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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
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.
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.
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.
Vrije Universiteit Brussel
Brussels, Belgium
RECRUITINGRotterdam University of Applied Sciences
Rotterdam, Netherlands
RECRUITINGBrief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Time frame: Change from baseline to 6 months (T3) after therapy completion
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Time frame: Difference between groups at 6 months (T3) after therapy completion
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Time frame: Baseline assessment (T0)
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Time frame: T1 assessment directly post treatment (i.e. 10 weeks after baseline)
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Time frame: T2-assessment 3 months after therapy completion
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Time frame: T3-assessment 6 months after therapy completion
Central sensitization inventory (CSI)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Time frame: Baseline Assessment (T0)
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)
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
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
TANITA Bio-electrical Impedance Analyzer
Body weight measurement used to calculate BMI (= weight\[kg\] / height\[m\]²)
Time frame: Baseline assessment (T0)
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)
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
SECA wall-fixed SECA wall-fixed stadiometer
Body height measurement used to calculate BMI (= weight\[kg\] / height\[m\]²)
Time frame: Baseline measurement
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)
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
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Body composition measurement - body fat
Time frame: Baseline
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)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Body composition measurement - body fat
Time frame: T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Body composition measurement - fat free mass
Time frame: Baseline
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)
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
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Body composition measurement - hydration status
Time frame: Baseline
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)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Body composition measurement - hydration status
Time frame: T3-assessment 6 months after therapy completion
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Time frame: Baseline
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Time frame: T2-assessment 3 months after therapy completion
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Time frame: T3-assessment 6 months after therapy completion
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
Time frame: Baseline
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)
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
Time frame: T2-assessment 3 months after therapy completion
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
Time frame: T3-assessment 6 months after therapy completion
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Time frame: Baseline
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)
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Time frame: T2-assessment 3 months after therapy completion
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Time frame: 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
Time frame: Baseline
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)
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
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
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
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)
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
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
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