Weight Reduction in CLBP

ConditionsChronic Low-back Pain Overweight or Obesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorVrije Universiteit Brussel

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.

Treatment groups

84 Participants

are divided into 2 treatment groups

Group A: Experimental interventionExperimental treatment 3 interventions

Group B: Control interventionActive comparator 2 interventions