Exploring Multidimensional Trajectories in People With Low Back Pain

Overview

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.

Interventions

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

Primary outcome measures

• Spinal motion: maximum movement amplitude [Time frame: Up to 25 weeks from enrollment.]
• Spinal motion: maximum/average movement velocity [Time frame: Up to 25 weeks from enrollment.]
• Movement-evoked low back pain [Time frame: Up to 25 weeks from enrollment.]
• Psychological factors: movement pain-related fear [Time frame: Up to 25 weeks from enrollment.]
• Psychological factors: task-specific pain-related fear [Time frame: Up to 25 weeks from enrollment.]
• Psychological factors: fear avoidance beliefs related to physical activity [Time frame: Up to 25 weeks from enrollment.]
• Psychological factors: pain catastrophizing [Time frame: Up to 25 weeks from enrollment.]
• Psychological factors: self-efficacy [Time frame: Up to 25 weeks from enrollment.]
• Psychological factors: stress [Time frame: Up to 25 weeks from enrollment.]
• Physical activity: heart rate [Time frame: Up to 25 weeks from enrollment.]

Secondary outcome measures (12)

• Patient demographics: sex [Time frame: At enrollment]
• Patient demographics: gender [Time frame: At enrollment]
• Patient demographics: occupational status [Time frame: At enrollment]
• Patient demographics: occupation [Time frame: At enrollment]
• Patient demographics: work satisfaction [Time frame: At enrollment]
• Patient demographics: work expectation [Time frame: At enrollment]
• Patient demographics: highest education [Time frame: At enrollment]
• Patient anthropometry: body mass [Time frame: At enrollment]
• Patient anthropometry: height [Time frame: At enrollment]
• Basic low back pain history: duration [Time frame: At enrollment]
• Basic low back pain history: other [Time frame: At enrollment]
• Low back pain beliefs [Time frame: At enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

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

Identifiers

NCT: NCT07176845 · 2024-01927 · 220434

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