Weight Reduction in CLBP

Vrije Universiteit Brussel

Status: Enrolling

Conditions: Chronic Low-back Pain; Overweight or Obesity

Treatments: Behavioral: Behavioral weight reduction program; Behavioral: Cognition-targeted exercise therapy; Behavioral: Pain Neuroscience Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04824248

B.U.N. 1432021000411

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

Experimental intervention

Experimental group

Description:

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

Treatment:

Behavioral: Pain Neuroscience Education

Behavioral: Cognition-targeted exercise therapy

Behavioral: Behavioral weight reduction program

Control intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Pain Neuroscience Education

Behavioral: Cognition-targeted exercise therapy