Exploring Multidimensional Trajectories in People With Low Back Pain

NCT07176845 | Not Yet Recruiting

• 2 other identifiers: 2024-01927220434
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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)

Keywords

low back pain; LBP; spinal motion; spine; disability; motor behavior; physical activity; pain-related fear; psychological factors

Outcome Measures

Primary Outcomes (15)

• Spinal motion: maximum movement amplitude

  Spine motion is recorded during multiple repetitions of several clinically relevant motions (trunk flexion, trunk extension, left/right trunk lateral flexion while standing), as well as a functional motion (picking up a lightweight object from the floor). The motion is measured using the internal inertial sensors of the patient's smartphone. The first main variable of interest is maximum movement amplitude (unit: degrees). Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Spinal motion: maximum/average movement velocity

  Spine motion is recorded during multiple repetitions of several clinically relevant motions (trunk flexion, trunk extension, left/right trunk lateral flexion while standing), as well as a functional motion (picking up a lightweight object from the floor). The motion is measured using the internal inertial sensors of the patient's smartphone. The second main variable of interest is maximum/average movement velocity (unit: degrees/second). Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Movement-evoked low back pain

  Movement-evoked low back pain (pain during movement) will be scored by patients on an 11-point numerical pain rating scale (0-10; whole-point, with 0 being 'no pain' and 10 'the worst pain you can imagine'), for each spinal motion separately, directly after performing each movement. Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Psychological factors: movement pain-related fear

  Pain-related fear will be assessed for each movement being measured, using an 11-point numerical rating scale (0-10; whole-point), with 0 being 'not harmful at all' and 10 'extremely harmful' (adapted from Photograph Series of Daily Activities-Short Electronic Version; PHODA-SeV). Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Psychological factors: task-specific pain-related fear

  Item four from the Photograph Series of Daily Activities-Short Electronic Version (PHODA-SeV), which shows a person lifting a pot, will be used to assess task-specific pain-related fear. Participants rate their fear on an 11-point numerical rating scale (0-10; whole-point), with 0 being 'not harmful at all' and 10 'extremely harmful'. Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Psychological factors: fear avoidance beliefs related to physical activity

  The physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ) will be used to assess fear avoidance beliefs related to physical activity. Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Psychological factors: pain catastrophizing

  Pain catastrophizing will be assessed using the Daily Pain Catastrophizing Scale (Daily PCS). Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Psychological factors: self-efficacy

  Self-efficacy will be measured using the 2-item short form of the Pain Self-Efficacy Questionnaire (PSEQ-2). Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Psychological factors: stress

  Stress across the last 24 hours will be assessed using the 11-point stress numerical rating scale (0-10, whole-point, with 0 being 'no stress' and 10 being 'worst stress imaginable'). Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Physical activity: heart rate

  Physical activity is measured continuously using a well-established, wrist-worn activity tracker. The first main variable of interest is heart rate (unit: beats per minute). Frequency of measurement: continuously during the 25-week study period.

  Up to 25 weeks from enrollment.

• Physical acitivity: step count

  Physical activity is measured continuously using a well-established, wrist-worn activity tracker. The second main variable of interest is step count (unit: number of steps). Frequency of measurement: continuously during the 25-week study period.

  Up to 25 weeks from enrollment.

• Low back pain intensity

  Average low back pain intensity, in the last 24 hours, will be scored by patients on an 11-point numerical pain rating scale (0-10; whole-point), with 0 being 'no pain' and 10 'the worst pain you can imagine'. Frequency of measurement: daily during the 25-week study period.

  Up to 25 weeks from enrollment.

• Disability: general level of disability (1)

  General level of disability will be rated by patients using an 11-point numerical rating scale (0-10; whole-point, with 0 'not at all', 5 'moderate limitation', 10 'totally limited'). Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Disability: general level of disability (2)

  General level of disability will also be rated by patients using the Roland-Morris Disability Questionnaire (RMDQ). Frequency of measurement: 6-weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

• Disability: lift-specific disability

  The LBP impact on the patient's ability to lift over the past 24 hours will be assessed using one single-item question and rated using an 11-point numeric rating scale (0-10; whole-point, with 0 being 'not al all', 5 'moderate limitation', 10 'totally limited'). Frequency of measurement: weekly during the 25-week study period.

  Up to 25 weeks from enrollment.

