show evidence of specific spinal pathology based on self-report (e.g., hernia, spi-nal stenosis, spondylolisthesis, infection, spinal fracture or malignancy), or a se-vere underlying comorbidity specific diagnoses that interfere with treatment (e.g., diagnosed diabetes, cardiovascular problems, metabolic diseases)
* Other severe diseases based on current medication intake or being currently treated by a medical doctor for a specific diagnosis, (e.g. diagnosed eating disorders).
* Ongoing problems or cases with insurance companies regarding their back.

Where it's running

• Vrije Universiteit Brussel
  Brussels, Belgium Recruiting
• Berner Fachhochschule
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Jo Nijs, PhD — Vrije Universiteit Brussel
• Study coordinator: Anneleen Malfliet, PhD
• Email: anneleen.malfliet@vub.be
• Phone: 003224774531

Similar studies

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

• Weight reduction program for chronic low-back pain

  This study is testing if a weight loss program combined with pain education and exercise can help overweight people with chronic low back pain feel better.

  Recruiting at 2 sites Vrije Universiteit Brussel · Brussels and 1 other locations · NCT04824248

• Ultrasound-Guided Thoracolumbar Fascia Injection for Chronic Low Back Pain in Type 2 Diabetes

  This trial tests whether an ultrasound-guided injection into the thoracolumbar fascia, added to standard care, helps reduce chronic low back pain in adults with type 2 diabetes.

  Recruiting Kanuni Sultan Suleyman Training and Research Hospital · Küçükçekmece, Istanbul · NCT07927530

• Subcutaneous Fat, Back Muscles, and Spine Shape in Back Pain Patients

  This study tests whether body fat under the skin and features of back muscles and spine joints are linked to lumbar facet joint degeneration in adults with chronic low back pain.

  Recruiting Marmara University · Istanbul, Istanbul · NCT07860697

• GZC8072 tablets: safety and how the body handles it after a single dose in healthy people and after multiple doses in people who are overweight or obese

  This study tests GZC8072 tablets to see if they are safe and how they behave in the body after a single dose in healthy adults and after repeated doses in adults who are overweight or obese.

  Recruiting Phase 1 Gan & Lee Pharmaceuticals. · Beijing · NCT07784699

• See if serum BDNF levels relate to outcomes in chronic low back pain

  This study tests whether blood BDNF levels can help predict how patients with chronic low back pain will do over time.

  Recruiting Keimyung University Dongsan Medical Center · Daegu, Daegu · NCT07776379

• Correlating periostin levels with spinal degeneration in back pain

  This study tests whether periostin levels in the intervertebral disc relate to the severity of disc degeneration in people with chronic low back pain and spinal stenosis.

  Recruiting Keimyung University Dongsan Medical Center · Daegu, Daegu · NCT07776366

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.