Clinical trial

Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT

Recruiting now · Not applicable · 2 countries · Registry ID NCT05811624

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight or Obesity, Chronic Low-back Pain

Full registry criteria

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.

Treatments and study arms

Physiotherapy intervention, including behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy.

Behavioral

14 weeks, 18 treatment sessions This includes: * 3 sessions of Pain Neuroscience Education during the first two weeks (of which the second one will be held online). The aim is to to reconceptualize pain, to increase pain coping skills and to convince the patients that pain is in the brain, and that hypersensitivity of the central nervous system rather than local tissue damage contributes to their symptoms. * 15 sessions which will focus simultaneously on cognition-targeted exercise therapy and behavioral weight reduction. The aim of the exercise program is to confront the patient with movements and activities that are feared, avoided and/or painful. The behavioral weight reduction program includes a lifestyle approach, with changes in diet, behavior, and a physical exercise weight loss program, all aiming for a caloric deficit of 500 to 700 kcal/day.

Physiotherapy intervention, including pain neuroscience education and cognition-targeted exercise therapy alone.

Behavioral

14 weeks, 18 treatment sessions This includes: * 3 sessions of Pain Neuroscience Education during the first two weeks (of which the second one will be held online). The aim is to to reconceptualize pain, to increase pain coping skills and to convince the patients that pain is in the brain, and that hypersensitivity of the central nervous system rather than local tissue damage contributes to their symptoms. * 15 sessions which will only focus on cognition-targeted exercise therapy. The aim of the exercise program is to confront the patient with movements and activities that are feared, avoided and/or painful.

Primary outcomes

Brief Pain Inventory - Average pain IntensityChange from baseline to 12 months post-intervention

Since CLBP is a fluctuating condition, the question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e., 0-10, a decrease of 30% is considered as clinically significant) numeric rating scale (NRS). Higher scores indicate higher pain intensity.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Vrije Universiteit Brussel🇧🇪 Brussels, Belgium

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Anneleen Malfliet, PhDContact

Matteo Van Roose, MScContact

Wouter Van Bogaert, PhDSub Investigator

Berner Fachhochschule🇨🇭 Bern, Switzerland

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Heiner BaurContact

Melanie Liechti, MScContact

Jan Taeymans, PhDPrincipal Investigator