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Weight Reduction in CLBP

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ClinicalTrials.gov Identifier: NCT04824248
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Malfliet Anneleen, Vrije Universiteit Brussel

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Overweight or Obesity Behavioral: Pain Neuroscience Education Behavioral: Cognition-targeted exercise therapy Behavioral: Behavioral weight reduction program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled clinical trial, including two comparative, balanced online treatment arms.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental intervention
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
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.
Other Name: Pain Education

Behavioral: 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: 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.
Active Comparator: Control intervention
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
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.
Other Name: Pain Education

Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Brief Pain inventory (BPI) [ Time Frame: Change from baseline to 6 months (T3) after therapy completion ]
    Questionnaire for assessing clinical pain

  2. Brief Pain inventory (BPI) [ Time Frame: Difference between groups at 6 months (T3) after therapy completion ]
    Questionnaire for assessing clinical pain


Secondary Outcome Measures :
  1. Brief Pain inventory (BPI) [ Time Frame: Baseline assessment (T0) ]
    Questionnaire for assessing clinical pain

  2. Brief Pain inventory (BPI) [ Time Frame: T1 assessment directly post treatment (i.e. 10 weeks after baseline) ]
    Questionnaire for assessing clinical pain

  3. Brief Pain inventory (BPI) [ Time Frame: T2-assessment 3 months after therapy completion ]
    Questionnaire for assessing clinical pain

  4. Brief Pain inventory (BPI) [ Time Frame: T3-assessment 6 months after therapy completion ]
    Questionnaire for assessing clinical pain

  5. Central sensitization inventory (CSI) [ Time Frame: Baseline Assessment (T0) ]
    Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.

  6. Central sensitization inventory (CSI) [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.

  7. Central sensitization inventory (CSI) [ Time Frame: T2-assessment 3 months after therapy completion ]
    Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.

  8. Central sensitization inventory (CSI) [ Time Frame: T3-assessment 6 months after therapy completion ]
    Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.

  9. TANITA Bio-electrical Impedance Analyzer [ Time Frame: Baseline assessment (T0) ]
    Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)

  10. TANITA Bio-electrical Impedance Analyzer [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)

  11. TANITA Bio-electrical Impedance Analyzer [ Time Frame: T3-assessment 6 months after therapy completion ]
    Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)

  12. SECA wall-fixed SECA wall-fixed stadiometer [ Time Frame: Baseline measurement ]
    Body height measurement used to calculate BMI (= weight[kg] / height[m]²)

  13. SECA wall-fixed SECA wall-fixed stadiometer [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Body height measurement used to calculate BMI (= weight[kg] / height[m]²)

  14. SECA wall-fixed SECA wall-fixed stadiometer [ Time Frame: T3-assessment 6 months after therapy completion ]
    Body height measurement used to calculate BMI (= weight[kg] / height[m]²)

  15. TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat [ Time Frame: Baseline ]
    Body composition measurement - body fat

  16. TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Body composition measurement - body fat

  17. TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat [ Time Frame: T3-assessment 6 months after therapy completion ]
    Body composition measurement - body fat

  18. TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass [ Time Frame: Baseline ]
    Body composition measurement - fat free mass

  19. TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Body composition measurement - fat free mass

  20. TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass [ Time Frame: T3-assessment 6 months after therapy completion ]
    Body composition measurement - fat free mass

  21. TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status [ Time Frame: Baseline ]
    Body composition measurement - hydration status

  22. TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Body composition measurement - hydration status

  23. TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status [ Time Frame: T3-assessment 6 months after therapy completion ]
    Body composition measurement - hydration status

  24. Food Frequency Questionnaire [ Time Frame: Baseline ]
    Self report questionnaire to asses dietary intake

  25. Food Frequency Questionnaire [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Self report questionnaire to asses dietary intake

  26. Food Frequency Questionnaire [ Time Frame: T2-assessment 3 months after therapy completion ]
    Self report questionnaire to asses dietary intake

  27. Food Frequency Questionnaire [ Time Frame: T3-assessment 6 months after therapy completion ]
    Self report questionnaire to asses dietary intake

  28. International Physical Activity Questionnaire (IPAQ) [ Time Frame: Baseline ]
    Self report questionnaire to asses physical activity

  29. International Physical Activity Questionnaire (IPAQ) [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Self report questionnaire to asses physical activity

  30. International Physical Activity Questionnaire (IPAQ) [ Time Frame: T2-assessment 3 months after therapy completion ]
    Self report questionnaire to asses physical activity

  31. International Physical Activity Questionnaire (IPAQ) [ Time Frame: T3-assessment 6 months after therapy completion ]
    Self report questionnaire to asses physical activity

  32. Sedentary Behavior Questionnaire of Busschaert et a [ Time Frame: Baseline ]
    Self report questionnaire to asses sedentary behavior

  33. Sedentary Behavior Questionnaire of Busschaert et a [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Self report questionnaire to asses sedentary behavior

  34. Sedentary Behavior Questionnaire of Busschaert et a [ Time Frame: T2-assessment 3 months after therapy completion ]
    Self report questionnaire to asses sedentary behavior

  35. Sedentary Behavior Questionnaire of Busschaert et a [ Time Frame: T3-assessment 6 months after therapy completion ]
    Self report questionnaire to asses sedentary behavior

  36. The Short Form Health Survey-36 items (SF-36) [ Time Frame: Baseline ]
    Self report questionnaire to evaluate functional status and well-being or quality of life

  37. The Short Form Health Survey-36 items (SF-36) [ Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline) ]
    Self report questionnaire to evaluate functional status and well-being or quality of life

  38. The Short Form Health Survey-36 items (SF-36) [ Time Frame: T2-assessment 3 months after therapy completion ]
    Self report questionnaire to evaluate functional status and well-being or quality of life

  39. The Short Form Health Survey-36 items (SF-36) [ Time Frame: T3-assessment 6 months after therapy completion ]
    Self report questionnaire to evaluate functional status and well-being or quality of life


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824248


Contacts
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Contact: Anneleen Malfliet, PhD 003224774503 anneleen.malfliet@vub.be

Locations
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Belgium
Vrije Universiteit Brussel Recruiting
Brussels, Belgium
Contact: Anneleen Malfliet, PhD       anneleen.malfliet@vub.be   
Sponsors and Collaborators
Vrije Universiteit Brussel
More Information
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Responsible Party: Malfliet Anneleen, Prof. Dr. Anneleen Malfiet, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT04824248    
Other Study ID Numbers: B.U.N. 1432021000411
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malfliet Anneleen, Vrije Universiteit Brussel:
chronic low back pain
chronic pain
physiotherapy
 physical therapy
weight reduction
pain management
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Overweight
Weight Loss
 Pain
Neurologic Manifestations
Body Weight
Body Weight Changes