Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2025-05-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Pain 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.
Cognition-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.
Behavioral 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.
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.
Pain 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.
Cognition-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.
Interventions
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Pain 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.
Cognition-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.
Behavioral 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Rotterdam University of Applied Sciences
OTHER
Vrije Universiteit Brussel
OTHER
Responsible Party
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Malfliet Anneleen
Prof. Dr. Anneleen Malfiet
Locations
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Vrije Universiteit Brussel
Brussels, , Belgium
Rotterdam University of Applied Sciences
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Lennard Voogt, PhD
Role: primary
Other Identifiers
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B.U.N. 1432021000411
Identifier Type: -
Identifier Source: org_study_id
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