Clinical trial NCT06594796: A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Lifestyle Intervention
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Physical activity will be assessed by the activPAL as the average number of daily steps over a period of one week.
timeFrame: Baseline, 6, 24 and 36 months. Primary outcome 36 months.
measure: Physical functioning will be measured using the Roland Morris Disability Questionnaire (RMDQ).
timeFrame: Baseline, 6, 12, 24 and 36 months. Primary outcome 36 months.
Secondary outcomes:
measure: Low back pain levels will be assessed by the Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, 6, 12, 24 and 36 months
measure: Weight and BMI
timeFrame: Baseline, 6, 12, 24 and 36 months
measure: Sleep quality and duration will be assessed with the Pittsburg Sleep Quality Index (PSQI)
timeFrame: Baseline, 6, 12, 24 and 36 months
measure: Habitual food intake will be assessed with a Food Frequency Questionnaire (FFQ)
timeFrame: Baseline, 6, 12, 24 and 36 months
measure: A process evaluation will be conducted alongside the RCT with a mixed-method approach.
timeFrame: Baseline, 6 and 24 months
measure: Systemic inflammation (TNF-alpha, hsCRP)
timeFrame: Baseline, 12 and 36 months
measure: Quality of Life (QALYs)
timeFrame: Baseline, 6, 12, 24 and 36 months
measure: Costs will be measured using a questionnaire based on various iMTA questionnaires.
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30 and 36 months
measure: Global perceived effect will be measured using a 7-point scale consisting of integers 1 through 7.
timeFrame: 6, 12, 24 and 36 months
Other outcomes:
measure: Pain beliefs will be assessed using the Brief Illness Perception Questionnaire (B-IPQ)
timeFrame: Baseline
measure: Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline
measure: Kinesiophobia will be assessed using the Tampa scale for kinesiophobia
timeFrame: Baseline
measure: Socio-economic status
timeFrame: Baseline
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
Study officials:
affiliation: VU University of Amsterdam
name: Gwendolyne Scholten-Peeters, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: