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RecruitingNCT04824248Updated Aug 20, 2026

Weight Reduction in CLBP

An interventional study of Pain Neuroscience Education and Cognition-targeted exercise therapy in Chronic Low-back Pain and Overweight or Obesity, sponsored by Vrije Universiteit Brussel. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Vrije Universiteit Brussel · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Low-back Pain
  • Overweight or Obesity

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Keywords

  • chronic low back pain
  • chronic pain
  • physiotherapy
  • physical therapy
  • weight reduction
  • pain management
03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 84 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Vrije Universiteit Brussel is the lead sponsor of 158 studies on the registry; 43 are open to participants now.

Browse Vrije Universiteit Brussel studies →

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Overweight ( ≥ 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

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 )
  • Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases)
  • ≥ 40 kg/m2
  • Being pregnant or given birth in the preceding year
  • Currently receiving dietary or exercise interventions
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Experimental intervention

    10 weeks blended therapy delivered using a blended approach. The blended (online and on site) therapy consists of instructive video's, challenges to complete, 1-on-1 sessions with the therapist, online quizzes, online booklets, and online diaries/workbooks. . The experimental group will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. The combined therapy will adhere to guidelines for patient-centered care

    Behavioral: Pain Neuroscience Education · Behavioral: Cognition-targeted exercise therapy · Behavioral: Behavioral weight reduction program

  • Active comparator
    Control intervention

    Identically to the experimental intervention, the therapy is provided in a blended format within 10 weeks. Also identical to the experimental intervention, the control intervention will adhere to guidelines for patient-centered care. The control group will receive pain neuroscience education in combination with cognition-targeted exercise therapy alone.

    Behavioral: Pain Neuroscience Education · Behavioral: Cognition-targeted exercise therapy

Interventions

  • BehavioralPain Neuroscience Education

    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.

    Also known as: Pain Education

  • BehavioralCognition-targeted exercise therapy

    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.

  • BehavioralBehavioral weight reduction program

    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.

06

What researchers measure

Primary outcomes

  1. Brief Pain inventory (BPI)

    Questionnaire for assessing clinical pain

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

  2. Brief Pain inventory (BPI)

    Questionnaire for assessing clinical pain

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

Secondary outcomes

  1. Brief Pain inventory (BPI)

    Questionnaire for assessing clinical pain

    Time frame: Baseline assessment (T0)

  2. Brief Pain inventory (BPI)

    Questionnaire for assessing clinical pain

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

  3. Brief Pain inventory (BPI)

    Questionnaire for assessing clinical pain

    Time frame: T2-assessment 3 months after therapy completion

  4. Brief Pain inventory (BPI)

    Questionnaire for assessing clinical pain

    Time frame: T3-assessment 6 months after therapy completion

  5. Central sensitization inventory (CSI)

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

    Time frame: Baseline Assessment (T0)

  6. Central sensitization inventory (CSI)

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

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

  7. Central sensitization inventory (CSI)

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

    Time frame: T2-assessment 3 months after therapy completion

  8. Central sensitization inventory (CSI)

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

    Time frame: T3-assessment 6 months after therapy completion

  9. TANITA Bio-electrical Impedance Analyzer

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

    Time frame: Baseline assessment (T0)

  10. TANITA Bio-electrical Impedance Analyzer

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

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

  11. TANITA Bio-electrical Impedance Analyzer

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

    Time frame: T3-assessment 6 months after therapy completion

  12. SECA wall-fixed SECA wall-fixed stadiometer

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

    Time frame: Baseline measurement

  13. SECA wall-fixed SECA wall-fixed stadiometer

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

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

  14. SECA wall-fixed SECA wall-fixed stadiometer

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

    Time frame: T3-assessment 6 months after therapy completion

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

    Body composition measurement - body fat

    Time frame: Baseline

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

    Body composition measurement - body fat

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

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

    Body composition measurement - body fat

    Time frame: T3-assessment 6 months after therapy completion

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

    Body composition measurement - fat free mass

    Time frame: Baseline

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

    Body composition measurement - fat free mass

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

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

    Body composition measurement - fat free mass

    Time frame: T3-assessment 6 months after therapy completion

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

    Body composition measurement - hydration status

    Time frame: Baseline

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

    Body composition measurement - hydration status

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

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

    Body composition measurement - hydration status

    Time frame: T3-assessment 6 months after therapy completion

  24. Food Frequency Questionnaire

    Self report questionnaire to asses dietary intake

    Time frame: Baseline

  25. Food Frequency Questionnaire

    Self report questionnaire to asses dietary intake

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

  26. Food Frequency Questionnaire

    Self report questionnaire to asses dietary intake

    Time frame: T2-assessment 3 months after therapy completion

  27. Food Frequency Questionnaire

    Self report questionnaire to asses dietary intake

    Time frame: T3-assessment 6 months after therapy completion

  28. International Physical Activity Questionnaire (IPAQ)

    Self report questionnaire to asses physical activity

    Time frame: Baseline

  29. International Physical Activity Questionnaire (IPAQ)

    Self report questionnaire to asses physical activity

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

  30. International Physical Activity Questionnaire (IPAQ)

    Self report questionnaire to asses physical activity

    Time frame: T2-assessment 3 months after therapy completion

  31. International Physical Activity Questionnaire (IPAQ)

    Self report questionnaire to asses physical activity

    Time frame: T3-assessment 6 months after therapy completion

  32. Sedentary Behavior Questionnaire of Busschaert et a

    Self report questionnaire to asses sedentary behavior

    Time frame: Baseline

  33. Sedentary Behavior Questionnaire of Busschaert et a

    Self report questionnaire to asses sedentary behavior

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

  34. Sedentary Behavior Questionnaire of Busschaert et a

    Self report questionnaire to asses sedentary behavior

    Time frame: T2-assessment 3 months after therapy completion

  35. Sedentary Behavior Questionnaire of Busschaert et a

    Self report questionnaire to asses sedentary behavior

    Time frame: T3-assessment 6 months after therapy completion

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

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

    Time frame: Baseline

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

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

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

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

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

    Time frame: T2-assessment 3 months after therapy completion

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

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

    Time frame: T3-assessment 6 months after therapy completion

  40. Fear avoidance Beliefs Questionnaire

    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.

    Time frame: Baseline

  41. Fear avoidance Beliefs Questionnaire

    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.

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

  42. Fear avoidance Beliefs Questionnaire

    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.

    Time frame: T2-assessment 3 months after therapy completion

  43. Fear avoidance Beliefs Questionnaire

    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.

    Time frame: T3-assessment 6 months after therapy completion

07

Study locations

2 of 2 sites recruiting
  • Vrije Universiteit Brussel
    Brussels, Belgium
    Recruiting
  • Rotterdam University of Applied Sciences
    Rotterdam, Netherlands
    Recruiting
    • Lennard Voogt, PhD · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Dec 2027, 31 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 31 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2021
First posted
Apr 1, 2021
StartActual
May 1, 2025
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04824248
Lead sponsor
Vrije Universiteit Brussel
Collaborators
Rotterdam University of Applied Sciences
Responsible party
Malfliet Anneleen (Prof. Dr. Anneleen Malfiet, Vrije Universiteit Brussel) — Principal investigator
First posted
Apr 1, 2021
Start date
May 1, 2025
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Aug 20, 2026

Study contacts

Anneleen Malfliet, PhD
Contact
anneleen.malfliet@vub.be
003224774503

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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