Chronic Low-back PainNCT04824248

Weight Reduction in CLBP

A study testing Pain Neuroscience Education, Cognition-targeted exercise therapy and Behavioral weight reduction program in people with Chronic Low-back Pain and Overweight or Obesity, run by Vrije Universiteit Brussel at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Low-back Pain, Overweight or Obesity
What is being tested?: Pain Neuroscience Education, Cognition-targeted exercise therapy and Behavioral weight reduction program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 2 sitesin 2 countries
Study dates: 1 May 2025to 1 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Anneleen Malfliet, PhD contact

003224774503

anneleen.malfliet@vub.be

Country

City, postcode or hospital

Sites recruiting now only

2 sites in 2 countries

Belgium1 site, 1 recruiting

Vrije Universiteit Brussel
Brussels
Anneleen Malfliet, PhD, anneleen.malfliet@vub.be
Recruiting

Other trials in Belgium

Netherlands1 site, 1 recruiting

Rotterdam University of Applied Sciences
Rotterdam
Lennard Voogt, PhD
Recruiting

Other trials in Netherlands

About this study

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

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.

Conditions: Chronic Low-back Pain, Overweight or Obesity
Being tested: Pain Neuroscience Education, Cognition-targeted exercise therapy, Behavioral weight reduction program
Keywords: chronic low back pain, chronic pain, physiotherapy, physical therapy, weight reduction, pain management
Medical subject headings: Overweight, Obesity, Chronic Pain, Weight Loss, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pain Neuroscience EducationBehavioural
Also called Pain 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.
Cognition-targeted exercise therapyBehavioural
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 programBehavioural
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.

Study groups in NCT04824248
Study group	Role	What they receive
Experimental intervention	Experimental	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 Receives: Behavioral: Pain Neuroscience Education; Behavioral: Cognition-targeted exercise therapy; Behavioral: Behavioral weight reduction program
Control intervention	Active comparator	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. Receives: Behavioral: Pain Neuroscience Education; Behavioral: Cognition-targeted exercise therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Measured: Change from baseline to 6 months (T3) after therapy completion
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Measured: Difference between groups at 6 months (T3) after therapy completion

Secondary outcomes (43)

Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Measured: Baseline assessment (T0)
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Measured: T1 assessment directly post treatment (i.e. 10 weeks after baseline)
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Measured: T2-assessment 3 months after therapy completion
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Measured: T3-assessment 6 months after therapy completion
Central sensitization inventory (CSI)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Measured: Baseline Assessment (T0)
Central sensitization inventory (CSI)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Central sensitization inventory (CSI)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Measured: T2-assessment 3 months after therapy completion
Central sensitization inventory (CSI)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Measured: T3-assessment 6 months after therapy completion
TANITA Bio-electrical Impedance Analyzer
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
Measured: Baseline assessment (T0)
TANITA Bio-electrical Impedance Analyzer
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA Bio-electrical Impedance Analyzer
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
Measured: T3-assessment 6 months after therapy completion
SECA wall-fixed SECA wall-fixed stadiometer
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
Measured: Baseline measurement
SECA wall-fixed SECA wall-fixed stadiometer
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
SECA wall-fixed SECA wall-fixed stadiometer
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
Measured: T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Body composition measurement - body fat
Measured: Baseline
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Body composition measurement - body fat
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Body composition measurement - body fat
Measured: T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Body composition measurement - fat free mass
Measured: Baseline
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Body composition measurement - fat free mass
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Body composition measurement - fat free mass
Measured: T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Body composition measurement - hydration status
Measured: Baseline
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Body composition measurement - hydration status
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Body composition measurement - hydration status
Measured: T3-assessment 6 months after therapy completion
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Measured: Baseline
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Measured: T2-assessment 3 months after therapy completion
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Measured: T3-assessment 6 months after therapy completion
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
Measured: Baseline
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
Measured: T2-assessment 3 months after therapy completion
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
Measured: T3-assessment 6 months after therapy completion
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Measured: Baseline
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Measured: T2-assessment 3 months after therapy completion
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Measured: T3-assessment 6 months after therapy completion
The Short Form Health Survey-36 items (SF-36)
Self report questionnaire to evaluate functional status and well-being or quality of life
Measured: Baseline
The Short Form Health Survey-36 items (SF-36)
Self report questionnaire to evaluate functional status and well-being or quality of life
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
The Short Form Health Survey-36 items (SF-36)
Self report questionnaire to evaluate functional status and well-being or quality of life
Measured: T2-assessment 3 months after therapy completion
The Short Form Health Survey-36 items (SF-36)
Self report questionnaire to evaluate functional status and well-being or quality of life
Measured: T3-assessment 6 months after therapy completion
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.
Measured: Baseline
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.
Measured: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
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.
Measured: T2-assessment 3 months after therapy completion
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.
Measured: T3-assessment 6 months after therapy completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20251 Dec 2027

First posted1 Apr 2021
Study start1 May 2025
Primary completion1 Dec 2027 (estimated)
Study completion1 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled clinical trial, including two comparative, balanced online treatment arms.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04824248
Sponsor's protocol ID: B.U.N. 1432021000411
Status last verified: Aug 2026
First submitted: 24 Mar 2021
Last updated: 20 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Anneleen Malfliet, PhD

