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

NCT06594796 | Recruiting

• 1 other identifier: NL85373.028.23
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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

Keywords

Low Back Pain; Lifestyle Intervention

Outcome Measures

Primary Outcomes (2)

• Physical activity will be assessed by the activPAL as the average number of daily steps over a period of one week.

  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.

  Baseline, 6, 24 and 36 months. Primary outcome 36 months.

• Physical functioning will be measured using the Roland Morris Disability Questionnaire (RMDQ).

  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).

  Baseline, 6, 12, 24 and 36 months. Primary outcome 36 months.

Secondary Outcomes (9)

• Low back pain levels will be assessed by the Numeric Pain Rating Scale (NPRS)

  Baseline, 6, 12, 24 and 36 months

• Weight and BMI

  Baseline, 6, 12, 24 and 36 months

• Sleep quality and duration will be assessed with the Pittsburg Sleep Quality Index (PSQI)

  Baseline, 6, 12, 24 and 36 months

• Habitual food intake will be assessed with a Food Frequency Questionnaire (FFQ)

  Baseline, 6, 12, 24 and 36 months

• A process evaluation will be conducted alongside the RCT with a mixed-method approach.

  Baseline, 6 and 24 months

Other Outcomes (4)

• Pain beliefs will be assessed using the Brief Illness Perception Questionnaire (B-IPQ)

  Baseline

• Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ)

  Baseline

• Kinesiophobia will be assessed using the Tampa scale for kinesiophobia

  Baseline

Study Arms (2)

Combined lifestyle intervention with LBP care

EXPERIMENTAL

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.

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

Usual care

NO INTERVENTION

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.

Interventions

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.

Combined lifestyle intervention with LBP care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Willeke Boonstra: lead

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities; Exercise Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Gwendolyne Scholten-Peeters, PhD, PT

  VU University of Amsterdam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwendolyne Scholten-Peeters, PhD, PT

CONTACT

31 205988557; g.g.m.scholten-peeters@vu.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

NL (1)