About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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).
Trial design
Cohort
Prospective
Treatments tested in this trial
Observational
Other interventionThis study is observational of nature: multidimensional data is collected and no interventional is imposed
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Patient demographics: sex
Data on sex (female, male, intersex) will be collected using a questionnaire.
Patient demographics: gender
Data on gender (woman, man, non-binary, a term not listed, I am questioning/not sure) will be collected using a questionnaire.
Patient demographics: occupational status
Data on occupational status will be collected using a questionnaire.
Patient demographics: occupation
Data on current or recent occupation will be collected using a questionnaire.
Sponsors and contacts
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Bern University of Applied Sciences
Lead sponsor
University of Applied Sciences of Western Switzerland
Collaborator
University of Zurich
Collaborator
University of Southern Denmark
Collaborator