Secondary Outcomes (19)

• Patient demographics: sex

  At enrollment

• Patient demographics: gender

  At enrollment

• Patient demographics: occupational status

  At enrollment

• Patient demographics: occupation

  At enrollment

• Patient demographics: work satisfaction

  At enrollment

Study Arms (2)

Acute low back pain

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

Other: Observational

Chronic low back pain

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

Other: Observational

Interventions

Observational OTHER

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

Acute low back pain; Chronic low back pain

Eligibility Criteria

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

Study Population

Patients will be recruited from ambulatory medical, physiotherapy and rehabilitation clinics in northern, central and western Switzerland (cantons: Bern, Zürich, Basel, Aargau, Luzern, Zug, Schwyz, Vaud, Fribourg, Wallis, and Neuchâtel).

You may qualify if:

• have low back pain (rate their LBP with an intensity of \>0 on a 0-10 numerical pain rating scale at enrollment)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bern University of Applied Sciences: lead
• University of Applied Sciences of Western Switzerland: collaborator
• University of Zurich: collaborator
• University of Southern Denmark: collaborator

Related Publications (11)

• Christe G, Benaim C, Jolles BM, Favre J. Changes in spinal motor behaviour are associated with reduction in disability in chronic low back pain: A longitudinal cohort study with 1-year follow-up. Eur J Pain. 2024 Aug;28(7):1116-1126. doi: 10.1002/ejp.2245. Epub 2024 Feb 1.

  PMID: 38299715 BACKGROUND

• Moissenet F, Armand S, Genevay S. Measurement properties of 72 movement biomarkers aiming to discriminate non-specific chronic low back pain patients from an asymptomatic population. Sci Rep. 2023 Apr 20;13(1):6483. doi: 10.1038/s41598-023-33504-5.

  PMID: 37081110 BACKGROUND

• Kongsted A, Kent P, Axen I, Downie AS, Dunn KM. What have we learned from ten years of trajectory research in low back pain? BMC Musculoskelet Disord. 2016 May 21;17:220. doi: 10.1186/s12891-016-1071-2.

  PMID: 27209166 BACKGROUND

• Martinez-Calderon J, Jensen MP, Morales-Asencio JM, Luque-Suarez A. Pain Catastrophizing and Function In Individuals With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Mar;35(3):279-293. doi: 10.1097/AJP.0000000000000676.

  PMID: 30664551 BACKGROUND

• Moissenet F, Rose-Dulcina K, Armand S, Genevay S. A systematic review of movement and muscular activity biomarkers to discriminate non-specific chronic low back pain patients from an asymptomatic population. Sci Rep. 2021 Mar 12;11(1):5850. doi: 10.1038/s41598-021-84034-x.

  PMID: 33712658 BACKGROUND

• Buchbinder R, Underwood M, Hartvigsen J, Maher CG. The Lancet Series call to action to reduce low value care for low back pain: an update. Pain. 2020 Sep;161 Suppl 1(1):S57-S64. doi: 10.1097/j.pain.0000000000001869. No abstract available.

  PMID: 33090740 BACKGROUND

• Wieser, S., Tomonaga, Y., Riguzzi, M., Fischer, B., Telser, H., Pletscher, M., Eichler, K., Trost, M., & Schwenkglenks, M. (2014). Die Kosten der nichtübertragbaren Krankheiten in der Schweiz: Schlussbericht. Zürich Open Repository and Archive. https://doi.org/10.5167/UZH-103453

  BACKGROUND

• Rheumaliga Schweiz. (2020). Rückenreport Schweiz 2020. https://www.rheumaliga.ch/blog/2020/rueckenreport-2020

  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.

  PMID: 29573870 BACKGROUND

• Bundesamt für Statistik. (2023). Schweizerische Gesundheitsbefragung 2022. Übersicht (No. BFS-Nummer 213-2201; S. 1-28). Bundesamt für Statistik. https://www.bfs.admin.ch/asset/de/28465284

  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.

  PMID: 37273833 BACKGROUND

Related Links

• Swiss National Science Foundation - Project page

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Stefan Schmid, Prof. Dr.

CONTACT

+41 31 848 37 96; stefan.schmid@bfh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 16, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol, including the statistical analysis plan, will be published in a scientific journal before the end of the data collection. All other publicly made data will be available indefinitely upon completion of the project.
• Access Criteria: Everyone via OLOS or upon reasonable request.