An observational study in Acute Low Back Pain and Chronic Low Back Pain (CLBP), sponsored by Bern University of Applied Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Bern University of Applied Sciences · Observational
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.
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).
Exclusion Criteria:
Patients with an acute low back pain episode (\<3 months of low back pain upon study enrollment)
Other: Observational
Patients with chronic low back pain (\>3 months of low back pain upon study enrollment)
Other: Observational
This study is observational of nature: multidimensional data is collected and no interventional is imposed
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 25 weeks from enrollment.
Patient demographics: sex
Data on sex (female, male, intersex) will be collected using a questionnaire.
Time frame: At enrollment
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.
Time frame: At enrollment
Patient demographics: occupational status
Data on occupational status will be collected using a questionnaire.
Time frame: At enrollment
Patient demographics: occupation
Data on current or recent occupation will be collected using a questionnaire.
Time frame: At enrollment
Patient demographics: work satisfaction
Data on work satisfaction (very unsatisfied; unsatisfied; neutral; satisfied; very satisfied; this is not relevant to me) will be collected using a questionnaire.
Time frame: At enrollment
Patient demographics: work expectation
Data on work expectation ('I think I will be able to do my regular job, without any restrictions, 4 weeks from now' and 'I think I will be able to do my regular job, without any restrictions, 3 months from now'; on a 7-point scale, 0-6 with 0 being 'unlikely' and 6 'definitely') will be collected using a questionnaire.
Time frame: At enrollment
Patient demographics: highest education
Data on highest education will be collected using a questionnaire.
Time frame: At enrollment
Patient anthropometry: body mass
Patient body mass (unit: kg) will be collected using a questionnaire
Time frame: At enrollment
Patient anthropometry: height
Patient height (unit: m) data will be collected using a questionnaire
Time frame: At enrollment
Basic low back pain history: duration
Data on duration of low back pain symptoms will be collected using a questionnaire
Time frame: At enrollment
Basic low back pain history: other
Data on location and previous episodes of low back pain symptoms, and other diagnoses or previous surgeries will be collected using a questionnaire.
Time frame: At enrollment
Low back pain beliefs
Data on low back pain beliefs will be collected using the BackPAQ questionnaire.
Time frame: At enrollment
Basic medical status: smoking status
Data on smoking status (yes; no, not anymore; no, never) will be collected using a questionnaire
Time frame: At enrollment
Basic medical status: comorbidities
Data on comorbidities will be collected using a questionnaire
Time frame: At enrollment
Basic medical status: anxiety
Data on anxiety will be collected using a questionnaire on an 11-point scale (0-10, whole-point) numerical rating scale, with 0 being 'not at all' and 10 'quite anxious'.
Time frame: At enrollment
Basic medical status: depression
Data on depression will be collected using a questionnaire on an 11-scale (0-10, whole-point) numerical rating scale, with 0 being 'never' and 10 'all the time'.
Time frame: At enrollment
Basic medical status: stress
Data on stress will be collected using the perceived stress scale 4 questionnaire, with for each of the four questions a 5-point scale (0-4, whole-point, with 0 being 'never' and 4 'very often').
Time frame: At enrollment
Basic medical status: medication and treatment
Data on medication as well as previous and current treatment will be collected using a questionnaire
Time frame: At enrollment
Basic medical status: neuropathic pain
Data on neuropathic pain symptoms will be collected using the first two questions of neuropathic pain diagnosis questionnaire (DN4). For both questions, participants select symptoms from a list, with each selected symptom scored as +1, with a total score of larger than or equal to 3 indicating neuropathic pain.
Time frame: At enrollment
No study locations are listed for this record.
Plan to share: Yes — Data will be stored in a private repository during the project and, upon its completion, will be made publicly available on the Swiss-based data management portal OLOS under a CC0 license. OLOS was chosen because it supports the FAIR principles and offers robust long-term preservation features. Data not publicly released on OLOS will be accessible upon reasonable request.
Supporting information: Study protocol, Sap
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Bern University of Applied Sciences