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

NCT ID: NCT06594796

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2029-02-28

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Combined lifestyle intervention with LBP care

A combined lifestyle intervention (GLI) integrated into standard care for LBP according to clinical guidelines of the Dutch physiotherapy (KNGF) and delivered by GLI certified physio/exercise therapists. A GLI aims to increase physical activity, improve diet and sleep, change health behavior, and are effective in reducing weight amongst overweight and obese adults. The intervention is tailored to the patient's lifestyle risk and clinical LBP factors using shared decision-making. Patients define their own treatment goals and remain in charge of the treatment procedures. The intervention has a duration of two years of which the first six months focus on behavioral change, the latter 18 months focus on maintenance of newly set behaviors. Participants are guided using group and individual sessions where evidence-based behavioral change techniques will be employed such as motivational interviewing, self-monitoring and action and coping planning.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Usual care

Usual care as prescribed by the medical specialist. This can vary from a watchful waiting strategy to referral to physiotherapy, exercise therapy, or general practitioner care according to the Dutch physiotherapy (KNGF) and general practice (NHG) guidelines for LBP; e.g. education, exercise therapy and pain medication. It may also involve re-entry to the hospital after failed treatment in primary care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Willeke Boonstra

OTHER

Sponsor Role: lead

Responsible Party

Willeke Boonstra

PhD candidate

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gwendolyne Scholten-Peeters, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

VU University of Amsterdam

Locations

Vrije Universiteit Amsterdam

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Gwendolyne Scholten-Peeters, PhD, PT

Role: CONTACT

g.g.m.scholten-peeters@vu.nl

31 205988557

Facility Contacts

Boonstra

Role: primary

w.boonstra2@vu.nl

31 657315059

Other Identifiers

NL85373.028.23

Identifier Type: -

Identifier Source: org_study_id