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

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 unhealthy diet contribute to the burden of LBP and the increasing demand
for care. Moreover, ~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 worthwhile care. Targeting lifestyle factors and clinical
factors (e.g., muscle strength, endurance, mobility) is important in the
management of this group of LBP patients to improve clinical outcomes (e.g.,
functioning, pain) 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 a 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 worthwhile care, and to reduce healthcare and societal costs.
The primary research question is: *Is a combined lifestyle intervention,
integrated into specific care for LBP, delivered by physio/exercise therapists
effective and cost-effective in improving physical functioning 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?*

A prospective randomized clinical trial (RCT) with a superiority design will be
conducted, with economic and process evaluations.

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 risks (such as physical
inactivity, unhealthy diet, sleep issues, and stress) and clinical factors
related to lower back pain (such as unhelpful pain beliefs and poor muscle
strength). This individualization will be achieved through shared
decision-making, aligning with current lower back pain guidelines and GLI
protocols.

Patients will actively define their treatment goals and retain control over the
treatment process. The core component of the intervention will comprise both
individual and group sessions spanning approximately six months (approximately
16 sessions). Spouses are welcome to partici-pate in individual sessions to
provide social support. Evidence-based behavioral change tech-niques will be
employed, including self-monitoring with activity trackers, goal setting,
action and coping planning, enhancing self-efficacy through skills training,
fostering positive patient-therapist interactions, and utilizing motivational
interviewing to promote healthy behaviors.

To further support patients in sustaining healthy behaviors, promoting
self-management, and preventing the recurrence of lower back pain, a
combination of digital and face-to-face individual and group sessions
(approximately 8 sessions) will be offered during the maintenance phase of the
intervention (months 7 to 24). The number of sessions will be tailored to the
individual needs of the patients. Patients can select from among five programs
(Samen Sportief in Beweging, Beweegkuur, SLIMMER, Cool, or X-Fittt GLI) that
reflect everyday practice, while also retaining access to standard care.

The control group will receive standard care, which may involve physiotherapy,
exercise therapy, or general practitioner care in accordance with the existing
Dutch physiotherapy (KNGF) and general practice (NHG) guidelines for lower back
pain. Standard care can include educational components, exercise therapy, and
the use of pain medication, as well as the possibility of hospital re-entry for
further treatment.

In our research, we are committed to minimizing the burden imposed on
participants during the course of this study. To this end, we have taken
several measures:
Selection of Tests and Questionnaires: We have meticulously selected a subset
of physical tests and questionnaires (as detailed in Table 1) to minimize the
extent of physical examinations and questionnaire completion, ensuring that
these measures do not unduly inconvenience participants.
Blood Sampling: Venous blood samples will be collected to assess systemic
inflammatory markers, with a strict limit of 21 ml (7 ml each) over the
duration of the study. This approach is designed to minimize the volume of
blood withdrawn from participants. Blood withdrawal can be accompanied with
small discomfort and hemorrhage.
Data Collection: Clinical data in the form of questionnaires will be
administered at specific time points*baseline, 6, 12, 24, and 36 months.
Additionally, cost questionnaires will be ad-ministered at regular intervals,
every 3 months during the initial 12 months and every 6 months from months 13
to 36, to assess costs incurred by participants.
Questionnaire Completion: The questionnaires utilized in this study are known
to be reliable and valid and can typically be completed in approximately 45
minutes, thus mitigating any un-due time burden on participants.
Activity Tracking: Participants will be required to wear an activity tracker on
their thigh for one week at four different time points, facilitating data
collection with minimal disruption to their daily routines.
Furthermore, it is essential to note that the interventions applied in this
study, including physio-therapy, exercise therapy, and lifestyle modifications,
are considered safe and have been as-sociated with negligible side effects in
patients with lower back pain (LBP), particularly those who are overweight or
obese. The potential side effects, such as soreness, fatigue, or stiff-ness,
are mild and transient.
We conducted a comprehensive systematic review of relevant literature, and none
of the included randomized controlled trials (RCTs) reported any adverse
effects resulting from combined lifestyle interventions in LBP patients with
overweight or obesity.
The findings from our systematic review strongly support the notion that
combining lifestyle interventions (GLI) with LBP treatment in accordance with
clinical guidelines can lead to improvements in physical activity, stress
reduction, and the promotion of a healthy diet. These interventions hold
promise in terms of cost-effectiveness and enhanced management of
over-weight/obese patients with persistent LBP within the Dutch healthcare
system.
It is important to highlight that combined lifestyle interventions (GLI)
administered by certified physiotherapists and exercise specialists are covered
and reimbursed as medical interventions through the basic Dutch health
insurance package. Eligibility criteria for coverage include a BMI of >=30 or a
BMI of >=25 with comorbid conditions such as osteoarthritis, sleep apnea, or
risk factors for cardiovascular diseases or diabetes mellitus. Notably,
patients with lower back pain meeting these criteria are not currently being
routinely referred to these interventions.