Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06594796

Recruiting nowNot applicableInterventional

What this study is about

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.

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 Not listed

SexAll

Healthy volunteersNot accepted

ConditionLow Back Pain

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Specific LBP (e.g., tumor or fracture) * Back surgery in the past six months * Psychiatric diseases that could hinder participation * Pregnancy or ≤9 months postpartum

Treatments and study arms

Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy)

Behavioral

One of five recognized combined lifestyle interventions (BeweegKuur, CooL, SSIB, SLIMMER, X-Fittt) integrated with LBP care.

Primary outcomes

Physical activity will be assessed by the activPAL as the average number of daily steps over a period of one week.Baseline, 6, 24 and 36 months. Primary outcome 36 months.

The activPAL is a small non-invasive electronic logger designed to quantify free-living daily activities. The activPAL measures physical activity and sedentary behaviour through measuring accelerations and posture of the thigh.

Physical functioning will be measured using the Roland Morris Disability Questionnaire (RMDQ).Baseline, 6, 12, 24 and 36 months. Primary outcome 36 months.

The RMDQ is a reliable tool to measure the impact of LBP on physical functioning. It is a 24-item self-report questionnaire about how low back pain affects functional activities. Each question is worth one point, therefore scores can range from 0 (no disability) to 24 (severe disability).

Study locations

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

Vrije Universiteit Amsterdam🇳🇱 Amsterdam, Netherlands

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BoonstraContact

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