Exploring Multidimensional Trajectories in People With Low Back Pain

NCT ID: NCT07176845

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2028-05-31

Brief Summary

Low back pain (LBP) is a major health problem in Switzerland and worldwide. Globally, LBP remains the leading cause of years lived with disability and its incidence and associated socioeconomic consequences are predicted to increase in the coming decades. In Switzerland, the condition is one of the most commonly reported physical complaints and negatively affects quality of life, resulting in significant personal burden and personal financial burden. LBP also generates enormous socioeconomic costs, with both direct and indirect costs estimated to reach billions of Swiss francs in Switzerland annually. Therefore, it is essential that LBP prevention, diagnosis, and management are improved.

LBP is a multifactorial condition. Social, psychological and biophysical factors, along with comorbidities and genetic factors, influence LBP development and associated disability. In individuals with LBP, psychological factors, such as pain catastrophizing, are associated with higher pain intensity and developing chronic LBP and the associated disability. Among biophysical factors, altered spinal motor behaviour (e.g. smaller trunk movement amplitude) and reduced physical activity have been observed in LBP patients and suggested to influence LBP. However, exactly how all these factors influence LBP and how they are interrelated remains unclear. In particular, the effect of altered spinal motor behaviour on LBP is not understood. However, altered motor behaviour could play an important role in changing LBP and related disability. Therefore, improving our understanding of the patterns of spinal motor behaviour and the interrelationships with other factors in LBP would increase our understanding of LBP progression and could help improve LBP management.

This study consists of a 6-month prospective longitudinal cohort observation of spinal motor behavior, physical activity, psychological factors, pain intensity, and disability in LBP patients (300 acute, 300 chronic LBP). Data collection will occur remotely and the frequency of repeated measures will be daily or weekly, depending on the measure. A custom smart-phone application will be used by participants to collect data on spinal motor behavior, psychological factors, pain intensity, and disability. Physical activity will be monitored using a wearable physical activity tracker.

Established trajectories of motor behavior will be investigated for potential interrelations with trajectories of other parameters (e.g. pain, psychological factors, and disability), to explore potential causal effects. In addition, risk factors or predictive factors for certain trajectories of motor behavior and other parameters will be identified. As such, this study will allow us to investigate the temporality of these relationships and identify LBP, and in particular spinal motor behavior, phenotypes.

Conditions

Acute Low Back Pain; Chronic Low Back Pain (CLBP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute low back pain

Patients with an acute low back pain episode (\<3 months of low back pain upon study enrollment)

Observational

Intervention Type: OTHER

This study is observational of nature: multidimensional data is collected and no interventional is imposed

Chronic low back pain

Patients with chronic low back pain (\>3 months of low back pain upon study enrollment)

Observational

Intervention Type: OTHER

This study is observational of nature: multidimensional data is collected and no interventional is imposed

Interventions

Observational

This study is observational of nature: multidimensional data is collected and no interventional is imposed

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• have low back pain (rate their LBP with an intensity of >0 on a 0-10 numerical pain rating scale at enrollment)
• 18 years old or older
• be proficient in German, French, or English
• own a smartphone that is able to run either Android or iOS (iPhone) apps
• own a smartphone that includes accelerometer and gyroscope sensors

Exclusion Criteria

• diagnosis of a specific LBP etiology (e.g. fracture, tumoral process, radiculopathy with evidence of neurological deficit or cauda equina)
• history of previous spinal fusion surgery, which would influence on motor behavior
• presence of any other medical conditions (pathologies, diseases, comorbidities, injuries, surgeries or painful conditions) that could jeopardize the patients' safety, prevent them from performing the spinal motion measurements safely (e.g., risk of falls due to frailty), or influence spinal motion (e.g., Parkinson's disease, stroke)
• inability to follow procedures
• inability to give consent (e.g. dementia)
• owner of a smartphone, not able to run an Android or iPhone application
• owner of a smartphone without accelerometer and gyroscope sensors

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

Sponsors

University of Applied Sciences of Western Switzerland

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Bern University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Stefan Schmid

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Stefan Schmid, Prof. Dr.

Role: CONTACT

stefan.schmid@bfh.ch

+41 31 848 37 96

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.

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Reference Type: BACKGROUND

GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016/S2665-9913(23)00098-X. eCollection 2023 Jun.

Reference Type: BACKGROUND

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Related Links

https://data.snf.ch/grants/grant/220434

Swiss National Science Foundation - Project page

Other Identifiers

220434

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-01927

Identifier Type: -

Identifier Source: org_study_id