Exploring Multidimensional Trajectories in People With Low Back Pain

Bern University of Applied Sciences

Status

Not yet enrolling

Conditions

Chronic Low Back Pain (CLBP)

Acute Low Back Pain

Treatments

Other: Observational

Study type

Observational

Funder types

Other

Identifiers

NCT07176845

2024-01927

220434 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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