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NCT Number: NCT04824248

Weight Reduction in CLBP

We will recruit overweight/ obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered in a blended format and will be a combination of online education material and face-to-face sessions with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.

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Key information

Conditions

Chronic Low-back Pain Agnosia Body Weight Body Weight Changes Chronic Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrije Universiteit Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) with chronic low back pain
  • Non-specific low back pain for at least 3 months' duration
  • Currently seeking care for low back pain
  • Native Dutch speaker
  • Access to internet and computer/tablet/smartphone

Exclusion criteria

  • Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale
  • Evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
  • Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases)
  • BMI ≥ 40 kg/m2
  • Being pregnant or given birth in the preceding year
  • Currently receiving dietary or exercise interventions

Treatment and study plan

pain neuroscience education

Behavioral

Increase pain coping skills and educating 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.

Other names: Pain Education

Cognition-targeted exercise therapy

Behavioral

Daily (physical) activity and exercise therapy. To confront the patient with movements and activities that are feared, avoided and/or painful using a gradual and cognition-targeted approach.

Behavioral weight reduction program

Behavioral

Changes in diet, behavior and a physical exercise to reach weight loss. It will include a lifestyle approach, incorporating behavioral theories and constructs to assist and facilitate healthy energy balance related behavior.

Primary outcomes

  1. Brief Pain inventory (BPI)

    Time frame: Change from baseline to 6 months (T3) after therapy completion

    Questionnaire for assessing clinical pain

  2. Brief Pain inventory (BPI)

    Time frame: Difference between groups at 6 months (T3) after therapy completion

    Questionnaire for assessing clinical pain

Secondary outcomes

  1. Brief Pain inventory (BPI)

    Time frame: Baseline assessment (T0)

    Questionnaire for assessing clinical pain

  2. Brief Pain inventory (BPI)

    Time frame: T1 assessment directly post treatment (i.e. 10 weeks after baseline)

    Questionnaire for assessing clinical pain

  3. Brief Pain inventory (BPI)

    Time frame: T2-assessment 3 months after therapy completion

    Questionnaire for assessing clinical pain

  4. Brief Pain inventory (BPI)

    Time frame: T3-assessment 6 months after therapy completion

    Questionnaire for assessing clinical pain

  5. Central sensitization inventory (CSI)

    Time frame: Baseline Assessment (T0)

    Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.

  6. Central sensitization inventory (CSI)

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.

  7. Central sensitization inventory (CSI)

    Time frame: T2-assessment 3 months after therapy completion

    Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.

  8. Central sensitization inventory (CSI)

    Time frame: T3-assessment 6 months after therapy completion

    Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.

  9. TANITA Bio-electrical Impedance Analyzer

    Time frame: Baseline assessment (T0)

    Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)

  10. TANITA Bio-electrical Impedance Analyzer

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)

  11. TANITA Bio-electrical Impedance Analyzer

    Time frame: T3-assessment 6 months after therapy completion

    Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)

  12. SECA wall-fixed SECA wall-fixed stadiometer

    Time frame: Baseline measurement

    Body height measurement used to calculate BMI (= weight[kg] / height[m]²)

  13. SECA wall-fixed SECA wall-fixed stadiometer

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Body height measurement used to calculate BMI (= weight[kg] / height[m]²)

  14. SECA wall-fixed SECA wall-fixed stadiometer

    Time frame: T3-assessment 6 months after therapy completion

    Body height measurement used to calculate BMI (= weight[kg] / height[m]²)

  15. TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat

    Time frame: Baseline

    Body composition measurement - body fat

  16. TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Body composition measurement - body fat

  17. TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat

    Time frame: T3-assessment 6 months after therapy completion

    Body composition measurement - body fat

  18. TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass

    Time frame: Baseline

    Body composition measurement - fat free mass

  19. TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Body composition measurement - fat free mass

  20. TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass

    Time frame: T3-assessment 6 months after therapy completion

    Body composition measurement - fat free mass

  21. TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status

    Time frame: Baseline

    Body composition measurement - hydration status

  22. TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Body composition measurement - hydration status

  23. TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status

    Time frame: T3-assessment 6 months after therapy completion

    Body composition measurement - hydration status

  24. Food Frequency Questionnaire

    Time frame: Baseline

    Self report questionnaire to asses dietary intake

  25. Food Frequency Questionnaire

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Self report questionnaire to asses dietary intake

  26. Food Frequency Questionnaire

    Time frame: T2-assessment 3 months after therapy completion

    Self report questionnaire to asses dietary intake

  27. Food Frequency Questionnaire

    Time frame: T3-assessment 6 months after therapy completion

    Self report questionnaire to asses dietary intake

  28. International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline

    Self report questionnaire to asses physical activity

  29. International Physical Activity Questionnaire (IPAQ)

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Self report questionnaire to asses physical activity

  30. International Physical Activity Questionnaire (IPAQ)

    Time frame: T2-assessment 3 months after therapy completion

    Self report questionnaire to asses physical activity

  31. International Physical Activity Questionnaire (IPAQ)

    Time frame: T3-assessment 6 months after therapy completion

    Self report questionnaire to asses physical activity

  32. Sedentary Behavior Questionnaire of Busschaert et a

    Time frame: Baseline

    Self report questionnaire to asses sedentary behavior

  33. Sedentary Behavior Questionnaire of Busschaert et a

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Self report questionnaire to asses sedentary behavior

  34. Sedentary Behavior Questionnaire of Busschaert et a

    Time frame: T2-assessment 3 months after therapy completion

    Self report questionnaire to asses sedentary behavior

  35. Sedentary Behavior Questionnaire of Busschaert et a

    Time frame: T3-assessment 6 months after therapy completion

    Self report questionnaire to asses sedentary behavior

  36. The Short Form Health Survey-36 items (SF-36)

    Time frame: Baseline

    Self report questionnaire to evaluate functional status and well-being or quality of life

  37. The Short Form Health Survey-36 items (SF-36)

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Self report questionnaire to evaluate functional status and well-being or quality of life

  38. The Short Form Health Survey-36 items (SF-36)

    Time frame: T2-assessment 3 months after therapy completion

    Self report questionnaire to evaluate functional status and well-being or quality of life

  39. The Short Form Health Survey-36 items (SF-36)

    Time frame: T3-assessment 6 months after therapy completion

    Self report questionnaire to evaluate functional status and well-being or quality of life

  40. Fear avoidance Beliefs Questionnaire

    Time frame: Baseline

    Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability.

  41. Fear avoidance Beliefs Questionnaire

    Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)

    Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability.

  42. Fear avoidance Beliefs Questionnaire

    Time frame: T2-assessment 3 months after therapy completion

    Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability.

  43. Fear avoidance Beliefs Questionnaire

    Time frame: T3-assessment 6 months after therapy completion

    Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Anneleen Malfliet, PhD

CONTACT

[email protected]

003224774503

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • Rotterdam University of Applied Sciences

Registry information

Official study title

The Added Value of a Behavioral Weight Reduction Program to Blended Rehabilitation in Patients With Chronic Low Back Pain: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2021
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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