Low back pain sciatica
Conditions
Interventions
Patients in the experimental group will receive the intervention, specifically
the GLI combined with standard care. The treatment approach will be
individualized based on the patient's lifestyle ris
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Overweight or obese patients with persistent(i.e. >3 months), non-specific LBP, who are referred from the hospital back to primary care, are eligible and will be recruited at the 7 participating hospitals. Patients need to have either a BMI>=30 or a BMI>=25 with at least one of the following: osteoarthritis, sleep apnea, risk factors for cardiovascular diseases or type 2 diabetes in line with the criteria for combined lifestyle interventions(i.e., GLI-criteria); decreased physical functioning defined as a RMDQ score of >= 4 out of 24, an average of LBP intensity >= 3 out of 10 on a numeric pain rating scale over the past week, and aged >=18 years.
Exclusion criteria
Exclusion criteria: Specific LBP(e.g. tumor, fracture), back surgery in the past 6 months, psychiatric diseases, pregnancy or postpartum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The physical function over 36 months will be measured using the Roland Morris Disability Questionnaire (RMDQ) and physical activity quantified by average number of daily steps over a week will be measured using the activPAL. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters: LBP intensity(NPRS), LBP perceived recovery(GPE), BMI(electronic scale/ portable stadiometer), lifestyle behaviors, including physical activity(activPAL activity tracker); sleep quality (PSQI), and food intake frequency questionnaire(FFQ), quality of life(EQ-5D-5L), costs. The duration to complete the reliable and valid questionnaires is approximately 30 minutes. The activity tracker will be worn on the thigh for one week at four time moments (incl. baseline). At baseline, various possible confounding factors will be assessed, including pain beliefs(B-IPQ), pain self-efficacy(PSEQ), fear(TAMPA), and socio-economic status. Clinical data will be collected at baseline, 6, 12, 24, and 36 months. Costs will be measured by cost questionnaires every 3 months during the first 12 months and every 6 months from months 13 to 36. As it is of utmost importance to maintain healthy behavior, 36 months after the baseline is the primary follow-up moment. Additionally, predictions to evaluate the cost-effectiveness of the intervention in the long-term with a time horizon of 5 and 10 years will be performed. Blood withdrawal will per performed for the measurement of systemic inflammatory markers (TNF-alpha, high sensitive CRP) at baseline, 12 month and 36 months. | — |
Countries
Netherlands
Outcome results
None listed