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Weight Reduction in CLBP

NCT04824248 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-05-25

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Rotterdam University of Applied Sciences

    collaborator OTHER

  • Vrije Universiteit Brussel

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824248 on ClinicalTrials.gov