Weight Reduction in CLBP

Not Applicable

Recruiting

• Conditions: Chronic Low-back Pain; Overweight or Obesity

• 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: 2025-05-20
• Last Update Posted: 2025-05-25
• 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

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
Sedentary Behavior Questionnaire of Busschaert et a	T3-assessment 6 months after therapy completion	Self report questionnaire to asses sedentary behavior
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
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.
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
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
Food Frequency Questionnaire	T3-assessment 6 months after therapy completion	Self report questionnaire to asses dietary intake
International Physical Activity Questionnaire (IPAQ)	T3-assessment 6 months after therapy completion	Self report questionnaire to asses physical activity
Fear avoidance Beliefs Questionnaire	T3-assessment 6 months after therapy completion	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.

Trial Locations

Locations (2)

Rotterdam University of Applied Sciences; 🇳🇱 Rotterdam, Netherlands

Vrije Universiteit Brussel; 🇧🇪 Brussels, Belgium