Weight Reduction in CLBP

Not Applicable

Recruiting

• Conditions: Chronic Low-back Pain; Overweight or Obesity
• Interventions: Behavioral: Pain Neuroscience Education; Behavioral: Cognition-targeted exercise therapy; Behavioral: Behavioral weight reduction program

• Registration Number: NCT04824248
• Lead Sponsor: Vrije Universiteit Brussel

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-04-01
• Status Verified: 2025-05
• Study Start: 2025-05-01
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental intervention	Cognition-targeted exercise therapy	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
Experimental intervention	Pain Neuroscience Education	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
Experimental intervention	Behavioral weight reduction program	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
Control intervention	Cognition-targeted exercise therapy	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.
Control intervention	Pain Neuroscience Education	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.

Primary Outcome Measures

Name	Time	Method
Brief Pain inventory (BPI)	Difference between groups at 6 months (T3) after therapy completion	Questionnaire for assessing clinical pain

Secondary Outcome Measures

Name	Time	Method
Fear avoidance Beliefs Questionnaire	T3-assessment 6 months after therapy completion	Self report questionnaire to evaluate fear avoidance beliefs
Brief Pain inventory (BPI)	T3-assessment 6 months after therapy completion	Questionnaire for assessing clinical pain
Central sensitization inventory (CSI)	T3-assessment 6 months after therapy completion	Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
The Short Form Health Survey-36 items (SF-36)	T3-assessment 6 months after therapy completion	Self report questionnaire to evaluate functional status and well-being or quality of life
TANITA Bio-electrical Impedance Analyzer	T3-assessment 6 months after therapy completion	Body weight measurement used to calculate BMI (= weight\[kg\] / height\[m\]²)
SECA wall-fixed SECA wall-fixed stadiometer	T3-assessment 6 months after therapy completion	Body height measurement used to calculate BMI (= weight\[kg\] / height\[m\]²)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat	T3-assessment 6 months after therapy completion	Body composition measurement - body fat
Food Frequency Questionnaire	T3-assessment 6 months after therapy completion	Self report questionnaire to asses dietary intake
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass	T3-assessment 6 months after therapy completion	Body composition measurement - fat free mass
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status	T3-assessment 6 months after therapy completion	Body composition measurement - hydration status
International Physical Activity Questionnaire (IPAQ)	T3-assessment 6 months after therapy completion	Self report questionnaire to asses physical activity
Sedentary Behavior Questionnaire of Busschaert et a	T3-assessment 6 months after therapy completion	Self report questionnaire to asses sedentary behavior

Trial Locations

Locations (2)

Rotterdam University of Applied Sciences; 🇳🇱 Rotterdam, Netherlands

Vrije Universiteit Brussel; 🇧🇪 Brussels, Belgium