Chronic Low-back Pain, Overweight or Obesity
Conditions
Keywords
chronic low back pain, chronic pain, physiotherapy, physical therapy, weight reduction, pain management
Brief 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.
Interventions
BEHAVIORALPain 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.
BEHAVIORALCognition-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.
BEHAVIORALBehavioral 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.
Sponsors
Vrije Universiteit Brussel
Rotterdam University of Applied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized controlled clinical trial, including two comparative, balanced online treatment arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain inventory (BPI) | Change from baseline to 6 months (T3) after therapy completion | Questionnaire for assessing clinical pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain inventory (BPI) | Baseline assessment (T0) | Questionnaire for assessing clinical pain |
| Central sensitization inventory (CSI) | Baseline Assessment (T0) | Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms. |
| TANITA Bio-electrical Impedance Analyzer | Baseline assessment (T0) | Body weight measurement used to calculate BMI (= weight\[kg\] / height\[m\]²) |
| SECA wall-fixed SECA wall-fixed stadiometer | Baseline measurement | Body height measurement used to calculate BMI (= weight\[kg\] / height\[m\]²) |
| TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat | Baseline | Body composition measurement - body fat |
| TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass | Baseline | Body composition measurement - fat free mass |
| TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status | Baseline | Body composition measurement - hydration status |
| Food Frequency Questionnaire | Baseline | Self report questionnaire to asses dietary intake |
| International Physical Activity Questionnaire (IPAQ) | Baseline | Self report questionnaire to asses physical activity |
| Sedentary Behavior Questionnaire of Busschaert et a | Baseline | Self report questionnaire to asses sedentary behavior |
| The Short Form Health Survey-36 items (SF-36) | Baseline | Self report questionnaire to evaluate functional status and well-being or quality of life |
| Fear avoidance Beliefs Questionnaire | Baseline | Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability. |
Countries
Belgium, Netherlands
Contacts
CONTACTAnneleen Malfliet, PhD
Outcome results
None listed