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RecruitingNCT07176845Updated Oct 7, 2026

Exploring Multidimensional Trajectories in People With Low Back Pain

An observational study in Acute Low Back Pain and Chronic Low Back Pain (CLBP), sponsored by Bern University of Applied Sciences. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Bern University of Applied Sciences · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Updated Oct 7, 2026Now RecruitingFirst site in Switzerland+2 moreGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 46 studies in Low Back Pain with a site in Switzerland — 8 open to participants now, 8 under way, none of them phase 3. Low Back Pain · Switzerland.

Planned enrollment
Largest of 15
600 · median 105
Started
2025
with 1 other
Observational
15 of 46
1 open now
Registered
45th of 46
by date
Lead sponsor
3 of 46
Bern University of Applied Sciences

Among the 46 studies in Low Back Pain with a site in Switzerland, this one has the largest planned enrollment of the 15 observational ones that give a count, is one of 2 that started in 2025, is one of 15 observational ones, and was the 45th registered.

Low Back Pain

2,923 studies on the registry are indexed under Low Back Pain; 579 are open to participants now.

Browse Low Back Pain studies →

Open to participants now

8 of the 46 studies in Low Back Pain with a site in Switzerland are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 332 Low Back Pain studies recruiting now, 92 (28%) set no upper age limit and 210 (63%) stop at 75 or younger; 8 take children under 18; 46 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

03

Conditions studied

  • Acute Low Back Pain
  • Chronic Low Back Pain (CLBP)

Keywords

  • low back pain
  • LBP
  • spinal motion
  • spine
  • disability
  • motor behavior
  • physical activity
  • pain-related fear
  • psychological factors
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acute low back pain

    Patients with an acute low back pain episode (\<3 months of low back pain upon study enrollment)

    Other: Observational

  • Chronic low back pain

    Patients with chronic low back pain (\>3 months of low back pain upon study enrollment)

    Other: Observational

Interventions

  • OtherObservational

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

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Secondary outcomes

  1. Patient demographics: sex

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

    Time frame: At enrollment

  2. 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

  3. Patient demographics: occupational status

    Data on occupational status will be collected using a questionnaire.

    Time frame: At enrollment

  4. Patient demographics: occupation

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

    Time frame: At enrollment

  5. 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

  6. 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

  7. Patient demographics: highest education

    Data on highest education will be collected using a questionnaire.

    Time frame: At enrollment

  8. Patient anthropometry: body mass

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

    Time frame: At enrollment

  9. Patient anthropometry: height

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

    Time frame: At enrollment

  10. Basic low back pain history: duration

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

    Time frame: At enrollment

  11. 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

  12. Low back pain beliefs

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

    Time frame: At enrollment

  13. 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

  14. Basic medical status: comorbidities

    Data on comorbidities will be collected using a questionnaire

    Time frame: At enrollment

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

07

Study locations

1 of 1 sites recruiting
  • Bern University of Applied Sciences
    Bern, 3008, Switzerland
    Recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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
  • Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21. PubMed 29573870 ↗
  • Bundesamt für Statistik. (2023). Schweizerische Gesundheitsbefragung 2022. Übersicht (No. BFS-Nummer 213-2201; S. 1-28). Bundesamt für Statistik. https://www.bfs.admin.ch/asset/de/28465284
  • GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016/S2665-9913(23)00098-X. eCollection 2023 Jun. PubMed 37273833 ↗

Individual participant data

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, Statistical analysis plan

Time frame: The study protocol, including the statistical analysis plan, will be published in a scientific journal before the end of the data collection. All other publicly made data will be available indefinitely upon completion of the project.

Access criteria: Everyone via OLOS or upon reasonable request.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for May 2028, 31 months after the start.

Of 176 non-industry observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 31 months is above that.

Counting every sponsor, half of 186 studies reached it within 24 months; a quarter within 10 and three quarters within 48.

Start moved once since we started tracking on Sep 25, 2026: Sep 2025 → Oct 2025, on Oct 7, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2025
First posted
Sep 16, 2025
StartActual
Oct 16, 2025was Sep 2025
Primary completionEst.
May 31, 2028
CompletionEst.
May 31, 2028
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 7, 2026
Sites
1 site added — first site in Switzerland
Show site
  • Bern University of Applied Sciences · Bern, Switzerland
Oct 7, 2026
Start date
Sep 15, 2025→Oct 16, 2025 (actual)
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Switzerland
    Show site
    • Bern University of Applied Sciences · Bern, Switzerland
    Start date Sep 15, 2025→Oct 16, 2025 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07176845
Lead sponsor
Bern University of Applied Sciences
Collaborators
University of Applied Sciences of Western Switzerland, University of Zurich, University of Southern Denmark
Responsible party
Stefan Schmid (Prof. Dr., Bern University of Applied Sciences) — Principal investigator
First posted
Sep 16, 2025
Start date
Oct 16, 2025
Primary completion
May 31, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Oct 7, 2026

Study contacts

Stefan Schmid, Prof. Dr.
Contact
stefan.schmid@bfh.ch
+41 31 848 37 96

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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