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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Vrije Universiteit Brussel
RECRUITING
Brussels
Netherlands
Rotterdam University of Applied Sciences
RECRUITING
Rotterdam
Contact Information
Primary
Anneleen Malfliet, PhD
anneleen.malfliet@vub.be
003224774503
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 84
Treatments
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
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.
Related Therapeutic Areas
Sponsors
Leads: Vrije Universiteit Brussel
Collaborators: Rotterdam University of Applied Sciences

This content was sourced from clinicaltrials.gov