Chronic low back pain long-term lower back pain & Obesity overweight
Conditions
Interventions
All participants will receive a combination of an online therapy program and
three 1-on-1 sessions with a physical therapist in person, within a 10-week
period. The online therapy (using the platfor
Sponsors
Hogeschool Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Overweight/obese women and men with CLBP (n=100), defined as non-specific low back pain for at least 3 months* duration, currently seeking care for low back pain, will be recruited. Non-specific low back pain implies that patients are not allowed to report leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale, or to have any evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy). Other inclusion criteria are aged between 18 and 65 years, being a native Dutch speaker, being overweight (BMI >= 25 kg/m2) or obese (BMI >= 30 kg/m2), and access to internet/computer/tablet/smartphone.
Exclusion criteria
Exclusion criteria: Patients with BMI >= 40 kg/m2 will be excluded as people being morbid obese are eligible to undergo abdominal surgery. Because BMI may not always correspond to the same body fat percentage in different individuals (e.g., athletic types with higher muscle mass may also have BMIs >= 25 km/kg2), each participant's body fat percentage will be measured and compared to the body fat percentage reference values35. Participants with exceeding BMI but falling into the healthy fat percentage range (which is sex-, age- and ethnicity dependent35) will be excluded. Exclusion criteria are: having a severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, metabolic diseases, etc.), being pregnant or given birth in the preceding year, or currently receiving dietary or exercise interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: pain intensity. The BPI (brief pain inventory) is one of the most widely used tools for assessing clinical pain. Among other things, this brief questionnaire contains 4 questions investigating PAIN INTENSITY (the worst pain in the last 24 hours, the least pain in the last 24 hours, the average pain and pain now). Since CLBP is a rather fluctuating condition, the question *please rate your pain by circling the one number that best describes your pain on the AVERAGE* is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e., 0-10, a decrease of 30% is considered as clinically significant) numeric rating scale (NRS), which is recommended as a core outcome measure in clinical trials of chronic pain treatments. Reliability and validity of the scores obtained with the BPI are established. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measure: other pain related outcomes Pain related outcomes will be evaluated by several questionnaires (online). (1) Besides pain intensity, the BPI (brief pain inventory) also evaluates the impact of pain on functioning. The BPI measures how much pain interferes with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep on an 11-point NRS (ranging from 0-10). Using the same inventory for different outcome measures limits the total burden for all included CLBP patients. (2) Furthermore, the Central sensitization inventory (CSI), is used to assess self-reported signs of central sensitization and its overlapping symptoms. It contains *part A* of 25 statements related to current health symptoms (scored on a 5-point Likert scale ranging from 0-4). The CSI has proven psychometric strength. Secondary outcome measure: body composition Body weight (TANITA Bio-electrical Impedance Analyzer) and height (SECA wall-fixed stadiometer) will be measured objectively and used to calculate BMI (= weight[kg] / height[m]²). Body composition (incl. body fat and fat free mass) will be assessed using TANITA MC-780SMA Bio-electrical Impedance Analyzer. Because research findings informed us that body fat distribution, in addition to total fat, should be considered when analyzing the obesity-CLBP relationship61, waist and hip circumference will be measured using Cescorf measuring tape. Secondary outcome measure: physical activity, sedentary behaviour, dietary intake, fear avoidance in relation to back pain, pain catastrophizing, and function. Valid self-report questionnaires will be used to assess energy balance related behavior, incl. dietary intake (Food Frequency Questionnaire - software developed and automated by the co-researchers), physical activity (International Physical Activity Questionnaire - IPAQ - Dutch version),sedentary behavior (Sedentary Behavior Questionnaire | — |
Countries
Netherlands
Outcome results
None listed