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| Name | Class |
|---|---|
| Rotterdam University of Applied Sciences | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain inventory (BPI) | Questionnaire for assessing clinical pain | Change from baseline to 6 months (T3) after therapy completion |
| Brief Pain inventory (BPI) | Questionnaire for assessing clinical pain | Difference between groups at 6 months (T3) after therapy completion |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain inventory (BPI) | Questionnaire for assessing clinical pain | Baseline assessment (T0) |
| Brief Pain inventory (BPI) | Questionnaire for assessing clinical pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anneleen Malfliet, PhD | Contact | 003224774503 | anneleen.malfliet@vub.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vrije Universiteit Brussel | Recruiting | Brussels | Belgium |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D059350 | Chronic Pain |
| D015431 | Weight Loss |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Randomized controlled clinical trial, including two comparative, balanced online treatment arms.
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| 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. |
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| 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. |
|
| T1 assessment directly post treatment (i.e. 10 weeks after baseline) |
| Brief Pain inventory (BPI) | Questionnaire for assessing clinical pain | T2-assessment 3 months after therapy completion |
| Brief Pain inventory (BPI) | Questionnaire for assessing clinical pain | T3-assessment 6 months after therapy completion |
| Central sensitization inventory (CSI) | Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms. | Baseline Assessment (T0) |
| Central sensitization inventory (CSI) | Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms. | 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. | T2-assessment 3 months after therapy completion |
| Central sensitization inventory (CSI) | Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms. | T3-assessment 6 months after therapy completion |
| TANITA Bio-electrical Impedance Analyzer | Body weight measurement used to calculate BMI (= weight[kg] / height[m]²) | Baseline assessment (T0) |
| TANITA Bio-electrical Impedance Analyzer | Body weight measurement used to calculate BMI (= weight[kg] / height[m]²) | 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) | 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) | Baseline measurement |
| SECA wall-fixed SECA wall-fixed stadiometer | Body height measurement used to calculate BMI (= weight[kg] / height[m]²) | 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) | T3-assessment 6 months after therapy completion |
| TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat | Body composition measurement - body fat | Baseline |
| TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat | Body composition measurement - body fat | 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 | T3-assessment 6 months after therapy completion |
| TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass | Body composition measurement - fat free mass | Baseline |
| TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass | Body composition measurement - fat free mass | 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 | T3-assessment 6 months after therapy completion |
| TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status | Body composition measurement - hydration status | Baseline |
| TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status | Body composition measurement - hydration status | 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 | T3-assessment 6 months after therapy completion |
| Food Frequency Questionnaire | Self report questionnaire to asses dietary intake | Baseline |
| Food Frequency Questionnaire | Self report questionnaire to asses dietary intake | T1-assessment directly post-treatment (i.e. 10 weeks after baseline) |
| Food Frequency Questionnaire | Self report questionnaire to asses dietary intake | T2-assessment 3 months after therapy completion |
| Food Frequency Questionnaire | Self report questionnaire to asses dietary intake | T3-assessment 6 months after therapy completion |
| International Physical Activity Questionnaire (IPAQ) | Self report questionnaire to asses physical activity | Baseline |
| International Physical Activity Questionnaire (IPAQ) | Self report questionnaire to asses physical activity | T1-assessment directly post-treatment (i.e. 10 weeks after baseline) |
| International Physical Activity Questionnaire (IPAQ) | Self report questionnaire to asses physical activity | T2-assessment 3 months after therapy completion |
| International Physical Activity Questionnaire (IPAQ) | Self report questionnaire to asses physical activity | T3-assessment 6 months after therapy completion |
| Sedentary Behavior Questionnaire of Busschaert et a | Self report questionnaire to asses sedentary behavior | Baseline |
| Sedentary Behavior Questionnaire of Busschaert et a | Self report questionnaire to asses sedentary behavior | 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 | T2-assessment 3 months after therapy completion |
| Sedentary Behavior Questionnaire of Busschaert et a | Self report questionnaire to asses sedentary behavior | 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 | Baseline |
| The Short Form Health Survey-36 items (SF-36) | Self report questionnaire to evaluate functional status and well-being or quality of life | 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 | 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 | 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. | 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. | 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. | 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. | T3-assessment 6 months after therapy completion |
| Rotterdam University of Applied Sciences | Recruiting | Rotterdam | Netherlands |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D001836 | Body Weight Changes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |