Acute Low Back PainNCT07176845
Exploring Multidimensional Trajectories in People With Low Back Pain
An observational study of Acute Low Back Pain and Chronic Low Back Pain (CLBP), run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Low Back Pain, Chronic Low Back Pain (CLBP)
- What is being tested?
- Observational
- How many people
- 600 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Oct 2025to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Bern University of Applied Sciences
Bern, 3008
Arlene von Aesch, +41 31 848 69 65, rueckenstudie.gesundheit@bfh.ch
About this study
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.
Read more
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.
- Conditions
- Acute Low Back Pain, Chronic Low Back Pain (CLBP)
- Being tested
- Observational
- Keywords
- low back pain, LBP, spinal motion, spine, disability, motor behavior, physical activity, pain-related fear, psychological factors
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This study is observational of nature: multidimensional data is collected and no interventional is imposed
| Study group | Role | What they receive |
|---|---|---|
| Acute low back pain | Patients with an acute low back pain episode (<3 months of low back pain upon study enrollment) Receives: Other: Observational | |
| Chronic low back pain | Patients with chronic low back pain (>3 months of low back pain upon study enrollment) Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 25 weeks from enrollment.
Secondary outcomes (19)
Patient demographics: sex
Data on sex (female, male, intersex) will be collected using a questionnaire.
Measured: 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.
Measured: At enrollment
Patient demographics: occupational status
Data on occupational status will be collected using a questionnaire.
Measured: At enrollment
Patient demographics: occupation
Data on current or recent occupation will be collected using a questionnaire.
Measured: 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.
Measured: 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.
Measured: At enrollment
Patient demographics: highest education
Data on highest education will be collected using a questionnaire.
Measured: At enrollment
Patient anthropometry: body mass
Patient body mass (unit: kg) will be collected using a questionnaire
Measured: At enrollment
Patient anthropometry: height
Patient height (unit: m) data will be collected using a questionnaire
Measured: At enrollment
Basic low back pain history: duration
Data on duration of low back pain symptoms will be collected using a questionnaire
Measured: 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.
Measured: At enrollment
Low back pain beliefs
Data on low back pain beliefs will be collected using the BackPAQ questionnaire.
Measured: At enrollment
Basic medical status: smoking status
Data on smoking status (yes; no, not anymore; no, never) will be collected using a questionnaire
Measured: At enrollment
Basic medical status: comorbidities
Data on comorbidities will be collected using a questionnaire
Measured: 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'.
Measured: 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'.
Measured: 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').
Measured: At enrollment
Basic medical status: medication and treatment
Data on medication as well as previous and current treatment will be collected using a questionnaire
Measured: 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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start16 Oct 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acute Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, University of Zurich, University of Southern Denmark
- Responsible party
- Principal investigator, Stefan Schmid, Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176845
- Sponsor's protocol ID
- 2024-01927
- Other IDs
- 220434
- Status last verified
- Oct 2026
- First submitted
- 30 Aug 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 38299715Moissenet 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 37081110Kongsted 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 27209166Martinez-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 30664551Moissenet 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 33712658Buchbinder 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 33090740Wieser, 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 29573870Bundesamt 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Multidimensional Trajectories in People With Low Back Pain
- ClinicalTrials.gov ID
- NCT07176845
- Acronym / sponsor ID
- 2024-01927
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, University of Zurich, University of Southern Denmark
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute low back pain | – | Other: ObservationalPatients with an acute low back pain episode (<3 months of low back pain upon study enrollment) |
| Chronic low back pain | – | Other: ObservationalPatients with chronic low back pain (>3 months of low back pain upon study enrollment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThis study is observational of nature: multidimensional data is collected and no interventional is imposed | Other | Acute low back pain, Chronic low back pain |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
19 secondary outcomes
Patient demographics: sex
Time frame: At enrollment
Patient demographics: gender
Time frame: At enrollment
Patient demographics: occupational status
Time frame: At enrollment
Patient demographics: occupation
Time frame: At enrollment
Patient demographics: work satisfaction
Time frame: At enrollment
Patient demographics: work expectation
Time frame: At enrollment
Patient demographics: highest education
Time frame: At enrollment
Patient anthropometry: body mass
Time frame: At enrollment
Patient anthropometry: height
Time frame: At enrollment
Basic low back pain history: duration
Time frame: At enrollment
Basic low back pain history: other
Time frame: At enrollment
Low back pain beliefs
Time frame: At enrollment
Basic medical status: smoking status
Time frame: At enrollment
Basic medical status: comorbidities
Time frame: At enrollment
Basic medical status: anxiety
Time frame: At enrollment
Basic medical status: depression
Time frame: At enrollment
Basic medical status: stress
Time frame: At enrollment
Basic medical status: medication and treatment
Time frame: At enrollment
Basic medical status: neuropathic pain
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 38299715Christe 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.
- Background: PubMed 37081110Moissenet 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.
- Background: PubMed 27209166Kongsted 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.
- Background: PubMed 30664551Martinez-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.
- Background: PubMed 33712658Moissenet 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.
- Background: PubMed 33090740Buchbinder 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.
- BackgroundWieser, 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
- BackgroundRheumaliga Schweiz. (2020). Rückenreport Schweiz 2020. https://www.rheumaliga.ch/blog/2020/rueckenreport-2020
- Background: PubMed 29573870Hartvigsen 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.
- BackgroundBundesamt 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
- Background: PubMed 37273833GBD 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.
- Swiss National Science Foundation - Project pageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Low Back Pain and Chronic Low Back Pain (CLBP), run by Bern University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Schmid, Prof. Dr. (+41 31 848 37 96, stefan.schmid@bfh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal motion: maximum movement amplitude (time frame: Up to 25 weeks from enrollment.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07176845, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.