A Combined Lifestyle Intervention Delivered by Physio/exercise Therapists for Patients with Persistent Low Back Pain and Overweight or Obesity (Back2Health)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Combined lifestyle intervention and LBP care (physiotherapy, exercise therapy)

• Study Type: Interventional
• Enrollment (Estimated): 318
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gwendolyne Scholten-Peeters, PhD, PT; Phone Number: 31 205988557; Email: g.g.m.scholten-peeters@vu.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Vrije Universiteit Amsterdam
    • Contact: Boonstra; Phone Number: 31 657315059; Email: w.boonstra2@vu.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low back pain levels will be assessed by the Numeric Pain Rating Scale (NPRS)	The NPRS is a 11-point scale consisting of integers from 0 to 10; 0 representing "no pain" and 10 represents "worst possible pain".	Baseline, 6, 12, 24 and 36 months
Weight and BMI	Weight will be objectively measured via a standardized procedure using the same scale throughout the study. Weight status will be classified using Body Mass Index by dividing body weight (kg) by height (m²).	Baseline, 6, 12, 24 and 36 months
Sleep quality and duration will be assessed with the Pittsburg Sleep Quality Index (PSQI)	The PSQI consists of 19 items that cover seven dimensions, including subjective sleep quality, sleep duration and latency (time it takes to fall asleep), and the frequency and severity of specific sleep-related complaints in the previous month. Scores from each dimension (range: 0-3) are summed to derive a sleep quality score, higher scores indicate worse sleep quality.	Baseline, 6, 12, 24 and 36 months
Habitual food intake will be assessed with a Food Frequency Questionnaire (FFQ)	The FFQ is an adapted version of the Dietary Instrument for Nutrition Education. It consists of 20 food items and has a reference period of one month.	Baseline, 6, 12, 24 and 36 months
A process evaluation will be conducted alongside the RCT with a mixed-method approach.	The process evaluation will study the implementation and mechanism of impact of the intervention. Both participants and physio/exercise therapists will be asked to fill in questionnaires at baseline, 6 and 24 months. A selection of participants will be invited to join a focus group and a selection of physio/exercise therapists will be invited for a semi-structured interview about their experiences during the intervention.	Baseline, 6 and 24 months
Systemic inflammation (TNF-alpha, hsCRP)	Three times, one vacutainer (7ml blood) will be extracted using venipuncture and serum will be stored at -80 degrees Celcius untill all data has been collected. Serum inflammatory concentrations (TNF-alpha, hsCRP) will be measured using highly sensitive ELLA by an experience laboratory technician. The choice of inflammatory markers may change before analyses due to new insights.	Baseline, 12 and 36 months
Quality of Life (QALYs)	The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures a participants' health state across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems". The participants' health states will be converted into utility values using the Dutch tariff, after which Quality Adjusted Life Years (QALYs) will be calculated by multiplying the participants spent in a certain health state by the respective utility value (45). In addition, each subject will rate their own perceived health status on a visual analogue scale (VAS) of 0 to 100.	Baseline, 6, 12, 24 and 36 months
Costs will be measured using a questionnaire based on various iMTA questionnaires.	Costs will be measured from a societal and a healthcare perspective. From the societal perspective, costs will include the cost of the intervention, other healthcare use (i.e., primary, secondary, and medication), informal care, sports memberships and equipment, as well as the cost of productivity losses from paid (i.e. absenteeism and presenteeism) and unpaid work. From the healthcare perspective, only costs accruing to the formal Dutch healthcare sector will be included. Intervention costs will be micro-costed, meaning that detailed data will be collected regarding the number of resources used and their respective unit prices. For this, data will be gathered from questionnaires filled in by participating physio/exercise therapists. Information on all other kinds of resource use will be collected using cost questionnaires. These questionnaires are based on the various iMTA questionnaires but tailored to the specific patient population and intervention under study.	Baseline, 3, 6, 9, 12, 18, 24, 30 and 36 months
Global perceived effect will be measured using a 7-point scale consisting of integers 1 through 7.	Each point on the scale indicates a different level of improvement; 1 representing "very much improved", 2 representing "much improved", 3 representing "minimally improved", 4 representing "no change", 5 representing "minimally worse", 6 representing "much worse" and 7 represent "very much worse". Participants will be asked to rate their overall status since the start of the study. The participants' responses to the GPE will be dichotomized into "Recovered" (1 and 2), and "Not Recovered" (3, 4, 5, 6, and 7).	6, 12, 24 and 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain beliefs will be assessed using the Brief Illness Perception Questionnaire (B-IPQ)	The B-IPQ is a tool used to evaluate cognitive and emotional representations of illness. It is an 8-item questionnaire where each item is rated on a 0-10 scale, with higher scores indicating a more threatening perception of the illness. Total score can be between 0 and 80, higher scores indicate worse illness perception. Cut-off points for the B-IPQ total score as follows: <42 indicating low experienced threat, 42-49 indicating moderate experienced threat, and ≥50 indicating high experienced threat in patients.	Baseline
Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ)	The PSEQ is developed to assess the confidence people with ongoing pain have in performing activities while in pain. The PSEQ is applicable to all persisting pain presentations. The questionnaire consists of 10 questions scored between 0 (no confidence) and 6 (full confidence). Total score can be between 0 and 60, where a higher score indicates greater levels of confidence in dealing with pain.	Baseline
Kinesiophobia will be assessed using the Tampa scale for kinesiophobia	The Tampa scale for kinesiophobia is a 17-item questionnaire which are scored between 1 (low fear of movement) and 4 (high fear of movement). Total score can be between 17 and 68. A score ≤37 is interpreted as absence of fear of movement, a score of >37 is interpreted as fear of movement.	Baseline
Socio-economic status	Education will be considered as a fundamental indicator of socioeconomic status.	Baseline

Collaborators and Investigators

• Sponsor: Willeke Boonstra
• Investigators: Principal Investigator: Gwendolyne Scholten-Peeters, PhD, PT, VU University of Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Low Back Pain; Lifestyle Intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nutrition Disorders; Overnutrition; Body Weight; Back Pain; Overweight; Low Back Pain
• Other Study ID Numbers: NL85373.028.23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No