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Weight Reduction in CLBP

Primary Purpose

Chronic Low-back Pain, Overweight or Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pain Neuroscience Education
Cognition-targeted exercise therapy
Behavioral weight reduction program
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring chronic low back pain, chronic pain, physiotherapy, physical therapy, weight reduction, pain management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vrije Universiteit BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental intervention

Control intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain

Secondary Outcome Measures

Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Brief Pain inventory (BPI)
Questionnaire for assessing clinical pain
Central sensitization inventory (CSI)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Central sensitization inventory (CSI)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Central sensitization inventory (CSI)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Central sensitization inventory (CSI)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
TANITA Bio-electrical Impedance Analyzer
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
TANITA Bio-electrical Impedance Analyzer
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
TANITA Bio-electrical Impedance Analyzer
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
SECA wall-fixed SECA wall-fixed stadiometer
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
SECA wall-fixed SECA wall-fixed stadiometer
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
SECA wall-fixed SECA wall-fixed stadiometer
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Body composition measurement - body fat
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Body composition measurement - body fat
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Body composition measurement - body fat
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Body composition measurement - fat free mass
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Body composition measurement - fat free mass
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Body composition measurement - fat free mass
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Body composition measurement - hydration status
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Body composition measurement - hydration status
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Body composition measurement - hydration status
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
Food Frequency Questionnaire
Self report questionnaire to asses dietary intake
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
International Physical Activity Questionnaire (IPAQ)
Self report questionnaire to asses physical activity
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
Sedentary Behavior Questionnaire of Busschaert et a
Self report questionnaire to asses sedentary behavior
The Short Form Health Survey-36 items (SF-36)
Self report questionnaire to evaluate functional status and well-being or quality of life
The Short Form Health Survey-36 items (SF-36)
Self report questionnaire to evaluate functional status and well-being or quality of life
The Short Form Health Survey-36 items (SF-36)
Self report questionnaire to evaluate functional status and well-being or quality of life
The Short Form Health Survey-36 items (SF-36)
Self report questionnaire to evaluate functional status and well-being or quality of life

