Weight Reduction in CLBP

Study Overview
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Brief Summary
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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 online and will be a combination of online education material and face-to-face video calls 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.

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

Conditions
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Chronic Low-back Pain, Overweight or Obesity

Intervention / Treatment
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* Behavioral: Pain Neuroscience Education
* Behavioral: Cognition-targeted exercise therapy
* Behavioral: Behavioral weight reduction program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial, including two comparative, balanced online treatment arms.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental intervention<br>10 weeks online therapy delivered using a blended approach. The online therapy consists of instructive video's, challenges to complete, 1-on-1 video calls 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<br>* 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.<br>* Other names: Pain Education;Behavioral: Cognition-targeted exercise therapy<br>* 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.<br>Behavioral: Behavioral weight reduction program<br>* 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.<br>|
| Active Comparator: Control intervention<br>Identically to the experimental intervention, the therapy is provided online 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<br>* 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.<br>* Other names: Pain Education;Behavioral: Cognition-targeted exercise therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic low back pain, chronic pain, physiotherapy, physical therapy, weight reduction, pain management