Weight loss program added to pain education and exercise for chronic low back pain
Tests adding weight loss to back pain care in overweight adults.
Key facts
- Who runs it
- Vrije Universiteit Brussel
- Where
- Brussels, BelgiumSee the siteAlso in 1 other country, 1 site
- Trial code
- Registry title
- Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT
- Status
- Recruiting
- People taking part
- 252 people, planned
- Started
- 13 Apr 2023
- Expected to end
- Nov 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Physiotherapy intervention, including behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy.
- Physiotherapy intervention, including pain neuroscience education and cognition-targeted exercise therapy alone.
- Record updated
- 20 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with overweight or obesity who have had low back pain for at least 3 months and are seeking care for it.
- Age
- 18 to 65 years
- Sex
- Women and men can join.
- Disease stage
- Overweight (BMI 25 or more) or obese (BMI 30 or more), with non-specific low back pain for at least 3 months. Leg pain must not be 7 or more out of 10.
- Earlier treatment
- People must continue their usual care for 6 weeks before and during the study. They must not be in a diet or exercise program now or in the past 6 weeks.
Main reasons for not taking part
- BMI of 40 or more
- Pregnant, breastfeeding, or gave birth in the past year
- Known spinal problem such as hernia, spinal stenosis, fracture, infection or cancer
- Severe other illness such as diagnosed diabetes, heart problems or an eating disorder
- Ongoing insurance problems or cases about their back
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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)
- 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
- Ongoing problems or cases with insurance companies regarding their back
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Belgium
Also in 1 other country, 1 site
- Vrije Universiteit BrusselBrussels, BelgiumContact: Anneleen Malfliet, PhDTaking people
About the trial
What the trial wants to find out
Chronic low back pain (CLBP) is the most expensive cause of workrelated disability: it causes the highest number of years lived with disability. The most severe and debilitated CLBP patients often have comorbidities such as overweight and obesity. Despite the growing body of scientific literature pointing towards the close interaction between overweight/obesity and CLBP, few treatment programs for people with CLBP nowadays take overweight into account. Therefore this study will examine the added value of a behavioral weight reduction program (changes in diet, behavior and physical exercise) to current best evidence rehabilitation (pain neuroscience education plus cognition-targeted exercise therapy) for overweight or obese people with CLBP. An international, multicenter randomized controlled trial comparing a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy versus pain neuroscience education and cognition-targeted exercise therapy alone, will be conducted. The primary outcome is pain and the primary endpoint was chosen at 12 months follow-up; secondary outcomes include health care use and daily functioning (see detailed description of outcomes for an overview of all secondary outcomes). If the promising results of the proof of concept study are corroborated, the new intervention will have a high socio-economic impact, including an annual health care cost reduction of €66 million in Switzerland, and €60 million in Flanders, and is expected to increase life expectancy in the long term.
The 2 groups in the trial
- Experimental InterventionTreatment being tested
Physiotherapy intervention, including behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy.
Treatment: Physiotherapy intervention, including behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy.
- Control InterventionExisting treatment, for comparison
Physiotherapy intervention, including pain neuroscience education and cognition-targeted exercise therapy alone.
Treatment: Physiotherapy intervention, including pain neuroscience education and cognition-targeted exercise therapy alone.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Lifestyle Intervention in Overweight/Obese People Suffering From Chronic Low Back Pain: an International Multi-center Randomized Controlled Trial
- Plain-language title
- Weight loss program added to pain education and exercise for chronic low back painGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05811624, who can take part
- Publications
- Record updated
- 20 August 2026