003224774503

anneleen.malfliet@vub.be

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or Dysfunction

All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Added Value of a Behavioral Weight Reduction Program to Blended Rehabilitation in Patients With Chronic Low Back Pain: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04824248
Acronym / sponsor ID: B.U.N. 1432021000411
Conditions: Chronic Low-back Pain, Overweight or Obesity
Keywords: chronic low back pain, chronic pain, physiotherapy, physical therapy, weight reduction, pain management
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 84 participants (estimated)
Lead sponsor: Vrije Universiteit BrusselUniversity, hospital or other
Collaborators: Rotterdam University of Applied Sciences
Study start: 1 May 2025 (actual)
Primary completion: 1 Dec 2027 (estimated)
Study completion: 1 Dec 2027 (estimated)
First posted: 1 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized controlled clinical trial, including two comparative, balanced online treatment arms.

Arm	Type	Receives
Experimental intervention	Experimental	Behavioral: Pain Neuroscience Education, Behavioral: Cognition-targeted exercise therapy, Behavioral: Behavioral weight reduction program10 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
Control intervention	Active comparator	Behavioral: Pain Neuroscience Education, Behavioral: Cognition-targeted exercise therapyIdentically 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pain Neuroscience EducationAlso: Pain EducationIncrease 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.	Behavioural	Control intervention, Experimental intervention
Cognition-targeted exercise therapyDaily (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.	Behavioural	Control intervention, Experimental intervention
Behavioral weight reduction programChanges 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.	Behavioural	Experimental intervention

Primary outcome

Brief Pain inventory (BPI)
Time frame: Change from baseline to 6 months (T3) after therapy completion
Questionnaire for assessing clinical pain
Brief Pain inventory (BPI)
Time frame: Difference between groups at 6 months (T3) after therapy completion
Questionnaire for assessing clinical pain

43 secondary outcomes

Brief Pain inventory (BPI)
Time frame: Baseline assessment (T0)
Brief Pain inventory (BPI)
Time frame: T1 assessment directly post treatment (i.e. 10 weeks after baseline)
Brief Pain inventory (BPI)
Time frame: T2-assessment 3 months after therapy completion
Brief Pain inventory (BPI)
Time frame: T3-assessment 6 months after therapy completion
Central sensitization inventory (CSI)
Time frame: Baseline Assessment (T0)
Central sensitization inventory (CSI)
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Central sensitization inventory (CSI)
Time frame: T2-assessment 3 months after therapy completion
Central sensitization inventory (CSI)
Time frame: T3-assessment 6 months after therapy completion
TANITA Bio-electrical Impedance Analyzer
Time frame: Baseline assessment (T0)
TANITA Bio-electrical Impedance Analyzer
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA Bio-electrical Impedance Analyzer
Time frame: T3-assessment 6 months after therapy completion
SECA wall-fixed SECA wall-fixed stadiometer
Time frame: Baseline measurement
SECA wall-fixed SECA wall-fixed stadiometer
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
SECA wall-fixed SECA wall-fixed stadiometer
Time frame: T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Time frame: Baseline
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Time frame: T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Time frame: Baseline
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Time frame: T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Time frame: Baseline
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Time frame: T3-assessment 6 months after therapy completion
Food Frequency Questionnaire
Time frame: Baseline
Food Frequency Questionnaire
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Food Frequency Questionnaire
Time frame: T2-assessment 3 months after therapy completion
Food Frequency Questionnaire
Time frame: T3-assessment 6 months after therapy completion
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline
International Physical Activity Questionnaire (IPAQ)
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
International Physical Activity Questionnaire (IPAQ)
Time frame: T2-assessment 3 months after therapy completion
International Physical Activity Questionnaire (IPAQ)
Time frame: T3-assessment 6 months after therapy completion
Sedentary Behavior Questionnaire of Busschaert et a
Time frame: Baseline
Sedentary Behavior Questionnaire of Busschaert et a
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Sedentary Behavior Questionnaire of Busschaert et a
Time frame: T2-assessment 3 months after therapy completion
Sedentary Behavior Questionnaire of Busschaert et a
Time frame: T3-assessment 6 months after therapy completion
The Short Form Health Survey-36 items (SF-36)
Time frame: Baseline
The Short Form Health Survey-36 items (SF-36)
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
The Short Form Health Survey-36 items (SF-36)
Time frame: T2-assessment 3 months after therapy completion
The Short Form Health Survey-36 items (SF-36)
Time frame: T3-assessment 6 months after therapy completion
Fear avoidance Beliefs Questionnaire
Time frame: Baseline

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.

Related trials for Chronic Low-back Pain

Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain With Lumbar Multifidus Muscle Injury or Dysfunction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Anneleen Malfliet, PhD contact

003224774503

anneleen.malfliet@vub.be

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anneleen Malfliet, PhD (003224774503, anneleen.malfliet@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain inventory (BPI) (time frame: Change from baseline to 6 months (T3) after therapy completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04824248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.