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NCT Number: NCT07176845

Exploring Multidimensional Trajectories in People With Low Back Pain

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.

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Key information

Conditions

Acute Low Back Pain Back Pain Behavior Chronic Low Back Pain (CLBP) Low Back Pain Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

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

Primary outcomes

  1. Spinal motion: maximum movement amplitude

    Time frame: Up to 25 weeks from enrollment.

    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.

  2. Spinal motion: maximum/average movement velocity

    Time frame: Up to 25 weeks from enrollment.

    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.

  3. Movement-evoked low back pain

    Time frame: Up to 25 weeks from enrollment.

    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.

  4. Psychological factors: movement pain-related fear

    Time frame: Up to 25 weeks from enrollment.

    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.

  5. Psychological factors: task-specific pain-related fear

    Time frame: Up to 25 weeks from enrollment.

    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.

  6. Psychological factors: fear avoidance beliefs related to physical activity

    Time frame: Up to 25 weeks from enrollment.

    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.

  7. Psychological factors: pain catastrophizing

    Time frame: Up to 25 weeks from enrollment.

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

  8. Psychological factors: self-efficacy

    Time frame: Up to 25 weeks from enrollment.

    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.

  9. Psychological factors: stress

    Time frame: Up to 25 weeks from enrollment.

    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.

  10. Physical activity: heart rate

    Time frame: Up to 25 weeks from enrollment.

    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.

  11. Physical acitivity: step count

    Time frame: Up to 25 weeks from enrollment.

    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.

  12. Low back pain intensity

    Time frame: Up to 25 weeks from enrollment.

    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.

  13. Disability: general level of disability (1)

    Time frame: Up to 25 weeks from enrollment.

    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.

  14. Disability: general level of disability (2)

    Time frame: Up to 25 weeks from enrollment.

    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.

  15. Disability: lift-specific disability

    Time frame: Up to 25 weeks from enrollment.

    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.

Secondary outcomes

  1. Patient demographics: sex

    Time frame: At enrollment

    Data on sex (female, male, intersex) will be collected using a questionnaire.

  2. Patient demographics: gender

    Time frame: At enrollment

    Data on gender (woman, man, non-binary, a term not listed, I am questioning/not sure) will be collected using a questionnaire.

  3. Patient demographics: occupational status

    Time frame: At enrollment

    Data on occupational status will be collected using a questionnaire.

  4. Patient demographics: occupation

    Time frame: At enrollment

    Data on current or recent occupation will be collected using a questionnaire.

  5. Patient demographics: work satisfaction

    Time frame: At enrollment

    Data on work satisfaction (very unsatisfied; unsatisfied; neutral; satisfied; very satisfied; this is not relevant to me) will be collected using a questionnaire.

  6. Patient demographics: work expectation

    Time frame: At enrollment

    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.

  7. Patient demographics: highest education

    Time frame: At enrollment

    Data on highest education will be collected using a questionnaire.

  8. Patient anthropometry: body mass

    Time frame: At enrollment

    Patient body mass (unit: kg) will be collected using a questionnaire

  9. Patient anthropometry: height

    Time frame: At enrollment

    Patient height (unit: m) data will be collected using a questionnaire

  10. Basic low back pain history: duration

    Time frame: At enrollment

    Data on duration of low back pain symptoms will be collected using a questionnaire

  11. Basic low back pain history: other

    Time frame: At enrollment

    Data on location and previous episodes of low back pain symptoms, and other diagnoses or previous surgeries will be collected using a questionnaire.

  12. Low back pain beliefs

    Time frame: At enrollment

    Data on low back pain beliefs will be collected using the BackPAQ questionnaire.

  13. Basic medical status: smoking status

    Time frame: At enrollment

    Data on smoking status (yes; no, not anymore; no, never) will be collected using a questionnaire

  14. Basic medical status: comorbidities

    Time frame: At enrollment

    Data on comorbidities will be collected using a questionnaire

  15. Basic medical status: anxiety

    Time frame: At enrollment

    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'.

  16. Basic medical status: depression

    Time frame: At enrollment

    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'.

  17. Basic medical status: stress

    Time frame: At enrollment

    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').

  18. Basic medical status: medication and treatment

    Time frame: At enrollment

    Data on medication as well as previous and current treatment will be collected using a questionnaire

  19. Basic medical status: neuropathic pain

    Time frame: At enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Schmid, Prof. Dr.

CONTACT

[email protected]

+41 31 848 37 96

Sponsors and collaborators

Lead sponsor

Bern University of Applied Sciences

Other

Collaborators

  • University of Applied Sciences of Western Switzerland
  • University of Southern Denmark
  • University of Zurich

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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