Full Information

First Posted
March 24, 2021
Last Updated
April 24, 2023
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04824248
Brief Title
Weight Reduction in CLBP
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Overweight or Obesity
Keywords
chronic low back pain, chronic pain, physiotherapy, physical therapy, weight reduction, pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial, including two comparative, balanced online treatment arms.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pain Neuroscience Education
Other Intervention Name(s)
Pain Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognition-targeted exercise therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight reduction program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain inventory (BPI)
Description
Questionnaire for assessing clinical pain
Time Frame
Change from baseline to 6 months (T3) after therapy completion
Title
Brief Pain inventory (BPI)
Description
Questionnaire for assessing clinical pain
Time Frame
Difference between groups at 6 months (T3) after therapy completion
Secondary Outcome Measure Information:
Title
Brief Pain inventory (BPI)
Description
Questionnaire for assessing clinical pain
Time Frame
Baseline assessment (T0)
Title
Brief Pain inventory (BPI)
Description
Questionnaire for assessing clinical pain
Time Frame
T1 assessment directly post treatment (i.e. 10 weeks after baseline)
Title
Brief Pain inventory (BPI)
Description
Questionnaire for assessing clinical pain
Time Frame
T2-assessment 3 months after therapy completion
Title
Brief Pain inventory (BPI)
Description
Questionnaire for assessing clinical pain
Time Frame
T3-assessment 6 months after therapy completion
Title
Central sensitization inventory (CSI)
Description
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Time Frame
Baseline Assessment (T0)
Title
Central sensitization inventory (CSI)
Description
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)
Title
Central sensitization inventory (CSI)
Description
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Time Frame
T2-assessment 3 months after therapy completion
Title
Central sensitization inventory (CSI)
Description
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Time Frame
T3-assessment 6 months after therapy completion
Title
TANITA Bio-electrical Impedance Analyzer
Description
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
Time Frame
Baseline assessment (T0)
Title
TANITA Bio-electrical Impedance Analyzer
Description
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)
Title
TANITA Bio-electrical Impedance Analyzer
Description
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
Time Frame
T3-assessment 6 months after therapy completion
Title
SECA wall-fixed SECA wall-fixed stadiometer
Description
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
Time Frame
Baseline measurement
Title
SECA wall-fixed SECA wall-fixed stadiometer
Description
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)
Title
SECA wall-fixed SECA wall-fixed stadiometer
Description
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
Time Frame
T3-assessment 6 months after therapy completion
Title
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Description
Body composition measurement - body fat
Time Frame
Baseline
Title
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Description
Body composition measurement - body fat
Time Frame
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Title
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Description
Body composition measurement - body fat
Time Frame
T3-assessment 6 months after therapy completion
Title
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Description
Body composition measurement - fat free mass
Time Frame
Baseline
Title
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Description
Body composition measurement - fat free mass
Time Frame
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Title
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Description
Body composition measurement - fat free mass
Time Frame
T3-assessment 6 months after therapy completion
Title
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Description
Body composition measurement - hydration status
Time Frame
Baseline
Title
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Description
Body composition measurement - hydration status
Time Frame
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Title
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Description
Body composition measurement - hydration status
Time Frame
T3-assessment 6 months after therapy completion
Title
Food Frequency Questionnaire
Description
Self report questionnaire to asses dietary intake
Time Frame
Baseline
Title
Food Frequency Questionnaire
Description
Self report questionnaire to asses dietary intake
Time Frame
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Title
Food Frequency Questionnaire
Description
Self report questionnaire to asses dietary intake
Time Frame
T2-assessment 3 months after therapy completion
Title
Food Frequency Questionnaire
Description
Self report questionnaire to asses dietary intake
Time Frame
T3-assessment 6 months after therapy completion
Title
International Physical Activity Questionnaire (IPAQ)
Description
Self report questionnaire to asses physical activity
Time Frame
Baseline
Title
International Physical Activity Questionnaire (IPAQ)
Description
Self report questionnaire to asses physical activity
Time Frame
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Title
International Physical Activity Questionnaire (IPAQ)
Description
Self report questionnaire to asses physical activity
Time Frame
T2-assessment 3 months after therapy completion
Title
International Physical Activity Questionnaire (IPAQ)
Description
Self report questionnaire to asses physical activity
Time Frame
T3-assessment 6 months after therapy completion
Title
Sedentary Behavior Questionnaire of Busschaert et a
Description
Self report questionnaire to asses sedentary behavior
Time Frame
Baseline
Title
Sedentary Behavior Questionnaire of Busschaert et a
Description
Self report questionnaire to asses sedentary behavior
Time Frame
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Title
Sedentary Behavior Questionnaire of Busschaert et a
Description
Self report questionnaire to asses sedentary behavior
Time Frame
T2-assessment 3 months after therapy completion
Title
Sedentary Behavior Questionnaire of Busschaert et a
Description
Self report questionnaire to asses sedentary behavior
Time Frame
T3-assessment 6 months after therapy completion
Title
The Short Form Health Survey-36 items (SF-36)
Description
Self report questionnaire to evaluate functional status and well-being or quality of life
Time Frame
Baseline
Title
The Short Form Health Survey-36 items (SF-36)
Description
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)
Title
The Short Form Health Survey-36 items (SF-36)
Description
Self report questionnaire to evaluate functional status and well-being or quality of life
Time Frame
T2-assessment 3 months after therapy completion
Title
The Short Form Health Survey-36 items (SF-36)
Description
Self report questionnaire to evaluate functional status and well-being or quality of life
Time Frame
T3-assessment 6 months after therapy completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anneleen Malfliet, PhD
Phone
003224774503
Email
anneleen.malfliet@vub.be
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anneleen Malfliet, PhD
Email
anneleen.malfliet@vub.be

12. IPD Sharing Statement

Learn more about this trial

Weight Reduction in CLBP

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