Идёт набор NCT06594796

A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity

Без фазы С лечением Low Back Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy).
Кому может быть актуально: Состояния в реестре: Low Back Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity: a Randomized Controlled Trial with Parallel Economic Evaluation

Обзор

Low back pain (LBP) is the leading cause of disability worldwide and is costly. Lifestyle factors, such as physical inactivity, stress, sleep, excess weight, and an unhealthy diet contribute to the burden of LBP and the associated increasing demand for care. Moreover, approximately 65% of LBP patients who visit the hospital are overweight. This group is considered a complex patient group. Of the LBP patients who visit the hospital, 74% are referred back to primary care as medical specialists cannot offer them high value care. Targeting both lifestyle factors (e.g., physical activity, sleep and stress) and clinical factors related to low back pain (e.g., muscle strength, endurance, mobility) is important in the management of this group of LBP patients to improve important outcomes (e.g., functioning, physical activity) and reduce costs. Addressing lifestyle factors may also offer additional health benefits like decreased risks of diabetes and cardiovascular diseases. The primary objective of this project is to improve the management of this complex group of LBP patients, that is, patients who are overweight or obese and who are referred back to primary care from the hospital because medical specialists cannot offer them high value care, and to reduce healthcare and societal costs. The primary research question is: 'Is a combined lifestyle intervention, integrated into standard care for LBP, delivered by physio/exercise therapists effective and cost-effective in improving physical functioning and/or physical activity over a 36-month period compared to usual care in overweight or obese LBP patients who are referred back from the hospital to primary care?' It is hypothesized that the combined lifestyle intervention, integrated into standard care for LBP, is both effective and cost-effective in managing LBP in patients who are overweight or obese over a 36-month period.

Вмешательства

Поведенческое Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy)
One of five recognized combined lifestyle interventions (BeweegKuur, CooL, SSIB, SLIMMER, X-Fittt) integrated with LBP care.

Первичные конечные точки

Physical activity will be assessed by the activPAL as the average number of daily steps over a period of one week. [Срок оценки: Baseline, 6, 24 and 36 months. Primary outcome 36 months.]
Physical functioning will be measured using the Roland Morris Disability Questionnaire (RMDQ). [Срок оценки: Baseline, 6, 12, 24 and 36 months. Primary outcome 36 months.]

Вторичные конечные точки (9)

Low back pain levels will be assessed by the Numeric Pain Rating Scale (NPRS) [Срок оценки: Baseline, 6, 12, 24 and 36 months]
Weight and BMI [Срок оценки: Baseline, 6, 12, 24 and 36 months]
Sleep quality and duration will be assessed with the Pittsburg Sleep Quality Index (PSQI) [Срок оценки: Baseline, 6, 12, 24 and 36 months]
Habitual food intake will be assessed with a Food Frequency Questionnaire (FFQ) [Срок оценки: Baseline, 6, 12, 24 and 36 months]
A process evaluation will be conducted alongside the RCT with a mixed-method approach. [Срок оценки: Baseline, 6 and 24 months]
Systemic inflammation (TNF-alpha, hsCRP) [Срок оценки: Baseline, 12 and 36 months]
Quality of Life (QALYs) [Срок оценки: Baseline, 6, 12, 24 and 36 months]
Costs will be measured using a questionnaire based on various iMTA questionnaires. [Срок оценки: Baseline, 3, 6, 9, 12, 18, 24, 30 and 36 months]
Global perceived effect will be measured using a 7-point scale consisting of integers 1 through 7. [Срок оценки: 6, 12, 24 and 36 months]

Критерии участия

Критерии включения

Patients with persistent (≥3 months) non-specific LBP who are referred back from the hospital to primary care
Either BMI≥30 OR BMI≥25 with at least one comorbidity (osteoarthritis, sleep apnea, risk factors for cardiovascular diseases or type 2 diabetes)
Decreased physical functioning (RMDQ ≥4 out of 24)
Average LBP intensity of ≥3 out of 10 over the past week (NPRS)
≥18 years old