Weight Reduction in CLBP

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

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 Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain; Overweight or Obesity
• Intervention / Treatment: Behavioral: Pain Neuroscience Education; Behavioral: Cognition-targeted exercise therapy; Behavioral: Behavioral weight reduction program

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anneleen Malfliet, PhD; Phone Number: 003224774503; Email: anneleen.malfliet@vub.be

Study Locations

• Belgium
  • Brussels, Belgium
    • Recruiting
    • Vrije Universiteit Brussel
    • Contact: Anneleen Malfliet, PhD; Email: anneleen.malfliet@vub.be
• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Rotterdam University of Applied Sciences
    • Contact: Lennard Voogt, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental intervention; 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	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 Names: 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 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.	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 Names: 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.

What is the study measuring?

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
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

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: Rotterdam University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: chronic pain; chronic low back pain; physiotherapy; physical therapy; pain management; weight reduction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Back Pain; Overweight; Weight Loss; Low Back Pain
• Other Study ID Numbers: B.U.N. 1432021000411

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No