Weight Reduction in CLBP

NCT04824248 | Recruiting DMC

• 1 other identifier: B.U.N. 1432021000411
• Study Type: interventional
• Target: 84
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chronic Low-back Pain; Overweight or Obesity

Keywords

chronic low back pain; chronic pain; physiotherapy; physical therapy; weight reduction; pain management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (43)

• Brief Pain inventory (BPI)

  Baseline assessment (T0)

• Brief Pain inventory (BPI)

  T1 assessment directly post treatment (i.e. 10 weeks after baseline)

• Brief Pain inventory (BPI)

  T2-assessment 3 months after therapy completion

• Brief Pain inventory (BPI)

  T3-assessment 6 months after therapy completion

• Central sensitization inventory (CSI)

  Baseline Assessment (T0)

Study Arms (2)

Experimental intervention

EXPERIMENTAL

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; Behavioral: Cognition-targeted exercise therapy; Behavioral: Behavioral weight reduction program

Control intervention

ACTIVE COMPARATOR

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; Behavioral: Cognition-targeted exercise therapy

Interventions

Pain Neuroscience Education BEHAVIORAL

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.

Also known as: Pain Education

Control intervention; Experimental intervention

Cognition-targeted exercise therapy BEHAVIORAL

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.

Control intervention; Experimental intervention

Behavioral weight reduction program BEHAVIORAL

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.

Experimental intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Rotterdam University of Applied Sciences: collaborator

Study Sites (2)

Vrije Universiteit Brussel

Brussels, Belgium

RECRUITING

Rotterdam University of Applied Sciences

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Chronic Pain; Weight Loss; Agnosia

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Body Weight Changes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Anneleen Malfliet, PhD

CONTACT

003224774503; anneleen.malfliet@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Anneleen Malfiet

Model Details: Randomized controlled clinical trial, including two comparative, balanced online treatment arms.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

BE (1); NL (1)