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

NCT05811624 | Recruiting

• 4 other identifiers: BUN1432022000296G094322N2022-02210S011866-42-PHYW
• Study Type: interventional
• Target: 252
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Overweight or Obesity; Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory - Average pain Intensity

  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.

  Change from baseline to 12 months post-intervention

Secondary Outcomes (19)

• Brief Pain Inventory - Pain intensity (Average, worst, least, now)

  This outcome will be assessed at Baseline, directly post-treatment, 3 months post-treatment, 6 months post-treatment and 12 months past-treatment

• Brief Pain Inventory - Pain interference on functioning

  This outcome will be assessed at Baseline, directly post-treatment, 3 months post-treatment, 6 months post-treatment and 12 months past-treatment

• Pain distribution and pain extent by pain drawings

  This outcome will be assessed at Baseline, directly post-treatment, and 12 months past-treatment

• Tampa Scale for Kinesiophobia (TSK)

  This outcome will be assessed at Baseline, directly post-treatment, 3 months post-treatment, 6 months post-treatment and 12 months past-treatment

• Fear Avoidance Belief Questionnaire

  This outcome will be assessed at Baseline, directly post-treatment, 3 months post-treatment, 6 months post-treatment and 12 months past-treatment

Study Arms (2)

Experimental Intervention

EXPERIMENTAL

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

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

Control Intervention

ACTIVE COMPARATOR

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

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

Interventions

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.

Also known as: EXP (Experimental intervention)

Experimental Intervention

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.

Also known as: CON (Control intervention)

Control Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Bern University of Applied Sciences: collaborator
• University of Applied Sciences and Arts of Southern Switzerland: collaborator

Study Sites (2)

Vrije Universiteit Brussel

Brussels, 1090, Belgium

RECRUITING

Berner Fachhochschule

Bern, 3012, Switzerland

RECRUITING

Related Publications (2)

• Schurz AP, Lutz N, Liechti M, Malfliet A, Vanroose M, Maebe Z, Nijs J, Van Bogaert W, Clarys P, Clijsen R, Baur H, Taeymans J, Deliens T. Cost of illness analysis in individuals with overweight or obesity and chronic low back pain in the Bern metropolitan area (the BO2WL trial). Front Public Health. 2026 Jan 13;13:1705891. doi: 10.3389/fpubh.2025.1705891. eCollection 2025.

  PMID: 41607914 DERIVED

• Schurz AP, Deliens T, Liechti M, Vanroose M, Clijsen R, Nijs J, Malfliet A, Van Bogaert W, Clarys P, Baur H, Taeymans J, Lutz N. Economic evaluation of a lifestyle intervention for individuals with overweight or obesity suffering from chronic low back pain (the BO2WL trial): a protocol for a health economic analysis. BMJ Open. 2025 Jun 20;15(6):e098272. doi: 10.1136/bmjopen-2024-098272.

  PMID: 40541436 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jo Nijs, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anneleen Malfliet, PhD

CONTACT

003224774531; anneleen.malfliet@vub.be

Jo Nijs, PhD

CONTACT

jo.nijs@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: Study participants will be randomized (1/1) into one of the two treatment arms (control or intervention)

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 13, 2023
• Study Start: April 13, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); BE (1)