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Recruiting NCT04824248

Weight Reduction in CLBP

No phase Interventional Chronic Low-back Pain Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pain Neuroscience Education, Cognition-targeted exercise therapy, Behavioral weight reduction program.
Who it may be relevant to
Registry conditions: Chronic Low-back Pain, Overweight or Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Brief Pain inventory (BPI) [Time frame: Change from baseline to 6 months (T3) after therapy completion]
  • Brief Pain inventory (BPI) [Time frame: Difference between groups at 6 months (T3) after therapy completion]
Secondary outcome measures (12)
  • Brief Pain inventory (BPI) [Time frame: Baseline assessment (T0)]
  • Brief Pain inventory (BPI) [Time frame: T1 assessment directly post treatment (i.e. 10 weeks after baseline)]
  • Brief Pain inventory (BPI) [Time frame: T2-assessment 3 months after therapy completion]
  • Brief Pain inventory (BPI) [Time frame: T3-assessment 6 months after therapy completion]
  • Central sensitization inventory (CSI) [Time frame: Baseline Assessment (T0)]
  • Central sensitization inventory (CSI) [Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)]
  • Central sensitization inventory (CSI) [Time frame: T2-assessment 3 months after therapy completion]
  • Central sensitization inventory (CSI) [Time frame: T3-assessment 6 months after therapy completion]
  • TANITA Bio-electrical Impedance Analyzer [Time frame: Baseline assessment (T0)]
  • TANITA Bio-electrical Impedance Analyzer [Time frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)]
  • TANITA Bio-electrical Impedance Analyzer [Time frame: T3-assessment 6 months after therapy completion]
  • SECA wall-fixed SECA wall-fixed stadiometer [Time frame: Baseline measurement]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Vrije Universiteit Brussel — Brussels
Netherlands · 1 center
  • Rotterdam University of Applied Sciences — Rotterdam

Identifiers

NCT: NCT04824248 · B.U.N. 1432021000411

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