Clinical trial

Weight Reduction in CLBP

Recruiting now · Not applicable · 2 countries · Registry ID NCT04824248

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionChronic Low-back Pain, Overweight or Obesity

Full registry 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

Treatments and study arms

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.

Primary outcomes

Brief Pain inventory (BPI)Change from baseline to 6 months (T3) after therapy completion

Questionnaire for assessing clinical pain

Brief Pain inventory (BPI)Difference between groups at 6 months (T3) after therapy completion

Questionnaire for assessing clinical pain

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Vrije Universiteit Brussel🇧🇪 Brussels, Belgium

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Anneleen Malfliet, PhDContact

Rotterdam University of Applied Sciences🇳🇱 Rotterdam, Netherlands

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Lennard Voogt, PhDContact